Rheumatoid Arthritis: LaValley MP

Felson DT, LaValley MP, Baldassare AR, Block JA, Caldwell JR, Cannon GW, Deal C, Evans S, Fleischmann R, Gendreau RM, Harris ER, Matteson EL, Roth SH, Schumacher HR, Weisman MH, Furst DE. · Boston University School of Medicine, Massachusetts, USA. · Arthritis Rheum. · Pubmed #10524687 links to  free full text

Abstract: OBJECTIVE: 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. METHODS: 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. 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 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. CONCLUSION: Apheresis with the Prosorba column is an efficacious treatment for RA in patients with active disease who have failed other treatments.

Allaire S, Wolfe F, Niu J, LaValley MP, Zhang B, Reisine S. · Boston University School of Medicine, Boston, Massachusetts 02118, USA. · Arthritis Rheum. · Pubmed #19248135 No free full text.

Abstract: OBJECTIVE: To explore, using recent data, whether and how risk factors for rheumatoid arthritis (RA) work disability may differ from previous studies. METHODS: Subjects were 953 individuals with RA from a US cohort who provided data semiannually over 18 months (years 2002-2005). A nested case-control design was used with matching on time of baseline data collection. All subjects were employed at baseline; cases were consistently not employed at followup, whereas controls remained employed. Hierarchical conditional logistic regression assessed the roles of demographic, RA disease, general health, and work factors as predictors of work disability. Recursive partitioning and causal modeling procedures were also used. RESULTS: Sample characteristics were mean age 51 years, 82% female, and 92% white. Older age (odds ratio [OR] 1.2, 95% confidence interval [95% CI] 1.1-1.4) and lower income (OR 1.7, 95% CI 1.0-2.7) predicted work disability, whereas more hours worked (OR 0.9, 95% CI 0.8-0.9) and preference to work full time (OR 0.2, 95% CI 0.1-0.4) or part time (OR 0.4, 95% CI 0.2-0.6) versus not to work were protective in the regression analysis. In recursive partitioning analyses, RA disease factors predicted work disability among older subjects, and functional limitation was the fourth most important factor. Job physical demand was not a significant or important factor. CONCLUSION: In this contemporary data from a large RA cohort, older age, lower income, fewer working hours, and preference not to work were the risk factors for work disability. The impact of disease factors was limited to subjects ages >or=56 years. Job physical demand level had little impact.