Clinical response to adalimumab treatment in patients with moderate to severe psoriasis: Double-blind, randomized controlled trial and open-label extension study - 09/08/11
, Richard G. Langley, MD b, Craig Leonardi, MD c, Darryl Toth, MD d, M. Alan Menter, MD e, Sewon Kang, MD f, Michael Heffernan, MD g, Bruce Miller, MD h, Regina Hamlin, MD i, Liberata Lim, BA j, Jianhua Zhong, PhD j, Rebecca Hoffman, MD j, Martin M. Okun, MD, PhD j
Reprint requests: Kenneth B. Gordon, MD, Division of Dermatology, Evanston Northwestern Healthcare, 9977 Woods Dr, Skokie, IL 60077.Skokie and Abbott Park, Illinois; Halifax, Nova Scotia, and Windsor, Ontario, Canada; St Louis, Missouri; Dallas, Texas; Ann Arbor, Michigan; Dayton, Ohio; Portland, Oregon; and Fresno, California
Abstract |
Background |
Tumor necrosis factor is pivotal in the pathogenesis of psoriasis. Adalimumab is a fully human monoclonal immunoglobulin G1 antibody that neutralizes tumor necrosis factor.
Objectives |
We sought to assess the efficacy and safety of adalimumab in patients with moderate to severe plaque psoriasis.
Methods |
In this multicenter, randomized, double-blind, placebo-controlled study, 147 patients received adalimumab (40 mg every other week or 40 mg/wk) or placebo. After 12 weeks of blinded therapy, patients taking adalimumab could continue their assigned dosages in a 48-week extension trial; patients taking placebo were switched to adalimumab (40 mg every other week).
Results |
At week 12, 53% of patients taking adalimumab every other week, 80% of patients taking adalimumab weekly, and 4% of patients taking placebo achieved 75% improvement in Psoriasis Area and Severity Index score (P < .001). Responses were sustained for 60 weeks. No new safety signals were noted compared with the existing adalimumab clinical safety database.
Limitations |
The study was insufficiently powered to detect rare adverse events associated with adalimumab.
Conclusions |
Adalimumab significantly improved psoriasis and was well tolerated for 60 weeks.
Le texte complet de cet article est disponible en PDF.Abbreviations used : AE, eow, PASI, PASI 50, PASI 75, PASI 100, PGA, SAE, TB, TNF
Plan
| Supported by Abbott Laboratories. Disclosure: Dr Gordon has received research support and honoraria and is a consultant for Abbott. Dr Langley is an investigator and has received research funding to conduct research studies with Abbott. Dr Leonardi is a consultant and speaker for Abbott. Dr Menter has received honoraria and is a consultant for Abbott. Dr Kang is an ad-hoc consultant for Abbott. Dr Heffernan is a consultant for and has received research funding from Abbott. Drs Zhong, Hoffman, and Okun and Ms Lim are full-time employees of Abbott. Presented in part at the following annual meetings of the American Academy of Dermatology: February 6-11, 2004, in Washington, DC, and February 18-22, 2005 in New Orleans, Louisiana, as well as at the following annual meetings of the European Academy of Dermatology and Venerology: October 12-16, 2005, in London, UK, and February 9-12, 2006 in Saariselkä, Lapland, Finland. |
Vol 55 - N° 4
P. 598-606 - octobre 2006 Retour au numéro
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