Your SlideShare is downloading. ×
Poster Abstracts
American Academy of Dermatology
66th Annual Meeting
February 1–5, 2008
San Antonio, Texas
Supported by
Ab...
Poster Exhibit Task Force
Mission Statement: The Poster Exhibit Task Force enhances the educational
value of the annual Ac...
Poster Abstracts
American Academy of Dermatology
66th Annual Meeting
February 1-5, 2008
San Antonio, Texas
Supported by
Ab...
Copyright Ó 2008 by the American Academy of Dermatology, Inc.
Editor
Jeffrey D. Bernhard, MD
Deputy Editors
Thomas G. Crop...
Dermatopharmacology/Cosmeceuticals AB62
Digital/Electronic Technology AB73
Education and Community Service AB73
Epidemiolo...
POSTER DISCUSSION SESSION 491—ACNE
P101
Heat-killed Propionibacterium acnes are capable of inducing inflamma-
tory respons...
P106
An open study comparing efficacy of 5% sodium L-ascorbyl-2- phosphate
lotion with 1% clindamycin gel in the treatment ...
P2630
Sustained long-term remission of chronic plaque psoriasis upon treat-
ment with multiple courses of alefacept
Janet ...
P2606
Sustained clinical efficacy and safety of adalimumab in patients with
moderate to severe psoriatic arthritis (PsA): 2...
POSTER DISCUSSION SESSION 493—PSORIASIS II
P1205
Potential misclassification of psoriasis patients in electronic databases
...
P2619
Depression and psoriasis: An epidemiologic study representing over 4.7
million patient visits for psoriasis
Madhulik...
POSTER DISCUSSION SESSION 494—PEDIATRIC
DERMATOLOGY
P100
Premature epiphyseal closure in pediatric patients on isotretinoi...
P1300
Pigmentary mosaicism of the penis—Correlation of embryology and
patterns of birthmark development on the penis
Nanet...
POSTER DISCUSSION SESSION 495—MEDICAL
DERMATOLOGY
P400
Successful treatment of the erythema and flushing of rosacea using a...
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
DERMATOLOGY
Upcoming SlideShare
Loading in...5
×

DERMATOLOGY

669

Published on

0 Comments
1 Like
Statistics
Notes
  • Be the first to comment

No Downloads
Views
Total Views
669
On Slideshare
0
From Embeds
0
Number of Embeds
0
Actions
Shares
0
Downloads
13
Comments
0
Likes
1
Embeds 0
No embeds

No notes for slide

Transcript of "DERMATOLOGY"

  1. 1. Poster Abstracts American Academy of Dermatology 66th Annual Meeting February 1–5, 2008 San Antonio, Texas Supported by Abbott Immunology Journal of the American Academy of DERMATOLOGYFEBRUARY 2008 • Volume 58 • Number 2 supplement to
  2. 2. Poster Exhibit Task Force Mission Statement: The Poster Exhibit Task Force enhances the educational value of the annual Academy meeting by organizing poster exhibits. These poster exhibits are solicited, reviewed, and approved by a peer review Task Force. The Task Force develops guidelines and monitors posters for quality educational content. Task Force Members: Theodore Rosen, MD, FAAD, Chair Khalid Mohd Al Aboud, MD Brian Berman, MD, PhD, FAAD Nicole V. Brey, MD Peter G. Ehrnstrom, MD, FAAD Carlos A. Garcia, MD Timothy F. Kelly, MD, FAAD Eve Judith Lowenstein, MD, PhD, FAAD Barbara M. Mathes, MD, FAAD William D. Posten, MD, FAAD Julie V. Schaffer, MD, FAAD Kenneth J. Tomecki, MD, FAAD Youwen Zhou, MD, FAAD 2009 Annual Meeting Program Submissions Visit http://www.aad.org for information regarding program participation for the 67th Annual Meeting, March 6-10, 2009 in San Francisco, California. FEBRUARY 2008 VOLUME 58 NUMBER 2 SUPPLEMENT TO JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
  3. 3. Poster Abstracts American Academy of Dermatology 66th Annual Meeting February 1-5, 2008 San Antonio, Texas Supported by Abbott Immunology FEBRUARY 2008 VOLUME 58 NUMBER 2 SUPPLEMENT TO JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
  4. 4. Copyright Ó 2008 by the American Academy of Dermatology, Inc. Editor Jeffrey D. Bernhard, MD Deputy Editors Thomas G. Cropley, MD Karen Wiss, MD Editorial Office University of Massachusetts Medical School 55 Lake Avenue North Worcester, MA 01655 508-856-2583 E-mail: melissa.derby@ umassmed.edu Associate Editors Ponciano D. Cruz, Jr, MD Dallas, Texas John J. DiGiovanna, MD Providence, Rhode Island Jane Grant-Kels, MD Farmington, Connecticut Nathaniel Jellinek, MD Providence, Rhode Island Timothy M. Johnson, MD Ann Arbor, Michigan Marta J. Petersen, MD Salt Lake City, Utah David S. Rubenstein, MD, PhD Chapel Hill, North Carolina Martin A. Weinstock, MD, PhD Providence, Rhode Island Statistical Consultant Suddhasatta Acharyya, PhD Providence, Rhode Island Assistant Editors Leah Belazarian, MD Worcester, Massachusetts Michael E. Bigby, MD Boston, Massachusetts Jean L. Bolognia, MD New Haven, Connecticut Luis A. Diaz, MD Chapel Hill, North Carolina Mark Lebwohl, MD New York, New York Donald J. Miech, MD Marshfield, Wisconsin Ginat W. Mirowski, DMD, MD Indianapolis, Indiana Scott A. Norton, MD Bethesda, Maryland Elise Olsen, MD Durham, North Carolina Jeffrey Orringer, MD Ann Arbor, Michigan Amy S. Paller, MD Chicago, Illinois Founding Editor J. Graham Smith, Jr, MD Mobile, Alabama Editor Emeritus Richard L. Dobson, MD Charleston, South Carolina POSTER DISCUSSION SESSIONS Supported by Abbott Immunology PDS 491—Acne AB1 PDS 492—Psoriasis I AB3 PDS 493—Psoriasis II AB5 PDS 494—Pediatric Dermatology AB7 PDS 495—Medical Dermatology AB9 PDS 496—Mycology AB11 Acne AB13 Aging/Geriatrics AB19 Basic Science AB27 Clinical Dermatology and Other Cutaneous Diseases AB32 Connective Tissue Disease AB45 Dermatitis, Atopic AB48 Dermatitis, Contact and Allergic Irritant AB54 Dermatopathology AB58 Continued on page 10A February 2008 VOLUME 58 NUMBER 2 SUPPLEMENT TO JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY The opinions or views expressed in this professional educational supplement are those of the author(s) and not necessarily those of the Editor(s), publisher, sponsor, or Academy, and the Editor(s) publisher, sponsor, and Academy disclaim any responsibility or liability for such material. Neither the Editor(s), publisher, nor the Academy guarantees, warrants, or endorses any product or service advertised in this publication, nor do they guarantee any claim made by the manufacturer of such product or service. Dosages, indications, and methods of use for products that are referred to in the supplement by the authors may reflect their clinical experience or may be derived from the professional literature or other clinical sources. Because of the differences between in vitro and in vivo systems and between laboratory animal models and clinical data in humans, in vitro and animal data may not necessarily correlate with clinical results. Future citation agreement/How to cite abstracts from this supplement: Author(s) agree(s) that citations to poster abstracts published in the Journal of the American Academy of Dermatology will adhere to the format of the examples given below, which clearly indicate that the cited item has been published in abstract form. Authors. Title of abstract (abstract). J Am Acad Dermatol 2008;58:AB page number. Abstract number. Munavalli G. Rapid acne regression using photopneumatic therapy (abstract). J Am Acad Dermatol 2008;58:AB1. Abstract P102. 9A
  5. 5. Dermatopharmacology/Cosmeceuticals AB62 Digital/Electronic Technology AB73 Education and Community Service AB73 Epidemiology and Health Services Administration AB76 Genodermatoses AB79 Hair and Nail Disorders AB81 Immunodermatology and Blistering Disorders AB84 Infection (Bacterial) AB86 Infection (Fungal) AB90 Infection (Viral) AB92 Internal Medicine Dermatology AB96 Lymphoma, Cutaneous/Mycosis Fungoides AB100 Melanoma and Pigmented Lesions AB102 Nonmelanoma Skin Cancer AB104 Pediatric Dermatology AB107 Photobiology, Phototherapy, and Photosensitivity Diseases AB110 Pigmentary Disorders and Vitiligo AB115 Psoriasis and Other Papulosquamous Disorders AB119 Skin Anatomy, Embryology, and Physiology AB135 Surgery (Cosmetic) AB135 Surgery (Dermatologic) AB138 Surgery (Laser) AB139 Wound Healing and Ulcers AB142 Author Disclosures AB146 Author Index AB166 Subject Index AB173 Contents continued 10A FEBRUARY 2008 J AM ACAD DERMATOL
  6. 6. POSTER DISCUSSION SESSION 491—ACNE P101 Heat-killed Propionibacterium acnes are capable of inducing inflamma- tory responses Peter Lyte, Johnson & Johnson, Skillman, NJ, United States; Marion Barry, Johnson & Johnson, Skillman, NJ, United States; Olivia Linton, Johnson & Johnson, Skillman, NJ, United States; Jue-Chen Liu, Johnson & Johnson, Skillman, NJ, United States Acne vulgaris is a common multifactorial disorder of the pilosebaceous follicles, involving sebaceous hyperplasia, follicular hyperkeratinization, bacterial infection, and immune hypersensitivity. Part of the inflammation seen in acne is the result of the host response to Propionibacterium acnes. P acnes responses appear to be mediated by the activation of Toll receptors found on numerous cell types within the skin. Many current treatments for acne have focused on heating the bacteria within acne lesions, presumably to induce a bactericidal process. However, it appears that although heat treatment is sufficient to reduce bacteria, it is unclear to what extent the technique is effective as a means of reducing the appearance of acne. Indeed, studies of other Gram-positive bacteria have demonstrated that cellular membrane components of dead bacteria can still trigger an inflammatory reaction. Therefore, we sought to determine whether heat treatment would affect P acnes viability and subsequently determine whether heat-treated P acnes could induce an inflamma- tory response. We found that direct heat treatment of P acnes bacteria cultures resulted in a temperature-dependent decrease in P acnes viability. Treatment of P acnes bacteria cultures with temperatures ranging from 508C to 708C reduced viability by 22% and 93%, respectively. We next examined the effect of heat-treated P acnes on macrophages and primary cultures of human keratinocytes. Inoculating macrophages with live P acnes resulted in a significant release of nitric oxide. Heat treatment of P acnes before inoculation did not decrease the amount of released nitric oxide as compared to live P acnes. In a similar manner, co-culturing human keratinocytes with live P acnes resulted in an increased release of proinflammatory cytokines, interleukin (IL)-8, and IL-1RA. However, treating human keratinocytes with heat-compromised P acnes did not correlate with a similar reduction in the release of proinflammatory cytokines. Treating Pacnes bacteria cultures up to 708C, which reduced P acnes viability by more than 90%, only resulted in a 21% and 57% decrease in IL-1RA and IL-8 cytokine release, respectively, suggesting that heat-killed P acnes are still capable of inducing significant inflammatory responses in skin. Taken together, these results indicate that heat is not an effective treatment for reducing P acneseinduced inflammation. 100% is sponsored by Johnson & Johnson. P102 Rapid acne regression using photopneumatic therapy Girish Munavalli, MD, MHS, Dermatology, Laser, and Vein Institute of the Carolinas, Charlotte, NC, United States Background: A multicenter study was performed to evaluate the safety and efficacy of an FDA-approved, vacuum-assisted pulsed light device in the treatment of active acne. Study design and materials: 15 subjects with Fitzpatrick skin types I to IV with comedonal, inflammatory papulo-pustular, or nodulocystic acne were treated with a series of 4 full-face treatments, performed at 1 to 4 week intervals. Treatment protocols employed multiple passes (2-4) with varying levels of vacuum and fluence with evaporative cooling. No treatment lasted more than 20 minutes. Standardized clinical photography was obtained at baseline, before each treatment, and 1 month following the final treatment. Acne severity was graded on a standardized scale, and blinded physician photographic assessment was performed. Results: Reduction of acne lesions began after 2 treatments. Overall reduction of acne activity included: cystic papules 65%, pustules 70%, and comedones 70% reduction. Reduction in facial oiliness was also reported. Pain was judged as minimal by immediate posttreatment survey. No blistering or pigmentation changes were observed. Conclusions: Rapid regression of active acne was observed following short treatment times with this relatively painless, novel pulsed light and vacuum device. 