Table 4.
Change from study Baseline in mTSS over 96 weeks—MMRM approach
|
(A) For patients originally randomised to CZP | |||
|---|---|---|---|
| Week 0 CZP 200 mg Q2W N=138 | Week 0 CZP 400 mg Q4W N=135 | Week 0 CZP dose combined N=273 | |
| Baseline (week 0) | |||
| LS mean (SE) | 14.0 (3.5) | 18.1 (3.6) | 16.1 (2.5) |
| 95% CI | (7.1 to 21.0) | (11.1 to 25.2) | (11.1 to 21.0) |
| Median | 4.5 | 3.5 | 3.5 |
| Q1–Q3 | 0.8–14.8 | 1.0–13.0 | 1.0–14.5 |
| Week 24 | |||
| LS mean CFB (SE) | 0.04 (0.06) | 0.14 (0.07) | 0.09 (0.05) |
| 95% CI | (−0.09 to 0.16) | (0.02 to 0.27) | (0.00 to 0.18) |
| Median CFB | 0.0 | 0.0 | 0.0 |
| Week 48 | |||
| LS mean CFB (SE) | 0.08 (0.09) | 0.13 (0.09) | 0.11 (0.06) |
| 95% CI | (−0.09 to 0.25) | (−0.04 to 0.30) | (−0.01 to 0.23) |
| Median CFB | 0.0 | 0.0 | 0.0 |
| Week 96 | |||
| LS mean CFB (SE) | 0.10 (0.13) | 0.19 (0.14) | 0.14 (0.09) |
| 95% CI | (−0.16 to 0.36) | (−0.08 to 0.46) | (−0.04 to 0.33) |
| Median CFB | 0.0 | 0.0 | 0.0 |
|
(B) For patients originally randomised to PBO | ||
|---|---|---|
| PBO to CZP at week 16* N=75 |
PBO to CZP at week 24 N=61 |
|
| Actual mTSS prior to initiation of CZP treatment | ||
| LS mean (SE) | 26.3 (4.9) | 16.5 (5.3) |
| 95% CI | (16.7 to 35.9) | (6.0 to 26.9) |
| Median | 3.0 | 4.5 |
| Q1–Q3 | 0.5–29.5 | 0.5–15.0 |
| Change in mTSS during CZP treatment (over 32 or 24 weeks)—week 48 | ||
| LS mean (SE) | 0.07 (0.11) | 0.02 (0.11) |
| 95% CI | (−0.16 to 0.29) | (−0.20 to 0.23) |
| Median change | 0.0 | 0.0 |
| Change in mTSS during CZP treatment (over 80 or 72 weeks)—week 96 | ||
| LS mean (SE) | −0.08 (0.17) | 0.04 (0.17) |
| 95% CI | (−0.42 to 0.27) | (−0.30 to 0.38) |
| Median change | 0.0 | 0.0 |
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.
*The PBO to CZP at week 16 treatment group also includes participants randomised to PBO withdrawing before having the opportunity to switch to CZP.
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.