Table 3.
Patient-reported outcome measures at months 3 (12 weeks) and 6 (24 weeks)*
| Week 12 | Week 24 | |||||
| OKZ every 2 weeks N=143 |
OKZ every 4 weeks N=142 |
PBO N=142 |
OKZ every 2 weeks N=143 |
OKZ every 4 weeks N=142 |
PBO N=142 |
|
| PtGA | −30.6 (1.7) 17.5 (2.5) −23.0 to −12.0 |
−31.0 (1.7) −17.9 (2.5) −23.4 to −12.4 |
−13.1 (1.8) | −32.1 (1.9) −12.7 (2.7) −18.8 to −6.6 |
−36.3 (2.0) −16.8 (2.8) −23.0 to −10.6 |
−19.4 (1.9) |
| Pain | −31.6 (1.8) −18.7 (2.6) −24.6 to −12.9 |
−31.8 (1.8) −19.0 (2.6) −24.8 to −13.1 |
−12.8 (1.9) | −34.5 (2.1) −13.0 (2.9) −19.5 to −6.5 |
−37.1 (2.1) −15.7 (2.9) −22.3 to −9.1 |
−21.4 (2.1) |
| Pain, patients with >30% improvement, n (%) | 94 (65.7) | 86 (60.6) | 37 (25.9) | 96 (67.1) | 95 (66.9) | 57 (39.9) |
| Pain, patients with >50% improvement, n (%) | 69 (48.3) | 60 (42.3) | 18 (12.6) | 69 (48.3) | 74 (52.1) | 25 (17.5) |
| Pain, patients with level of <10 mm, n (%) | 12 (8.4) | 13 (9.2) | 0 (0.0) | 23 (16.1) | 24 (16.9) | 6 (4.2) |
| Pain, patients with level of <20 mm, n (%) | 38 (26.6) | 27 (19.0) | 8 (5.6) | 41 (28.7) | 37 (26.1) | 16 (11.2) |
| Pain, patients with level of <40 mm, n (%) | 78 (54.5) | 80 (56.3) | 29 (20.3) | 80 (55.9) | 85 (59.9) | 41 (28.7) |
| HAQ-DI† | −0.55 (0.05) −0.27 (0.07) −0.43 to −0.12 |
−0.65 (0.05) −0.37 (0.07) −0.53 to −0.22 |
−0.28 (0.05) | |||
| HAQ-DI <0.5, n (%) | 13 (9.1) | 13 (9.2) | 2 (1.4) | 17 (11.9) | 21 (14.8) | 5 (3.5) |
| SF-36 PCS | 6.7 (0.6) 4.5 (0.8) 2.7 to 6.3 |
6.0 (0.6) 3.8 (0.8) 2.0 to 5.6 |
2.2 (0.6) | 7.8 (0.7) 4.3 (0.9) 2.2 to 6.4 |
8.7 (0.7) 5.2 (1.0) 3.1 to 7.4 |
3.5 (0.7) |
| SF-36 MCS | 6.5 (0.7) 3.0 (1.0) 0.7 to 5.3 |
7.0 (0.7) 3.6 (1.1) 1.2 to 5.9 |
3.5 (0.8) | 6.2 (0.8) 3.7 (1.1) 1.2 to 6.2 |
8.9 (0.8) 6.4 (1.1) 3.8 to 8.9 |
2.5 (0.8) |
| EQ-5D score | 19.7 (1.7) 12.2 (2.4) 6.8 to 17.6 |
18.7 (1.7) 11.2 (2.4) 5.8 to 16.7 |
7.4 (1.7) | 20.9 (2.0) 12.6 (2.7) 6.5 to 18.7 |
23.6 (2.0) 15.3 (2.8) 8.9 to 21.7 |
8.3 (2.0) |
| FACIT-F | 8.2 (0.7) 4.6 (1.0) 2.4 to 6.8 |
8.7 (0.7) 5.1 (1.0) 2.9 to 7.3 |
3.6 (0.7) | 8.5 (0.8) 4.8 (1.1) 2.3 to 7.3 |
10.6 (0.8) 6.9 (1.1) 4.3 to 9.5 |
3.7 (0.8) |
Pain: patient’s assessment of arthritis pain.
*With the exception of pain, n (%) LSM change from baseline (SE), treatment comparison vs placebo LSM difference (SE), and 97.5% CI for LSM difference are presented.
†Secondary endpoint (refer to table 2).
EQ-5D, European Quality of Life-5 Dimensions; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue Scale (MCID ≥4 units); HAQ-DI, Health Assessment Questionnaire Disability Index; LSM, least squares mean; MCID, minimal clinically important difference; MCS, Mental Component Score (MCID ≥2.5 units); N, number of subjects; OKZ, olokizumab; PBO, placebo; PCS, Physical Component Score (MCID ≥2.5 units); PtGA, Patient Global Assessment of Disease Activity; SF-36, Short Form-36.