Leflunomide (Arava) is a useful DMARD in Indian (Asian) patients: a clinic-based observational study of 1-year treatment.

Several drug trials, predominantly of Caucasian patients, have demonstrated the therapeutic role of leflunomide (LEF) in the treatment of rheumatoid arthritis (RA). We report an Indian (Asian) experience from a prospective observational study. Two hundred thirty affording patients with moderately severe active RA (naïve for LEF), mostly failing methotrexate (MTX), were begun LEF (Aravatrade mark; 20 mg daily, post loading 100 mg od x 3 days) in a clinic setting and followed regularly in an open cohort as per standard of care practice guidelines. A priori, LEF was to be preferably used as a single-agent disease-modifying anti-rheumatic drug (DMARD). One hundred forty-three patients and 87 patients were clinically assigned to the LEF monotherapy and LEF + MTX combination, respectively; less than one third received prednisolone. We focus on 146 patients (64%) completing 1 year treatment. Patients improved significantly (p < 0.05, analysis of variance) in several measures (including Health Assessment Questionnaire). Though unintended (non-randomized), the treatment subgroups matched at baseline. Of patients, 42% and 24% in LEF monotherapy and LEF + MTX, respectively showed American College of Rheumatology 50% Response Criteria (ACR 50) improvement. LEF monotherapy showed a better 'time to first ACR 20 improvement' outcome over 1 year (survival function curve, Cox Hazard Ratio = 0.71, 95% confidence interval 0.52, 0.96). Ten percent to 30% patients reported diarrhea, hair loss, skin rash, and dyspepsia; <3% reported abnormal liver functions. Eighty-four patients (36.5%) withdrew (8.7% adverse events and 18.7% non-affordability). LEF is an effective and safe DMARD in our ethnic patient population and may suffice as a single agent (to treat moderately severe RA) during the initial 1 year.