An Emerging Therapy for
the Effective Treatment
of Rheumatoid Arthritis:
      The Evidence for a Selective
      Co-Stimu...
An Emerging Therapy for the Effective Treatment of Rheumatoid Arthritis:
The Evidence for a Selective Co-Stimulation Modul...
An Emerging Therapy for the Effective Treatment of Rheumatoid Arthritis:
The Evidence for a Selective Co-Stimulation Modul...
An Emerging Therapy for the Effective Treatment of Rheumatoid Arthritis:
The Evidence for a Selective Co-Stimulation Modul...
An Emerging Therapy for the Effective Treatment of Rheumatoid Arthritis:
The Evidence for a Selective Co-Stimulation Modul...
An Emerging Therapy for the Effective Treatment of Rheumatoid Arthritis:
The Evidence for a Selective Co-Stimulation Modul...
An Emerging Therapy for the Effective Treatment of Rheumatoid Arthritis:
The Evidence for a Selective Co-Stimulation Modul...
An Emerging Therapy for the Effective Treatment of Rheumatoid Arthritis:
The Evidence for a Selective Co-Stimulation Modul...
An Emerging Therapy for the Effective Treatment of Rheumatoid Arthritis:
The Evidence for a Selective Co-Stimulation Modul...
An Emerging Therapy for the Effective Treatment of Rheumatoid Arthritis:
The Evidence for a Selective Co-Stimulation Modul...
An Emerging Therapy for the Effective Treatment of Rheumatoid Arthritis:
The Evidence for a Selective Co-Stimulation Modul...
An Emerging Therapy for the Effective Treatment of Rheumatoid Arthritis:
The Evidence for a Selective Co-Stimulation Modul...
An Emerging Therapy for the Effective Treatment of Rheumatoid Arthritis:
The Evidence for a Selective Co-Stimulation Modul...
An Emerging Therapy for the Effective Treatment of Rheumatoid Arthritis:
The Evidence for a Selective Co-Stimulation Modul...
An Emerging Therapy for the Effective Treatment of Rheumatoid Arthritis:
The Evidence for a Selective Co-Stimulation Modul...
An Emerging Therapy for the Effective Treatment of Rheumatoid Arthritis:
The Evidence for a Selective Co-Stimulation Modul...
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Rhematoid Arthritis_CME symposium program abstracts and introduction written by Crystal Kaczkowski

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Abstracts and intro written having been given only the titles of the abstracts. I did all the literature reviews/research to write and reference the abstracts for these rheumatologists (key opinion leaders) for this Mexican meeting. I also attended the meeting and subsequently wrote a report.

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Rhematoid Arthritis_CME symposium program abstracts and introduction written by Crystal Kaczkowski

  1. 1. An Emerging Therapy for the Effective Treatment of Rheumatoid Arthritis: The Evidence for a Selective Co-Stimulation Modulator e pl m sa g in rit iw sk Mexican Canadian th Congreso de Annual Meeting 61 st 1st 34 w ko Mexicano of the Canadian Congress of cz Rheumatologia Rheumatology Ka Rheumatology al Association st ry C FEBRUARY 20, 2006 THE FAIRMONT ACAPULCO PRINCESS ACAPULCO, MEXICO Mexican Canadian Congress A University of Alberta of Rheumatology CME accredited program
  2. 2. An Emerging Therapy for the Effective Treatment of Rheumatoid Arthritis: The Evidence for a Selective Co-Stimulation Modulator INTRODUCTION Rheumatoid Arthritis (RA) is a debilitating disease that results in significant morbidity, reduced quality of life, and a decreased life span. In recent years, major progress has been made in understanding the immunopathology of RA, leading to the development of new therapeutic agents, biologics and non-biologics. Agents such as Disease- Modifying Anti-Rheumatic Drugs (DMARDs) and Tumour Necrosis Factor-α Inhibitors have proven efficacious for many patients with RA. However, these agents are not effective in all cases and some patients may experience side effects that can be problematic. New options are needed for patients who do not benefit sufficiently from, or cannot tolerate, these therapeutics. The immune system mediators have been targeted in the search for more effective management strategies, such as the actions of T and B lymphocytes, macrophages, and e cytokines. The selective T cell co-stimulation modulator represents an emerging class pl m sa of