Introduction: Leflunomide is a disease-modifying anti-rheumatic drug (DMARD) for rheumatoid arthritis (RA). It has been widely studied in the West but there is no available local Pakistani data.
Objective: To evaluate the efficacy and safety profile of leflunomide in Pakistani patients with RA, either alone or in combination with methotrexate.
Materials and methods: A prospective, non-comparator, open-label study in a setting of 'care as usual' was performed. In this study, 63 consecutive RA patients on leflunomide were enrolled. Leflunomide dose was started with full loading in 5 (8%), half loading in 39 (62%) and without loading in 19 (30%) patients. Methotrexate was also used in 20 (32%) patients. Primary end-point was 20% improvement in American College of Rheumatology response criteria (ACR-20). Safety was assessed by adverse events and abnormalities in laboratory parameters.
Results: Out of 63 patients, 54 (85.7%) were female. Mean age was 46 ± 12.6 years. Mean disease duration was 5.1 ± 4.5 years. Fifty-two (86.6%) patients achieved ACR-20 response at 6 months; 32 (53%) achieved ACR-50 response at 6 months; 20% experienced at least one adverse event, which resolved by reducing leflunomide dose. Only seven (11%) had raised liver enzymes from baseline.
Conclusion: This prospective study conducted in the setting of a daily rheumatology practice shows that leflunomide is an effective and safe DMARD in treatment of RA in Pakistani patients.
© 2011 The Authors. International Journal of Rheumatic Diseases. © 2011 Asia Pacific League of Associations for Rheumatology and Blackwell Publishing Asia Pty Ltd.