Table 2

Efficacy outcomes at week 12 (full analysis set) 

Efficacy endpointDosing
frequency
PBO
OKZ
60 mg
OKZ
120 mg
OKZ
240 mg
TCZ
8 mg/kg
ΔDAS28(CRP),* LS mean (SE)Q2W−0.78 (0.26)−1.16 (0.28)−1.88 (0.26)−2.01 (0.25)
Q4W−0.19 (0.26)−1.91 (0.28)−1.84 (0.26)−1.63 (0.25)−2.01 (0.19)
DAS28(CRP)≤3.2,%†Q2W13.620.022.730.4
Q4W4.518.230.427.330.2
DAS28(CRP)<2.6,%†Q2W4.510.013.626.1
Q4W0.013.621.79.120.9
ΔDAS28(ESR),* LS mean (SE)Q2W−0.65 (0.25)−1.53 (0.27)−2.05 (0.25)−1.80 (0.25)
Q4W−0.16 (0.25)−2.04 (0.26)−1.57 (0.26)−1.59 (0.25)−1.79 (0.18)
ACR20, estimated response % (95% CI)‡Q2W29.9 (15.3 to 50.2)49.7 (31.0 to 68.5)55.5 (36.9 to 72.7)55.5 (37.1 to 72.4)
Q4W17.1 (7.3 to 35.0)60.7 (41.4 to 77.1)58.4 (39.5 to 75.1)32.5 (18.1 to 51.2)68.3 (53.0 to 80.5)
ACR50, estimated response % (95% CI)‡Q2W4.9 (0.7 to 28.0)19.1 (7.6 to 40.4)24.9 (11.4 to 46.2)31.9 (16.0 to 53.5) –
Q4W1.3 (0.1 to 14.4)33.2 (16.8 to 55.0)21.3 (9.0 to 42.8)11.5 (4.2 to 27.7)27.7 (15.4 to 44.8)
ACR20, observed response n (%)†Q2W7 (33.3)6 (35.3)10 (50.0)11 (52.4)
Q4W1 (5.0)12 (75.0)11 (61.1)7 (33.3)27 (65.9)
ACR50, observed response n (%)†Q2W1 (4.8)3 (17.6)5 (25.0)5 (23.8)
Q4W06 (37.5)3 (16.7)3 (14.3)10 (24.4)
ΔCDAI,*Q2W−8.95 (−41.5, 13.8)−8.00 (−36.4, 19.0)−14.65 (−57.9, 14.3)−16.30 (−58.2, 8.9)
Median (min, max)Q4W−3.03 (−44.1, 23.8)−18.51 (−69.2, 48.0)−19.09 (−35.2, 8.8)−12.99 (−42.9, 4.0)−17.30 (−49.2, 15.1)
CDAI≤10.0, estimated response % (95% CI)§,¶Q2W13.6 (4.5 to 34.8)9.9 (2.5 to 32.3)22.7 (9.8 to 44.3)30.3 (15.1 to 51.5)
Q4W9.1 (2.3 to 29.9)9.1 (2.3 to 29.9)30.4 (15.2 to 51.5)13.6 (4.4 to 34.7)27.8 (16.5 to 42.9)
CDAI≤10.0, observed response n (%)¶Q2W3 (13.6)2 (10.0)5 (22.7)7 (30.4)
Q4W2 (9.1)2 (9.1)7 (30.4)3 (13.6)12 (27.9)
ΔHAQ-DI,* median (min, max)Q2W0.00 (−1.0, 0.6)−0.25 (−1.0, 0.9)−0.25 (−0.9, 1.4)−0.38 (−1.6, 0.1)
Q4W0.06 (−1.0, 2.1)−0.50 (−1.6, −0.1)−0.25 (−1.5, 0.4)0.00 (−1.0, 0.5)−0.25 (−1.5, 0.3)
ΔTJC,* median (min, max)Q2W−10.00 (−46.0, 33.0)−8.00 (−34.0, 5.0)−10.00 (−55.0, 3.2)−10.30 (−48.0, 13.0)
Q4W−3.00 (−49.0, 18.3)−18.00 (−68.0, 7.7)−15.00 (−29.0, 12.0)−8.50 (−18.3, 7.0)−11.00 (−46.0, 8.0)
ΔSJC,* median (min, max)Q2W−3.00 (−18.0, 22.3)−7.00 (−26.0, 4.0)−7.00 (−55.0, 7.0)−10.00 (−41.6, 7.0)
Q4W−3.00 (−37.0, 22.0)−11.00 (−51.0, 19.0)−9.89 (−21.0, 15.0)−8.25 (−22.3, 22.0)−7.45 (−29.5, 11.0)
  • *change (Δ) from baseline, MMRM analysis.

  • †observed rate.

  • ‡estimate from the GEE-MI model.

  • §estimate from the Logistic Regression (non-response imputation) model.

  • ¶results of posthoc analysis.

  • ACR, American College of Rheumatology; CDAI, Clinical Disease Activity Index; CRP, C-reactive protein; DAS28, Disease Activity Score 28-joint count; ESR, erythrocyte sedimentation rate; GEE, generalised estimating equation; HAQ-DI, HAQ (Health Assessment Questionnaire) Disability Index; LDA, low disease activity; LS, least squares; MI, multiple imputation; MMRM, mixed effects model for repeated measures; OKZ, olokizumab; PBO, placebo; SJC, swollen joint count; TCZ, Tocilizumab; TJC, tender joint count.