mTSS non-progression analysis
| mTSS non-progressor rate (%) | ||||
|---|---|---|---|---|
| Non-progressor cut-off (mTSS) | Imputation of missing values | Placebo (n=136) | CZP 200 mg Q2W (n=138) | CZP 400 mg Q4W (n=135) |
| 0† | ≥2 mTSS: NRI‡§ <2 mTSS: considered progressors‡ | 34.6 | 83.3* | 76.3* |
| 0† | ≥2 mTSS: linear imputation <2 mTSS: no imputation | 81.9 | 91.7* | 87.8 |
| ≤0.5 | ≥2 mTSS: linear imputation <2 mTSS: no imputation | 86.6 | 96.2* | 96.7* |
| ≤0.5 | ≥2 mTSS: linear imputation <2 mTSS: mean mTSS change from BL of all patients observed | 87.5 | 96.4* | 97.0* |
| ≤0.5 | ≥2 mTSS: linear imputation <2 mTSS: median mTSS change from BL of all patients observed | 87.5 | 96.4* | 97.0* |
| ≤0.5 | ≥2 mTSS: linear imputation <2 mTSS: maximum mTSS change from BL of all patients observed | 79.4 | 92.8* | 88.1 |
For placebo patients who escaped early to CZP, the week 24 values were linearly extrapolated.
*p<0.05 versus placebo.
†Prespecified non-progressor cut-off mTSS.
‡Prespecified imputation.
§Patients with missing values considered progressors.
BL, baseline; CZP, certolizumab pegol; mTSS, modified Total Sharp Score; NRI, non-responder imputation; Q2W, every 2 weeks; Q4W, every 4 weeks.