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Title: BSR: Potentially Serious Pulmonary Complications With Leflunomide
URL: http://www.pslgroup.com/dg/1F943A.htm
Doctor's Guide
April 26, 2001


By David Jack M.D.
Special to DG News


EDINBURGH, SCOTLAND -- APRIL 26, 2001 -- Although the exact details of the relationship between leflunomide and pulmonary side effects remain to be established, researchers make a plea for caution when using this drug to treat patients with underlying interstitial lung disease. They add that all patients should be carefully monitored for pulmonary complications.

This presentation at the Annual Meeting of the British Society of Rheumatology was given by Dr. C. Balakrishnan and colleagues from the Rheumatology Department, Southend General Hospital, Essex, England.

They treated patients with resistant polyarthritis with leflunomide starting with 100 mg daily for the first three days, followed by a maintenance dose of 20 mg daily. This dose was reduced to 10 mg daily if any side-effects were reported. Corticosteroid and antiinflammatory treatments were continued but no patient was on any other disease modifying antirheumatic drug (DMARD). All patients were monitored at two-weekly intervals using blood counts, liver function tests and creatinine clearance.

Since January 2000, they have treated 34 (22 female and 12 male) patients with inflammatory arthritis (31 cases of RA, 2 cases of psoriatic arthritis and one case of ankylosing spondylitis) with leflunomide. The mean age of the patients was 58.4 years (range : 29-76) and the mean duration of the illness was 9.7 years (range : 3-40). A total of 22 patients (64 percent) were on steroids and the mean number of DMARDs prior to leflunomide was 2.76. Fourteen (41 percent) patients developed side-effects which required stopping treatment in 12 cases (35 percent). Pulmonary side-effects occurred in 11 patients (32 percent) and treatment had to be discontinued in 10 (29 percent), 7 (21 percent) were admitted to hospital for treatment and three (9 percent) died.

This study clearly demonstrates the pulmonary side-effects associated with leflunomide treatment. However, the researchers do point out that RA varies enormously in its manifestations, severity and degree of extra-articular involvement and warn that extrapolation from the results of small randomized controlled trails to clinical use may not necessarily be valid.

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