Table 1.
Demographic and other baseline characteristics (ITT population)*
| Characteristics, n (%) unless otherwise specified | OKZ q2w, n=138 | OKZ q4w, n=161 | PBO, n=69 |
| Age, years; mean (SD) | 53.4 (12.7) | 53.9 (11.7) | 53.0 (13.7) |
| Female | 122 (88.4) | 130 (80.7) | 55 (79.7) |
| Race | |||
| Asian | 6 (4.3) | 3 (1.9) | 2 (2.9) |
| Black or African American | 11 (8.0) | 11 (6.8) | 1 (1.4) |
| White | 110 (79.7) | 139 (86.3) | 53 (76.8) |
| Other/mixed | 11 (8.0) | 8 (5.0) | 13 (18.8) |
| Ethnicity | |||
| Hispanic or Latino ethnicity | 64 (46.4) | 77 (47.8) | 42 (60.9) |
| Not Hispanic or Latino | 74 (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 use | 78 (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 bDMARD | 26 (18.8) | 36 (22.4) | 16 (23.2) |
| Prior exposure to ≥3 bDMARD | 4 (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.