Baseline and disease characteristics (Intent-to-treat population)
| Placebo (n=75) | Mavrilimumab | |||||
|---|---|---|---|---|---|---|
| 10 mg (n=39) | 30 mg (n=41) | 50 mg (n=39) | 100 mg (n=39) | Total (n=158) | ||
| Demography | ||||||
| Age, mean (SD) | 50.9 (12.7) | 52.2 (12.2) | 49.7 (11.9) | 53.3 (10.2) | 49.3 (11.7) | 51.1 (11.6) |
| Gender, n (%) | ||||||
| Male | 9 (12.0) | 7 (17.9) | 5 (12.2) | 2 (5.1) | 5 (12.8) | 19 (12.0) |
| Female | 66 (88.0) | 32 (82.1) | 36 (87.8) | 37 (94.9) | 34 (87.2) | 139 (88.0) |
| Race, n (%) | ||||||
| White | 75 (100.0) | 39 (100.0) | 38 (92.7) | 39 (100.0) | 39 (100.0) | 155 (98.1) |
| Other | 0 (0) | 0 (0) | 3 (7.3) | 0 (0) | 0 (0) | 3 (1.9) |
| Weight (kg), mean (SD) | 69.7 (13.9) | 68.5 (15.2) | 72.8 (14.5) | 67.7 (13.2) | 71.9 (10.6) | 70.2 (13.5) |
| BMI (kg/m2), mean (SD) | 26.1 (5.4) | 25.1 (4.9) | 26.6 (5.7) | 26.1 (4.7) | 26.9 (4.2) | 26.2 (4.9) |
| Baseline characteristics | ||||||
| Disease duration (years), mean (SD) | 7.5 (7.7) | 9.8 (6.9) | 5.6 (5.5) | 7.5 (7.4) | 6.4 (7.1) | 7.3 (6.9) |
| Methotrexate dose, n (%) | ||||||
| Low (<12.5 mg/week) | 23 (30.7) | 11 (28.2) | 16 (39.0) | 20 (51.3) | 14 (35.9) | 61 (38.6) |
| Medium (≥12.5–<20 mg/week) | 43 (57.3) | 23 (59.0) | 21 (51.2) | 15 (38.5) | 24 (61.5) | 83 (52.5) |
| High (≥20 mg/week) | 9 (12.0) | 5 (12.8) | 4 (9.8) | 4 (10.3) | 1 (2.6) | 14 (8.9) |
| Concomitant steroids, n (%) | 37 (49.3) | 20 (51.3) | 17 (41.5) | 16 (41.0) | 19 (48.7) | 72 (46.0) |
| Prior biologic therapy | 4 (5.3) | 7 (17.9) | 1 (2.4) | 0 (0.0) | 0 (0.0) | 8 (5.1) |
| RF positive, n (%) | 65 (86.7) | 39 (100.0) | 39 (95.1) | 36 (92.3) | 34 (87.2) | 148 (93.7) |
| ACPA positive, n (%) | 65 (86.7) | 32 (82.1) | 38 (92.7) | 35 (89.7) | 33 (84.6) | 138 (87.3) |
| Baseline disease activity | ||||||
| DAS28-CRP, mean (SD) | 5.6 (1.0) | 5.3 (1.0) | 5.5 (1.0) | 5.3 (1.0) | 5.4 (0.7) | 5.4 (0.9) |
| Swollen joint count, mean (SD) | 14.7 (8.6) | 15.1 (10.6) | 13.8 (8.7) | 13.3 (10.1) | 12.6 (6.1) | 13.7 (9.0) |
| Tender joint count, mean (SD) | 24.0 (12.5) | 21.1 (12.9) | 23.9 (12.1) | 25.9 (12.3) | 21.5 (10.2) | 23.1 (11.9) |
| Patient pain (mm), mean (SD) | 61.8 (19.8) | 57.5 (23.8) | 58.6 (24.1) | 58.1 (18.7) | 57.7 (15.8) | 58.0 (20.8) |
| Patient global assessment of disease activity (mm), mean (SD) | 61.9 (19.4) | 58.0 (21.9) | 60.5 (21.1) | 59.7 (17.4) | 58.1 (14.2) | 59.1 (18.8) |
| Physician global assessment of disease activity (cm), mean (SD) | 6.3 (1.3) | 5.2 (1.9) | 6.1 (1.6) | 6.3 (1.6) | 5.7 (1.4) | 5.8 (1.7) |
| HAQ-DI, mean (SD) | 1.5 (0.6) | 1.4 (0.6) | 1.4 (0.6) | 1.5 (0.6) | 1.5 (0.5) | 1.4 (0.6) |
| CRP (mg/l), geometric mean (CV%) | 5.8 (165.9) | 4.3 (119.9) | 5.9 (136.4) | 5.1 (174.6) | 6.1 (121.5) | 5.3 (145.7) |
| ESR (mm/hr), geometric mean (CV%) | 33.4 (58.3) | 31.1 (54.1) | 39.6 (55.7) | 39.6 (49.9) | 31.9 (50.8) | 35.3 (53.5) |
ACPA, anti-citrullinated protein antibody; BMI, body mass index; CRP, c-reactive protein; CV, coefficient of variation; DAS, disease activity score; ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessments Questionnaire-Disability Index; RF, rheumatoid factor; SD, standard deviation.