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.
To evaluate the efficacy and safety profile of leflunomide in Pakistani patients with RA, either alone or in combination with methotrexate.
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.
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.
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.