50% sponsored by Aesthera. P109 Early signs and frequency of inflammatory lesions—Can we predict the next pimple? Theresa Chen, PhD, Neutrogena Corporation, Los Angeles, CA, United States; Yohini Appa, PhD, Neutrogena Corporation, Los Angeles, CA, United States Acne consists of both noninflammatory lesions and inflammatory lesions. But an acne sufferer is much more concerned about the latter. Moreover, for a person with acne prone skin, the biggest frustration is not knowing where the next pimple will surface. However, noninflammatory lesions (ie, closed comedones and open comedones) have been known to transform into inflammatory lesions. It has also been suggested that closed comedones are more likely to transform into inflamma- tory lesions than open comedones. At the same time, clinical observations suggest that inflammatory lesions can also appear de novo. Combining a specially developed image analysis software with a multi-modal imaging system that can visualize subsurface acne (ie, not yet visible on the skin surface) and a hyperspectral imaging system that uses discrete spectral bands to identify and measure specific chromaphores (oxy-hemoglobin, deoxy-hemoglobin, and melanin) in the skin, we have tracked the pleomorphic progression of acne lesions from follicular plugs to microcomedones to comedones to full-fledged inflammatory lesions on study subjects. The image analysis results show that more inflammatory lesions arise out of closed comedones than open comedones, but some also arise de novo. Furthermore, our evaluations reveal subsurface signs that may indicate predisposi- tion of a microcomedone or a comedone to become an inflammatory lesion. 100% sponsored by Neutrogena Corporation. P105 Detection of TNF-a in inflammatory and noninflammatory acneiform lesions Brian Berman, MD, PhD, University of Miami, Miami, FL, United States; Oliver Perez, MD, University of Miami, Miami, FL, United States; Ran Huo, University of Miami, Miami, FL, United States; Martha Viera, MD, University of Miami, Miami, FL, United States Background: Acneiform lesions can be noninflammatory or inflammatory. Tissue necrosis factor-alpha (TNF-a) is a pivotal cytokine involved in inflammation. Studies have shown increased in vitro production of TNF-a by macrophages and keratino- cytes after stimulation by Propionibacterium acnes. However, in vivo studies have not been performed to determine TNF-a concentrations in inflammatory and noninflammatory acneiform lesions and the possible effect of concomitant sulfamethoxazole/trimethoprim (SMX/TMP) therapy on TNF-a concentrations. Purpose: To detect levels of TNF-a in clinically inflammatory and noninflammatory acneiform lesions and possible effect of concomitant SMX/TMP therapy on TNF-a concentrations. Materials and methods: After informed consent was obtained, samples from 19 acneiform lesions from the face of 6 subjects were collected and characterized during office visits. Each sample was weighed, normalized to 600 mg of acneiform material per mL, and analyzed by enzyme-linked immunosorbent assay to determine the concentration of TNF-a. Results: Noninflammatory acneiform lesions (n ¼ 3) from subjects who were not receiving SMX/TMP therapy had a mean TNF-a concentration of 0.55 pg/mL, while inflammatory lesions (n ¼ 9) from the same subjects had a mean TNF-a concen- tration of 1.80 pg/mL (P ¼.59). Noninflammatory acneiform lesions (n ¼ 2) from patients who were receiving SMX/TMP therapy had a mean TNF-a concentration of 8.36 pg/mL, while inflammatory lesions (n ¼ 5) from the same subjects were nonstatistically significantly lower (P ¼.12) at 1.16 pg/mL. Conclusions: TNF-a was detected in clinically inflammatory and noninflammatory acneiform lesions. It appears that treatment with SMX/TMP subjects failed to significantly reduce TNF-a levels below that in untreated subjects. In light of SMX/TMP being solely an antibiotic, future studies are needed to determine whether other classes of antibiotics possessing antiinflammatory activities (macrolides, tetracyclines) are able to reduce TNF-a concentrations in acneiform lesions. Supported in part by research sponsorship by Collagenex. FEBRUARY 2008 J AM ACAD DERMATOL AB1
  7. 7. P106 An open study comparing efficacy of 5% sodium L-ascorbyl-2- phosphate lotion with 1% clindamycin gel in the treatment of facial acne vulgaris Hiroshi Ikeno, MD, Ikeno Clinic, Tokyo, Japan; Takeshi Nishikawa, MD, PhD, Medicine and Nursing Hokkaido University of Education, Hokkaido, Japan Background: We reported the efficacy of 5% sodium L-ascorbyl-2-phosphate lotion (5% APS) in the treatment of acne achieved by an open comparative study at the 2004, 2006, and 2007 American Academy of Dermatology meetings. APS is a stable vitamin C derivative that is esterified by phosphate at the second ascorbic acid position. It is absorbed in the skin, transformed enzymatically to vitamin C at the cell membrane, and continuously taken up to the cytoplasm. Miwa et al also reported that APS strongly and actively scavenges active oxygen species. This time, we studied the clinical efficacy of 5% APS lotion, compared with 1% clindamycin (1% CL) gel, which is widely prescribed in Asia, for the treatment of facial acne vulgaris. Methods: In a randomized, multicenter, open label, parallel study, 40 patients were divided and assigned to receive 5% APS lotion (n ¼ 20), or 1%CL gel (n ¼ 20) with twice daily treatment. Efficacy was assessed in 5 grades at the beginning and at 4, 8, and 12 weeks of treatment based on digital CCD microscopic device, which can capture both clinical digital photographs and microscopic images by the blinded investigator. Patients were instructed to refrain from receiving treatment, which has some possibility to have an effect on acne lesions, such as administration of antibiotics, pill and sex hormone, metronidazole, other retinoids, and so on for 4 weeks before enrollment in the study. Results: The number of patients who complied with the treatment protocol was 19 on 5% APS lotion and 18 on 1% CL gel. The number of patients who were evaluated as good and excellent was 15 on 5% APS lotion and 7 on 1% CL gel. Both agents were well tolerated. Conclusion: Efficacy rate for APS and CL was 78.9% and 38.9%, respectively. The efficacy of 5% APS lotion was superior to that of 1% CL gel, which is widely prescribed in Asia for the treatment of acne vulgaris. It can be concluded that 5% APS lotion is more effective than 1% CL gel in the treatment of facial acne vulgaris. Commercial support: None identified. P107 Is combination of ultrapulsed CO2 laser and medication therapy better than medication alone in patients with moderate acne vulgaris? Waewsiri Sappachang, MD, Bangkok, Thailand; Suthep Jerasutus, MD, Rajdhevee Dermatology Clinic, Phrae, Thailand Background: The ultrapulsed CO2 laser can precisely vaporize the covered skin of comedones and inflammatory acnes, enabling the portal drainage of acne content and may rapidly alleviate acne lesions. Objective: Our aim was to compare the efficacy and safety of the combination of ultrapulsed CO2 laser and medication (doxycycline and 5% benzoyl peroxide) with medication alone in the treatment of moderate acne vulgaris. Methods: A prospective 8-week study evaluated the changes in inflammatory and noninflammatory lesion counts from baseline and Investigator’s Static Global Assessment in 50 subjects. Subjective evaluations of response to treatment were assessed. Results: The combination demonstrated superior efficacy to medication alone, especially in the first 4 weeks. Combination with ultrapulsed CO2 laser was significantly more effective in reducing inflammatory, noninflammatory and total lesion counts (P.000) than treatment with medication alone. In addition, the time taken to achieve a 50% reduction in total lesion counts was 3 weeks in the combination group which was significantly shorter when compared to the medi- cation group ([8 weeks; P.000). No pigmentary alteration, scarring, or infection was observed. The Investigator’s Static Global Assessment and subjective satisfac- tions were much greater with the combination group. Conclusion: The combination of ultrapulsed CO2 laser and medication was safe, well tolerated, and significantly more effective than medication alone for the treatment of moderate acne vulgaris. Commercial support: None identified. P909 Topical AHA-emulsions efficacy and tolerance in a series of 81 acne patients Marius Anton Ionescu, MD, PhD, Saint-Louis Hospital, Polyclinique Dermatologie, Paris, France; Anne-Marie Matta, PhD, Laboratoires Dermatologiques d’Uriage, Courbevoie, France; Florence Poli, MD, Henry Mondor Hospital, Creteil, France; Agnes Gougerot, MD, Laboratoires Dermatologiques d’Uriage, Courbevoie, France Purpose: To assess the efficacy of two alpha-hidroxy-acid (AHA) formulations in acne patients. Methods: Two emulsions were assessed in this double-blind study: Emulsion A (AHA- arginine complex associated with retinol ester) and emulsion B (regular AHA and vitamin A derivate). Two groups of randomized subjects were studied; each group tested one emulsion (applied twice/day during 8 weeks). The study included adult patients with light to moderate acne (ECLA scale): retentional lesions score FIR3 and superficial inflammatory lesions score FIIs 2. Assessments were made at baseline, week 4, and week 8, evaluating the number of retentional and inflamma- tory lesions. Global efficacy was assessed at weeks 4 and 8. Results: Group A: n ¼ 42; sex ratio female to male: 4.2; mean age, 21.6 years; mean baseline lesions, retentional, 14.7; inflammatory, 3.9. Group B: n ¼ 39; sex ratio female to male, 4.5; mean age, 21.9 years; mean baseline lesions, retentional, 14.5; inflammatory, 3.4. The retentional lesions outcome showed a faster decrease in group A at week 4 and a significant decrease at week 8 for both groups (P.05). The superficial inflammatory lesion outcome showed significant lesion decrease at week 8 only for group A (P .05). Global efficacy for emulsion A group: 50% of cases improved at week 4 and 60% at week 8; for group B: 52.6% of cases were improved at week 4 and 54.3% at week 8. Emulsion A tolerance was excellent in 88.1% of cases at week 4 and 90.2% at week 8; for emulsion B: 75.6% (week 4) and 89.5% (week 8). Conclusions: Both AHA emulsions significantly improved retentional and inflam- matory acne lesions, with a better skin tolerance and faster efficacy for emulsion A (AHAearginine complex). Supported by Laboratoires Dermatologiques d’Uriage. P900 Isotretinoin, self-injury, and suicide: A negative association in data representing over 9.6 million patient visits involving isotretinoin use Madhulika Gupta, MD, University of Western Ontario, London, ON, Canada; Aditya Kumar Gupta, MD, PhD, University of Toronto, Department of Medicine, London, ON, Canada Background: Isotretinoin has been associated with a wide range of psychiatric reactions including suicide. Reports of self-injury and suicide in patients using isotretinoin mainly involve small case series; larger studies, including some epide- miologic studies, have failed to demonstrate a significant association between isotretinoin use and suicide. Objective: We investigated the comorbidity between isotretinoin and suicide, in the data (collected between 1993-2003) from the National Ambulatory Medical Care Survey (NAMCS) and National Hospital Ambulatory Medical Care Survey (NHAMCS), which are both nationally representative samples of patient visits in the United States. Methods: An ‘‘isotretinoin’’ variable was created if any of the medications reported for the visit included isotretinoin. A ‘‘suicide’’ variable was created for if any items under ‘‘suicide and self- inflicted injury’’ were endorsed for the visit (using ICD-9-CM codes E950-E959). For the determination of ‘‘concurrent validity’’ of our method, variables were created for ‘‘fluoxetine’’ (which is used for the treatment of depression and would be expected to be associated with suicide) and ‘‘narcan’’ (which one would expect to be used in cases of suicide attempts with narcotic overdose). All analyses were carried out using the complex samples module of SPSS v. 15, which accounts for the multi-stage probability sampling design used to collect the data. Results: There were 521 patient visits involving isotretinoin use (representingmore than 9.6 million weighted visits); there were 1176 patient visits associated with ‘‘suicide and self-inflicted injury’’ (representing more than 4.2 million weighted visits). There were 5939 visits involving fluoxetine use (more than 79 million weighted visits) and 360 visits associated with narcan use (more than 1.2 million weighted visits). No isotretinion-related visits were associated with the ‘‘suicide’’ variable. There was a significant association between ‘‘fluoxetine’’ (odds ratio [OR] ¼ 2.5; 95% CI, 1.36-4.7) and ‘‘narcan’’ (OR ¼ 417.9; 95% CI, 257.8-677.4) and ‘‘suicide.’’ Conclusion: Our findings indicate that none of the patient visits involving isotret- inoin use was associated with suicide or self-injury. However, there was a significant OR of 2.5 for ‘‘suicide’’ in visits involving the use of the antidepressant fluoxetine, as one would expect the depressed patient population to also be at a higher risk for suicide; the much higher OR of 417.9 in visits involving narcan use is also entirely consistent with the fact that many cases of narcan would be used for suicide attempts with narcotic overdose. Therefore, the findings with fluoxetine and narcan support the ‘‘concurrent validity’’ for our method. The lack of an association between isotretinoin and ‘‘suicide’’ in this large database (representing 10 years of patient visits) further suggests that suicidal behavior with isotretinoin represents an uncommon idiosyncratic phenomenon. Commercial support: None identified. AB2 J AM ACAD DERMATOL FEBRUARY 2008
