Original article
Efficacy and safety of adalimumab across subgroups of patients with moderate to severe psoriasis

https://doi.org/10.1016/j.jaad.2009.09.040Get rights and content

Background

The phase III randomized controlled evaluation of adalimumab every other week dosing in moderate to severe psoriasis trial (REVEAL) demonstrated adalimumab induced significant improvements and was well tolerated for patients with moderate to severe psoriasis.

Objective

We sought to determine the efficacy and safety of adalimumab for various subgroups of patients in REVEAL with moderate to severe psoriasis and to determine whether these profiles were consistent with the overall results.

Methods

Patients (N = 1212) with moderate to severe psoriasis were randomized to adalimumab or placebo during the first 16 weeks of the trial. The primary efficacy endpoint was percentage of patients achieving at least 75% improvement in the Psoriasis Area and Severity Index (PASI) score at week 16. Post hoc subgroup analyses were conducted to determine relationships between adalimumab efficacy and/or safety and age group, sex, race, baseline weight intervals, baseline body mass index, disease duration, baseline severity, prior treatments, and comorbidities.

Results

Consistent 75% or greater improvement in the PASI score responses were observed across all patient subgroups, with moderately reduced responses noted for patients in the greater weight and body mass index categories. A multivariate analysis identified treatment received, weight, and age as the most influential factors for mean percentage change in PASI score at week 16. No significant differences in the risk of serious adverse events in adalimumab- versus placebo-treated patients were observed across weight categories or for patients with baseline comorbidities.

Limitations

These subanalyses are limited by their relatively short, 16-week duration.

Conclusion

Treatment of moderate to severe psoriasis with adalimumab led to consistent 75% or greater improvement in PASI score response rates across the majority of patient subgroups, with no significant differences in serious adverse events.

Section snippets

Methods

Detailed methods for REVEAL have been published.11 Methods relevant to the current subgroup analyses are included herein.

REVEAL period A safety and efficacy

Of 1212 patients entering the study at week 0, 814 were randomized to adalimumab treatment and 398 were randomized to placebo. As previously reported, baseline demographics and disease characteristics were similar between treatment groups, including duration of psoriasis, baseline PASI score, BSA involvement, and baseline PGA.11 The mean (±SD) baseline weight for placebo-treated patients was 94.1 ± 23.0 kg and for adalimumab-treated patients was 92.3 ± 23.0 kg. In all, 31 patients discontinued

Discussion

As previously published, REVEAL was a randomized, double-blind, placebo-controlled clinical trial of subcutaneously administered adalimumab that demonstrated significant efficacy at 16 weeks for the treatment of moderate to severe psoriasis (as measured by PASI 75 score, at least 90% improvement from baseline in the PASI score, 100% improvement from baseline in the PASI score, mean percentage PASI score improvement, and PGA of “clear” or “minimal”).11 REVEAL also demonstrated comparable AE

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Funding for manuscript development was provided by Abbott Laboratories, with editorial support provided by Michael A. Nissen, ELS, of Abbott Laboratories, and Arbor Communications Inc.

Disclosure: Dr Menter is a consultant and member of the advisory boards and speakers bureaus of Abbott Laboratories, Amgen, Astellas, Centocor, Genentech, and Wyeth; he is a consultant and investigator for Eli Lilly; and he has received investigator funding from Abbott Laboratories, Amgen, Astellas, Centocor, Genentech, and Novo Nordisk. Dr Gordon has received investigator funding and consulting fees from and serves as a member of the advisory boards of Abbott Laboratories, Amgen, Centocor, Galderma, and Novo Nordisk. Dr Leonardi is a consultant for Abbott Laboratories, Amgen, Centocor, and Genentech and is an investigator for Abbott Laboratories, Allergan, Altana, Amgen, Astellas, Biogen, Bristol-Myers Squibb, Centocor, CombinatoRx, Fujisawa, Galderma, Genentech, RTL, Schering-Plough, Serono, Vitae, and 3M Pharmaceuticals; he also received an educational grant from Amgen and Genentech, and is part of the speakers bureaus for Abbott Laboratories, Amgen, Centocor, Genentech, and Warner Chilcott. Ms Gu and Dr Goldblum are employees of Abbott Laboratories.

Reprints not available from the authors.

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