The Prosorba column for treatment of refractory rheumatoid arthritis - A randomized, double-blind, sham-controlled trial

Objective, To evaluate the efficacy and safety of the Prosorba column as a treatment for rheumatoid arthritis (RA) in patients with active and treatme nt-resistant (refractory) disease. Methods. A sham-controlled, randomized, double-blind, multicenter trial of Prosorba versus sham apheresis was performed in patients with RA who had fa iled to respond to treatment with methotrexate or at least 2 other second-l ine drugs. Patients received 12 weekly treatments with Prosorba or sham aph eresis, with efficacy evaluated 7-8 weeks after treatment ended. Patients w ere characterized as responders if they experienced improvement according t o the American College of Rheumatology (ACR) response criteria at the effic acy time point, A data safety monitoring board (DSMB) evaluated interim ana lyses for the possibility of early completion of the trial. Results. 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 patient s 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 f or interim analysis). When results from 8 additional patients, who had comp leted blinded treatments at the time of DSMB action, were added to the anal ysis (n = 99), results were unchanged. The most common adverse events were a short-term flare in joint pain and swelling following treatment, a side e ffect 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. Conclusion. Apheresis with the Prosorba column is an efficacious treatment for RA in patients with active disease who have failed other treatments.