Table 2

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

Outcomes, n (%) unless otherwise specifiedOKZ q2w, n=138OKZ q4w, n=161PBO, n=69
Primary endpoint
 ACR20 response (NRI)84 (60.9)96 (59.6)28 (40.6)
  Comparison vs PBO risk difference0.203 (0.038 to 0.353)**0.190 (0.030 to 0.337)**
Secondary endpoints
 DAS28 (CRP) <3.255 (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.