biologic agents that decrease the activation of T cells, which are critical to the g initiation and progression of RA. Results of current Phase III clinical trials investigating in rit iw the first of these agents, abatacept, have shown that it is effective, safe, and offers sk considerable improvement in quality of life measures. w ko cz Ka The complexity and rapid evolution of this field requires that physicians keep abreast al st of these new advances in preparation for providing optimal clinical treatment for ry C patients with RA. In this symposium, respected Canadian and Mexican rheumatologists will discuss clinical and scientific developments in the evolving management of RA, and examine the prevailing research related to the emerging role of selective T cell co-stimulation modulation. 1
  3. 3. An Emerging Therapy for the Effective Treatment of Rheumatoid Arthritis: The Evidence for a Selective Co-Stimulation Modulator TARGET AUDIENCE This symposium is intended primarily for rheumatologists from Canada and Mexico and other physicians with an interest in learning more about the pathophysiology, management, and emerging research in the care of patients with rheumatoid arthritis. EDUCATIONAL OBJECTIVES • Identify the major immunological events underlying the initiation of RA • Discuss the pivotal role of T cell co-stimulation in the development and perpetuation of RA • Describe the mechanism of action of co-stimulation modulation • Evaluate the latest Phase III safety, efficacy, and quality of life data on co-stimulation modulation in RA ACCREDITATION e pl m sa This education event is approved as an Accredited g in Group Learning Activity under Section 1 of the rit iw Framework of Continuing Professional Development sk w options for the Maintenance of Certification Program of ko cz the Royal College of Physicians and Surgeons of Canada. Ka al st FACULTY ry C Carlos Abud-Mendoza, MD (Co-chair) Departmento de Immunologia, Facultad de Medicina Universidad Autónoma de San Luis Potosi (UASLP) Hospital Regional San Luis Potosi San Luis Potosi, México Anthony S. Russell, MB, ChB, FRCPC (Co-chair) Division of Rheumatology, Faculty of Medicine, University of Alberta Walter C. Mackenzie Health Sciences Centre Edmonton, Alberta, Canada Mario H. Cardiel, MD, MSc (Speaker) Unidad de Investigación, Hospital General “Dr. Miguel Silva” Morelia, Michoacan, México J. Carter Thorne, MD, FRCPC, FACP (Speaker) Division of Rheumatology, Faculty of Medicine, University of Toronto Toronto, Ontario, Canada Southlake Regional Health Care The Arthritis Program Research Group Newmarket, Ontario, Canada 2
  4. 4. An Emerging Therapy for the Effective Treatment of Rheumatoid Arthritis: The Evidence for a Selective Co-Stimulation Modulator AGENDA Chairmen Carlos Abud-Mendoza, MD Anthony S. Russell, MD 14:00 – 14:10 Welcome and Introduction Anthony S. Russell, MD Carlos Abud-Mendoza, MD 14:10 – 14:15 Establishing a Baseline for Current Knowledge and Contemporary Practice (Touch Pad Response) e Anthony S. Russell, MD pl m sa 14:15 – 14:30 Immunopathology and Clinical Challenges g in rit in the Evolving Treatment of RA iw sk Anthony S. Russell, MD w ko cz 14:30 – 14:50 The Efficacy and Safety of Existing and Ka Emerging RA Therapies: An Evidence Based Profile al st ry J. Carter Thorne, MD C 14:50 – 15:05 Maximizing Quality of Life for RA Patients with Emerging Therapies: Key Findings from Clinical Trials Mario H. Cardiel, MD 15:05 – 15:20 Questions and Answers Carlos Abud-Mendoza MD 15:20 – 15:25 Measuring Post-Meeting Knowledge and Propensity for Clinical Application of New Scientific Information (Touch Pad Response) Carlos Abud-Mendoza, MD 15:25 – 15:30 Conclusion Anthony S. Russell, MD Carlos Abud-Mendoza, MD 3
