Table 1

Demographic and other baseline characteristics (ITT population)*

Characteristics, n (%) unless otherwise specifiedOKZ q2w, n=138OKZ q4w, n=161PBO, n=69
Age, years; mean (SD)53.4 (12.7)53.9 (11.7)53.0 (13.7)
Female122 (88.4)130 (80.7)55 (79.7)
Race
 Asian6 (4.3)3 (1.9)2 (2.9)
 Black or African American11 (8.0)11 (6.8)1 (1.4)
 White110 (79.7)139 (86.3)53 (76.8)
 Other/mixed11 (8.0)8 (5.0)13 (18.8)
Ethnicity
 Hispanic or Latino ethnicity64 (46.4)77 (47.8)42 (60.9)
 Not Hispanic or Latino74 (53.6)84 (52.2)27 (39.1)
Duration of RA, years; mean (SD)11.8 (9.2)12.7 (8.8)9.8 (7.0)
MTX dose, mg*; mean (SD)16.3 (3.7)16.7 (3.8)16.5 (3.8)
Duration of prior MTX use, months; mean (SD)74.7 (68.2)71.3 (56.7)66.3 (56.7)
Systemic corticosteroids use78 (56.5)94 (58.4)46 (66.7)
Prednisone dose or equivalent, mg; mean (SD)5.9 (2.3)6.0 (2.3)5.9 (2.1)
Prior exposure to ≥2 bDMARD26 (18.8)36 (22.4)16 (23.2)
Prior exposure to ≥3 bDMARD4 (2.9)10 (6.2)6 (8.7)
BMI, kg/m; mean (SD)28.8 (7.0)29.2 (6.0)28.4 (5.6)
RF+ (≥20 IU/mL)105 (76.1)128 (79.5)55 (79.7)
Anti-CCP+ (>10 U/mL)96 (69.6)124 (77.0)58 (84.1)
CRP (mg/L)†; mean (SD)20.7 (21.7)21.4 (24.3)19.4 (20.2)
TJC‡; mean (SD)26.0 (13.7)25.6 (12.8)28.2 (13.7)
SJC‡; mean (SD)16.8 (8.2)17.0 (7.8)19.3 (9.5)
DAS28 (CRP); mean (SD)5.9 (0.9)6.0 (0.8)6.2 (0.9)
CDAI (0–76); mean (SD)40.7 (12.5)41.7 (10.6)44.4 (11.7)
HAQ-DI; mean (SD)1.8 (0.6)1.8 (0.6)1.8 (0.6)
HAQ-DI <0.5, n (%)2 (1.4)3 (1.9)5 (7.2)
PtGA (VAS) (mm); mean (SD)64.8 (20.5)68.1 (19.1)72.1 (18.5)
Pain (VAS) (mm); mean (SD)67.2 (19.5)69.3 (19.1)69.6 (21.9)
PGA (VAS) (mm); mean (SD)64.6 (17.8)65.9 (17.5)69.5 (14.9)
  • *100% patients were on MTX.

  • †Upper limit of normal=6 mg/L.

  • ‡Joints were assessed based on 66–68 joint counts.

  • Anti-CCP, anti-cyclic citrullinated peptide positivity; BMI, body mass index; CDAI, Clinical Disease Activity Index; DAS28 (CRP), Disease Activity Score 28 based on C-reactive protein; HAQ-DI, Health Assessment Questionnaire Disability Index; IIT, intention-to-treat; MTX, methotrexate; N, number of subjects; OKZ, olokizumab; Pain, patient assessment of pain; PBO, placebo; PGA, Physician Global Assessment of Disease Activity; PtGA, Patient Global Assessment of Disease Activity; q2w, every 2 weeks; q4w, every 4 weeks; RA, rheumatoid arthritis; RF+, rheumatoid factor positivity; SJC, swollen joint count; TJS, tender joint count; VAS, visual analogue scale.