A prospective phase II trial was conducted to assess the feasibility, tolerance, and efficacy of a device designed for selective removal of
rheumatoid factor from the plasma of
rheumatoid arthritis patients. The device contained terpolymer
hydrogel-coated plates with chemically attached, aggregated human
immunoglobulin G, and it operated as an immunoaffinity column. Sixty-one patients aged 25 to 73 underwent weekly
plasmapheresis treatments (the primary
therapy phase). During the trial, patients continued current
rheumatoid arthritis medications without dose adjustments. All patients received two to six treatments (primary
therapy). Responding patients were eligible to continue
apheresis treatment every 2 to 6 weeks (maintenance
therapy). No serious, untoward side effects were noted in the course of this study; of 640 treatments, only 2 (in different patients) were aborted, one because of complaints of
dizziness and
angioedema and the other because of chest tightness and
shortness of breath. Except for a significant (p less than 0.05) decrease in serum
iron, no significant changes in complete blood count, serum
electrolytes, renal and hepatic function tests, or serum C3 and C4 were noted. Although the trial was not designed to determine clinical efficacy, patients noted less morning stiffness, longer time to onset of
fatigue, and improved global
pain assessment (p less than 0.004); significant objective improvements were noted in
joint pain, tenderness, swelling, and the number of affected joints (p less than 0.001). One-half of the treated patients had at least a 50 percent improvement in objective measures of antirheumatic activity.(ABSTRACT TRUNCATED AT 250 WORDS)