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Adalimumab therapy for moderate to severe psoriasis: A randomized, controlled phase III trial

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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.

Section snippets

Patients

Institutional review boards at each participating medical center approved the protocol, and all patients provided written informed consent before any study-related procedures were performed. Eligibility requirements were age 18 years or older, clinical diagnosis of psoriasis for at least 6 months, stable plaque psoriasis for at least 2 months before screening, moderate to severe plaque psoriasis defined as 10% or more of body surface area affected, a Psoriasis Area and Severity Index (PASI)

Patients

A total of 1212 patients were randomized at week 0: 814 to adalimumab treatment and 398 to placebo treatment (Fig 2). Of those, 580 adalimumab-treated patients and 26 placebo-treated patients entered open-label period B based on a PASI 75 response; 203 adalimumab-treated patients and 329 placebo-treated patients with less than PASI 75 response at week 16 were eligible to receive adalimumab in a separate, open-label extension study. A total of 490 PASI 75 responders were rerandomized and

Discussion

In this 52-week, randomized, double-blind, placebo-controlled, multicenter study, adalimumab demonstrated significant efficacy, as assessed by several measures. At week 16 of the study, 71% of patients who had received 40 mg of adalimumab (eow) achieved PASI 75 response, compared with 7% of patients who had received placebo (P < .001). Response to adalimumab was rapid, with significantly greater improvements for adalimumab-treated patients than placebo-treated patients in mean percentage PASI

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Supported by Abbott Laboratories.

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.

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