Baseline PRO scores
| PRO (mean (SD)) | PBO+MTX (n=127) | CZP 200 mg+MTX (n=246) | CZP 400 mg+MTX (n=246) |
|---|---|---|---|
| Pain VAS (range 0–100 mm) | 59.7 (22.2) | 62.0 (19.3) | 60.5 (20.1) |
| PtGA VAS (range 0–100 mm) | 59.7 (21.9) | 62.5 (20.3) | 61.0 (19.6) |
| HAQ-DI (range 0–3) | 1.6 (0.6) | 1.6 (0.6) | 1.6 (0.6) |
| Fatigue FAS NRS (range 0–10) | 6.5 (1.8) | 6.7 (1.9) | 6.4 (1.8) |
| SF-36 (range 0–100) | |||
| PCS | 31.1 (6.7) | 30.6 (5.9) | 31.1 (6.3) |
| MCS | 40.1 (11.4) | 38.6 (10.9) | 39.6 (10.9) |
| Domains | |||
| Physical functioning | 34.5 (21.4) | 30.5 (20.0) | 32.9 (20.0) |
| Role physical | 16.8 (27.8) | 12.3 (24.4) | 14.2 (25.7) |
| Bodily pain | 30.8 (16.9) | 29.2 (14.3) | 30.8 (14.7) |
| General health | 34.4 (15.8) | 34.7 (15.5) | 34.3 (14.7) |
| Vitality | 36.9 (18.7) | 36.0 (17.7) | 38.1 (17.2) |
| Social functioning | 48.8 (25.0) | 46.2 (23.0) | 49.3 (24.4) |
| Role emotional | 38.0 (41.6) | 27.1 (39.3) | 31.4 (38.7) |
| Mental health | 53.5 (19.3) | 52.1 (18.1) | 52.9 (18.2) |
CZP, certolizumab pegol; FAS, Fatigue Assessment Scale; HAQ-DI, Health Assessment Questionnaire-Disability Index; ITT, intent to treat; MCS, mental component summary; MTX, methotrexate; NRS, numeric rating scale; PBO, placebo; PCS, physical component summary; PRO, patient-reported outcomes; PtGA, patient's global assessment of disease activity; SF-36, short-form 36-item health survey; VAS, Visual Analogue Scale.