Infliximab induction therapy for patients with severe plaque-type psoriasis: a randomized, double-blind, placebo-controlled trial

J Am Acad Dermatol. 2004 Oct;51(4):534-42. doi: 10.1016/j.jaad.2004.02.021.


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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antibodies, Monoclonal / adverse effects
  • Antibodies, Monoclonal / therapeutic use*
  • Chills / chemically induced
  • Double-Blind Method
  • Female
  • Flushing / chemically induced
  • Headache / chemically induced
  • Humans
  • Infliximab
  • Infusions, Intravenous
  • Male
  • Middle Aged
  • Nausea / chemically induced
  • Psoriasis / drug therapy*
  • Psoriasis / enzymology
  • Psoriasis / immunology
  • Quality of Life
  • Severity of Illness Index
  • Treatment Outcome


  • Antibodies, Monoclonal
  • Infliximab