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.