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An Assessment of Adalimumab Efficacy in Three Phase III Clinical Trials Using the European Consensus Programme Criteria for Psoriasis Treatment Goals.

Mrowietz, U; Kragballe, K; Reich, K; Griffiths, C E M; Gu, Y; Wang, Y; Rozzo, S J

The British journal of dermatology. 2012;.

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Abstract

Background:  The European Consensus Programme (ECP) established pan-European consensus definitions of psoriasis disease severity and treatment goals among 19 psoriasis experts from European nations. Objectives: Use ECP treatment goals to retrospectively assess adalimumab efficacy in patients who participated in Phase III clinical trials and met ECP criteria for moderate to severe psoriasis. Methods:  Three trials were analyzed: CHAMPION (N=108), REVEAL (N=814), and BELIEVE (N=364). Moderate to severe psoriasis was defined as Dermatology Life Quality Index (DLQI) >10, with either >10% body surface area (BSA) involvement or Psoriasis Area and Severity Index (PASI) >10. Treatment goals were achieved with either Treatment Success (≥75% PASI score reduction) or Intermediate Response (PASI response ≥50% and <75%) with DLQI ≤5. Results:  Percentages of patients who achieved treatment goals at Week 16 in CHAMPION, REVEAL, and BELIEVE were, respectively, 1) Treatment Success, 79.3%, 72.1%, and 68.2%; 2) Intermediate Response, 1.7%, 5.0%, and 5.0%; or 3) either goal, 81.0%, 77.1%, and 73.2%. DLQI ≤5 at Week 16 was achieved by 70.7%, 70.1%, and 67.4% of patients, respectively. Differences between percentages of adalimumab- vs. placebo-treated patients achieving Treatment Success were statistically significant (P <0.001) from Week 4 and Week 8 of REVEAL and CHAMPION, respectively. Conclusion:  Treatment Success was achieved by >93% of patients who attained treatment goals. At Week 16 >70% of patients achieved ECP treatment goals and met ECP criteria for continued treatment without modification. These results support the utility of ECP treatment goals for the assessment of therapeutic efficacy in moderate to severe psoriasis.

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Digital Object Identifier:
10.1111/j.1365-2133.2012.11214.x
Pubmed Identifier:
22880843
Access state:
Active

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Record metadata

Manchester eScholar ID:
uk-ac-man-scw:180702
Created by:
Griffiths, Christopher
Created:
1st November, 2012, 13:08:40
Last modified by:
Griffiths, Christopher
Last modified:
1st March, 2014, 13:06:01

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