  5. 5. An Emerging Therapy for the Effective Treatment of Rheumatoid Arthritis: The Evidence for a Selective Co-Stimulation Modulator ABSTRACTS Immunopathology and Clinical Challenges in the Evolving Treatment of RA Anthony S. Russell, MB, ChB, FRCPC Division of Rheumatology, Faculty of Medicine, University of Alberta Walter C. Mackenzie Health Sciences Centre Edmonton, Alberta, Canada available in the management of rheumatoid arthritis (RA) have advanced considerably in the T HERAPEUTIC OPTIONS last two decades. Biological therapies hold the promise of targeted intervention. Recent progress in the develop- ment of these therapies shows that rational targeting can provide clinical benefit to RA patients.1 Although the devel- opment of biologic agents (eg, tumour necrosis factor-α inhibitors, interleukin inhibitors) have revolutionized the treatment of RA, some patients still suffer from inadequate response to treatment.2 A substantial proportion of RA patients either do not respond to these agents or experience a reduction in their initial response.3,4 Furthermore, anti- e pl TNF agents are associated with increased rates of infection, lymphoma, and tuberculosis. These issues of long-term m sa efficacy and safety have created a compelling need to develop new therapeutic strategies. g Ongoing research efforts have resulted in a clearer understanding of the role of inflammatory mediators and have in rit led to the development of additional biologic agents. These agents fall into three major groups: those that target T cells, iw sk those that target B cells, and those that target the cytokine pathways involved in RA. Novel therapeutic options on the w horizon include: abatacept, a selective T cell co-stimulation modulator; rituximab (RTX), a B cell depleting agent; and ko cz tocilizumab (MRA), an interleukin-6 (IL-6) inhibitor. Clinical trials are underway to investigate the efficacy and safety Ka of these emerging therapeutic agents. al st Abatacept has demonstrated considerable efficacy and safety in treating the signs and symptoms of RA.5-9 This ry C agent has recently gained regulatory approval in the United States. Two recent Phase III trials and two long-term exten- sion trials evaluated the efficacy of abatacept, one in patients who were not responding adequately to methotrexate (MTX)6 and the other in patients who were not responding adequately to anti-TNF-α therapy.7 A third Phase III clin- ical study compared the safety of abatacept use with other RA therapies.9 Rituximab is a genetically engineered chimeric monoclonal antibody against CD20, and has been approved for the treatment of relapsed or refractory B cell non- Hodgkin’s lymphoma in Canada and the United States. This agent is undergoing clinical trials for treatment of RA, with early studies showing promising results in patients who were not responding adequately to methotrexate10,11 and in patients who were not responding adequately to management with anti-TNF-α therapy.12 IL-6 is a pleiotropic cytokine that plays an important role in immune response.13,14 It is involved in both initiation and maintenance of inflammatory and immunologic responses in certain autoimmune diseases and plays a key role in acute phase protein induction as well as B and T cell growth and differentiation. Tocilizumab is the first humanized anti-IL-6 receptor antibody to reach Phase III clinical trials. It is now being studied in RA patients, with early studies showing promising results.15-18 Like other biologic disease-modifying anti-rheumatic drugs (DMARDs), these agents are associated with slightly increased rates of infection and serious infection. Phase III trials and long-term extension studies are being carried out to provide further evidence of the relative efficacy and safety of these drugs for the treatment of RA. References: 1. Carter RH. B cell signaling as therapeutic target. Ann Rheum Dis. 2004;63(Suppl II):ii65-ii66. 2. Weinblatt ME. Will our current success in treating rheumatoid arthritis hinder new drug development? That is the question!! Ann Rheum Dis 2005;64:1529–1531. 3. Keystone EC. Tumor necrosis factor-a blockade in the treatment of rheumatoid arthritis. Rheum Dis Clin North Am 2001;27:427-443. 4. Olsen NJ, Stein CM. New drugs for rheumatoid arthritis. N Engl J Med 2004;350:2167-2179. 4
