Peyronie's drug

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Peyronie's drug

  1. 1. Composite Responders Showed Improvement in BothPenile Curvature Deformity and Symptom Botherin Two Large Double-Blind, Randomized,Placebo-Controlled Phase 3 Studies of CollagenaseClostridium Histolyticum in the Treatmentof Peyronie’s DiseaseWayne JG Hellstrom1, Robert Feldman2, Ted Smith3,Sue Hobson3, James Tursi3, Guy Bernstein41Tulane University Health Sciences Center, New Orleans, LA, USA;2Connecticut Clinical Research Center and Urology Specialists, Middlebury,CT, USA; 3Auxilium Pharmaceuticals, Chesterbrook, PA, USA;4Urology Health Specialists, Bryn Mawr, PA, USA
  2. 2. Background• In addition to the physical symptoms associated with PD, thepsychological impact of PD should also be considered duringthe evaluation and treatment process• Some studies have looked at the psychosocial impact of PDon patients and found that many patients experience poorself-image, emotional and relationship difficulties, and clinicaldepression2-41Ralph D, et al. J Sex Med 2010;7:2359-74; 2Smith JF, et al. J Sex Med 2008;5:2179-84;3Nelson CJ, et al. J Sex Med 2008;5:1985-90; 4Rosen R, et al. J Sex Med 2008;5:1977-84. 2• Peyronie’s disease (PD) is a progressivedisease resulting in penile curvaturedeformity that may be accompanied byother symptoms, such as erectiledysfunction and penile pain in the acutephase of the disease1
  3. 3. Background (cont.)• Placebo-controlled studies showing treatment efficacy arelimited for the majority of historically available minimallyinvasive PD treatments1,2• Collagenase clostridium histolyticum (CCH) is an investigational,intralesional, minimally invasive treatment for PD• In the largest studies conducted in subjects with PD to date, theInvestigation for Maximal Peyronie’s Reduction Efficacy andSafety Studies (IMPRESS) I and II examined the clinical efficacyof CCH compared with placebo in subjects with PD3– Significant CCH treatment effects at Week 52 were found for theco-primary outcomes:» Improved penile curvature deformity» Improved PD symptom bother domain score as measured using thePeyronies Disease Questionnaire (PDQ)1Ralph D, et al. J Sex Med 2010;7:2359-74; 2Muller A, Mulhall JP. J Sex Med 2009;6:848-61;3Gelbard M, et al. J Urol 2013 Jan 30. [Epub ahead of print] 3
  4. 4. Current Study Objective• To examine the effect of CCH treatment comparedwith placebo on the percentage of subjects with PDin IMPRESS I and II who were composite responders4Composite Responder Definition:Improvement in penilecurvature deformity≥20%Improvement in thePDQ PD symptombother domain score of≥1, or a change fromreporting no sexualactivity at screening toreporting sexual activityAND
  5. 5. Study Measures• Objective measures of penilecurvature during chemically-inducederection using a goniometer– The point of maximal penilecurvature deformity was recordedas the distance from the corona tothe maximum point of curvature1Auxilium Pharmaceuticals. http://www.auxilium.com/PDQ. Accessed April 30, 2013;2Hellstrom WJ, et al. J Urol 2013 Jan 31. [Epub ahead of print]• The Peyronie’s Disease Questionnaire (PDQ)1– A validated, disease-specific, self-administered, patient-reported outcome instrument designed to measure thesymptoms and psychosexual impact of PD2– The PDQ contains 3 domains that are scored individually– Higher scores indicate a greater negative impact of PD5
