Table 1.
Demographic and other baseline characteristics (ITT population)*
| Characteristics, mean (SD) unless otherwise specified | OKZ every 2 weeks N=143 |
OKZ every 4 weeks N=142 |
PBO N=143 |
| Age (years) | 52.0 (11.8) | 49.1 (12.1) | 52.7 (11.3) |
| Female (%) | 81.1 | 83.1 | 83.9 |
| Duration of RA (years) | 8.7 (8.0) | 7.3 (7.0) | 8.4 (7.8) |
| MTX dose (mg)† | 16.1 (3.4) | 16.3 (3.4) | 16.1 (3.7) |
| Duration of prior MTX use (weeks) | 201.5 (232.1) | 157.4 (165.6) | 210.1 (208.2) |
| Glucocorticoid use, n (%) | 52 (36.4)‡ | 50 (35.2)‡ | 41 (28.7)‡ |
| Prednisone dose or equivalent (mg) | 7.6 (6.0) | 6.1 (2.3) | 6.6 (2.4) |
| Prior exposure to TNF inhibitors, n (%) | 0 | 0 | 4 (2.8) |
| BMI (kg/m2) | 26.6 (5.1) | 26.4 (5.5) | 26.9 (5.0) |
| RF+ (≥15 IU/mL), n (%) | 115 (80.4) | 122 (85.9) | 127 (88.8) |
| Anti-CCP+ (>10 IU/mL), n (%) | 110 (76.9) | 115 (81.0) | 117 (81.8) |
| CRP (mg/L)§ | 23.5 (23.1) | 22.7 (22.7) | 25.8 (28.7) |
| TJC¶ | 24.4 (11.4) | 22.2 (10.3) | 24.0 (11.3) |
| SJC¶ | 14.8 (6.5) | 14.5 (6.7) | 14.6 (6.9) |
| DAS28-CRP | 6.0 (0.7) | 5.9 (0.7) | 6.0 (0.8) |
| CDAI score (0–76) | 40.5 (9.8) | 38.7 (9.4) | 40.4 (10.5) |
| HAQ-DI score | 1.74 (0.47) | 1.64 (0.50) | 1.78 (0.49) |
| PtGA (VAS) (mm) | 70.4 (16.0) | 68.5 (14.5) | 69.6 (15.9) |
| Pain (VAS) (mm) | 70.2 (16.3) | 67.4 (18.5) | 68.3 (17.6) |
| PGA (VAS) (mm) | 70.5 (13.9) | 66.4 (14.2) | 68.0 (14.3) |
Pain: patient assessment of pain.
*All patients with exception of one were Caucasian.
†100% patients were on MTX.
‡P=0.33 (χ2 test).
§Upper limit of normal: >6 mg/L.
¶Joint counts were assessed based on 66–68 joint counts.
anti-CCP+, anticyclic citrullinated peptide positivity; BMI, body mass index; CDAI, Clinical Disease Activity Index; CRP, C reactive protein; DAS28-CRP, Disease Activity Score 28 based on C reactive protein; HAQ-DI, Health Assessment Questionnaire Disability Index; ITT, intention-to-treat; MTX, methotrexate; N, number of subjects; OKZ, olokizumab; PBO, placebo; PGA, Physician Global Assessment of Disease Activity; PtGA, Patient Global Assessment of Disease Activity; RA, rheumatoid arthritis; RF+, rheumatoid factor positivity; SJC, swollen joint count; TJC, tender joint count; TNF, tumour necrosis factor; VAS, Visual Analogue Scale.