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. Copyright 2009 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.
RCT Entities:
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. Copyright 2009 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.