  6. 6. An Emerging Therapy for the Effective Treatment of Rheumatoid Arthritis: The Evidence for a Selective Co-Stimulation Modulator 5. Moreland LW, Alten R, Van den Bosch F, et al. Costimulatory blockade in patients with rheumatoid arthritis: a pilot, dose-finding, double- blind, placebo-controlled clinical trial evaluating CTLA-4Ig and LEA29Y eighty-five days after the first infusion. Arthritis Rheum 2002;46:1470- 1479. 6. Kremer JM, Westhovens R, Leon M. et al. Treatment of rheumatoid arthritis by selective inhibition of T-cell activation with fusion protein CTLA4Ig. N Engl J Med 2003;349:1907-1915. 7. Genovese MC, Becker JC, Schiff M, et al. Abatacept for rheumatoid arthritis refractory to Tumor Necrosis Factor α inhibition. N Engl J Med 2005;353:1114-1123. 8. Kremer JM, Dougados M, Emery P, et al. Treatment of rheumatoid arthritis with the selective costimulation modulator abatacept: twelve- month results of a phase IIb, double-blind, randomized, placebo-controlled trial. Arthritis Rheum 2005;52:2263-2271. 9. Weinblatt M, Combe B, White A, et al. Safety of Abatacept in patients with active rheumatoid arthritis receiving background non-biologic and biologic DMARDS: 1-year results of the ASSURE trial. Ann Rheum Dis 2005;64(Suppl. 3):60(Abstract OP0012). 10. Edwards JC, Szczepanski L, Szechinski J, et al. Efficacy of B-cell-targeted therapy with rituximab in patients with rheumatoid arthritis. N Engl J Med 2004;350:2572-2581. 11. Edwards JC, Leandro MJ, Cambridge G. B lymphocyte depletion in rheumatoid arthritis: targeting of CD20. Curr Dir Autoimmun 2005;8:175- 192. 12. Cohen SB, Greenwald M, Dougados MR, et al. Efficacy and safety of rituximab in active RA patients who experienced an inadequate response to one or more anti-TNF-α therapies (REFLEX study). Arthritis Rheum 2005;52(9 Suppl):S677(Abstract 1830). 13. KishimotoT. Interleukin-6 and its receptor in autoimmunity. J Autoimmune 1992;5:I123-132. 14. Guerne PA, Zuraw BL, Vaughan JH, et al. Synovium as a source of interleukin 6 in vitro. Contribution to local and systemic manifestations of arthritis. J Clin Invest 1989;83:585-592. 15. Nishimoto N, Yoshizaki K, Miyasaka N, et al. Long-term safety and efficacy of anti-interleukin 6 receptor antibody (MRA) in patients with e rheumatoid arthritis. Paper presented at: Program and Abstracts of the American College of Rheumatology 67th Annual Scientific Meeting; pl m October 23-28, 2003; Orlando, Florida. Abstract S216. sa 16. Nishimoto N, Yoshizaki K, Maeda K, et al. Toxicity, pharmacokinetics, and dose-finding study of repetitive treatment with the humanized anti- g in interleukin 6 receptor antibody MRA in rheumatoid arthritis. Phase I/II clinical study. J Rheumatol 2003;30:1426-1435. rit iw 17. Nishimoto N, Yoshizaki K, Miyasaka N, et al. Treatment of rheumatoid arthritis with humanized anti-interleukin-6 receptor antibody: a mul- sk ticenter, double-blind, placebo-controlled trial. Arthritis Rheum 2004;50:1761-1769. w 18. Maini RN, Taylor PC, Pavelka K, et al. Efficacy of IL-6 receptor antagonist MRA in rheumatoid arthritis patients with an incomplete response ko to methotrexate (CHARISMA). Paper presented at: Program and Abstracts of the American College of Rheumatology 67th Annual Scientific cz Ka Meeting; October 23-28, 2003; Orlando, Florida. Abstract S1704. al st ry C 5
  7. 7. An Emerging Therapy for the Effective Treatment of Rheumatoid Arthritis: The Evidence for a Selective Co-Stimulation Modulator The Efficacy and Safety of Existing and Emerging RA Therapies: An Evidence Based Profile J. Carter Thorne, MD, FRCPC, FACP Division of Rheumatology, Faculty of Medicine, University of Toronto Toronto, Ontario, Canada Southlake Regional Health Care The Arthritis Program Research Group Newmarket, Ontario, Canada EW PARADIGMS in the management of Rheumatoid Arthritis have permitted the concept of ‘Treatment to Remission’ N rather than just ‘Improvement’. These treatment initiatives have included: Early Diagnosis and Treatment; Early Combination Treatment; Treatment based on Outcomes; Introduction of Biologic Agents. Yet, using current strategies and agents, a ‘State of Remission’ is achieved and sustained in only approximately 40% of patients. Other options are required, and these may be best attained by recognition of ‘Mechanism of Action’ as a determinant of Outcome. Selective co-stimulation modulation of T cell activation has been shown to be efficacious and safe in treating the signs and symptoms of RA. The first agent in this class, abatacept, has been investigated in Phase III trials.1-4 The e pl Phase III AIM (Abatacept in Inadequate Responders to Methotrexate [MTX]) trial,2 assessed efficacy, safety, and qual- m sa ity of life (QoL) parameters in patients