Clinical efficacy and adverse effects of weekly single dose leflunomide in refractory rheumatoid arthritis

Abstract

Aim To study the clinical efficacy and adverse events of weekly single dose of leflunomide in patients with refractory rheumatoid arthritis in comparison with conventional daily regimen. Methods Patients with refractory rheumatoid arthritis were taken up for the study; 91 patients were enlisted of whom 3 became non-compliant and were excluded. A concurrent parallel study was designed with the patients divided into two groups and efficacy and adverse events recorded at third and sixth months. Results A total of 88 patients were included in the study and were divided into two groups. At the end of 6 months, in the daily group 37 (82.2%) out of 45 patients had disease activity score (DAS) less than 3.2 indicating a low disease activity and 8 patients (17.8%) had moderate disease activity. None had high disease activity. In the weekly group, 36 (83.7%) out of 43 patients had low disease activity and 7 (16.3%) had moderate disease. None had high disease activity. Four (8.9%) patients developed adverse reactions in the daily group. One patient (2.2%) had alopecia and the other (2.2%) had diarrhoea and were withdrawn from the study. Two (4.4%) patients had elevated liver enzymes and the drug was stopped at 6 months. None in the weekly group reported any adverse events. Conclusions Weekly regimen was found to be better in terms of compliance and had a lower adverse effect profile. The result was statistically significant. Clinical efficacy of weekly therapy was found to be similar to that of conventional therapy in terms of DAS.