  8. 8. P2630 Sustained long-term remission of chronic plaque psoriasis upon treat- ment with multiple courses of alefacept Janet Roberts, MD, Northwest Cutaneous Research Specialists, Portland, OR, United States; Jean-Paul Ortonne, MD, Hoˆpital L’Archet II, Nice, France; Jerry Tan, MD, Windsor Clinical Research Inc, Windsor, ON, Canada; Ellen Frankel, MD, Clinical Partners, LLC, Cranston, RI, United States Rationale and goal: Alefacept is a safe and effective biologic drug for psoriasis. Prolonged remission has been demonstrated with up to 2 courses of alefacept in phase 3 trials. This open-label, multicenter, phase 3 extension study evaluated the duration of remission with additional courses of alefacept. Methods: Eligible patients were $18 years old, had chronic plaque psoriasis with a body surface area involvement of $10%, had previously received 1 or 2 courses of alefacept, and required systemic therapy or phototherapy. Patients received between 1 and 3 (A, B, and C) additional courses of alefacept in the current study. Each course consisted of 12 weeks of once-weekly 15 mg IM injections, and was followed by 12 weeks of observation. Patients were evaluated by the Physician Global Assessment (PGA) Scale during and after courses A and B. Duration of remission was measured in patients who achieved a PGA rating of ‘‘clear’’ or ‘‘almost clear’’ (C/AC) in course A, course B, or both. Results: Of 183 patients enrolled in the study, 175 received course A, 121 received course B, and 88 received course C. Among patients who achieved PGA C/AC at 2 weeks after course A (n ¼ 28, 16%), the median duration at PGA C/AC was 213.5 days (95% CI, 168.5-436.5) and at PGA ‘‘mild’’ or better (MOB) was 340.0 days (95% CI, 185.5-540.0). Among patients who achieved PGA C/AC at 2 weeks after course B (n ¼ 27, 22%), the median duration at PGA C/AC was 126.0 days (95% CI, 105.0- 199.5) and at PGA MOB was 282.5 days (95% CI, 172.5-345.0). Among patients who achieved PGA C/AC at any time during course A (n ¼ 61, 35%), the median duration at PGA C/AC was 146.0 days (95% CI, 97.0-208.5) and at PGA MOB was 286.5 days (95% CI, 182.5-399.0). Among patients who achieved PGA C/AC at any time during course B, (n ¼ 51, 42%), the median duration at PGA C/AC was 123.0 days (95% CI, 91.0-161.0) and at PGA MOB was 220.5 days (95% CI, 155.0-283.0). Conclusions: In responders, multiple courses of alefacept reproducibly provide long-term remission of chronic plaque psoriasis. Research study and poster production/management fees paid for by Astellas. P2614 A phase 2 study demonstrating the efficacy and safety of the oral therapy CC-10004 in subjects with moderate to severe psoriasis Kim Papp, MD, PhD, Probity Medical Research Inc., Waterloo, ON, Canada; Jerome Zeldis, MD, PhD, Celgene Corporation, Summit, NJ, United States; Patricia Rohane, MD, Celgene Corporation, Summit, NJ, United States; Diamant Thaci, MD, Uniklinkum Johann Wolfgang Goethe Universita¨t, Frankfurt, Germany Background: CC-10004 is an oral therapy that has broad antiinflammatory activity, including inhibition of PDE4 enzyme function and TNF-a production. This phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose- comparison study evaluated the efficacy and safety of CC-10004 in subjects with moderate to severe plaque-type psoriasis who were candidates for systemic therapy. Methods: This study included a 12-week treatment phase followed by a 4-week observational follow-up phase. A total of 260 subjects were randomized to receive CC-10004 20 mg BID, CC-10004 20 mg QD, or placebo for 12 weeks. The primary endpoint for this study was the proportion of subjects treated with CC-10004 who achieved a PASI-75 at week 12/last treatment in reference to the baseline visit. Last treatment is defined as the last PASI assessment completed during the 12-week treatment phase. Results: At week 12/last treatment, a significantly higher proportion of subjects treated with 20 mg BID (24%) achieved PASI-75 compared with the placebo group (10%; P ¼.023). Of the subjects receiving 20 mg BID or placebo, 57% versus 23% achieved PASI-50 at week 12/last treatment, respectively; whereas 14% versus 6% achieved PASI-90, respectively. At week 12/last treatment, subjects achieved a mean decrease of 52% versus 17% in PASI from baseline in the 20 mg BID versus placebo groups, respectively. Subjects receiving CC-10004 continued to improve over time, showing the greatest mean percent reduction in PASI score at week 12. Overall, the AE profiles were similar across all 3 treatment groups. The majority of AEs reported were mild. The percentage of subjects who reported at least 1 AE in the 20 mg BID group (54%) was comparable with the placebo group (60%). A lower percentage of subjects discontinued study drug due to an AE in the 20 mg BID group (4%) versus the placebo group (8%). No study drugerelated serious adverse events were reported in this study. No subjects in the 20 mg BID group experienced psoriasis flare during the observational follow-up period. Discussion: In this clinical study, CC-10004 was shown to be well tolerated and safe in subjects with moderate to severe plaque-type psoriasis. The proportions of subjects that achieved 50%, 75%, and 90% improvement in PASI demonstrate the clinical activity of CC-10004 after 12 weeks of treatment. 100% is sponsored by Celgene Corporation. P2603 Epidermal normalization following treatment with infliximab in psoriatic subjects: Histology and gene expression analyses Alice B. Gottlieb, MD, PhD, Tufts-New England Medical Center, Boston, MA, United States; Carrie Brodmerkel, PhD, Centocor Research and Development, Inc., Malvern, PA, United States; James Krueger, MD, PhD, The Rockefeller University, New York, NY, United States; Kenneth B. Gordon, MD, Northwestern University Feinberg School of Medicine, Skokie, IL, United States Objective: Psoriasis is an inflammatory skin disease marked by hyperproliferation of the epidermis. A new paradigm for the pathogenesis of psoriasis is emerging with identification of the involvement of the Th17 pathway. Cytokines including interleukin (IL)-20, IL-12, IL-23, and tumor necrosis factor (TNF)-alpha as well as other proteins, such as the S100 calcium binding proteins, have been implicated in the hyperproliferation of keratinocytes. The effects of infliximab (IFX), a TNF- neutralizing monoclonal antibody, on the epidermis were studied during EXPRESS II, a phase III clinical study of IFX in psoriasis. Methods: Both histologic response and gene expression were evaluated in a subset of subjects in this 50-week, phase 3, randomized, double-blind, placebo-controlled trial of 835 patients evaluating the safety and efficacy of IFX induction monotherapy (3 and 5 mg/kg at weeks 0, 2, and 6) followed by 4 regimens of IFX maintenance monotherapy (scheduled either every 8 weeks or as needed at each of the 2 doses). In the subset of subjects (n ¼ 70) participating in the biopsy study, skin samples collected at baseline, day 3, and week 10 were bisected for histology (formalin-fixed) and gene expression (microarray and RT-PCR). Results: TNF blockade induced by IFX was associated with diminished cell proliferation (Ki67) and epidermal thickness by day 3, and significant improvement was seen by week 10 in responders to IFX (PASI improvement [50%). Epidermal related genes, such as K6, K16, MKi67, S100A7, A8, A9 and others, were down- regulated by day 3 and continued to be suppressed at week 10 compared with baseline. When normal skin was compared with skin at week 10 histologically and by gene expression, the data were similar. Additional analyses on the correlation of these results with clinical outcomes are also being performed. Conclusions: Overall, the decreased expression of genes related to the epidermis mirrored the histologic improvements in the epidermis following IFX treatment, demonstrating normalization of the epidermis of psoriatic skin. Supported by Centocor Research and Development, Inc. POSTER DISCUSSION SESSION 492—PSORIASIS I P2601 Infliximab for the treatment of severe pustular psoriasis: 7 years of follow-up Rajat Varma, MD, University of Alabama School of Medicine, Birmingham, AL, United States; Wendy Cantrell, NP, RN, University of Alabama School of Medicine, Birmingham, AL, United States; Craig Elmets, MD, University of Alabama School of Medicine, Birmingham, AL, United States; Boni Elewski, MD, University of Alabama School of Medicine, Birmingham, AL, United States Background: Infliximab has been used in the treatment of psoriatic and rheumatoid arthritis for several years and has only recently been approved for plaque psoriasis. In 2002, we reported this patient as one of the first cases of pustular psoriasis successfully treated with infliximab, and we now report his continued success 7 years later. Report: Our patient was first seen in 2001 during his hospital admission for severe pustular psoriasis affecting 90% of his body surface area (BSA). At that time, he had been treated with methotrexate, acitretin, and prednisone. During his admission, he was started on infliximab 5 mg/kg intravenously. Following his first infusion, he noted a significant decrease in pustules. After his third infusion, he was nearly clear of psoriasis with 5% BSA affected. He was eventually weaned from acitretin and prednisone, but continued on infliximab and methotrexate. In 2003, he stopped infliximab and started etanercept because of insurance issues. However, within 4 months he noted significant worsening of his psoriasis requiring hospitalization and subsequently returned to infliximab. At the present time, he continues to have5% BSA affected when treated with infliximab infusions every 7 weeks and methotrex- ate. To date, there have been no complications from this treatment regimen. Conclusions: Infliximab can be a tremendous asset to pustular psoriasis patients and dermatologists alike. Our observations highlight the continued efficacy and long- term safety of infliximab. Commercial support: None identified. FEBRUARY 2008 J AM ACAD DERMATOL AB3