with inadequate responses to MTX. Patients were randomized to receive a fixed g in dose of abatacept (~10 mg/kg) or placebo intravenously on Days 1, 15, and 29, and every 28 days thereafter. Treatment rit with abatacept produced statistically significant improvements in American College of Rheumatology (ACR) 20, 50, iw sk and 70 responses at 6 months and 1 year compared with placebo (p<0.001). Disease Activity Score 28 (DAS28) <2.6 w ko remission rates were also significantly higher at 6 months (14.8% vs 2.8%) and 1 year (23.8% vs 1.9%) in abatacept- cz and placebo-treated patients respectively (p<0.001). A Phase II, open-label, long-term extension of this trial up to 3 Ka years provided further evidence of the efficacy of abatacept in this patient population with significantly improved ACR al st scores and pain reduction.5 ry C The ATTAIN (Abatacept Trial in Treatment of Anti-TNF INadequate responders) trial3 assessed efficacy, safety, and QoL parameters in patients who had failed one or more TNF-α inhibitors over 18 months, comprising 6 months of double-blind treatment and a 1-year, open-label, long-term extension. Clinical improvements in ACR and health assessment questionnaire scores were noted soon after treatment commenced (at Day 15). Sustained improvements continued throughout the 18-month study. DAS28 remission was achieved in 22.5% of the patients who completed 18 months of abatacept treatment. Treatment with abatacept/MTX demonstrated significantly better ACR 50 and 70 scores (35.0% and 18.0%, respectively) at 18 months compared with MTX/placebo treatment. The safety of the co-stimulation modulator, abatacept, has also been demonstrated. Moreland et al evaluated the results of five clinical trials, including 1955 patients treated with abatacept and DMARDs, representing 1527.4 person- years of exposure.7 Results demonstrated that overall deaths, adverse events (AEs), serious adverse events (SAEs), and discontinuations were comparable between abatacept and placebo treatment groups. The most commonly reported AEs with abatacept/DMARD treatment (occurring at a rate > 2% higher than placebo/DMARD treatment) were headache (18.2%), nasopharyngitis (11.5%), dizziness (9.4%), hypertension (6.6%), and dyspepsia (6.4%). Abatacept is generally safe and well-tolerated, especially when given in combination with non-biologic DMARDs. However, when abatacept is coadministered with biologic DMARDs, higher rates of AEs, SAEs, and infections have been reported.7 Thus, abatacept is not recommended in combination with biologic DMARDs. Like other biologic DMARDs, abatacept is associated with slightly increased rates of infection and serious infection. These adverse reac- tions may be related to blockade of TNF-α and thus represent class effects of these agents.8 Results from long-term extension studies should give further supportive evidence of relative safety. Registry databases that have been set up to monitor biologic therapies in a number of countries will be required to provide evidence of the safety of these prod- ucts when administered outside the constraints of a clinical trial. 6
  8. 8. An Emerging Therapy for the Effective Treatment of Rheumatoid Arthritis: The Evidence for a Selective Co-Stimulation Modulator References: 1. Moreland LW, Alten R, Van den Bosch F, et al. Costimulatory blockade in patients with rheumatoid arthritis: a pilot, dose-finding, double- blind, placebo-controlled clinical trial evaluating CTLA-4Ig and LEA29Y eighty-five days after the first infusion. Arthritis Rheum 2002;46:1470- 1479. 2. Kremer JM, Westhovens R, Leon M. et al. Treatment of rheumatoid arthritis by selective inhibition of T-cell activation with fusion protein CTLA4Ig. N Engl J Med 2003;349:1907-1915. 3. Genovese MC, Becker JC, Schiff M, et al. Abatacept for rheumatoid arthritis refractory to Tumor Necrosis Factor α inhibition. N Engl J Med 2005;353:1114-1123. 4. Kremer JM, Dougados M, Emery P, et al. Treatment of rheumatoid arthritis with the selective costimulation modulator abatacept: twelve- month results of a phase IIb, double-blind, randomized, placebo-controlled trial. Arthritis Rheum 2005;52:2263-2271. 