Efficacy and safety of leflunomide in psoriatic arthritis

Objective: To compare the effectiveness and safety of leflunomide with methotrexate (MTX) in the treatment of psoriatic arthritis. Methods: An open, randomized clinical trial was conducted in 32 patients of psoriatic arthritis at the department of Dermatology and Venereology and Rheumatology wing of Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh, from June 2002 to December 2003. 17 patients of leflunomide group were treated with oral leflunomide l00 mg for first three days followed by 20 mg daily. 15 patients of MTX group were treated with methotrexate 10 mg weekly. Both groups were allowed to take ibuprofen, maximum 1400 mg daily. For both groups hematological and biochemical tests were done at baseline and at every follow-up. All patients were assessed clinically for articular features, psoriasis area and severity index (PASI) for effectiveness and for side effects of drugs was listed for safety measure. Results: Sixteen patients of leflunomide group and 14 of MTX group completed 24 weeks followup. Male: female ratio was 14:2, in leflunomide and 13:1 in MTX group. Significant improvement was observed in tender joint count, swollen joint count, joint tenderness index, NSAIDs score and PASI score in both groups. Adverse effects in both groups were tolerable and did not require any withdrawal or dose reduction. Asthenia, alopecia, nausea and vomiting were common side effects noticed by patients but overall there was no significant difference in between two groups. Conclusion: Leflunomide appears to be as effective and safe as methotrexate in psoriatic arthritis.