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  • Title: Leflunomide and rheumatoid arthritis: new preparation. Neither the safest nor the most effective slow-acting antirheumatic drug.
    Journal: Prescrire Int; 2001 Apr; 10(52):36-9. PubMed ID: 11718154.
    Abstract:
    (1) There is no consensus on the reference disease-modifying antirheumatic drug. Three drugs are often prescribed as a first line option: methotrexate for its efficacy, and sulfasalazine and hydroxychloroquine for their lesser adverse effects. (2) Leflunomide, an immunosuppressive drug, is approved in the European community for oral treatment of rheumatoid arthritis, as a slow-acting antirheumatic agent. (3) The clinical file answers only some practical questions. (4) At a dose of 10-20 mg/day, patients start to notice the efficacy of leflunomide after 4-8 weeks. (5) One of the two available trials versus methotrexate shows that the latter is significantly more effective than leflunomide on clinical end points. The other trial, which was smaller, showed no difference between the treatments. Another trial showed no difference in clinical efficacy between leflunomide and sulfasalazine. (6) Leflunomide was more often associated with severe adverse events than methotrexate or sulfasalazine: elevated transminase levels, haematological disorders and cutaneous reactions. (7) Leflunomide is teratogenic in animals. The summary of product characteristics recommends a two-year period between conception and the end of leflunomide treatment. (8) The two-week half-life of the active metabolite of leflunomide is a major disadvantage when adverse effects occur.
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