Radiologic evidence of disease modification in rheumatoid arthritis patients treated with cyclosporine. Results of a 48-week multicenter study comparing low-dose cyclosporine with placebo. Norwegian Arthritis Study Group. Adding low-dose cyclosporin A to parenteral gold therapy in rheumatoid arthritis: a double-blind placebo-controlled study. Cyclosporin in rheumatoid arthritis: a double blind, placebo controlled study in 52 patients.
To evaluate the therapeutic efficacy of 46 weeks of treatment with cyclosporine (5 mg/kg/day) in patients with rheumatoid arthritis (RA).
                A 48-week randomized, double-blind, placebo-controlled, multicenter study of cyclosporine was conducted in 122 patients with active RA. Patients were evaluated by objective and subjective clinical and radiologic measurements at baseline and at the end of the study.
                Statistically significant improvement and clinically important changes were seen for the number of tender joints, number of swollen joints, pain score, duration of morning stiffness, and Lee's functional index in the cyclosporine-treated group at the end of the study. Radiographic examination showed that cyclosporine was capable of retarding joint destruction. In the cyclosporine-treated group, serum creatinine levels increased by 17.5 mumoles/liter (23%) at week 24 and by 21.8 mumoles/liter (26%) at week 48. There was no significant difference in mean serum creatinine levels in patients treated with cyclosporine alone and those treated with cyclosporine plus nonsteroidal antiinflammatory drugs. Five patients had to be treated with antihypertensive drugs, and 2 patients were withdrawn from the study because of increased serum creatinine.
                The study shows that cyclosporine seems to have disease-modifying effects in RA. A double-blind, randomized comparison between parenteral gold therapy (PGT) and cyclosporin A (CyA) vs PGT and placebo during 6 months was performed in 40 RA patients experiencing a decreasing effect of ongoing PGT. Patients' overall assessment of health was the only efficacy variable significantly better in the CyA- and PGT-treated vs the placebo- and PGT-treated group. Higher blood pressure and more signs of renal impairment were found during the 6 months treatment in the former compared with the latter group. Six months after the end of the combination therapy, a higher potassium value in the CyA-treated group was the only difference. In conclusion, no effects additional to those expected with single-drug therapy or additional risks of side-effects of either drug were found when combining low-dose CyA with ongoing PGT in RA patients with long disease duration. The efficacy and safety of cyclosporin A (CyA) for patients with rheumatoid arthritis were assessed in a four month double blind, placebo controlled study using an initial dosage of 5 mg/kg daily. Six patients withdrew from the study (two in the placebo group because of inefficacy of treatment and four in the CyA group because of side effects). These six patients were considered therapeutic failures. At the end of the trial the study treatment was considered as good or very good by 14 out of the 26 CyA group patients and by only two out of the 26 placebo group patients. Moreover, in the CyA group significant improvement was observed in five of the seven clinical assessment criteria. Clinical improvement was correlated with a decrease in C reactive protein, alpha 1 glycoprotein levels, and platelet count but not with erythrocyte sedimentation rate or rheumatoid factor titres. Renal toxicity (13 cases) remained the major problem in the management of these patients. This study shows that CyA is effective in active rheumatoid arthritis but requires close monitoring for toxicity.
Cyclosporine has an important clinical benefit in the short-term (up to one year) treatment of patients with progressive rheumatoid arthritis.