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


CONCLUSIONS
Lack of an active comparator and evaluation of maintenance of response beyond week 52 are limitations.


CONCLUSIONS
Adalimumab is efficacious and well-tolerated in the treatment of chronic plaque psoriasis.


BACKGROUND
Clinical trials.gov. NCT00237887.
Menter
Alan
A
Division of Dermatology, Baylor Research Institute, University of Texas Southwestern Medical School, 3900 Junius St, 125, Dallas, TX 75246-1613, USA. amderm@gmail.com
Tyring
Stephen K
SK
Gordon
Kenneth
K
Kimball
Alexa B
AB
Leonardi
Craig L
CL
Langley
Richard G
RG
Strober
Bruce E
BE
Kaul
Martin
M
Gu
Yihua
Y
Okun
Martin
M
Papp
Kim
K
D000068879:Adalimumab; D000328:Adult; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000188:drug therapy* / Q000473:pathology; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000276:immunology
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D014409:Tumor Necrosis Factor-alpha; D000068879:Adalimumab