Endpoint* | N (%) of Patients | ||
---|---|---|---|
Fostamatinib, 100 mg bid, n = 105 | Fostamatinib, 100 mg bid (4 weeks) then 150 mg qd, n = 108 | Placebo, n = 109 | |
Primary endpoint | |||
ACR20 at Week 24 | 38 (36.2) | 30 (27.8) | 23 (21.1) |
Secondary endpoints | |||
ACR50 at Week 24 | 19 (18.1) | 14 (13.0) | 9 (8.3) |
ACR70 at Week 24 | 15 (14.3) | 3 (2.8) | 3 (2.8) |
HAQ-DI reduction ≥ 0.22 at Week 24 | 44 (41.9) | 34 (31.5) | 26 (23.9) |
ACR20 at Week 1 | 54 (25.4)# | 4 (3.7) | |
DAS28-CRP ≤ 3.2 at Week 12 | 19 (18.1) | 22 (20.4) | 6 (5.5) |
DAS28-CRP ≤ 3.2 at Week 24 | 26 (24.8) | 12 (11.1) | 6 (5.5) |
DAS28-CRP < 2.6 at Week 12 | 10 (9.5) | 10 (9.3) | 4 (3.7) |
DAS28-CRP < 2.6 at Week 24 | 12 (11.4) | 8 (7.4) | 4 (3.7) |
n = 81 | n = 87 | n = 88 | |
Mean change from baseline in mTSS score at Week 24 | 0.80 | 0.18 | 0.84 |
Patients with mTSS change ≤ 0.5 from baseline at Week 24 | 56 (69.1) | 72 (82.8) | 63 (71.6) |
Mean change in ES at Week 24 | 0.25 | 0.07 | 0.40 |
Mean change in JSN at Week 24 | 0.55 | 0.11 | 0.44 |
↵* Nonresponder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no postbaseline data. mTSS, DAS28-CRP < 2.6 at Week 12, and DAS28-CRP ≤ 3.2 at Week 24 were not part of the multiple testing procedure.
↵# Group A and B values merged because all patients were taking 100 mg bid at Week 1. ACR20: American College of Rheumatology 20% response; ACR50: ACR 50% response; ACR70: ACR 70% response; bid: twice daily; DAS28-CRP: Disease Activity Score based on a 28-joint count-C-reactive protein; DMARD: disease-modifying antirheumatic drug; ES: erosion score; HAQ-DI: Health Assessment Questionnaire–Disability Index; JSN: joint space narrowing; mTSS: modified total Sharp score; qd: once daily.