Leflunomide (ARAVA™)- the Indian experience: a multicenter assessment of its safety and effectiveness in treatment of active rheumatoid arthritis

Abstract

Objective: To assess the safety and efficacy of leflunomide, a newly introduced disease-modifying antirheumatic drug (DMARD), in Indian patients with active rheumatoid arthritis (RA). Methods: A multicentre, open, noncomparative study of 16 weeks’ duration was undertaken in which 121 patients with RA, who consented to participate in the study received leflunomide 100 mg, once daily, for the first three days, followed by 20 mg, once daily, for the rest of the study period. These patients were seen at baseline, 4, 8, 12 and 16 weeks and disease activity was assessed for using the modified Disease Activity Score (DAS 28) and American College of Rheumatology (ACR) response criteria. Results: Of the 121 patients enrolled, predominantly (86%) women with age range 18–63 years and mean disease duration of 4.26 years, 102 (84.3%) completed the study. There was statistically significant improvement in primary and secondary outcome measures. At 16 weeks, the DAS 28 and the ACR20% response rate was 74% and 70% respectively, with 8.19 weeks being the mean time to initial response. Leflunomide treatment also improved measures of physical function and health related quality of life. Leflunomide was well tolerated, with only 6 (5%) patients reporting serious adverse events. No clinically relevant changes were observed in biochemical or hematological parameters, ECG or chest radiograph. Conclusion: Leflunomide, an effective, safe, and welltolerated drug with an early (4-weeks) onset of action, demonstrated important clinical benefits in Indian patients, presenting early or late, with active rheumatoid arthritis. Leflunomide, will be a valuable addition to the therapeutic repertoire of rheumatologists in clinical practice.