The open randomised trial of cyclosporine vs methotrexate in refractory rheumatoid arthritis

Patients with refractory rheumatoid arthritis are difficult to treat. We conducted an open randomised trial to assess clinical efficacy and comparison of cyclosporine Vs Methotrexate in refractory rheumatoid arthritis. In a six month open trial, we compared cyclosporine (2.5 to 5 mg/kg of body weight) and methotrexate at 15-30 mg/ Week (at the maximal tolerated dose) in 100 patients with rheumatoid arthritis who had residual inflammation and disability despite partial response to other SAARD's. The primary outcome measure was the change in the number of tender joints, swollen joints, global assessment by physician and patient himself, pain and degree of disability. In both the treatment groups, there was equal improvement in both the regimens in about 60% of patients (observed difference was less than 2 SE/at 6 months of therapy and beyond one year also. The adverse effect i.e. thrombocytopenia, mouth ulcers, renal insufficiency and injury were high in both the groups. About 60% of patients improved on both the regimens showing equal efficacy (Z <1.96) but side effects were more in methotrexate group. Though we can use immunosuppressive drugs early in refractory rheumatoid arthritis but their side effect must be monitored carefully and long term follow up of patients treated with this therapy is needed.