  9. 9. P2606 Sustained clinical efficacy and safety of adalimumab in patients with moderate to severe psoriatic arthritis (PsA): 2-year results from an open- label extension study Philip Mease, MD, Seattle Rheumatology, Seattle, WA, United States; Christopher Ritchlin, MD, University of Rochester, Rochester, NY, United States; Robert Wong, MD, Abbott, Parsippany, NJ, United States; Dafna Gladman, MD, University of Toronto, Toronto, ON, Canada Objectives: Adalimumab, a tumor necrosis factor (TNF) antagonist, has demon- strated efficacy in psoriatic arthritis (PsA) patients in 2 double-blind, placebo- controlled trials.1,2 This study was designed to investigate the efficacy and safety of adalimumab through 2 years of treatment in patients with moderate to severe PsA. Methods: Patients who completed either: (1) the 24-week ADEPT trial or (2) the 12- week M02-570 trial enrolled into an open-label (OL) extension study, in which patients received adalimumab 40 mgevery other week. After 12 weeks of OL therapy, patients with an inadequate response could increase to 40 mg weekly. Efficacy was assessed by ACR 20/50/70, PASI 50/75/90, Physician’s Global Assessment (PGA) of Psoriasis, PsARC, HAQ (disability), and SF-36 (physical function) through 2 years of exposure to adalimumab. Safety was assessed throughout the study. Results: Adalimumab treatment provided statistically and clinically significant improvement versus placebo in both double-blind, placebo-controlled trials: ACR 20 for ADEPT, 57% vs. 15% (P #.001) at week 241 ; ACR 20 for M02-570, 39% vs. 16% (P ¼.012) at week 12.2 A total of 395 patients were included in this analysis of 2-year adalimumab exposure. Adalimumab showed rapid efficacy in PsA patients that was sustained through 2 years of exposure. ACR 20/50/70 response rates (%) for patients with available data at weeks 12, 24, 48, and 104 were 55/32/16, 64/43/23, 67/49/33, and 73/56/37, respectively. At weeks 48 and 104, PASI 50/75/90 responders (%) were 84/69/55 and 83/70/53; PsARC responders (%) were 77 and 81; and patients (%) with PGA of psoriasis (‘‘clear/almost clear’’) were 38/30 and 40/31, respectively. Mean changes from baseline at weeks 48 and 104 in HAQ scores were -0.4 and -0.4, and for SF-36, 15.1 and 18.2, respectively. The following adverse events (AEs) were observed per 100 patient years during the 2-year treatment period: any serious AE, 10.6 E/100PY; serious infectious AEs, 2.4 E/100PY; malignancies other than nonmelanoma skin cancers, 0.5 E/100PY; nonmelanoma skin cancer, 0.7 E/100PY; and AEs leading to discontinuation, 5.0 E/100PY. One case of tuberculosis was reported, while no cases of demyelinating disease, lupus/lupus-like disease, or congestive heart failure were observed. There were 2 deaths: 1 alcohol-related sudden death possibly related to adalimumab, and 1 myocardial infarction probably not related to adalimumab. Conclusion: Adalimumab demonstrated sustained efficacy and safety for both skin and joint manifestations through 2 years in patients with PsA. References 1. Mease PJ, Gladman DD, Ritchlin CT, et al. Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: results of a double- blind, randomized, placebo-controlled trial. Arthritis Rheum 2005;52:3279-89. 2. Genovese MC, et al. Ann Rheum Dis 2005;64(Suppl III):313. 100% sponsored by Abbott. P2611 Safety and efficacy (PASI 90 and global evaluation) of subcutaneous certolizumab pegol in patients with moderate to severe chronic plaque psoriasis: Results from a double-blind, placebo-controlled trial Jean-Paul Ortonne, MD, PhD, University of Nice-Sophia Anitpolis, Nice, France; Kristian Reich, MD, PhD, Georg-August University, Goettingen, Germany; Wolfram Sterry, MD, PhD, Charite-Universita¨tsmedizin Berlin, Berlin, Germany; Ido Terpstra, UCB, Braine-l’Alleud, Belgium Purpose: Certolizumab pegol is the first PEGylated, Fc-free anti-tumor necrosis factor (TNF)-alpha Fab’ and targets TNF-alpha with high affinity in inflamed tissue. It has proven efficacy and tolerability in Crohn’s disease and rheumatoid arthritis. The safety and efficacy of subcutaneous (sc) administration of certolizumab pegol was assessed in this phase II clinical trial of patients with chronic plaque psoriasis. Methods: Patients were randomized to receive double-blind treatment with certolizumab pegol 200 mg sc (starting dose of 400 mg; n ¼ 59), certolizumab pegol 400 mg (n ¼ 58), or placebo (n ¼ 59) every 2 weeks for 12 weeks. Patients were followed for an additional 12 to 24 weeks without treatment. The co-primary endpoints were assessed at 12 weeks: the proportion of responders on the Psoriasis Area and Severity Index ($90% decrease from baseline; PASI 90) and a global evaluation scale (GES) scored patients from marked worsening to marked improve- ment. Adverse events (AEs) and safety parameters were monitored throughout the study. Results: Significantly more patients treated with certolizumab pegol 200 mg or 400 mg sc achieved PASI 90 than patients treated with placebo (200 mg, 39.0% [odds ratio vs. placebo, 39.6; P .001]; 400 mg, 46.6% [odds ratio vs. placebo, 53.2; P .001]; placebo, 1.7%). On the GES, more patients treated with certolizumab pegol (200 mg 80.8%, 400 mg 90.2%) achieved marked improvement compared with placebo (13.5%). The frequency of AEs was similar across all treatment groups. Serious AEs were reported for 3.3%, 7.0%, and 1.7% of patients in the 200 mg, 400 mg, and placebo groups, respectively. AEs leading to discontinuation were reported in 3.3%, 3.5%, and 3.4%, in the 200 mg, 400 mg, and placebo groups, respectively. Conclusions: Certolizumab pegol 200 mg and 400 mg liquid formulation showed statistically significant superior efficacy compared with placebo in patients with moderate to severe plaque psoriasis. Similar results were achieved with the high and low dose. Certolizumab pegol was well tolerated with no new safety concerns. 100% is sponsored by UCB. P2620 Long-term continuous maintenance therapy with CNTO 1275 (anti-IL-12/ 23p40) as treatment for psoriasis: Phase 3 trial results Kenneth B. Gordon, MD, Northwestern University Feinberg School of Medicine and Evanston Northwestern Healthcare, Skokie, IL, United States; Newman Yeilding, MD, Centocor Research and Development, Inc., Malvern, PA, United States; Shu Li, MS, Centocor Research and Development, Inc., Malvern, PA, United States; Craig Leonardi, MD, St. Louis University Medical School, St. Louis, MO, United States Background: CNTO 1275, a fully human monoclonal antibody against interleukin 12/23p40, showed significant efficacy in treating patients with moderate to severe plaque psoriasis. To evaluate the optimal use of CNTO 1275 in long-term manage- ment of psoriasis, long-term continuous use of CNTO 1275 was assessed using a randomized withdrawal trial design. Methods: The PHOENIX 1 study was a double-blind, placebo-controlled trial of 766 patients randomized to receive subcutaneously administered CNTO 1275 (two 45 or 90 mg doses 4 weeks apart followed by 45 or 90 mg every 12 weeks) or placebo. Patients randomized to placebo crossed over to 45 or 90 mg doses at weeks 12 and 16 followed by dosing every 12 weeks. Patients responding to CNTO 1275 through week 40 were randomized to either continue treatment with CNTO 1275 or switch to placebo. Results: Significantly higher proportions of patients continuing CNTO 1275 maintained PASI 75 at week 52 compared with those switching to placebo. In patients who continued 45 and 90 mg dosing, 87% and 91%, respectively, sustained PASI 75 compared with 64% and 62% of patients who switched to placebo (P ¼.001 for 45 mg comparison and P.001 for 90 mg comparison vs. placebo). Ninety-seven percent and 98% of patients who continued 45- and 90-mg CNTO 1275 dosing, respectively, maintained at least a PASI 50 at week 52. At the week 40 randomization, 66% and 73% of patients in the 45 and 90 mg dosing groups were PASI 90 responders. The proportions of PASI 90 responders remained stable through week 52 with continued dosing, but decreased to 37% and 38% of patients withdrawn from 45 and 90 mg dosing, respectively. Continuous long-term maintenance therapy with CNTO 1275 was generally well tolerated. After randomization, 46% and 49% of patients continuing 45 and 90 mg CNTO 1275 dosing, respectively, experienced at least one adverse event compared with 56% and 48% of patients switched to placebo; 0.0% and 1.2% of patients continuing on these respective CNTO 1275 regimens experienced at least one serious adverse event compared with 0.0% and 2.3% of patients switched to placebo. Conclusions: Long-term continuous therapy with CNTO 1275 is generally well tolerated and maintains a high level of efficacy. Supported by Centocor Research and Development, Inc. P2638 Efficacy of tacalcitol ointment and 308-nm monochromatic excimer light (308-nm MEL) in the treatment of persistent plaque psoriasis Alessia Pacifico, MD, Phototherapy Unit, S. Gallicano Institute, Rome, Italy; Aldo Di Carlo, MD, Phototherapy Unit, S. Gallicano Institute, Rome, Italy; Andrea Paro Vidolin, MD, Phototherapy Unit, S. Gallicano Institute, Rome, Italy; Giovanni Leone, MD, Phototherapy Unit, S. Gallicano Institute, Rome, Italy Phototherapy has been shown to be one of the most effective treatment modalities for patients with psoriasis. The 308-nm monochromatic excimer light (MEL), a non- laser source emitting narrowband ultraviolet B (NBUVB) light, has been recently introduced for the treatment of localized psoriasis. Unlike NBUVB phototherapy, the 308-nm MEL can selectively treat single lesions, sparing nonaffected areas. Furthermore, several studies have established that psoriatic lesions can tolerate much more ultraviolet (UV) light than the adjacent uninvolved skin and can clear even faster if higher doses of UV light are selectively delivered to psoriatic plaques. Nevertheless, combination therapies capable both of reducing cumulative UV doses and of accelerating clearance of skin lesions have been suggested. The aim of this randomized, double-blind study was to assess the efficacy, safety, and tolerability of tacalcitol ointment (4 g/g) compared to placebo in combination with the 308-nm MEL in the treatment of patients with localized persistent plaque psoriasis. Twenty- one patients with symmetrical lesions were enrolled in this study. There were no significant differences in the baseline Psoriasis Area Severity Index (PASI) score between the selected symmetrical psoriatic plaques. Target lesions were treated with tacalcitol ointment and vehicle in a half-side distribution according to the randomization once daily for a period of 4 weeks. All subjects received on both symmetrical target lesions 308-nm MEL phototherapy 3 times a week for a total of 12 sessions. Lesions treated with tacalcitol ointment showed higher reductions from baseline in the PASI scores compared with lesions treated with phototherapy alone (62.3% vs. 42.1%). In conclusion, our study suggests that treatment with 308-nm MEL phototherapy in combination with tacalcitol ointment may be an effective treatment in recalcitrant plaque psoriasis and that it may determine complete remission in a shorter period of time if compared to targeted phototherapy alone, thus decreasing the cumulative UV dose necessary to achieve clearing. Commercial support: None identified. AB4 J AM ACAD DERMATOL FEBRUARY 2008