5. Russell A, Kremer J, Zhou Y, Mokliatchouk O, Moreland L. Abatacept induces sustained improvements in physical function and pain over 3 years in rheumatoid arthritis patients with inadequate responses to methotrexate. Arthritis Rheum 2005;52(9 Suppl):S659(Abstract 1778). 6. Genovese M, Luggen M, Schiff M, et al. Sustained improvements through 18 months with abatacept in rheumatoid arthritis patients with an inadequate response to anti-TNF therapy. Presented at: The 69th Annual Scientific Meeting of The American College of Rheumatology (ACR) 2005; November 12–17, 2005; San Diego, California. Late-breaking Abstract L16. 7. Moreland L, Kaine J, Espinoza L, et al. Safety of abatacept in rheumatoid arthritis patients in five double-blind, placebo-controlled trials. Arthritis Rheum. 2005;52(9 Suppl):S350(Abstract 886). 8. US Food and Drug Administration: Arthritis Advisory Committee March 4, 2003. Update on the TNF-α Blocking Agents. Available at http://www.fda.gov/ohrms/dockets/ac/03/briefing/3930B1_01_B-TNF.Briefing.htm. Accessed November 23, 2005. e pl m sa g in rit iw sk w ko cz Ka al st ry C 7
  9. 9. An Emerging Therapy for the Effective Treatment of Rheumatoid Arthritis: The Evidence for a Selective Co-Stimulation Modulator Maximizing Quality of Life for RA Patients with Emerging Therapies: Key Findings from Clinical Trials Mario H. Cardiel, MD, MSc Unidad de Investigación, Hospital General “Dr. Miguel Silva” Morelia, Michoacan, México (QoL) is considerably reduced in rheumatoid arthritis (RA) patients despite advanced treat- Q UALITY OF LIFE ments.1-3 Even with current therapeutic options, most patients report that their disease limits normal daily living.3,4 Treatment with emerging therapies such as rituximab (RTX) and abatacept holds the promise of targeted intervention. Rituximab is a genetically engineered, chimeric, monoclonal antibody against CD20, currently approved for the treatment of relapsed or refractory B-cell non-Hodgkin’s lymphoma. RTX is now being investigated for the treatment of RA, with early studies showing promising results.5,6 Two recent reports assessed QoL measures in randomized, double-blind studies with RTX.7,8 Patients had active disease despite treatment with DMARDs, other than MTX, and/or biological response modifiers. Patients received a single course of placebo or RTX (500 mg or 1000 mg) admin- istered on Days 1 and 15 by IV infusion along with concurrent MTX. Results from these trials with RTX showed sig- e pl nificant and clinically meaningful improvements in QoL (ie, physical function, fatigue reduction, and pain reduction) m sa as measured by Health Assessment Questionnaire Disability Index, Short Form-36, visual analog scale, and Functional g Assessment of Chronic Illness Therapy – Fatigue. These findings support the possibility of RTX as an important ther- in rit apeutic option for RA patients in the coming years. iw A second emerging therapy, abatacept, was recently approved by the FDA in the United States. Abatacept is a sk w chimeric fusion protein of CTLA4, a surface receptor on T cells and the Fc portion of Immunoglobulin (Ig)G1. Two ko cz key Phase III clinical trials, AIM (Abatacept in Inadequate Responders to MTX) and ATTAIN (Abatacept Trial in Ka Treatment of Anti-TNF INadequate Responders), assessed efficacy, safety, and QoL parameters in patients with inad- al equate responses to MTX and anti-TNF-α therapies, respectively. Patients were randomized to receive a fixed dose of st ry abatacept (~10 mg/kg) or placebo intravenously on Days 1, 15, and 29, and every 28 days thereafter. C In the AIM study, significant improvements were demonstrated for pain and all eight subscales of the physical and mental component summaries with abatacept/MTX therapy.9 Sleep quality and fatigue were also significantly improved in patients treated with abatacept in the AIM trial.9 Treatment with abatacept/MTX demonstrated signifi- cant and clinically meaningful improvements in physical function and reductions in pain.10 Reductions in pain (aver- aging over 50%) were seen even after the first dose. Furthermore, sustained improvements continued throughout, up to 3 years in a Phase II open-label, long-term extension, lending credence of a real-life setting.10 These QoL benefits were also consistent with the ATTAIN trial. Clinically meaningful benefits were seen after the first dose in physical function, pain, fatigue, and sleep quality.11 Sustained improvements continued throughout the 18-month study in the ATTAIN long-term extension.12 Together, these trials provide evidence of clinically meaningful QoL benefits with RTX and abatacept in patients previously non-responsive to treatment. References: 1. Fraenkel L, Bogardus ST, Concato J, et al. Patient preference for treatment of rheumatoid arthritis. Ann Rheum Dis 2004;63:1372-1378. 