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BSR: Leflunomide Safe And Effective In Treating Rheumatoid Arthritis By David Jack, M.D. Special to DG News EDINBURGH, SCOTLAND -- April 25, 2001 -- A number of recent studies have shown that leflunomide is as effective and safe as sulfasalazine or methotrextae in the treatment of rheumatoid arthritis (RA). However, the patient profiles in some of the published studies are not typical of those encountered in routine clinical practice. Dr. S. A. Irvine and colleagues at the Department of Rheumatology, Southern General Hospital, Glasgow, Scotland, set out to address this problem in a retrospective study of consecutive RA patients (n = 37) started on leflunomide over a one year period. All these patients had previously failed to respond to treatment with other disease modifying drugs (DMARDs). These results were presented at the annual meeting of the British Society of Rheumatology. Their patient population was predominantly female (84 percent) with a median age of 60 years (range 23-80 years). The mean duration of RA was 13 years (range 1.5 - 32) and the median number of DMARDs tried previously was five (range two to eight). In addition, 73 percent had a positive rheumatoid factor, the median ESR was 53 mm/h (range 5-117), 73 percent were on NSAIDs and 11 percent were on prednisolone. The median duration of leflunomide therapy was 21 weeks (range six to 51). Adverse events were reported in 20 patients (54 percent) and dose-reduction was required in 10 (27 percent) in order to be able to continue treatment. A total of 12 patients (33 percent) stopped leflunomide treatment : seven (19 percent) on account of adverse effects, three (8 percent) because of lack of effect and two (5 percent) for other reasons. At >12 weeks of treatment, 13 (35 percent) of the patients reported an improvement, eight (22 percent) found no change and a further eight (22 percent) reported a worsening of their symptoms. The median change in ESR at 12 - 16 weeks compared with baseline was -7mm/h. The authors patient cohort was very different for previous study populations both in terms of the longer duration of RA and greater previous exposure to DMARDs. However, in spite of this, the data on short-term efficacy and tolerability were similar to that reported in the study cohorts. Nevertheless, a significant number of patients required a dose-reduction in order to continue with treatment and this could potentially be a major factor restricting longer term treatment. Dr Irvine and his group hope to report on this in the future. E-mail this page to a friend or colleague! To print, use this version