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


OBJECTIVE
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.


CONCLUSIONS
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.
Gordon
Kenneth B
KB
Division of Dermatology, Evanston Northwestern Healthcare and Northwestern University Feinberg School of Medicine, Skokie, IL 60077, USA. kgordon@enh.org
Langley
Richard G
RG
Leonardi
Craig
C
Toth
Darryl
D
Menter
M Alan
MA
Kang
Sewon
S
Heffernan
Michael
M
Miller
Bruce
B
Hamlin
Regina
R
Lim
Liberata
L
Zhong
Jianhua
J
Hoffman
Rebecca
R
Okun
Martin M
MM
D000068879:Adalimumab; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000009:adverse effects / 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*; D012720:Severity of Illness Index
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000068879:Adalimumab