  10. 10. POSTER DISCUSSION SESSION 493—PSORIASIS II P1205 Potential misclassification of psoriasis patients in electronic databases Hilal Maradit Kremers, MD, MS, Mayo Clinic, Rochester, MN, United States; Murat Icen, MD, Mayo Clinic, Rochester, MN, United States; Cynthia Crowson, MS, Mayo Clinic, Rochester, MN, United States; Marian McEvoy, MD, Mayo Clinic, Rochester, MN, United States Background: Electronic claims and medical record databases are increasingly used for observational studies. Psoriasis (PsO) is a common inflammatory disorder with a variable clinical course. The purpose of this study is to assess the validity of PsO diagnostic codes in an electronic database. Methods: This study was performed in a population-based setting in the United States where all diagnoses and procedures from all health care providers in a large community are indexed and recorded in an electronic database. The database was searched for subjects aged $18 years with diagnostic codes consistent with PsO for the time period 1970 to 2000. The investigators also had access to the complete medical records and reviewed them manually. PsO diagnosis was validated by either a confirmatory diagnosis in the medical record by a dermatologist or review of the medical record by the dermatologist investigator (M.T.E.). Results: We identified and reviewed the complete medical records of a total of 1595 subjects with at least 1 diagnostic code consistent with PsO between 1970 and 2000. Based on medical record review, 960 (61%) subjects were confirmed to have PsO, of which the majority (82%) were identified based on the in-chart dermatologist’s confirmation of psoriasis. The 635 subjects who were classified as non-PsO were cases where PsO was considered in differential diagnosis with no further confirma- tion, or the final diagnoses were other than PsO (eg, parapsoriasis, pitriasis rosea, or psoriasiform dermatitis). The most commonly used diagnostic code was a nonspe- cific code (PsO NOS) in 975 (62%) subjects and the yield rate for this code was 64%. Specific PsO codes were much less common but had higher yield rates. Subjects with guttate, sebo, or pustular PsO were more likely to receive specific codes than chronic plaque PsO (P .001). Subjects with 2 or more PsO codes were also more likely to have PsO than those with only 1 code, but, even for those with only 1 code in a 5-year time window, the yield rate was 40%. Conclusions: Because of the wide spectrum of disease course, identification of PsO subjects by diagnostic codes alone is likely to produce great inaccuracy. These results demonstrate the possibility of false-positive PsO diagnoses in electronic databases and underscore the importance of validation. Future database studies in PsO should consider the extent to which diagnoses are validated, such as through review of original medical records. Supported by Amgen Inc. P2602 A practical understanding of mean percent PASI reduction for biologics Ronald Vender, MD, Dermatrials Research, Hamilton, ON, Canada; Penny Lovell, RN, Michael G. Degroote School of Medicine, Hamilton, ON, Canada Aims: Psoriasis in clinical trials is often measured by the Psoriasis Area and Severity Index (PASI) score. This measurement is well understood by clinical trialists and many dermatologists, but rarely by patients and some clinicians. Patients may not understand their chance of improvement based on a PASI 75 value. They would better understand a mean percent improvement of the PASI score from baseline. This is an attempt to simplify these terms of reduction from baseline in PASI scores as related to treatment with biologic agents. This may be more meaningful for patients and clinicians when discussing their average chance of improvement. PASI 75 and mean PASI improvement can be compared and contrasted in order to demonstrate the limitations in interpreting and also explaining the significance of PASI 75. Mean PASI improvement, unlike PASI 75, is understandable, and its implications can be easily translated to patients. Efficacy of the biologics studied in clinical trials is often measured using the primary endpoint of 12 and 24 weeks. Methods: An extensive search of peer-reviewed and published clinical trials was performed using various search engines including Medline and Embase. Results: In clinical trials, the medication may be considered effective if a significant PASI 75 is achieved. This is meaningful for clinical trialists, but has limitations for clinicians and patients unfamiliar with the chance of improvement based on PASI 75 values. Although these percentage values are required for standardization of clinical trials, it is not always clear if they are meaningful to all. Most patients and clinicians understand the term put plainly, ‘‘What is the chance of improvement for the average patient?’’ This is determined by using the mean percent PASI improvement obtained in clinical trials, which is usually measured at the 12 and 24 week endpoints. In other words, what is the mean percent improvement of the PASI score from baseline? Conclusion: This poster compares and contrasts the differences in interpretation of mean PASI improvement versus PASI 75. Mean PASI improvement diagrams are presented and discussed in such a way that patients can comprehend their average chance in improvement of calculated psoriatic signs of redness, thickness, and scale as well as body surface area of involvement. Poster sponsored by an unrestricted educational grant from Amgen Canada Wyeth Pharmaceuticals Inc. P2624 Impact of gender on depression in patients with psoriasis Omar Dabbous, MD, MPH, Centocor, Inc., Horsham, PA, United States; Boxiong Tang, MD, PhD, Centocor, Inc., Horsham, PA, United States; Heidi Thompson, MS, MBA, Centocor, Inc., Horsham, PA, United States; Mirza Rahman, MD, MPH, Centocor, Inc., Horsham, PA, United States Purpose: To evaluate the impact of gender on depression in patients with psoriasis (PsO). Methods: A retrospective analysis, using the PharMetrics database, of patients with a diagnosis of PsO (ICD-9 code 696.1) from January 1, 2000 through June 30, 2005 was conducted. Patients had to be continuously enrolled for 6 months pre- and 12 months postinitial PsO diagnosis, and have 2 distinct claims for PsO. A control group was matched on age and gender and did not have an inflammatory disease. Multivariable logistic regression analysis was conducted to determine the impact of gender on depression, adjusting for age, and comorbidities (DeyoeCharlson comorbidity index score). Results: The study cohort consisted of 91,987 patients, of which 24,256 had a PsO diagnosis. Female patiets with PsO constituted 52% of the PsO patient cohort. Mean age was similar for female and male patients with PsO (45.5 6 13.0 vs. 46.2 6 12.0, respectively). Both female and male PsO patients had similar rates of comorbidities (0.75 vs. 0.71; P ¼ .0939). Female PsO patients had higher rates of depression, selective serotonin reuptake inhibitor (SSRI) use, and depression or SSRI use than males (10.0% vs. 5.7%, 19.0% vs. 9.1%, and 23.0% vs. 11.6%, respectively; all P values .0001). Female patients without PsO also had higher rates of depression, use of SSRI, and depression or SSRI use than males (6.1% vs. 3.1%, 10.5% vs. 4.8%, and 13.3% vs. 6.4%, respectively; all P values .0001); however, these rates were significantly lower than in those observed in the PsO cohort (all P values .0001). After adjusting in the multivariate analysis, female PsO patients were twice as likely to suffer from depression, or to be treated with an SSRI (odds ratio, 2.30; 95% CI, 2.10-2.42), than male PsO patients. Conclusions: Depression was significantly higher in patients with PsO compared to patients without PsO. In this study, 23.0% of female patients with PsO suffered from depression or used an SSRI. Female PsO patients were twice as likely to suffer from depression or to use an SSRI compared to male patients with PsO. New therapies that can reduce the disease burden may have the potential to decrease overall psychological burden for patients with PsO. 100% sponsored by Centocor, Inc. P2628 Psoriasis: Evaluation of self-perceived stress and quality of life Laurent Misery, MD, Hopital Morvan, Brest, France; Sami Boussetta, PhD, Pierre Fabre, Boulogne, France; Guy Macy, PhD, Laboratoires Dermatologiques Ducray, Lavaur, France; Charles Taieb, MD, MBA, Pierre Fabre, Boulogne, France Context: Stress has long been considered to aggravate or trigger many conditions. This is particularly true for skin diseases. Conversely, however, certain dermatoses such as psoriasis (PsO), eczema, and acne are in themselves a source of stress and impaired quality of life (QoL). Stress disturbs the delicate balance of neuromediators in the skin, which explains why dermatoses are aggravated in periods of stress. Objective: Evaluate QoL and self-perceived stress (SPS) in a population with PsO. Methods: For 5 consecutive days, 5 dermatology departments in France handed out SPS (PCV-Metra) and QoL questionnaires (SF-12) to patients attending their outpatient clinics. Results: Of 658 adult patients (age, 46 6 17 yrs; 39.6% female vs. 60.4% male) who attended an appointment and responded during these 5 days, 10.2% presented with PsO diagnosed by a dermatologist. Many patients (62.8%) had suffered from PsO for more than 5 years, while for 15.7%, their condition had been diagnosed more recently (1 yr). More than half of the patients (53.2%) made an appointment with their dermatologist because their dermatosis had worsened. The SPS level is 11.4 6 4.2. Patients who had suffered from psoriasis for more than 5 years had a SPS level of 11.8 6 4.1 vs. 10.8 6 4.7 in patients whose condition had been diagnosed within the last 5 years. In parallel, the SPS score was 12.2 6 4.1 in patients seeing their dermatologist because their condition had worsened vs. 11.8 6 3.9 in those consulting for another reason. QoL evaluated using the SF-12 showed a change in the mental score (MS) 39.3 6 10.9 and a physical score (PS) of 46.3 6 11.7. The SF-12 MS was 40.7 6 12.5 in patients with recently diagnosed PsO (5 yrs) vs. 38.5 6 9.9 in patients whose condition was diagnosed more than 5 years ago. In addition, the SF-12 MS was 36.0 6 11.9 in patients seeing their dermatologist because their condition had worsened vs. 44.0 6 8.0 in those consulting for another reason. The PS as a function of condition exacerbation were 42.6 6 13.2 vs. 51.6 6 9.2, respectively. Discussion: The mean age and sex ratios in our study are coherent with the data in the literature. However, a statistically significant difference in SF-12 MS (P ¼.04) and PS (P ¼.04) was observed in patients seeing their dermatologist because their PsO had worsened. SPS levels did not present statistically significant differences as a function of sex, condition age, or exacerbation of PsO. The SPS evaluation is strongly correlated with the scores obtained for the SF-12 mental component (R ¼ À0.77). In this study, there was no relationship between active episodes of PsO and SPS levels. Supported 50% by Ducray and 50% by Pierre Fabre. FEBRUARY 2008 J AM ACAD DERMATOL AB5
  11. 11. P2619 Depression and psoriasis: An epidemiologic study representing over 4.7 million patient visits for psoriasis Madhulika Gupta, MD, University of Western Ontario, London, ON, Canada; Aditya Gupta, MD, PhD, University of Toronto, Department of Medicine, London, ON, Canada; Lauren Badalato, University of Western Ontario, London, ON, Canada Background: Several studies have reported a relation between psoriasis and depressive disease; however, few epidemiologic studies exist to support these findings. Objective: We investigated the comorbidity between psoriasis and depression, from the National Ambulatory Medical Care Survey (NAMCS) and National Hospital Ambulatory Medical Care Survey (NHAMCS), which are both nationally represen- tative surveys of health care visits in the United States. Methods: Data from 1994 to 1996 which contained a rating for depression at each patient visit were examined. A ‘‘psoriasis’’ variable was created using ICD-9-CM codes 696, 696.0, and 696.1. A ‘‘depression’’ variable was created using physician responses to the checklist question, ‘‘Is the patient depressed?’’; (answer options: ‘‘yes’’ or ‘‘no’’) at the time of the initial visit. In addition, the following confounding factors for depression were controlled for in the logistic regression: ‘‘obesity’’ (ICD- 9-CM codes 278.00 and 278.01); ‘‘alcoholism’’ (ICD-9-CM codes 303, 303.0, and 303.9); ‘‘age’’ (age #40 yrs and[40 yrs); and sex. All analyses were carried out using the complex samples module of SPSS v. 15, which accounts for the multistage probability sampling design used to collect the data. Results: There were more than 4.7 million weighted visits for psoriasis (57.4% female and 42.6% male). There was a significant association between psoriasis and depression (odds ratio [OR], 2.70; 95% confidence interval [CI], 1.57-4.62) when obesity, alcoholism, age, and gender were controlled for. Interestingly, we observed that the odds ratio for depression in psoriasis was much higher for the #40 years age group (OR, 4.52; 95% CI, 1.86-10.96) vs. the [40 years age group (OR, 1.785; 95% CI, 0.84-3.785). Conclusion: The findings from this nationally representative epidemiologic data- base, which includes visits for all possible medical problems, are consistent with earlier studies on psoriasis and depression. The finding of greater psychological morbidity among the younger age group is also consistent with the earlier literature. Our findings from this large database further highlight the robustness of the association between depression and psoriasis, and further support the clinical importance of evaluating depression in the psoriasis patient. Commercial support: None identified. P2622 A psoriasis patient screening questionnaire and treatment algorithm to assist with the selection of appropriate systemic therapy Ian Landells, MD, St. John’s, NF, Canada; Caroline MacCallum, Memorial