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Efficacy and safety of adalimumab across subgroups of patients with moderate to severe psoriasis - 24/04/13

Doi : 10.1016/j.jaad.2009.09.040 
Alan Menter, MD a, , Kenneth B. Gordon, MD b, Craig L. Leonardi, MD c, Yihua Gu, MS d, Orin M. Goldblum, MD d
a Baylor Psoriasis Research Institute, Dallas, Texas 
b Northwestern University, Evanston, Illinois 
c Central Dermatology Inc, St Louis, Missouri 
d Abbott Laboratories, Abbott Park, Illinois 

Correspondence to: Alan Menter, MD, Baylor Psoriasis Research Institute, Baylor University Medical Center, 3900 Junius St, Suite 145, Dallas, TX 75246.

Abstract

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.

Le texte complet de cet article est disponible en PDF.

Key words : age, body mass index, body weight, disease duration, health-related quality of life, race, symptom severity, tumor necrosis factor antagonist

Abbreviations used : AE, BMI, BSA, PASI, PASI 75, PGA, PsA, REVEAL


Plan


 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.


© 2009  American Academy of Dermatology, Inc.. Publié par Elsevier Masson SAS. Tous droits réservés.
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Vol 63 - N° 3

P. 448-456 - septembre 2010 Retour au numéro
Article précédent Article précédent
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