Table 2

Efficacy outcomes at the end of the maintenance period (Week 96) of C-OPTIMISE (n=313)

ImputationCZP 200 mg Q2W
(n=104)
P vs placeboCZP 200 mg Q4W
(n=105)
P vs placeboPlacebo
(n=104)
ASDAS disease activity state, n (%)
 ID (<1.3)OC75/87 (86.2)58/83 (69.9)14/24 (58.3)
 LD (≥1.3 and <2.1)OC12/87 (13.8)19/83 (22.9)6/24 (25.0)
 HD (≥2.1 and ≤3.5)OC0/87 (0)6/83 (7.2)4/24 (16.7)
 vHD (>3.5)OC0/87 (0)0/83 (0)0/24 (0)
Disease activity responses from Week 0, n (%)
ASDAS clinical improvement*
 CIINRI86 (82.7)<0.00179 (75.2)<0.00122 (21.2)
 MINRI70 (67.3)<0.00161 (58.1)<0.00111 (10.6)
ASAS responder rates*
 20NRI89 (85.6)<0.00182 (78.1)<0.00124 (23.1)
 40NRI88 (84.6)<0.00177 (73.3)<0.00122 (21.2)
 5/6NRI73 (70.2)<0.00166 (62.9)<0.00113 (12.5)
 Partial remissionNRI81 (77.9)<0.00174 (70.5)<0.00118 (17.3)
BASDAI50a NRI87 (83.7)<0.00181 (77.1)<0.00123 (22.1)
Change from Week 48
Efficacy outcomes, LS mean±SE
 ASDASMMRM0.2±0.1<0.0010.5±0.1<0.0011.7±0.1
 BASDAIMMRM0.6±0.2<0.0010.8±0.2<0.0013.0±0.2
 BASFIMMRM0.3±0.2<0.0010.5±0.2<0.0011.9±0.2
 BASMIMMRM0.0±0.10.074−0.0±0.10.0360.2±0.1
MRI outcomes, mean (SD; n)
 SIJ SPARCC scoreOC0.2 (2.4; 79)0.1950.6 (3.8; 77)0.4321.1 (3.6; 24)
 ASspiMRI-aOC0.0 (0.8; 79)0.0400.0 (0.8; 78)0.0740.4 (0.9; 24)
Additional outcomes, mean (SD; n)
 MASESOC0.1 (0.6; 90)0.1 (0.6; 84)−0.1 (0.9; 24)
 Tender joint countOC−0.1 (0.6; 90)0.1 (0.9; 84)0.0 (1.0; 24)
 Swollen joint countOC0.0 (0.2; 90)0.0 (0.2; 84)0.0 (0.0; 24)
  • P values were obtained using a logistic regression model or, for MRI outcomes, an ANCOVA model, with factors for treatment group, geographical region and mNY classification (Week 48 baseline was included as a covariate in the ANCOVA model).

  • *Calculated from Week 0 baseline.

  • ANCOVA, analysis of covariance; ASAS, Assessment of Spondyloarthritis international Society; ASDAS, Ankylosing Spondylitis Disease Activity Score; ASDAS-ID/LD/HD/vHD, ASDAS-inactive disease/low disease/high disease/very high disease; ASspiMRI-a, Ankylosing Spondylitis spine MRI score for activity; BASDAI50, Bath Ankylosing Spondylitis Disease Activity Index 50% improvement; BASFI, Bath Ankylosing Spondylitis Functional Index; BASMI, Bath Ankylosing Spondylitis Metrology Index; CII, clinically important improvement; CZP, certolizumab pegol; LS, least squares; MASES, Maastricht Ankylosing Spondylitis Enthesitis Score; MI, major improvement; MMRM, mixed effect model for repeated measures; mNY, modified New York; NRI, non-responder imputation; OC, observed case; Q2W, every 2 weeks; Q4W, every 4 weeks; SIJ SPARCC, sacroiliac joint Spondyloarthritis Research Consortium of Canada.