(A) For patients originally randomised to CZP | ||
---|---|---|
Week 0 CZP dose combined LS mean (SE) (95% CI) | ||
Study Baseline (week 0) | Week 96 | |
Baseline mTSS ≤3.5 (N=138) | ||
Actual mTSS | 1.2 (0.1) (1.0 to 1.4) | 1.2 (0.1) (1.0 to 1.4) |
CFB in mTSS | – | 0.07 (0.04) (0.00 to 0.15) |
Baseline mTSS >3.5 (N=131) | ||
Actual mTSS | 32.1 (4.7) (22.8 to 41.4) | 32.4 (4.7) (23.1 to 41.7) |
CFB in mTSS | – | 0.24 (0.19) (−0.14 to 0.62) |
(B) For patients originally randomised to PBO | ||
---|---|---|
PBO to CZP at week 16 LS mean (SE) (95% CI) | PBO to CZP at week 24 LS mean (SE) (95% CI) | |
Baseline mTSS ≤3.5 | ||
Number of patients | 37 | 29 |
Actual mTSS prior to initiation of CZP treatment | 1.1 (0.2) (0.7 to 1.5) | 0.9 (0.2) (0.5 to 1.3) |
Change in mTSS during CZP treatment (over 80 or 72 weeks) | 0.14 (0.05) (0.03 to 0.24) | −0.03 (0.06) (−0.14 to 0.08) |
Baseline mTSS >3.5 | ||
Number of patients | 35 | 30 |
Actual mTSS prior to initiation of CZP treatment | 53.0 (9.1) (35.0 to 71.0) | 32.1 (9.9) (12.7 to 51.5) |
Change in mTSS during CZP treatment (over 80 or 72 weeks) | −0.31 (0.37) (−1.03 to 0.42) | 0.11 (0.35) (−0.58 to 0.81) |
Data are shown for the randomised set. LS means and corresponding SEs and 95% CIs are estimated using a mixed model with mTSS as the dependent variable, treatment and visit as fixed-effect factors, treatment by visit as an interaction term, and by specifying an unstructured covariance matrix. Medians are calculated based on the observed values.
CFB, change from baseline; CZP, certolizumab pegol; LS, least squares; MMRM, mixed effect model for repeated measures; mTSS, modified total Sharp score; PBO, placebo; Q2W, every 2 weeks.