Table 2.
Improvement from baseline in SPARCC (SI joints) and Berlin (spine) at week 12 of the RAPID-axSpA trial for all patients in the imaging set (observed data)
| CZP (dose combined) |
Placebo |
||||||||
|---|---|---|---|---|---|---|---|---|---|
| N | Mean score at baseline (SD)* | Mean score at week 12 (SD) | Mean change from baseline (SD) | N | Mean score at baseline (SD)* | Mean score at week 12 (SD) | Mean change from baseline (SD) | p Value† | |
| SPARCC (SI joints) | |||||||||
| axSpA | 97 | 6.9 (10.4) | 2.1 (4.1) | −4.8 (8.6) | 45 | 12.9 (16.6) | 11.2 (14.5) | −1.6 (7.8) | <0.001 |
| r-axSpA | 58 | 6.5 (10.8) | 1.5 (3.6) | −5.0 (9.1) | 28 | 13.3 (18.0) | 9.9 (14.4) | −3.4 (8.9) | <0.001 |
| nr-axSpA | 39 | 7.4 (9.9) | 2.9 (4.7) | −4.4 (7.9) | 17 | 12.2 (14.5) | 13.4 (14.9) | 1.2 (4.6) | <0.001 |
| Berlin (spine) | |||||||||
| axSpA | 99 | 4.4 (5.4) | 1.4 (2.4) | −2.9 (4.2) | 49 | 4.9 (7.4) | 5.2 (7.3) | 0.2 (4.8) | <0.001 |
| r-axSpA | 60 | 5.3 (5.9) | 1.8 (2.8) | −3.6 (4.7) | 32 | 5.5 (7.0) | 5.8 (6.5) | 0.2 (5.8) | <0.001 |
| nr-axSpA | 39 | 2.9 (4.2) | 0.9 (1.4) | −2.0 (3.2) | 17 | 3.7 (8.3) | 4.0 (8.7) | 0.3 (1.6) | 0.006 |
*Matched baseline readings; in the week 96 reading campaign, MRIs from each previous visit were reread.
†Difference to placebo in mean change from baseline scores using an ANCOVA model with treatment, region, mNY criteria (yes or no; for the axSpA analysis only) and prior anti-TNF exposure (yes or no) as factors and baseline score as covariate.
ANCOVA, analysis of covariance; axSpA, axial spondyloarthritis; CZP, certolizumab pegol; mNY, modified New York; nr-axSpA, non-radiographic axial spondyloarthritis; r-axSpA, radiographic axial spondyloarthritis; SI, sacroiliac; SPARCC, Spondyloarthritis Research Consortium of Canada; TNF, tumour necrosis factor.