The Pharmaceutical Journal
Vol 269 No 7223 p668
9 November 2002

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Arthritis patients benefit when leflunomide is added

Adding leflunomide (Arava) to methotrexate therapy produces clinical benefits for patients with rheumatoid arthritis (RA) and is generally well tolerated, a new study shows.

Researchers from North America conducted a randomised, placebo-controlled trial to test whether the two antimetabolites could be given together without producing intolerable side effects.

They randomised 263 patients with active RA despite at least six months treatment with methotrexate to receive leflunomide or placebo in addition to the existing methotrexate therapy. At 24 weeks, the researchers found that more patients treated with leflunomide than placebo had a 20 per cent improvement in disease symptoms (46.2 per cent versus 19.5 per cent, P<0.001).

The researchers comment that the potential for hepatotoxicity is a concern when combining methotrexate with leflunomide. However, the benefits of combination therapy did not appear to be accompanied by an increased incidence of adverse events (89.2 per cent for leflunomide plus methotrexate versus 89.5 per cent for placebo plus methotrexate).

Patients in the leflunomide group were more likely to experience elevated levels of liver aminotransferase enzymes. However, raised levels returned to normal in most cases without the need for dose adjustment. The researchers expect that monitoring liver enzyme levels, already performed for patients receiving methotrexate, will eliminate any hepatoxicity associated with this drug combination (Annals of Internal Medicine 2002;137:726).