University of Newfoundland, St. John’s, NF, Canada; Lyn Guenther, MD, The Guenther Dermatology Research Centre, London, ON, Canada Introduction: Patients with moderate to severe psoriasis usually require treatment with phototherapy, traditional systemic agents (eg, methotrexate, cyclosporine, or acitretin) or biologics. When choosing an appropriate therapy for a particular patient, comorbidities, contraindications, response (including adverse effects) to previous therapy, concomitant therapies, family history, convenience, access, and patient preference must be considered. This can be a complex, daunting, and time- consuming process, particularly because there are many therapies from which to choose. Time management is a priority for dermatologists, particularly because there are physician shortages in many regions. Inadequate time to devote to this decision process may lead to avoidance of the use of systemic agents and therefore undertreatment of patients with moderate to severe psoriasis, or inappropriate choices with adverse events that could have been avoided. Comprehensive simple decision tools are needed. Methods: Product monographs and a literature search were conducted looking specifically at efficacy, ease and method of administration, contraindications, adverse effects, safety concerns, drug interactions and cost for the following medications: psoralen plus ultraviolet A light phototherapy (PUVA), methotrexate, cyclosporine, acitretin, alefacept, efalizumab, etanercept, and infliximab, products that are currently approved for treatment of psoriasis, in order to determine which treatments would be appropriate for a particular patient. Results: There are contraindications and safety concerns for all of the treatments reviewed. To simplify the decision process, two tools were developed: a screening questionnaire checklist that can be completed by patients in the waiting room and a treatment algorithm. The material from the patient questionnaire can be easily entered into the algorithm in order to determine optimal treatment for a particular patient. Conclusions: The selection of optimal systemic antipsoriatic therapy for an individ- ual patient is a complex task. The use of a comprehensive patient questionnaire and treatment algorithm may simplify the task, save the physician time, and enhance patient safety. Commercial support: None identified. P2612 Phenotypic associations of a cohort of psoriasis patients whose disease worsens with ‘‘infection’’ Tina Rakkhit, MD, University of Utah, Salt Lake City, UT, United States; Clifton Hall, MD, University of Utah, Salt Lake City, UT, United States; Gerald Krueger, MD, University of Utah, Salt Lake City, UT, United States; Kristina Duffin, MD, University of Utah, Salt Lake City, UT, United States Purpose: To observe the phenotypic associations in a large cohort of psoriasis patients who experience worsening in disease severity with upper respiratory infection. Methods: A genome-wide scan using a Celera microarray platform of more than 25,000 gene-centric single nucleotide polymorphisms (SNPs) was conducted to discover SNPs that may confer disease risk for psoriasis. Among those SNPs identified, both case only and replication data in a case-control analysis revealed that one SNP (rs6887695), associated with the p40 subunit of interleukin (IL)-12 and IL-23, is more commonly expressed among those who report worsening of psoriasis with infection. After this association was identified, the Utah Psoriasis Initiative (UPI) database (n ¼ 801) was reviewed to identify those who reported worsening of psoriasis with infection (n ¼ 136) and assess their psoriasis-associated phenotypic characteristics. Nearly all reported infections were upper respiratory tract infections of either viral or bacterial etiology. We examined gender, family history, psoriatic arthritis, nail disease, Koebner phenomenon, plaque size and thickness, smoking status, alcohol use, and HLA-C genotype. The HLA-C alleles can be grouped into 2 subclasses (C1 and C2), which appear to have opposing effects on HLA-C immune- mediated processes. x2 analysis was conducted to determine statistical significance. Results: Among those phenotypic characteristics observed, females are more likely to report psoriasis worsening with infection (P.0001). Patients who worsen with infection are also more likely to report a positive family history (P ¼ .034), the Koebner phenomenon (P ¼.005), and less frequent nail disease in association with their psoriasis (P ¼.050). With respect to HLA-C status, those in the C2 subset are more likely to report psoriasis worsening with infection (P ¼.029). No statistically significant difference was observed with respect to psoriatic arthritis, plaque size and thickness, smoking status, or alcohol use. Conclusions: Patients who report disease worsening with the incidence of infection represent a unique cohort of patients with respect to gender, family history, Koebner phenomenon, and nail disease. Their association with the p40 SNP that associates with risk of psoriasis and with the C2 subset of HLA-C cause us to predict an underlying genetic association for the phenotype ‘‘psoriasis worsens with infection.’’ Commercial support: None identified. P2613 Smoking associates with a delay in onset of psoriatic arthritis Tina Rakkhit, MD, University of Utah, Salt Lake City, UT, United States; Bob Wong, PhD, University of Utah, Salt Lake City, UT, United States; Kristina Duffin, MD, University of Utah, Salt Lake City, UT, United States; Gerald Krueger, MD, University of Utah, Salt Lake City, UT, United States Purpose: To examine the effects of environmental influence, such as cigarette smoking, on the phenotypic expression of psoriasis. Methods: The Utah Psoriasis Initiative (UPI) is a phenotypic database, currently with more than 800 psoriasis (PsO) cases, used to facilitate discovery of genotypee phenotype relationships. Each patient undergoes a standardized enrollment process examining phenotypic variables including age of onset, distribution, comorbid states, response to therapy, et cetera. Two major cohorts were identified: smokers and nonsmokers. We used this to focus on phenotypic features that might be influenced by smoking. Age of onset of PsO in smokers and nonsmokers, time of smoking onset (before or after PsO onset), and age of onset of psoriatic arthritis (PsA) in smokers vs. nonsmokers were observed. Using two definitive timepoints (onset of cutaneous disease and onset of joint disease), we analyzed the time to diagnosis of PsA in those who started to smoke before and after the onset of PsO and compared it with those who did not smoke between onset of PsO and onset of PsA. Those who developed PsA before cutaneous disease were excluded from the analysis. Results: In the UPI, the mean age of onset of PsO in smokers compared to nonsmokers is 29.4 vs. 26.1 years. The mean time to onset of PsA after developing PsO is 12.4 years. This time remains unchanged when comparing smokers (12.2 6 11.7) to nonsmokers (12.5 6 12.6). Assessment of a smoking timeline with respect to skin disease onset reveals a significant difference in interim time to develop PsA. Those who smoke before PsO onset have a mean time to PsA onset of 8.2 6 9.3 years. Those who smoke after PsO onset but before PsA onset have a dramatically longer time to onset of PsA (23.2 6 15.3 yrs; P ¼.005). Among nonsmokers, nearly 50% more women developed PsA than men (n ¼ 73 vs. n ¼ 49), while among smokers, there were 30 females and 33 males (P ¼ .124) who developed PsA. Patients with a positive family history did not develop PsA more frequently than those without affected relatives (P ¼.845). Conclusion: While genetic variation affects phenotypic expression of PsO, the role of environmental influence is unknown. Our observation shows that onset of PsA can be modified. The health hazards of smoking are well known; our data support the concept that agents without such detrimental effects could be used to delay and possibly prevent the onset of this significant comorbid state. Commercial support: None identified. AB6 J AM ACAD DERMATOL FEBRUARY 2008
  12. 12. POSTER DISCUSSION SESSION 494—PEDIATRIC DERMATOLOGY P100 Premature epiphyseal closure in pediatric patients on isotretinoin therapy Anh Tran, University of Ottawa Faculty of Medicine, Ottawa, ON, Canada; James Walker, MD, Ottawa Hospital, Ottawa, ON, Canada; Markian Shulakewych, MD, University of Ottawa Hospital, Ottawa, ON, Canada Introduction: Premature epiphyseal closure associated with isotretinoin therapy in the pediatric population has been rarely reported in the literature. In previous reports, this risk appeared to increase with decreasing age of the patient, higher dose, and longer duration of therapy. We report a case of premature epiphyseal closure in an adolescent male athlete during a 4.5-month course of isotretinoin for acne in a dose of approximately 1 mg/kg/day. A literature review is included. Case history: Our patient, a 15-year-old otherwise healthy male athlete, presented in December 2005 with severe facial acne. He was unresponsive to other treatments; Accutane 80 mg/day was started in June 2006. Throughout the course, he had persistent hip, knee, and ankle pain. Being a competitive basketball player, he followed his height closely with a growth chart. The cessation of his growth was noted in October 2006 and the isotretinoin was stopped. A radiograph of his knee was done, showing irreversible closure of the epiphyseal growth plate, a finding not noted on his June 2006 radiograph, done for possible OsgoodeSchlatter’s disease. Other likely causes of premature epiphyseal closure and the possibility of this occurrence being a normal variant were considered and felt to be unlikely. Conclusion: Review of the literature and our report show premature epiphyseal closure can occur in patients at different ages, dosages, and duration. With the use of isotretinoin in adolescents for severe acne vulgaris, the risk of premature epiphyseal closure in these patients should be considered carefully. Proper studies are needed to assess the significance of bone changes in these patients. Furthermore, patients should be warned of this possible side effect of isotretinoin therapy. Commercial support: None identified. P601 Oral vapitadine, a new non-sedating antihistamine, relieves itch associ- ated with atopic dermatitis Jean Marie Naeyaert, MD, PhD, Ghent University Hospital, Department of Dermatology, Ghent, Belgium; Johan Beetens, PharmD, PhD, Barrier Therapeutics, Geel, Belgium; Luc Wouters, MMSc, Barrier Theraopeutics, Geel, Belgium; Geert Cauwenbergh, MMSc, PhD, Barrier Therapeutics, Geel, Belgium Objectives: Vapitadine is a new selective, nonsedative H1 antihistamine. The compound is currently in clinical development, mainly for oral application in chronic idiopathic urticaria, atopic dermatitis, and other itch-related dermatologic disorders. Our objective was to assess the efficacy of oral vapitadine on the alleviation of itch in patients with atopic dermatitis using concomitantly a weak topical corticosteroid and to assess the safety and tolerability of oral vapitadine in atopic dermatitis patients. Design: This was a randomized, placebo-controlled, double-blind, multicenter exploratory trial. After a 1-week lead-in period, 43 adult patients with atopic dermatitis were randomized to treatment with oral vapitadine 60 mg twice daily (n ¼ 22) or placebo (n ¼ 21) for 1 week. All patients applied daily a weak topical corticosteroid (1% hydrocortisone acetate cream) and an emollient throughout the run-in and treatment period. Patients evaluated itch and sleep (daily) and itch relief (end of study); physicians evaluated itch and atopic lesions (EASI score, all visits) and itch relief (end of study). Efficacy: Vapitadine significantly reduced daily itch scores, as evaluated by the patients (vs placebo; P ¼.027). Furthermore, itch relief, as assessed by the patients, was more pronounced in the vapitadine group (P ¼.013). Nine out of 22 patients reported either a marked improvement or an almost complete to complete relief of their itch symptoms vs. none of the 21 patients in the placebo group. Physician’s assessment of itch and itch relief showed the same tendency in favor of the vapitadine group; however, this did not reach statistical significance. No significant differences were observed for changes in sleep or EASI score between both treatment groups. Safety and tolerability: Treatment was well tolerated. No patients reported signs of sedation. The incidence of reported adverse events was similar within the different treatments and were graded as doubtfully or not related to study medication. Conclusion: Oral vapitadine relieves itch in atopic dermatitis patients concomitantly using a weak topical corticosteroid. The treatment was well tolerated and no sedation was reported, confirming previous findings. The results of this exploratory trial warrant further clinical development of vapitadine for the treatment of itch in atopic dermatitis. 