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Leflunomide is a disease modifying drug with proven efficacy in the treatment of rheumatoid arthritis (RA).1–6 Clinical trials have indicated that low level, reversible, asymptomatic increases in serum transaminases may occur, although serious hepatotoxicity is uncommon.6–8 It remains unclear as to whether the characteristics of leflunomide transaminitis, reported in clinical trials, occur in a less vigorously monitored and clinically heterogeneous normal care RA population.
METHODS AND RESULTS
Between November 1999 and September 2001 we audited all non-hospital clinic patients with RA, privately managed with leflunomide by one physician (GOL), for the frequency and severity of transaminitis. These patients received usual care and were felt to be more likely to have other comorbidities, polypharmacy, and poorer review compliance than clinical trial patients.
Serum alanine aminotransferase (ALT) …