Adalimumab therapy for moderate to severe psoriasis: A randomized, controlled phase III trial - 24/04/13
, Stephen K. Tyring, MD, PhD, MBA b, Kenneth Gordon, MD c, Alexa B. Kimball, MD, MPH d, Craig L. Leonardi, MD e, Richard G. Langley, MD f, Bruce E. Strober, MD, PhD g, Martin Kaul, MD h, Yihua Gu, MS i, Martin Okun, MD, PhD i, Kim Papp, MD j
Reprint requests: Alan Menter, MD, Division of Dermatology, Baylor Research Institute, University of Texas Southwestern Medical School, 3900 Junius St, 125, Dallas, TX 75246-1613.Abstract |
Background |
Adalimumab is a fully human monoclonal antibody that binds tumor necrosis factor, a key proinflammatory cytokine involved in the pathogenesis of psoriasis.
Objective |
We sought to evaluate clinical efficacy and safety of adalimumab for moderate to severe psoriasis and investigate continuous versus interrupted therapy.
Methods |
We conducted a 52-week, multicenter study of 1212 patients randomized to receive adalimumab (40 mg) or placebo every other week for the first 15 weeks. At least 75% improvement in the Psoriasis Area and Severity Index (PASI) score was the criterion for advancement through this multiphase study.
Results |
At week 16, 71% (578 of 814) of adalimumab- and 7% (26 of 398) of placebo-treated patients achieved greater than or equal to 75% improvement in the PASI score. During weeks 33 to 52, the percentage of patients rerandomized to placebo who lost adequate response (defined as <50% improvement in the PASI response relative to baseline and at least a 6-point increase in PASI score from week 33) was 28% compared with 5% of patients treated continuously with adalimumab.
Limitations |
Lack of an active comparator and evaluation of maintenance of response beyond week 52 are limitations.
Conclusion |
Adalimumab is efficacious and well-tolerated in the treatment of chronic plaque psoriasis.
Trial Registration |
Clinical trials.gov. NCT00237887.
Le texte complet de cet article est disponible en PDF.Abbreviations used : AAA, AE, eow, ITT, PASI, PGA, TNF, UV
Plan
| Supported by Abbott Laboratories. |
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| Disclosure: Dr Menter has received research support and/or lecture honoraria from Abbott, Amgen, Astellas, Biogen, Centocor, Genentech, and Wyeth. Dr Tyring has received research support from, has consulted for, and is part of the speakers’ bureaus for Abbott. Dr Gordon has received research support and honoraria from Abbott, Amgen, and Centocor. Dr Kimball is an investigator, speaker, and consultant for Abbott, Amgen, Biogen, Centocor, and Genentech. Dr Leonardi is a consultant for Abbott, Amgen, Centocor, and Genentech and is an investigator for Abbott, Allergan, Altana, Amgen, Astellas, Biogen, Bristol Myers, Centocor, Fujisawa, Galderma, Genentech, Serono, CombinatoRx, 3M Pharmaceuticals, Schering Plough, RTL, and Vitae; he also received an educational grant from Amgen and Genentech, and is part of the speakers’ bureaus for Abbott, Amgen, Centocor, Genentech, and Warner Chilcott. Dr Langley is a scientific advisory board member, investigator, and speaker for Abbott, Amgen, Astellas, Centocor, Norvartis, and Wyeth. Dr Strober serves on the advisory boards of, has received honoraria from, and is an investigator for Abbott, Amgen, Astellas, Centocor, Genentech, and Wyeth, and is part of the speakers’ bureaus for Abbott, Amgen, Astellas, Genentech, and Wyeth. Dr Kaul, Ms Gu, and Dr Okun are employees of Abbott Laboratories. Dr Papp is a consultant for and has received honoraria and travel grants from Abbott, Alza, Amgen, Astellas, Celgene, Centocor, Genentech, Isotechnika, Johnson and Johnson, Serono, Schering-Plough, and UCB. |
Vol 58 - N° 1
P. 106-115 - janvier 2008 Retour au numéro
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- Change of address
- Alefacept revisited: Our 3-year clinical experience in 200 patients with chronic plaque psoriasis
- Amy Perlmutter, Jennifer Cather, Billy Franks, Eileen Jaracz, Alan Menter
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