RT Journal Article
SR Electronic
T1 Effects of Fostamatinib (R788), an Oral Spleen Tyrosine Kinase Inhibitor, on Health-related Quality of Life in Patients with Active Rheumatoid Arthritis: Analyses of Patient-reported Outcomes from a Randomized, Double-blind, Placebo-controlled Trial
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP 369
OP 378
DO 10.3899/jrheum.120923
VO 40
IS 4
A1 Michael E. Weinblatt
A1 Arthur Kavanaugh
A1 Mark C. Genovese
A1 David A. Jones
A1 Theresa K. Musser
A1 Elliott B. Grossbard
A1 Daniel B. Magilavy
YR 2013
UL http://www.jrheum.org/content/40/4/369.abstract
AB Objective. To assess the influence of fostamatinib on patient-reported outcomes (PRO) in patients with active rheumatoid arthritis and an inadequate response to methotrexate (MTX). Methods. Patients taking background MTX (N = 457) were enrolled in a phase II clinical trial (NCT00665925) and randomized equally to placebo, fostamatinib 100 mg twice daily (bid), or fostamatinib 150 mg once daily (qd) for 24 weeks. Self-administered PRO measures included pain, patient's global assessment (PtGA) of disease activity, physical function, health-related quality of life (HRQOL), and fatigue. Mean change from baseline and a responder analysis of the proportion of patients achieving a minimal clinically important difference were determined. Results. At Week 24, there were statistically significant improvements in pain, PtGA, physical function, fatigue, and the physical component summary of the Medical Outcomes Study Short Form-36 (SF-36) for fostamatinib 100 mg bid compared with placebo. Mean (standard error) changes from baseline in the fostamatinib 100 mg bid group versus the placebo group were −31.3 (2.45) versus −17.8 (2.45), p < 0.001 for pain; −29.1 (2.26) versus −16.7 (2.42), p < 0.001 for PtGA; −0.647 (0.064) versus −0.343 (0.062), p < 0.001 for physical function; 7.40 (1.00) versus 4.50 (0.94), p < 0.05 for fatigue; 8.52 (0.77) versus 4.90 (0.78), p < 0.01 for SF-36 physical component score; and 3.99 (0.93) versus 3.71 (0.99), p = 0.83 for SF-36 mental component score. Patients receiving fostamatinib 150 mg qd showed improvements in some PRO, including physical function. Conclusion. Patients treated with fostamatinib 100 mg bid showed significant improvements in HRQOL outcomes.