2. Wolfe F, Michaud K. Fatigue, rheumatoid arthritis, and anti-tumor necrosis factor therapy: an investigation in 24,831 patients. J Rheumatol 2004;31:2115-2120. 3. Arthritis Foundation. Living with Rheumatoid Arthritis: Unmet Needs. Available at: http://www.arthritis.org/conditions/diseasecenter/RA/ RASurveyWhitePaperFinal.pdf . Accessed November 23, 2005. 4. Young A, Dixey J, Cox N, et al. How does functional disability in early rheumatoid arthritis (RA) affect patients and their lives? Results of 5 years of follow-up in 732 patients from the Early RA Study (ERAS). Rheumatology (Oxford) 2000;39:603-611. 5. Edwards JC, Szczepanski L, Szechinski J, et al. Efficacy of B-cell-targeted therapy with rituximab in patients with rheumatoid arthritis. N Engl J Med 2004;350:2572-2581. 8
  10. 10. An Emerging Therapy for the Effective Treatment of Rheumatoid Arthritis: The Evidence for a Selective Co-Stimulation Modulator 6. Edwards JC, Leandro MJ, Cambridge G. B lymphocyte depletion in rheumatoid arthritis: targeting of CD20. Curr Dir Autoimmun 2005;8:175- 192. 7. Keystone EC, Burmester GR, Furie R, et al. Improved quality of life with rituximab plus methotrexate in patients with active rheumatoid arthri- tis who experienced inadequate response to one or more anti-TNF-α therapies. Arthritis Rheum 2005;52(9 Suppl):S659(Abstract 287). 8. Mease P, Szechinski J, Greenwald M, et al. Improvements in patient reported outcomes over 24 weeks for rituximab with methotrexate in rheumatoid arthritis patients in phase IIb trial (DANCER). Arthritis Rheum 2005;52(9 Suppl):S258(Abstract 280). 9. Emery P, Russell A, Markenson J, et al. Abatacept induces sustained improvements in quality of life, sleep quality and fatigue over 3 years in rheumatoid arthritis patients with inadequate responses to methotrexate. Arthritis Rheum 2005;52(9 Suppl):S258(Abstract 626). 10. Russell A, Kremer J, Zhou Y, Mokliatchouk O, Moreland L. Abatacept induces sustained improvements in physical function and pain over 3 years in rheumatoid arthritis patients with inadequate responses to methotrexate. Arthritis Rheum 2005;52(9 Suppl):S659(Abstract 1778). 11. Westhovens R, Schiff M, Russell A, et al. Abatacept significantly improves health-related quality of life in patients with inadequate responses to anti-TNF therapy: the Attain trial. Arthritis Rheum 2005;52(9 Suppl):S659(Abstract 1781). 12. Genovese M, Luggen M, Schiff M, et al. Sustained improvements through 18 months with abatacept in rheumatoid arthritis patients with an inadequate response to anti-TNF therapy. Arthritis Rheum 2005;52(9 Suppl):S659(Abstract L16).. e pl m sa g in rit iw sk w ko cz Ka al st ry C 9
  11. 11. An Emerging Therapy for the Effective Treatment of Rheumatoid Arthritis: The Evidence for a Selective Co-Stimulation Modulator EVALUATION FORM Academic/Professional Degree(s): Hospital/Professional Affiliation: City/Province-State/Country: In order to improve the quality of educational programming, we would appreciate you taking a few minutes of your time to complete this evaluation. Your comments and suggestions will help us to plan future activi- ties that meet your educational needs. OVERALL PROGRAM Please circle the appropriate response. What is your overall rating of this program? Poor – 1 2 3 4 5 – Excellent Please rate the overall educational quality of this CME activity. Poor – 1 2 3 4 5 – Excellent To what extent will the information provided in this program contribute to your clinical practice? Not at all – 1 2 3 4 5 – Completely NA – Not Applicable Did this CME activity receive support from a commercial source? e pl Yes No m sa Please rate the degree of objectivity you observed in the educational material of this CME activity: g in None – 1 2 3 4 5 – Completely rit iw Did this activity comply with the Code of