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Clinical response to adalimumab treatment in patients with moderate to severe psoriasis: Double-blind, randomized controlled trial and open-label extension study

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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.

Section snippets

Patients

Eligible patients included men and women age 18 years and older with plaque psoriasis of at least 1-year duration and involving 5% or more of their body surface area. Patients had active psoriasis despite topical therapies and were all naive to anti-TNF treatment. Concomitant psoriasis therapies were not allowed with the exception of low- to mid-potency corticosteroids applied topically to the palms, soles, face, and groin. The washout period for prior psoriasis therapies was 2 weeks for

Patients

A total of 148 patients were randomized and 147 patients received at least one dose of study medication and were included in the efficacy analyses; one patient was randomized to the eow group, but did not receive study drug because of withdrawal of informed consent (Fig 2). The first study patient was screened in March 2003, and the last patient's final study visit was in June 2004. The majority of patients (95% [140 of 147]) completed the initial 12-week study with no differences observed in

Discussion

In this multicenter, randomized, placebo-controlled trial, adalimumab demonstrated both short- and long-term, statistically and clinically significant efficacy in the treatment of psoriasis as assessed by a variety of efficacy measures. At week 12 of the study, 53% of patients who had received 40 mg of adalimumab eow and 80% of patients who had received 40 mg/wk of adalimumab achieved at least PASI 75 compared with 4% of patients who had received placebo (P < .001). The patients treated with

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  • Cited by (0)

    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.

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