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        Leflunomide May Be Effective in Treatment of Psoriatic Arthritis and Psoriasis: Presented at ACR

        By Jerry Ingram

        ORLANDO, FL -- October 27, 2003 -- Leflunomide appears to be an effective treatment for patients with psoriatic arthritis and psoriasis, according to research presented here on October 26th at the American College of Rheumatology 67th Annual Scientific Meeting.

        "What was shown in this trial is that leflunomide in psoriatic arthritis results in a psoriatic arthritis response criteria improvement in 59% of patients as compared to 30% in the placebo group, which is statistically significant," said Philip Mease, MD, lead researcher, Seattle Rheumatology Associates, Chief of Clinical Rheumatology Research Division, Swedish Hospital Medical Center, Seattle, Washington.

        "The drug can work in the arthritis component. Also patients showed improvement in their skin scores," Dr. Mease said. "So this puts leflunomide in play as an efficacious agent in treatment of psoriatic arthritis and potentially psoriasis."

        For this study, Dr. Mease and colleagues randomised 190 patients with active psoriatic arthritis and psoriasis to either leflunomide 100 mg/daily loading dose for 3 days followed by 20 mg/daily orally or placebo for 24 weeks.

        The researchers implemented the Psoriatic Arthritis Response Criteria, assessing the number of patients classified as responders (PsARC; Clegg et. al., Arthritis Rheumatology, 1996). Additionally, they examined secondary end points, including the modified American College of Rheumatology 20% (ACR20) response as well as changes in patients Psoriasis Area and Severity Index (PASI). Safety and quality of life assessments were also performed.

        Greater improvement was observed with leflunomide in terms of PsARC, modified ACR20, and PASI at end point compared to placebo. Patients experienced improvements in joint counts and skin involvement within 3 months. The results lasted throughout the study. In comparison to placebo, leflunomide treatment produced significant reductions in tender and swollen joint counts as well as all three aspects of the psoriasis severity assessment (erythaema, infiltration, and desquamation).

        Mease reported that the safety profile of leflunomide was not unlike that observed in rheumatoid arthritis trials with diarrhoea (24.0% versus 13.0%) and increases in serum glutamic pyruvic transaminase (12.5% versus 5.0%) that occur at higher rates in the leflunomide group than the placebo group. All transaminase elevations were reversible and no serious liver toxicity was observed, Dr. Mease said.


        [Study title: Leflunomide in the Treatment of Psoriatic Arthritis and Psoriasis: Joint and Skin Efficacy and Safety in the TOPAS Study. Abstract P342]



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