The prosorba column for treatment of refractory rheumatoid arthritis: A randomized, double-blind, sham-controlled trial
Article first published online: 26 APR 2001
Copyright © 1999 by the American College of Rheumatology
Arthritis & Rheumatism
Volume 42, Issue 10, pages 2153–2159, October 1999
How to Cite
Felson, D. T., LaValley, M. P., Baldassare, A. R., Block, J. A., Caldwell, J. R., Cannon, G. W., Deal, C., Evans, S., Fleischmann, R., Gendreau, R. M., Harris, E. R., Matteson, E. L., Roth, S. H., Schumacher, H. R., Weisman, M. H. and Furst, D. E. (1999), The prosorba column for treatment of refractory rheumatoid arthritis: A randomized, double-blind, sham-controlled trial. Arthritis & Rheumatism, 42: 2153–2159. doi: 10.1002/1529-0131(199910)42:10<2153::AID-ANR16>3.0.CO;2-W
- Issue published online: 26 APR 2001
- Article first published online: 26 APR 2001
- Manuscript Accepted: 1 JUN 1999
- Manuscript Received: 12 FEB 1999
- Cypress Bioscience, Inc
- National Center for Research Resources. Grant Number: M01-RR00064
To evaluate the efficacy and safety of the Prosorba column as a treatment for rheumatoid arthritis (RA) in patients with active and treatment-resistant (refractory) disease.
A sham-controlled, randomized, double-blind, multicenter trial of Prosorba versus sham apheresis was performed in patients with RA who had failed to respond to treatment with methotrexate or at least 2 other second-line drugs. Patients received 12 weekly treatments with Prosorba or sham apheresis, with efficacy evaluated 7–8 weeks after treatment ended. Patients were characterized as responders if they experienced improvement according to the American College of Rheumatology (ACR) response criteria at the efficacy time point. A data safety monitoring board (DSMB) evaluated interim analyses for the possibility of early completion of the trial.
Patients in the trial had RA for an average of 15.5 years (range 1.7–50.6) and had failed an average of 4.2 second-line drug treatments prior to entry. After the completion of treatment of 91 randomized patients, the DSMB stopped the trial early due to successful outcomes. Of the 47 patients in the Prosorba arm, 31.9% experienced ACR-defined improvement versus 11.4% of the 44 patients in the sham-treated arm (P = 0.019 after adjustment for interim analysis). When results from 8 additional patients, who had completed blinded treatments at the time of DSMB action, were added to the analysis (n = 99), results were unchanged. The most common adverse events were a short-term flare in joint pain and swelling following treatment, a side effect that occurred in most subjects at least once in both treatment arms. Other side effects, although common, occurred equally as frequently in both treatment groups.
Apheresis with the Prosorba column is an efficacious treatment for RA in patients with active disease who have failed other treatments.