100% is sponsored by Barrier Therapeutics. P608 Methotrexate for atopic dermatitis in children Christopher Rouse, MD, Saint Louis University, Saint Louis, MO, United States; Elaine Siegfried, MD, Saint Louis University, Saint Louis, MO, United States Background: Atopic dermatitis is the most common cause of severe skin disease in children. Treatment is often challenging, because no well-studied or FDA-approved systemic options exist. Small case series and review articles have described cyclosporine, oral or pulsed intravenous corticosteroids, phototherapy, mycophe- nylate mofetile, azathioprine, and interferon-gamma. FDA-approved in 1953, meth- otrexate has a long history of pediatric use for a variety of inflammatory conditions, including rheumatoid arthritis, Crohn’s disease, and psoriasis. It is inexpensive, conveniently dosed once-weekly, and is especially well-tolerated in children. Case reports have documented efficacy of methotretate for the treatment of severe atopic dermatitis in adults, but no information is published on treatment in children with this disease. Methods: We retrospectively reviewed 30 cases of children with severe atopic dermatitis treated with methotrexate over the past 3 years, including indications, initial and adjusted dosing, laboratory parameters, adverse events, and efficacy. Results: Patients ranged in age from 2 to 16 years. All failed topical therapy for a variety of reasons. Many had received previous therapy with cyclosporine and were successfully crossed-over to methotrexate. All received an initial dose of 0.5 mg/kg/week (maximum 15 mg). Most tolerated tablet form. Of children who received liquid, most were given syringes of the concentrated 25 mg/cc parenteral formulation. Supplemental folic acid (1 mg) was added after the first month on nonmethotrexate days. In-office follow-up and laboratory assessments occurred at baseline and monthly for 3 months, then every 3 months thereafter if the dose was stable. Laboratory parameters included a complete blood count with red blood cell indices and a comprehensive metabolic panel. Elevations in hepatic transaminases were transient and unusual, most commonly caused by blood specimens obtained within 1 to 2 days after methotrexate was administered, or a presumed viral illness. No child underwent liver biopsy. On average, dose adjustments were made every 2 to 3 months as needed. The majority of patients had partial to complete response to treatment. No serious adverse events occurred after an average of 12 months. Conclusions: Methotrexate is a useful systemic treatment option for children with severe atopic dermatitis. We recommend following similar guidelines for treatment. Commercial support: None identified. P701 Allergic contact dermatitis in 136 children patch tested between 2000 and 2006 Lonnie Hammonds, MD, Mayo Clinic Jacksonville, Jacksonville, FL, United States; Virginia Hall, MD, Mayo Clinic Jacksonville, Jacksonville, FL, United States; Mark Davis, MD, Mayo Clinic Rochester, Rochester, MN, United States A retrospective review of the Mayo patch test database was performed on all children 18 or younger tested between 2000 and 2006. One-hundred thirty-six children were patch tested from age 3 to 18. Females constituted 66% of those tested and males 34%. Eighty percent of the children were equally distributed between age groups 11-15 and 16-18, with the remainder being 10 years or younger. Sixty-one percent of the children tested positive to at least one allergen. Males younger than 10 were most likely to have a positive patch test; however, the percent of positive tests in males decreased with increasing age. Females younger than age 10 were less likely to have a positive test than older females. The most common allergens were nickel, cobalt, gold, and thimerosol. Commercial support: None identified. FEBRUARY 2008 J AM ACAD DERMATOL AB7
  13. 13. P1300 Pigmentary mosaicism of the penis—Correlation of embryology and patterns of birthmark development on the penis Nanette Silverberg, MD, St. Luke’s-Roosevelt Hospital Center, New York, NY, United States The penis develops in the latter half of the first trimester. The penis forms from the ectoderm, mesoderm, and endoderm. The ectodermal skin over the penis forms from the urogenital folds, which fuse ventrally in the median plane forming the penile raphe. By the twelfth week of gestation, the prepuce forms as a circular ingrowth of the ectoderm. The urethra is formed from the endodermal urogenital sinus and the connective tissue and smooth muscle from the mesoderm. Congenital lesions of the penis have been described, but no systematic look at their relationship to development has been published. In this poster, the development of the penis is described and the pattern of Blaschko’s lines of the penis is demonstrated. An analogy of penile birthmarks to the pattern Happle schema of pigmentary mosaicism is demonstrated pictorially, including nevoid hypermelanosis, cafe´ au laits, and segmental neurofibromas of the penis and speckling. Commercial support: None identified. P1409 Isopropyl myristate 50% as a novel pediculicide in the treatment of head lice Aditya Gupta, MD, PhD, MBA, Mediprobe Research Inc., London, ON, Canada; Nalini Kaul, PhD, Saint Boniface General Hospital Research Centre, Winnipeg, AB, Canada; Kathleen Palma, PhD, Piedmont Pharmaceuticals, Greensboro, NC, United States Infestations with head lice are most common among school aged children and affect between 6 and 12 million Americans annually. Standard treatment for lice has historically been over-the-counter neurotoxic pediculicides, such as permethrin, pyrethrin, and lindane. However, growing concern over the use of such neurotoxic treatments and the increasing resistance of lice to these products has led to the development of new non-neurotoxic treatments. A new pesticide-free hair rinse containing 50% isopropyl myristate (IPM 50%) has demonstrated efficacy in several phase 2 and phase 3 clinical trials. In a Canadian study, IPM 50% was shown to have a 96.5% cure rate (complete eradication of lice) with 100% lice mortality at 24 hours after a 10-minute treatment. In a phase II trial in the United States, higher success rates were reported for IPM 50% when compared with 0.33% pyrethrin plus 4% piperonyl butoxide with no live lice (57% of subjects vs. 22%; P.001). In a phase II study in the United Kingdom, success rates were also higher for IPM 50% when compared to permethrin 1% (no live lice 77.1% of subjects vs. 20%; P.001). Most recently, a phase III study conducted in the United Kingdom showed cure rates (complete eradication of lice) for IPM 50% to be significantly higher than cure rates for 1% permethrin, (78.4% vs. 20%; P .001). IPM 50% has been safely used in cosmetic and dermatologic products for years, and given the efficacy data from clinical trials, it appears to be an acceptable option for the treatment of head lice. Supported by Piedmont Pharmaceuticals and Altana Pharma Inc., a Nycomed company. P2300 Etanercept treatment in children and adolescents with plaque psoriasis Amy Paller, MD, Children’s Memorial Hospital and Northwestern University Medical School, Chicago, IL, United States; Richard Langley, MD, Dalhousie Medical School, Halifax, NS, Canada; Elaine Siegfried, MD, Kids Dermatology, Creve Coeur, MO, United States; Alice Gottlieb, MD, PhD, Tufts-New England Medical Center, Boston, MA, United States Treating psoriasis (PsO) in children is challenging. Patients may not respond to or tolerate conventional agents, and neither topical nor systemic therapies have been well-studied in children. Although there are published case reports on the use of biologics in children with promising results, this is the first clinical study assessing etanercept (ETN) in children with PsO. In this 48-week study, 211 children (4 to 17 yrs) with PsO involving $10% body surface area and PASI score $12 were randomly assigned 1:1 in a 12-week, double-blind, placebo-controlled treatment period to once-weekly subcutaneous placebo or ETN 0.8 mg/kg (#50 mg), followed by 24 weeks of open-label ETN, then a 12-week randomized, double-blind withdrawal- retreatment period. Patients who did not achieve PASI 50 at week 24 or PASI 75 at week 36 could add topical standard of care therapy. The primary endpoint was PASI 75 response at week 12. Further endpoints included, but were not limited to, PASI 75 at other time points, PASI 50, PASI 90, static Physician’s Global Assessment (PGA), and safety measures. Baseline demographics and disease characteristics were similar across treatment arms. At week 12, 57% of ETN patients achieved PASI 75, compared with 11% of those who received placebo (P .001); proportions of patients who achieved PASI 50, PASI 90, and PGA clear or almost clear were also significantly greater in the ETN arm than the placebo arm. Differences in PASI 75 between treatment arms were observed by week 4. At week 24, percentages of patients who achieved PASI 75/PGA clear or almost clear were 62%/56% for the original placebo arm and 69%/57% for the original ETN arm. PASI 75 response was maintained through week 36; 56% (original placebo arm) and 53% (original ETN arm) had PGA clear or almost clear. Proportions of patients with PASI 50 and PASI 90 at weeks 24 and 36 increased in both groups compared with week 12. Exposure-adjusted rates of noninfectious adverse events (431 per 100 patient years in the placebo group; 288 per 100 patient years in the ETN group) and infections (308 per 100 patient years in the placebo group; 229 per 100 patient years in the ETN group), were comparable between the 2 groups; most events were mild or moderate. Upper respiratory tract infection, headache, and nasopharyngitis were the most common events. During the withdrawal period, no patient experienced PsO rebound or change of PsO morphology. In this study, ETN was well-tolerated and provided significant and sustained improvement in disease severity in children and adolescents with moderate to severe plaque PsO. Research funded by Immunex Corporation, a wholly owned subsidiary of Amgen Inc., and by Wyeth Pharmaceuticals. P2301 Lack of recurrence of multiple connective tissue nevi after surgical debulking and application of topical imiquimod 5% cream Oliver Perez, MD, University of Miami, Miller School of Medicine, Miami, FL, United States; Cynthia Burk, MD, University of Miami Miller School of Medicine, Miami, FL, United States; Brian Berman, MD, PhD, University of Miami Miller School of Medicine, Miami, FL, United States; Elizabeth Alvarez Connelly, MD, University of Miami Miller School of Medicine, Miami, FL, United States A 16-year-old white female presented to the pediatric dermatology clinic for evaluation of multiple, enlarging tumors of the plantar surface of her feet and toes bilaterally, affecting her ambulation. The tumors of her feet were first noticed at 5 years of age and had been increasing in size thereafter. The lesions were initially diagnosed as keloids. Attempts at excision had resulted in the recurrence of larger tumors. Her past dermatologic history was significant for multiple lipomas of her abdomen and left breast beginning at 2 years of age, which were removed but had partially recurred. Her past medical history was significant for a gastrointestinal bleed of undetermined etiology, occurring at 4 years of age, and a venous malformation of the left leg. Her ophthalmology examination was normal. Her family history was negative for skin tumors, gastrointestinal bleeds, and colon or breast cancer. On physical examination, she exhibited macrocephaly and multiple verrucous, cerebriform tumors on the plantar surface of the left foot and toes bilaterally. The largest tumor measured 5 cm 3 3.5 cm on her left lateral foot. Wedge biopsies performed at presentation revealed papillomatosis with hyperkeratosis and fibromatosis, consistent with connective tissue nevi (CTN) of the collagenoma subtype. The patient’s biopsy did not show evidence of scar or keloid tissue formation and showed overlying hyperkeratosis and dense dermal fibrosis. Given her history as well as the clinical and histologic findings, the diagnosis of BannayaneRileyeRuvalcaba syndrome was considered. Of all her dermatologic findings, the CTN caused the most morbidity to the patient. Imiquimod 5% cream is known to upregulate interferon production. Interferon is known to have proapop- totic, antiproliferative, and antiangiogenic activities that may be useful for the treatment of expanding CTN, specifically targeting the fibroblasts. Imiquimod, when applied to the skin, activates macrophages, natural killer cells, and Langerhans cells as well as induces local interferon-a, -g, TNF-a, and interleukin-1, -6, -8, and -12 production. This background rationale led to our clinical approach to this patient, which included surgical debulking to remove the majority of the CTN. Subsequently, the patient applied imiquimod 5% cream nightly for 12 weeks. At the patient’s 10- month follow-up, her CTN had not recurred. We report this as a novel treatment for CTN, because it has not been reported previously in the literature. Commercial support: None identified. AB8 J AM ACAD DERMATOL FEBRUARY 2008
