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Selective in vivo removal of rheumatoid factor by an extracorporeal treatment device in rheumatoid arthritis patients
Author(s) -
Lazarus H.M.,
Cohen S. B.,
Clegg D. O.,
Menitove J. E.,
Sorin S. B.,
Hinkle S.,
Markenson J. A.,
Saal S.,
Goodnough L. T.,
Fleischmann R. M.
Publication year - 1991
Publication title -
transfusion
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.045
H-Index - 132
eISSN - 1537-2995
pISSN - 0041-1132
DOI - 10.1046/j.1537-2995.1991.31291142942.x
Subject(s) - medicine , rheumatoid arthritis , rheumatoid factor , surgery , joint pain , adverse effect , plasmapheresis , arthritis , clinical trial , gastroenterology , antibody , immunology
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 < 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 < 0.004); significant objective improvements were noted in joint pain, tenderness, swelling, and the number of affected joints (p < 0.001). One‐half of the treated patients had at least a 50 percent improvement in objective measures of antirheumatic activity. Although serum rheumatoid factor could be recovered in vitro in large quantities, no correlation was noted between changes in serum rheumatoid factor concentration and clinical response. This therapeutic modality was safe, well tolerated, and associated with clinical improvement in some patients. It merits further evaluation in a prospective phase III clinical trial.