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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

Authors


  • Funding sources
    Abbott Laboratories funded this study and participated in the study design, data analysis and preparation of the manuscript.

  • Conflicts of interest
    U.M. has received honoraria as a speaker and advisor and has participated in clinical trials for Abbott and has received educational grants. C.E.M.G. has received honoraria and/or research grants from Abbott Laboratories, Almirall, Amgen, Biogen Idec, Biotest, Eli Lilly, Incyte, Janssen-Cilag, Leo Pharma, Novartis and Pfizer. K.K. has received honoraria and/or research grants from Abbott Laboratories, Janssen-Cilag, Leo Pharma, Novo Nordisk, MSD Pharma and Pfizer. K.R. has served as consultant and/or paid speaker for and/or participated in clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis including Abbott Laboratories, Biogen Idec, Celgene, Centocor, Janssen-Cilag, Leo Pharma, Medac, Merck & Co., MSD Pharma (formerly Essex, Schering-Plough), Novartis and Pfizer (formerly Wyeth). S.R., Y.G. and Y.W. are employees of Abbott Laboratories and hold Abbott Laboratories stock.

Ulrich Mrowietz.
E-mail: umrowietz@dermatology.uni-kiel.de

Summary

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  To use the 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 analysed: CHAMPION (n = 108), REVEAL (n = 814) and BELIEVE (n = 364). Moderate to severe psoriasis was defined as Dermatology Life Quality Index (DLQI) score > 10, with either > 10% body surface area involvement or Psoriasis Area and Severity Index (PASI) score > 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  The percentages of patients who achieved treatment goals at week 16 in CHAMPION, REVEAL and BELIEVE were, respectively, (i) treatment success, 79·3%, 72·1% and 68·2%; (ii) intermediate response, 1·7%, 5·0% and 5·0%; or (iii) 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 the percentages of adalimumab- vs. placebo-treated patients achieving treatment success were statistically significant (< 0·001) from week 4 and week 8 of REVEAL and CHAMPION, respectively.

Conclusions  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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