Leflunomide improves psoriasis in patients with psoriatic arthritis: an in-depth analysis of data from the TOPAS study

Dermatology. 2006;212(3):238-49. doi: 10.1159/000091251.

Abstract

Background: Leflunomide has shown promise in the treatment of psoriasis.

Objective: To provide an in-depth analysis of the effect of leflunomide on psoriasis in patients with psoriatic arthritis (PsA).

Methods: 190 patients with plaque psoriasis (at least 3% skin involvement) and active PsA were randomized to double-blind treatment with leflunomide (100 mg/day loading dose for 3 days followed by 20 mg/day orally) or placebo for 24 weeks.

Results: As previously reported, leflunomide resulted in a significantly higher Psoriatic Arthritis Response Criteria response rate than placebo (58.9 vs. 29.7%; p < 0.0001). Significant differences in favor of leflunomide were also observed in the Psoriasis Area and Severity Index (PASI 50 in 30.4% of patients vs. 18.9% for placebo; p = 0.05), target lesion response (46.4 vs. 25.3%; p = 0.0048), combined skin and joint response (27.2 vs. 8.9%; p < 0.0001), Dermatology Life Quality Index (improvement of 1.9 points vs. 0.2; p = 0.0173) and certain SF-36 subdomains. Dermatological responses were observed at the earliest examination (4 weeks) and increased throughout the 24-week study.

Conclusion: Once-daily oral leflunomide is an effective and convenient treatment for PsA and plaque psoriasis.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adjuvants, Immunologic / administration & dosage
  • Adjuvants, Immunologic / therapeutic use
  • Administration, Oral
  • Adult
  • Aged
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use*
  • Arthritis, Psoriatic / drug therapy*
  • Double-Blind Method
  • Female
  • Humans
  • Immunosuppressive Agents / administration & dosage
  • Immunosuppressive Agents / therapeutic use*
  • Isoxazoles / administration & dosage
  • Isoxazoles / therapeutic use*
  • Leflunomide
  • Male
  • Middle Aged
  • Psoriasis / drug therapy*
  • Psoriasis / pathology
  • Quality of Life
  • Skin / pathology

Substances

  • Adjuvants, Immunologic
  • Anti-Inflammatory Agents, Non-Steroidal
  • Immunosuppressive Agents
  • Isoxazoles
  • Leflunomide