To evaluate the safety and effectiveness of extracorporeal immunoadsorption with protein A (PROSORBA) columns in the treatment of refractory rheumatoid arthritis (RA).
Eleven patients with refractory RA were enrolled in an open prospective trial of 24 weeks' duration. Nine patients received 15 treatments over a 12-week period, 1 patient received 15 treatments over a 15-week period, and 1 patient received 12 treatments over a 9-week period.
Using the composite criteria of Paulus, et al, 9 patients met the > or = 50% criteria when tested at Week 13, while 4 and 2 patients met the > or = 50% and > or = 20% criteria, respectively, when tested at Week 24. In addition, most of the clinical variables in the 9 responders at Week 13 had significantly improved (p < 0.05); 8 of these responders were able to continue for the entire 24-week study without a change in their arthritic medications, and 2 met the American College of Rheumatology criteria for clinical remission at Weeks 12, and 28 and have remained in remission for 6 and 5 months, respectively. Treatment associated side effects were of short duration and resolved without sequela. Four patients became symptomatically anemic during the treatments.
Our preliminary study suggests that extracorporeal immunoadsorption therapy with protein A columns was well tolerated and may be effective in the treatment of RA. Further expanded and controlled trials are indicated to explore this new therapeutic modality.