Infliximab induction therapy for patients with severe plaque-type psoriasis: a randomized, double-blind, placebo-controlled trial.
BACKGROUND
Tumor necrosis factor-alpha is a key mediator in the pathogenesis of psoriasis. Infliximab is a monoclonal antibody that specifically binds to tumor necrosis factor-alpha, blocking its biologic activity.


OBJECTIVE
The purpose of this study was to access the efficacy and safety of infliximab induction therapy for patients with severe plaque psoriasis.


METHODS
In this multicenter, double-blind, placebo-controlled trial, 249 patients with severe plaque psoriasis were randomly assigned to receive intravenous infusions of either 3 or 5 mg/kg of infliximab or placebo given at weeks 0, 2, and 6. The primary end point was the proportion of patients who achieved at least 75% improvement in Psoriasis Area and Severity Index score from baseline at week 10. At week 26, patients whose Physician Global Assessment indicated moderate or severe disease were eligible for a single intravenous infusion of their assigned treatment to assess the safety of retreatment after a 20-week, treatment-free interval.


RESULTS
At week 10, 72% of patients treated with infliximab (3 mg/kg) and 88% of patients treated with infliximab (5 mg/kg) achieved a 75% or greater improvement from baseline in Psoriasis Area and Severity Index score compared with 6% of patients treated with placebo (P <.001). Improvement was observed in both infliximab groups as early as 2 weeks. Overall, 63%, 78%, and 79% of patients in the placebo, 3-, and 5-mg/kg groups, respectively, reported one or more adverse events.


CONCLUSIONS
Infliximab treatment resulted in a rapid and significant improvement in the signs and symptoms of psoriasis. Infliximab was generally well tolerated.
Gottlieb
Alice B
AB
University of Medicine and Dentistry of New Jersey Robert Wood Johnson Medical School, New Brunswick, NJ 08901, USA. gottliab@umdnj.edu
Evans
Robert
R
Li
Shu
S
Dooley
Lisa T
LT
Guzzo
Cynthia A
CA
Baker
Daniel
D
Bala
Mohan
M
Marano
Colleen W
CW
Menter
Alan
A
D000328:Adult; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D023341:Chills / Q000139:chemically induced; D004311:Double-Blind Method; D005260:Female; D005483:Flushing / Q000139:chemically induced; D006261:Headache / Q000139:chemically induced; D006801:Humans; D000069285:Infliximab; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D011565:Psoriasis / Q000188:drug therapy* / Q000201:enzymology / Q000276:immunology; D011788:Quality of Life; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D000069285:Infliximab