  6. 6. PDQ PD Symptom Bother DomainPDQ PD Symptom Bother Domain Questions1*Q10. Thinking about the last time you had an erection, how bothered were you byany pain or discomfort you may have felt in your erect penis?Q11. Thinking about the last time you looked at your erect penis, how bothered wereyou by the way your penis looked?Q13. Thinking of the last time you had or tried to have vaginal intercourse, howbothered were you by your Peyronie’s disease?Q15. How bothered are you with having vaginal intercourse less often?*Q12 and Q14 (not shown) are “yes/no” screening questions and are not scored.• PDQ PD symptom bother domain consists of 4 scored items and2 “yes/no” questions that are not scored• PD symptom bother severity is measured on a 5-point, Likert-typeresponse scale– 0 (not at all bothered) to 4 (extremely bothered)• Score for the PD symptom bother domain is calculated as the sum of allresponses and ranges from 0 to 161Auxilium Pharmaceuticals. http://www.auxilium.com/PDQ. Accessed April 30, 2013.6
  7. 7. IMPRESS Treatment ScheduleInduction of ErectionPenile Curvature MeasurementPrimary Plaque IdentifiedCCH or PlaceboInjection intoPrimary PlaqueSubjects may receive up to 4 treatment cycles (up to 8 injections)Each treatment cycle is separated by 6 weeksCCH or PlaceboInjection intoPrimary PlaquePenile PlaqueModeling24-72 hours 24-72 hoursTreatment Cycle7
  8. 8. Methods: Population and Data Used for Analysis• Subjects had stable disease (≥12 months), penilecurvature deformity >30 to <90 , and vaginalintercourse within the past 3 months (in order toanswer the PDQ questions)• Data analysis:– Baseline, Week 24, and Week 52 data fromIMPRESS I and II were combined– Treatment groups were compared controlling forstratum of baseline penile curvature deformity(30 to 60 and 61 to 90 ) and study (IMPRESS Ior II)8
  9. 9. IMPRESS Study PopulationBaselineCharacteristicsCCH(n=551)Placebo(n=281)Age, yearsMean (SD) 57.6 (8.5) 57.9 (8.3)Median 59 59Min, Max 23, 84 30, 81PD duration, yearsMean (SD) 4.1 (4.1) 4.1 (4.8)Median 2.9 2.9Min, Max 1.0, 35.9 1.0, 50.8Penile curvature deformity, n (%)30 to 60 425 (77.1) 218 (77.6)60 to 90 126 (22.9) 63 (22.4)9
  10. 10. Results: Percentage of Subjects With PD Who WereComposite Responders at Weeks 24 and 52• The group of men who received CCH treatment had asignificantly greater percentage of composite responderscompared with the placebo group at Week 24 and Week 52(both P<0.0001)48.826.546.628.00%10%20%30%40%50%60%CCH PlaceboPercentageofCompositeRespondersWeek 24Week 5210
  11. 11. Exploratory Outcome• Using a more restrictive criterion of change inthe PDQ PD symptom bother domain score, thepercentage of composite responders was comparedin CCH-treated vs placebo-treated subjects11Exploratory Composite Responder Definition:Improvement in penilecurvature deformity≥20%Improvement in thePDQ PD symptombother domain score of≥2, or a change fromreporting no sexualactivity at screening toreporting sexual activityAND
  12. 12. Results: Percentage of Subjects With PD Who WereComposite Responders Using PD Bother Change ≥2at Weeks 24 and 52• Again, the group of men who received CCH treatment had asignificantly greater percentage of composite responderscompared with the placebo group at Week 24 and Week 52(both P<0.0001)44.123.841.824.20%10%20%30%40%50%CCH PlaceboPercentageofCompositeRespondersWeek 24Week 5212
  13. 13. Conclusions• A significantly greater percentage of CCH-treated PD subjectscompared with placebo-treated subjects met the definition ofcomposite responder– Composite responders showed improvement in both penilecurvature deformity and PDQ PD symptom bother domainscore• The significantly greater percentage of composite responders inthe CCH-treated subjects compared with placebo-treatedsubjects was shown at Week 24 and remained consistent atWeek 52• The greater percentage of composite responders in the CCHtreatment group compared with placebo remained when thecomposite responder definition was made more stringent• These findings support the clinical efficacy of CCH treatmentcompared with placebo for both the physical and psychosexualaspects of PD 13

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