Table 3.
Mean baseline values and LSM changes from baseline to week 12 for PROs
| Baseline, mean (SD) | 12 weeks LSM changes (SE) | |||||
| OKZ q2w, n=138 | OKZ q4w, n=161 | PBO, n=69 | OKZ q2w, n=138 | OKZ q4w, n=161 | PBO, n=69 | |
| PtGA-VAS (mm) | 64.8 (20.5) | 68.1 (19.1) | 72.1 (18.5) | −24.9 (2.1) | −25.0 (1.9) | −16.9 (2.9) |
| Pain-VAS (mm) | 67.2 (19.5) | 69.3 (19. 1) | 69.6 (21.9) | −28.2 (2.2)** | −27.5 (2.0)** | −15.0 (3.0) |
| HAQ-DI | 1.79 (0.53) | 1.78 (0.56) | 1.78 (0.64) | −0.49 (0.05)* | −0.39 (0.04) | −0.32 (0.07) |
| SF-36 PCS score | 31.4 (6.8) | 30.6 (7.2) | 30.6 (5.9) | 6.9 (0.7)** | 5.7 (0.6) | 3.9 (0.9) |
| SF-36 MCS score | 44.3 (12.6) | 44.5 (11.1) | 45.1 (10.2) | 4.1 (0.8)* | 3.4 (0.8) | 0.5 (1.1) |
| FACIT-Fatigue | 27.0 (10.2) | 26.6 (10.6) | 27.3 (9.9) | 7.8 (0.9) | 6.8 (0.8) | 4.6 (1.2) |
| EQ-5D Health Today Score | 45.0 (23.35) | 43.7 (22.42) | 50.4 (28.31) | 17.8 (2.06) | 18.0 (1.92) | 12.6 (2.92) |
Missing data resulted from study withdrawal imputed based on the return to baseline assumption.
*p≤0.025; **p<0.01; ***p<0.001 compared with placebo.
*Secondary endpoint: OKZ q2w p=0.0227 and OKZ q4w p=0.1814 compared with placebo.
EQ-5D, EuroQol 5-Dimensions; FACIT, Functional Assessment of Chronic Illness Therapy-Fatigue; HAQ-DI, Health Assessment Questionnaire Disability Index; LSM, least squares mean; MCS, Mental Component Summary; OKZ, olokizumab; PBO, placebo; PCS, Physical Component Summary; PRO, patient-reported outcome; PtGA, Patient Global Assessment of Disease Activity; q2w, every 2 weeks; q4w, every 4 weeks; SF-36, Short Form-36 Health Survey; VAS, visual analogue scale.