Demography and baseline disease characteristics: full analysis set.
| Characteristics | Fostamatinib, 100 mg bid, n = 105 | Fostamatinib, 100 mg bid (4 weeks), then 150 mg qd, n = 108 | Placebo, n = 109 |
|---|---|---|---|
| Sex, n (%) | |||
| Female | 89 (84.8) | 87 (80.6) | 85 (78.0) |
| Male | 16 (15.2) | 21 (19.4) | 24 (22.0) |
| Age, yrs | |||
| Median | 55 | 52 | 54 |
| Race, n (%) | |||
| White | 86 (81.9) | 92 (85.2) | 91 (83.5) |
| Black or African American | 9 (8.6) | 5 (4.6) | 9 (8.3) |
| Asian | 0 (0.0) | 1 (0.9) | 0 (0.0) |
| Native American or Alaska Native | 1 (1.0) | 4 (3.7) | 1 (0.9) |
| Indian or Pakistani | 2 (1.9) | 0 (0.0) | 1 (0.9) |
| Other | 7 (6.7) | 6 (5.6) | 7 (6.4) |
| Duration of RA, yrs | |||
| Median (range) | 10.0 (1.0–48.8) | 8.2 (0.6–41.1) | 7.9 (1.1–50.5) |
| Disease characteristics | |||
| Swollen joint count, mean (SD) | 12 (5.1) | 12 (5.0) | 13 (5.5) |
| Tender joint count (based on 28 joints), mean (SD) | 17 (6.4) | 15 (6.6) | 16 (6.3) |
| Patient’s assessment of pain, mean (SD) | 66 (23.1) | 63 (20.1) | 61 (20.3) |
| Patient’s global assessment of disease activity, mean (SD) | 64 (21.9) | 62 (19.4) | 60 (21.6) |
| Physician’s global assessment of disease activity, mean (SD) | 65 (17.1) | 64 (15.8) | 65 (17.0) |
| HAQ-DI score, mean (SD) | 1.7 (0.62) | 1.6 (0.66) | 1.5 (0.58) |
| CRP (mg/l), mean | 19 | 17 | 22 |
| Median (range; normal range 0–6 mg/l) | 13 (1–139) | 11 (1–81) | 9 (1–376) |
| ESR, mm/h, mean | 53 | 47 | 51 |
| Median (range; normal range 0–20 mm/h) | 45 (5–138) | 45 (3–128) | 45 (11–146) |
| DAS28-CRP, mean (SD) | 5.98 (0.82) | 5.79 (0.83) | 5.81 (0.95) |
| Presence of radiological erosions, n (%)* | |||
| No | 48 (46.6) | 53 (49.5) | 58 (53.2) |
| Yes | 55 (53.4) | 54 (50.5) | 51 (46.8) |
| mTSS (0–448), median, mean (SD) | 18, 46 (63.9) | 14, 40 (61.5) | 12, 36 (51.2) |
| ES, median, mean (SD) | 9, 19 (27.1) | 5, 19 (33.3) | 5, 18 (27.3) |
| JSN, median, mean (SD) | 9, 24 (32.4) | 6, 22 (31.6) | 5, 21 (28.4) |
↵* From the investigator report. bid: twice daily; CRP: C-reactive protein; DAS28-CRP: Disease Activity Score based on a 28-joint count; ES: erosion score; ESR: erythrocyte sedimentation rate; HAQ-DI: Health Assessment Questionnaire–Disability Index; JSN: joint space narrowing; mTSS: modified total Sharp score; qd: once daily; RA: rheumatoid arthritis.