Ethics for parties involved in CME? sk Yes No w ko Potential conflicts of interest of speakers were disclosed: cz Yes No Ka al Comments: st ry C PROGRAM CONTENT Please rate the degree to which the following objectives were met using the following scale: (1 = Not at all; 2 = Minimally; 3 = Moderately; 4 = Largely; 5 = Completely) After taking part in this program, how well do you understand the immunopathology of RA and of emerg- ing therapies, such as T cell co-stimulators, as related to the treatment of patients with rheumatoid arthri- tis (RA)? Not at all – 1 2 3 4 5 – Completely Are you now better able to assess the role of targeted therapies and their efficacy in the management of RA? Not at all – 1 2 3 4 5 – Completely Have you become more familiar with the safety issues associated with the management of RA T cell co- stimulators? Not at all – 1 2 3 4 5 – Completely Do you have a clearer understanding of the role of T cell co-stimulation in the management of quality of life in patients with RA? Not at all – 1 2 3 4 5 – Completely Comments: In future CME activities, what topics and/or teaching formats would you like to include? 11
  12. 12. An Emerging Therapy for the Effective Treatment of Rheumatoid Arthritis: The Evidence for a Selective Co-Stimulation Modulator SECTION EVALUATIONS Please rate the degree to which the following objectives were met, using the scale provided: Immunopathology and Clinical Challenges in the Evolving Treatment of RA Anthony S. Russell, MD Poor Fair Neutral Good Excellent Not Applicable Stated objectives were met 1 2 3 4 5 NA Ideas expressed clearly 1 2 3 4 5 NA Material well organized 1 2 3 4 5 NA Useful examples presented 1 2 3 4 5 NA Content thorough 1 2 3 4 5 NA Tables and figures clear and effective 1 2 3 4 5 NA Content at an appropriate level of complexity 1 2 3 4 5 NA Comments: Examining the Efficacy and Safety of Existing and Emerging RA Therapies: An Evidence Based Profile J. Carter Thorne, MD Stated objectives were met 1 2 3 4 5 NA Ideas expressed clearly 1 2 3 4 5 NA Material well organized 1 2 3 4 5 NA Useful examples presented 1 2 3 4 5 NA e Tables and figures clear and effective 1 2 3 4 5 NA pl m Content thorough 1 2 3 4 5 NA sa Content at an appropriate level of complexity 1 2 3 4 5 NA g in Comments: rit iw sk Maximizing Quality-of-Life for RA Patients with Emerging Therapies: w Key Findings from Clinical Trials ko cz Mario H. Cardiel, MD Ka Stated objectives were met 1 2 3 4 5 NA al Ideas expressed clearly 1 2 3 4 5 NA st ry Material well organized 1 2 3 4 5 NA C Useful examples presented 1 2 3 4 5 NA Tables and figures clear and effective 1 2 3 4 5 NA Content thorough 1 2 3 4 5 NA Content at an appropriate level of complexity 1 2 3 4 5 NA Comments: Establishing Current Knowledge and Practice, Questions and Answers Anthony S. Russell, MD, and Carlos Abud-Mendoza, MD Stated objectives were met 1 2 3 4 5 NA Access instructions clear and easy to understand 1 2 3 4 5 NA Technology operated well 1 2 3 4 5 NA Discussion was well moderated 1 2 3 4 5 NA Information was useful 1 2 3 4 5 NA Comments: Please provide us with any additional comments you may have regarding this educational program. We welcome your feedback. 12
  13. 13. An Emerging Therapy for the Effective Treatment of Rheumatoid Arthritis: The Evidence for a Selective Co-Stimulation Modulator NOTES e pl m sa g in rit iw sk w ko cz Ka al st ry C 13
  14. 14. An Emerging Therapy for the Effective Treatment of Rheumatoid Arthritis: The Evidence for a Selective Co-Stimulation Modulator NOTES e pl m sa g in rit iw sk w ko cz Ka al st ry C 14
  15. 15. An Emerging Therapy for the Effective Treatment of Rheumatoid Arthritis: The Evidence for a Selective Co-Stimulation Modulator NOTES e pl m sa g in rit iw sk w ko cz Ka al st ry C 15
  16. 16. An Emerging Therapy for the Effective Treatment of Rheumatoid Arthritis: The Evidence for a Selective Co-Stimulation Modulator NOTES e pl m sa g in rit iw sk w ko cz Ka al st ry C 16
  17. 17. e pl m sa g in rit iw sk w ko cz Ka al st ry C This symposium has been made possible A continuing medical education program of by the independent sponsorship SNELL Medical Communication Inc. of Bristol-Myers Squibb. SNELL

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