Table 2.

Main efficacy results at week 12 in the intent‐to‐treat population

Outcomes, n (%) unless otherwise specified	OKZ q2w, n=138	OKZ q4w, n=161	PBO, n=69
Primary endpoint
ACR20 response (NRI)	84 (60.9)	96 (59.6)	28 (40.6)
Comparison vs PBO risk difference	0.203 (0.038 to 0.353)**	0.190 (0.030 to 0.337)**
Secondary endpoints
DAS28 (CRP) <3.2	55 (39.9)	45 (28.0)	8 (11.6)
Comparison vs PBO risk difference*	0.283 (0.139 to 0.396)***	0.164 (0.029 to 0.268)**
HAQ-DI LSM (SE), mean difference from baseline	−0.49 (0.05)	−0.39 (0.04)	−0.32 (0.07)
Comparison vs PBO risk difference*	−0.17 (−0.35 to 0.02)*	−0.07 (−0.26 to 0.11)
ACR50 response (NRI)	46 (33.3)	52 (32.3)	11 (15.9)
Comparison vs PBO risk difference*	0.174 (0.027 to 0.294)**	0.164 (0.020 to 0.278)**
CDAI≤2.8 (NRI)	9 (6.5)	5 (3.1)	0
Comparison vs PBO risk difference*	0.065 (−0.023 to 0.134)*	0.031 (−0.052 to 0.083)
Other endpoints
DAS28 (CRP) <2.6†	30 (21.7)	25 (15.5)	3 (4.3)
Comparison vs PBO risk difference*	0.174 (0.059 to 0.267)**	0.112 (0.005 to 0.192)*
CDAI <10†	43 (31.2)	41 (25.5)	9 (13.0)
Comparison vs PBO risk difference*	0.181 (0.040 to 0.296)**	0.124 (−0.011 to 0.231)*
ACR70 response (NRI)	27 (19.6)	21 (13.0)	4 (5.8)
Comparison vs PBO risk difference*	0.138 (0.021 to 0.232)**	0.072 (−0.037 to 0.153)
HAQ-DI improvement of ≥0.22 (NRI)	75 (54.3)	89 (55.3)	33 (47.8)
Comparison vs PBO risk difference*	0.08 (−0.086 to 0.236)	0.074 (−0.084 to 0.229)

*p≤0.025; **p<0.01; ***p<0.001 compared with placebo.

*97.5% CI was calculated for comparison of OKZ vs PBO

†Not predefined by protocol (post hoc).

ACR, American College of Rheumatology response; CDAI, Clinical Disease Activity Index; CRP, C-reactive protein; DAS28 (CRP), Disease activity Score 28 based on CRP; HAQ-DI, Health Assessment qQuestionnaire Disability Index; LSM, least squares mean; n (%), number and percentage of responders; N, number of subjects; NRI, non-responder imputation; OKZ, olokizumab; PBO, placebo; q2w, every 2 weeks; q4w, every 4 weeks.