  14. 14. POSTER DISCUSSION SESSION 495—MEDICAL DERMATOLOGY P400 Successful treatment of the erythema and flushing of rosacea using a topically applied selective a1 adrenergic receptor agonist, oxymetazoline Stuart Shanler, MD, Las Cruces Dermatology, Las Cruces, NM, United States; Andrew Ondo, MD, Las Cruces Dermatology, Las Cruces, NM, United States Background: Rosacea is a common chronic cutaneous disorder affecting more than 40 million people worldwide. Type I, or erythematotelangiectatic rosacea (ETR), is the subtype of rosacea characterized by frequent episodes of transient facial erythema (flushing) and/or persistent erythema, and may be accompanied by facial edema, burning, or stinging. ETR in general responds poorly to treatment and there are no effective topical therapies directed towards the erythema and telangiectasias. While rosacea remains a disorder of uncertain etiology and pathogenesis, the abnormal flushing and persistent erythema have usually been theorized to arise from a progressive dysregulation of the cutaneous vasomotor response resulting in an abnormal and persistent dilation of facial blood vessels. The mechanism of such ‘‘dysregulation’’ has never been elucidated. The regulation of the cutaneous circulation is extremely complex and activation of adrenergic receptors (adreno- ceptors) present on vascular smooth muscle may result in vasoactive changes that are difficult to predict. Recent studies, however, have demonstrated that the contraction of peripheral vascular smooth muscle is primarily mediated by a1A and a1D adrenoceptor subtypes, and certain experimental models indicate several a2 receptors may play a role as well. Objective: An attempt to treat ETR using topically applied oxymetazoline, an over- the-counter drug known to be a potent selective a1A and partially selective a2A adrenoceptor agonist—a potent vasoconstrictor—was undertaken. Methods: A commercially available preparation ofoxymetazoline 0.05% solution was applied once daily to the faces of 4 patients with ETR. Clinical evaluation and high resolution digital photographs were performed pretreatment, 1, 3, and 24 hours after a single application and 1 and 3 months after initiating once daily application. Results: All 4 patients showed clinical improvement in the erythema, marked decrease in the erythematous flares (flushing), relief from the stinging/burning, and no adverse effects. The effect was noted within 1 hour of drug application, lasted more than 6 hours, and was maintained at 3-month follow-up. Conclusion: We propose that the erythema and flushing of ETR may be caused by an abnormal expression, function, distribution, or responsiveness of a adrenoceptors, likely of an a1 subtype, and that ETR may be successfully treated by the topical application of agonists selective for these receptors, such as oxymetazoline. Commercial support: None identified. P805 Cutaneous metastases: Utility of skin biopsy in the diagnosis of non skin neoplasias Brenda Lopez Tintos, MD, Instituto Nacional de Ciencias Medicas y Nutricion, Mexico City, Mexico; Ana Ruelas Villavicencio, MD, Instituto Nacional de Ciencias Medicas y Nutricion, Mexico City, Mexico; Linda Garcia Hidalgo, MD, Instituto Nacional de Ciencias Medicas y Nutricion, Mexico City, Mexico; Rocio Orozco Scholtes, MD, Instituto Nacional de Ciencias Medicas y Nutricion, Mexico City, Mexico Background: Cutaneous metastases present in 2% to 10% of stage IV neoplasias. They are the initial presentation of neoplasia in 0.8%. Melanoma, breast, colon, and lung cancer are the most often found. The utility of skin biopsy in the diagnosis of primary tumors has not been quantified. Objective: To describe the epidemiologic and clinical features of skin metastases and determine the utility of skin biopsy in the diagnosis of primary tumor. Methods: We reviewed the medical charts of patients with skin metastases or leucemic infiltration from 1979 to 2006. We excluded patients with primary cutaneous lymphoma or unavailable chart. Results: Patients: We found 40 patients (50% male) with a mean age of 57 years (617 yrs). Time elapsed from initial presentation of a skin metastasis to skin biopsy was 5.85 months (range, 0-96 mos). In patients who died, survival after skin biopsy was 5.43 months. Two patients reached cure (seminoma and breast carcinoma). Four patients with a follow-up of less than 5 months arestill alive. Metastases: Most frequent primary tumors were: breast cancer (17.5%), gastrointestinal tract adenocarcinoma (20%), hematologic (17.5%), and primary unknown adenocarcinoma (after an exhaustive medical search; 12.5%). The most frequent sites included the thorax (27.5%) and abdomen (15%), scalp (10%), legs (12.5%), groin, neck, and surgical scar (7.5% each). Nodular metstases were 78.4% (13% erysipeloid). Skin biopsy utility: Skin biopsy diagnosed a previously unknown neoplasia in 45% patients, a metastasis of an already known tumor was confirmed in 40%, skin and primary tumor biopsies coincided in 10%, and there was an equivocal diagnosis of primary tumor with skin biopsy in 5%. In 3 cases, this method detected recurrence of neoplasia. Discussion: Skin metastases are found mostly in late stages of a neoplasia, and prognosis is usually ominous and short-term. However, depending of the type of neoplasia, there are still some cases that may be cured. In this study, we included diverse types of neoplasia and we confirmed the utility of skin biopsy for the initial diagnosis of a systemic neoplasia (up to 45% of cases obtained diagnosis by this method). This high incidence of new diagnosis of cancer by skin biopsy could also reflect a tendency of our population to search for health care in a delayed fashion. Conclusions: Skin biopsy is an accesible, fast, and useful method to diagnose a non- skin neoplasia. In some cases, it is still necessary to biopsy the primary tumor for confirmation of histology. Commercial support: None identified. P1202 Incidence of nonmelanoma skin cancer in a cohort of 479 vitiligo patients Camile L. Hexsel, MD, Department of Dermatology, Henry Ford Hospital, Detroit, MI, United States; Melody Eide, MD, MPH, Department of Dermatology, Henry Ford Hospital, Detroit, MI, United States; Richard Krajenta, Christine C. Johnson, PhD, Department of Biostatistics and Epidemiology, Henry Ford Hospital, Detroit, MI, United States; Iltefat Hamzavi, Henry W. Lim, MD, Department of Dermatology, Henry Ford Hospital, Detroit, MI, United States Background: Despite the loss of melanin in vitiligo, the incidence of skin cancer is unknown. Objective: To quantify the incidence of skin cancer in a cohort of 479 vitiligo patients. Methods: Using the HFHS database, 518 patients were identified by the ICD-9 code for vitiligo recorded at least twice from January 2001-July 2006. Medical record abstraction was performed to validate cases of vitiligo (n ¼ 479, 92%) and to identify patients who developed biopsy-confirmed skin cancer within the inclusion period. The incidence rates were age-adjusted to the 2000 US standard million, and for the purpose of comparison, to previously reported incidence rates of nonmelanoma skin cancer in the United States, also standardized to the 1970 US standard million.1 Results: A total of 6 patients developed skin cancer, 4 basal cell carcinomas (all male), 2 squamous cell carcinomas (1 male, 1 female) diagnosed in both vitiliginous (n ¼ 2) and unaffected skin (n ¼ 4). All skin cancer patients were white ([61 yrs of age). Annual incidence rates in white vitiligo patients, age-adjusted to the 2000 and 1970 US Standard Million were: basal cell carcinoma (BCC) males, 772/100,000 and 627/100,000; squamous cell carcinoma (SCC), males 153/100,000 and 112/100,000; SCC, females 149/100,000 and 107/100,000. Incidence rates are higher than incidence rates of NMSC in the US white population derived from the Kaiser- Permanente database by Miller and Weinstock.1 Conclusion: Skin cancer incidence in the white vitiligo cohort was higher than white US rates. The risk of nonmelanoma skin cancer in white vitiligo patients should not be ignored. Because of the limited sample size, incidence in non-whites could not be assessed. Reference 1. Miller DL, Weinstock MA. Nonmelanoma skin cancer in the United States: incidence. J Am Acad Dermatol 1994;30:774-8. Commercial support: None identified. P1411 A phase II randomized bilateral comparison study of bexarotene 1% gel in alopecia areata Rakhshandra Talpur, MD, University of Texas MD Anderson Cancer Center, Houston, TX, United States; Roland Bassett, MS, University of Texas MD Anderson Cancer Center, Houston, TX, United States; Madeleine Duvic, MD, University of Texas MD Anderson Cancer Center, Houston, TX, United States; Victor Stevens, PhD, Ligand Pharmaceuticals, San Diego, CA, United States Alopecia areata (AA), a T-cell mediated autoimmune disease directed against hair follicles, can result in patchy (AA) or total loss (alopecia totalis [AT]) of scalp hair or loss of all hair (alopecia universalis [AU]), and is often refractory to therapy. Bexarotene (bex) is an RXR selective retinoid that induces T-cell apoptosis and is effective for the treatment of cutaneous T-cell lymphoma. We previously observed that bexarotene reversed alopecia in CTCL patients and therefore conducted a phase II study of topical targretin gel for AA. Forty-two patients (11 males, 31 females) with AT (n ¼ 3), AU (n ¼ 5) or patchy AA (n ¼ 34) were randomized to apply 1% topical bexarotene gel to one half of the scalp once daily for 2 weeks, then twice daily for 24 weeks. Responders were allowed continue therapy on both sides of the scalp for another 24 weeks. Assessments of index lesions, hair density, labs, and adverse events were performed monthly. Thirty-nine patients used the drug and were evaluable for response. Twelve patients of 39 (30.7%) had [50% partial hair regrowth: 6 improved on both sides including 1 with ATand 6 had responses limited to 1 side. Twenty patients had stable disease, 7 progressed while on therapy, and 3 patients withdrew after 2 weeks of study. Erythema, scaling, and/or itching caused by local irritation at the application site were experienced by 26 patients, and required a decreased application frequency in 8 patients. Four patients with no response were grade 3 dermal irritation. Five of 12 responders elected to continue treatment for 48 weeks: 3 achieved complete hair regrowth, 1 had bilateral partial responses, and 1 patient had a complete response on 1 side and stable disease on the other. Topical bex 1% is generally well tolerated with mild irritation and was associated with a 30% response in AA. Commercial support: None identified. FEBRUARY 2008 J AM ACAD DERMATOL AB9

×