Table 1

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 (%)
  Male9 (12.0)7 (17.9)5 (12.2)2 (5.1)5 (12.8)19 (12.0)
  Female66 (88.0)32 (82.1)36 (87.8)37 (94.9)34 (87.2)139 (88.0)
 Race, n (%)
  White75 (100.0)39 (100.0)38 (92.7)39 (100.0)39 (100.0)155 (98.1)
  Other0 (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 therapy4 (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.