The following additional members of the Methotrexate- Cyclosporine Combination Study Group participated in this trial: M. Cornett, BScN (Tucson center) and P. Dale, Philip Baker, BSc, and J. Groh (Ottawa center), research coordinators; T. Croft (Ottawa center), data entry manager; E. Yetisir, MSc (Ottawa center), biostatistician.
Combination treatment of severe rheumatoid arthritis with cyclosporine and methotrexate for forty-eight weeks. An open-label extension study
Article first published online: 12 DEC 2005
Copyright © 1997 American College of Rheumatology
Arthritis & Rheumatism
Volume 40, Issue 10, pages 1843–1851, October 1997
How to Cite
Stein, C. M., Pincus, T., Yocum, D., Tugwell, P., Wells, G., Gluck, O., Kraag, G., Torley, H., Tesser, J., McKendry, R., Brooks, R. H. and The Methotrexate-Cyclosporine Combination Study Group (1997), Combination treatment of severe rheumatoid arthritis with cyclosporine and methotrexate for forty-eight weeks. An open-label extension study. Arthritis & Rheumatism, 40: 1843–1851. doi: 10.1002/art.1780401018
- Issue published online: 12 DEC 2005
- Article first published online: 12 DEC 2005
- Manuscript Revised: 14 MAY 1997
- Manuscript Accepted: 28 FEB 1997
- Sandoz Pharmaceuticals Ltd., USA
- Sandoz Canada
Objective. To determine whether the clinical benefit and favorable safety profile previously noted with the combination of cyclosporine (CSA) and methotrexate (MTX) given for 24 weeks in patients with rheumatoid arthritis (RA) would be maintained for a further 24 weeks, and whether the addition of CSA in patients who had previously been randomized to receive placebo + MTX would result in clinical benefit.
Methods. Eligible subjects from the initial study (weeks 0–24), in which the addition of placebo or CSA to MTX therapy was compared in patients with RA that was partially responsive to MTX, were enrolled. Patients who had received CSA + MTX continued this regimen for a further 24 weeks (weeks 24–48) (group 1; n = 48), and patients who had initially received placebo + MTX now received CSA + MTX for 24 weeks (weeks 24–48) (group 2; n = 44), in an open-label extension study. The primary outcome measures were the number of tender joints, number of swollen joints, physician and patient global assessments, pain, functional disability as measured by the modified Health Assessment Questionnaire, and erythrocyte sedimentation rate.
Results. Of the 92 patients enrolled, 80 (87%) completed the extension study. In patients in group 1, the clinically and statistically significant improvement in response outcomes previously noted at week 24, ranging from 25% to 50%, was maintained through week 48. In patients in group 2, the addition of CSA resulted in significant clinical improvement. By week 48, most outcome measures in group 2 patients were similar to those in group 1 patients. CSA treatment resulted in a small increase in serum creatinine levels, but only 1 patient was withdrawn from the study for this reason.
Conclusion. The clinical improvement previously observed in patients treated with the CSA + MTX combination for 24 weeks was maintained for 24 subsequent weeks, without serious adverse effects, and was also observed in the patients whose treatment was switched from placebo + MTX to CSA + MTX.