CYCLOSPORINE-A IN THE TREATMENT OF EARLY RHEUMATOID-ARTHRITIS - A PROSPECTIVE, RANDOMIZED 24-MONTH STUDY

Objective To investigate the efficacy, tolerability and safety of cycl osporine A (CSA) in early rheumatoid arthritis (RA) patients. Methods Patients with an early diagnosis of RA, a disease duration of less tha n 3 years, and without prior disease modifying antirheumatic drug (DMA RD) treatment were studied. They randomly received oral CSA (3 mg/kg/d ay) or oral methotrexate (MTX) (0.15 mg/kg/week). In addition, all pat ients in both groups received oral prednisone (7.5 mg/day). Results Fi fty-two patients were assigned to the CSA group and 51 to the MTX grou p. After 24 months of treatment, 48 patients from the CSA group and 48 from the MTX group showed significant clinical improvement. This was evaluated by the duration of morning stiffness, grip strength, the tot al joint count, joint swelling, and joint tenderness and pain, compare d to pr e-treatment values. The clinical improvement was also associat ed with a significant decrease in ESR and CRP values in both groups. N o significant radiological deterioration was observed in the CSA patie nts compared to those treated with MTX after 24 months. Four patients front the CSA group dropped out of the study, two because of a synovit is flare, one because of severe hypertrichosis and one because of seve re gingival hyperplasia. Three patients from the MTX group withdrew on e because of disease flare-up and two because of gastrointestinal dist urbances. Conclusion Early immunointervention in RA patients appears t o be crucial to limit the development of joint damage. Cyclosporine A appears to be effective well tolerated and safe in the long-term treat ment of RA and can therefore be used as a first immunomodulatory drug in the armamentarium for the treatment of RA.