Table 3

Patient-reported outcome measures at months 3 (12 weeks) and 6 (24 weeks)*

Week 12Week 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 PCS6.7 (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 MCS6.5 (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 score19.7 (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-F8.2 (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.