Table 2.
Demographics, baseline disease characteristics and baseline PRO scores of patients in the OPTION, BREVACTA and SUMMACTA study populations
| Baseline characteristic* | OPTION | BREVACTA | SUMMACTA | |||
| TCZ-intravenous 8 mg/kg every 4 weeks (n=205) |
Placebo every 4 weeks (n=204) |
TCZ-subcutaneous 162 mg every 2 weeks (n=437) |
Placebo every 2 weeks (n=219) |
TCZ-subcutaneous 162 mg weekly (n=558) |
TCZ-intravenous 8 mg/kg every 4 weeks (n=537) |
|
| Age (years) | 50.8 (11.8) | 50.6 (12.1) | 52.1 (11.5) | 52.0 (11.7) | 52.4 (12.3) | 52.5 (12.5) |
| Female, n (%) | 175 (85) | 159 (78) | 375 (86) | 181 (83) | 461 (83) | 444 (83) |
| White, n (%) | 148 (72) | 149 (73) | 321 (74) | 152 (69) | 432 (77) | 403 (75) |
| Disease duration (years) | 7.5 (7.3) | 7.8 (7.2) | 11.1 (8.2) | 11.1 (8.4) | 8.7 (8.2) | 8.7 (7.9) |
| Number of prior csDMARDs/TNFis | 1.5 (1.4) | 1.7 (1.5) | 1.3 (0.7) | 1.4 (0.8) | 1.4 (0.7) | 1.4 (0.7) |
| CDAI | 43.4 (13.5) | 44.0 (12.0) | 41.0 (12.7) | 40.3 (12.4) | 39.3 (13.0) | 41.2 (13.9) |
| PtGA, VAS 0–100 mm | 64.8 (22.2) | 63.6 (21.8) | 63.6 (22.4) | 62.1 (20.8) | 67.3 (21.7) | 67.5 (21.6) |
| Pain, VAS 0–100 mm | 59.9 (22.4) | 57.3 (22.2) | 57.8 (22.8) | 56.8 (22.3) | 60.2 (22.5) | 61.8 (21.9) |
| HAQ-DI, 0–3 | 1.6 (0.6) | 1.5 (0.6) | 1.6 (0.6) | 1.6 (0.6) | 1.6 (0.6) | 1.7 (0.7) |
| FACIT-Fatigue, 0–52 | 27.7 (10.6) | 26.7 (11.1) | 27.0 (10.4) | 27.3 (10.2) | – | – |
| SF-36 PCS (mean, 50; SD, 10) |
32.1 (7.0) | 32.3 (7.0) | 31.7 (7.3) | 32.4 (6.9) | 30.2 (7.2) | 30.2 (7.5) |
| SF-36 MCS (mean, 50; SD, 10) |
40.8 (10.6) | 39.1 (11.0) | 38.6 (11.7) | 39.6 (11.0) | 39.7 (11.6) | 39.0 (12.1) |
| SF-36 domains, 0–100 | ||||||
| Physical functioning | 38.8 (22.6) | 39.8 (24.0) | 35.5 (22.5) | 37.1 (22.2) | 33.4 (21.3) | 33.2 (22.7) |
| Role-physical | 15.9 (29.0) | 14.0 (26.8) | 35.0 (22.4) | 37.2 (20.2) | 33.6 (22.4) | 32.8 (23.3) |
| Bodily pain | 28.9 (16.4) | 29.6 (17.3) | 30.2 (17.3) | 31.9 (16.3) | 27.3 (16.4) | 27.5 (17.6) |
| General health | 38.8 (18.3) | 36.1 (18.1) | 39.7 (18.2) | 41.5 (18.7) | 40.1 (18.6) | 38.7 (18.1) |
| Vitality | 39.1 (19.2) | 37.0 (18.9) | 39.4 (19.4) | 40.5 (19.4) | 36.1 (19.8) | 35.6 (20.0) |
| Social functioning | 53.4 (24.2) | 49.9 (23.8) | 48.2 (24.6) | 51.7 (23.7) | 48.2 (25.1) | 47.1 (25.5) |
| Role-emotional | 33.7 (41.0) | 30.3 (39.5) | 47.6 (27.7) | 49.9 (25.7) | 50.0 (28.1) | 48.1 (30.2) |
| Mental health | 55.8 (19.5) | 53.4 (20.6) | 54.0 (19.9) | 55.1 (19.3) | 56.5 (19.9) | 55.5 (20.0) |
*All values are presented as mean (SD) unless otherwise indicated.
CDAI, Clinical Disease Activity Index; csDMARD, conventional synthetic disease-modifying antirheumatic drug; FACIT, Functional Assessment of Chronic Illness Therapy; HAQ-DI, Health Assessment Questionnaire-Disability Index; MCS, mental component summary; PCS, physical component summary; PRO, patient-reported outcome; PtGA, patient global assessment; SF-36, Short Form-36; TCZ, tocilizumab; TNFi, tumour necrosis factor inhibitor; VAS, visual analogue scale.