Table 1

Post hoc analyses of change from baseline at week 24 in mTSS

Imputation in patients with <2 analysable mTSS*mTSS change from BL at week 24
Placebo (n=136)CZP 200 mg Q2W (n=138)CZP 400 mg Q4W (n=135)CZP 200 mg Q2W+CZP 400 mg Q4W (n=273)
Prespecified†Minimum observed score (0) if missing BL
Maximum observed score (356.5) if missing week 24
28.9 (7.73)11.5 (7.59)
p=0.071‡
25.1 (7.92)
p=0.688‡
18.3 (6.07)
p=0.203
Post hoc 1§No imputation0.29 (0.08)0.01 (0.08)
p=0.004‡
0.12 (0.08)
p=0.083‡
0.06 (0.06)
p=0.008
Post hoc 2¶Median mTSS change from BL of all patients observed0.28 (0.07)0.01 (0.07)
p=0.004‡
0.11 (0.08)
p=0.072‡
0.06 (0.06)
p=0.007
Post hoc 3¶Mean mTSS change from BL of all patients observed0.28 (0.07)0.01 (0.07)
p=0.004‡
0.11 (0.08)
p=0.072‡
0.06 (0.06)
p=0.007
Post hoc 4¶Maximum mTSS change from BL of all patients observed0.66 (0.13)0.18 (0.13)
p=0.003‡
0.52 (0.13)
p=0.380‡
0.35 (0.10)
p=0.028
Post hoc 5¶Maximum mTSS change from BL by treatment group0.39 (0.11)0.14 (0.11)
p=0.077‡
0.49 (0.12)
p=0.483‡
0.31 (0.09)
p=0.538
  • Values are least squares mean (SE). For placebo patients who escaped early to CZP, the week 24 values were linearly extrapolated. p Values of CZP versus placebo are based on analysis of covariance.

  • *For patients with two radiographs but missing week 24 or baseline film, linear extrapolation was performed in all approaches.

  • †21 patients had fewer than two analysable mTSS; the number of patients was not equally distributed between the treatment groups.

  • ‡The study was not powered to detect statistical significance between individual CZP dosage groups and placebo, therefore, these p values should be considered nominal.

  • §26 patients had fewer than two analysable mTSS more than 8 weeks apart (required for post hoc analysis).

  • ¶28 patients had fewer than two analysable mTSS more than 8 weeks apart, including two placebo patients who escaped to CZP before their second mTSS.

  • BL, baseline; CZP, certolizumab pegol; mTSS, modified Total Sharp Score; Q2W, every 2 weeks; Q4W, every 4 weeks.