Radiographic assessments at wk 104
No radiographic progression* | Treatment group | n | No progression rate (%) | Estimated mean (95% CI) | Marginal difference (95% CI)† | Nominal P-value |
---|---|---|---|---|---|---|
SEC 150 mg | 283 | 66.1 | 66.63 (60.73, 72.54) | 1.51 (−6.63, 9.64) | 0.716 | |
SEC 300 mg | 280 | 66.9 | 66.80 (60.45, 73.14) | 1.67 (−6.61, 9.95) | 0.693 | |
SDZ-ADL 40 mg | 283 | 65.6 | 65.13 (58.77, 71.49) | - | - | |
Change from BSL in mSASSS# | Treatment group | n | Within treatment | Treatment contrast in LS mean† | ||
LS mean (SE) | LS mean (SE) | 95% CI | ||||
SEC 150 mg | 283 | 0.54 (0.18) | −0.18 (0.24) | −0.65, 0.29 | ||
SEC 300 mg | 280 | 0.55 (0.18) | −0.16 (0.24) | −0.64, 0.32 | ||
SDZ-ADL 40 mg | 283 | 0.72 (0.18) | - | - | ||
No new syndesmophytes*‡ | Treatment group | n (%)‡ | Pts with no new syndesmophyte(s) (%) | Estimated mean (95% CI) | Marginal difference (95% CI)† | |
SEC 150 mg | 211 (73.5) | 56.9 | 57.22 (50.16, 64.28) | 4.32 (−5.62, 14.27) | ||
SEC 300 mg | 204 (71.3) | 53.8 | 53.98 (46.19, 61.78) | 1.09 (−9.13, 11.31) | ||
SDZ-ADL 40 mg | 212 (74.1) | 53.3 | 52.89 (45.54, 60.24) | - |
SEC 150 mg, N=287; SEC 300 mg, N=286; SDZ-ADL 40 mg, N=286.
*Estimated mean, marginal difference, 95% CI, and p-value are from logistic regression model with treatment as a factor and BSL mSASSS score/count of vertebral corners with syndesmophyte as covariate using marginal standardisation method.
#LS Mean and 95% CI are from ANCOVA model with treatment as a factor and BSL mSASSS score as covariate.
†Comparison vs SDZ-ADL 40 mg.
‡pts with syndesmophyte(s) at BSL