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Leflunomide Appears Safe, Effective For Psoriatic Arthritis and Psoriasis

Leflunomide is a safe, effective, and convenient alternative to current treatment options for patients with psoriatic arthritis (PsA), reports a multicentre, international study.

Current treatment options for patients with PsA are limited by cost and invasive, inconvenient administration. Safe, effective treatments are needed that are also easier to administer and more cost-effective, write researchers. The disease-modifying antirheumatic drug (DMARD), leflunomide, which is approved for the treatment of rheumatoid diseases in a number of countries, has shown promising activity in small, open-label studies and case reports of PsA and psoriasis.

To evaluate the safety and efficacy of leflunomide in the treatment of PsA and psoriasis in a placebo-controlled clinical trial, J. Peter Kaltwasser, MD, J.W. Goethe-Universitä\t, Frankfurt am Main, Germany, and colleagues randomised 98 patients with active PsA and psoriasis to leflunomide (100 mg/day loading dose for 3 days, 20 mg/day orally thereafter) and 92 to placebo for 24 weeks. Efficacy, the primary end point, was determined by response to therapy based on the Psoriatic Arthritis Response Criteria (PsARC). Secondary endpoints included joint and skin involvement, safety, and quality-of-life.

Based on 95 evaluable patients in the leflunomide arm and 91 in the placebo arm, leflunomide was significantly superior to placebo in the number of patients classified as responders (58.9% vs. 29.7%, respectively; P < .0001) at 24 weeks. Leflunomide was also significantly superior to placebo in secondary endpoints assessed, including joint swelling score (P = .0013), tender joint count (P = .0006), swollen joint count (P = .0009), and American College of Rheumatology 20% improvement criteria as modified for psoriatic arthritis (modified ARC20) (P = .0138). During the 24-week treatment period, leflunomide also significantly improved psoriasis (P = .0030) and quality-of-life (P = .0173).

Adverse events related to treatment were reported in 85.4% of evaluable patients treated by leflunomide and 76.1% of the placebo patients. The most frequent adverse events in the leflunomide treated patients were diarrhoea and elevated alanine aminotransferase (ALT) levels. Overall, significantly fewer patients in the leflunomide arm discontinued therapy compared to placebo (38 vs. 51, respectively; P = .03), largely due to lack of efficacy (19.8% vs. 35.9%, respectively).

The safety, efficacy, and convenience of leflunomide shown in this study indicates to the authors that "leflunomide may provide an important treatment option for patients with PsA and psoriasis."

Arthritis Rheum 2004 Jun;50:6:1939-50. "Efficacy and safety of leflunomide in the treatment of psoriatic arthritis and psoriasis: A multinational, double-blind, randomized, placebo-controlled clinical trial"

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