Secondary, exploratory clinical and MRI endpoints
| Endpoint | Placebo (n=121) | Ponesimod 10 mg (n=108) | Ponesimod 20 mg (n=114) | Ponesimod 40 mg (n=119) |
|---|---|---|---|---|
| Annualised relapse rate up to Week 24*,† (95% CI) | 0.525 (0.358 to 0.770) | 0.332 (0.198 to 0.557) | 0.417 (0.266 to 0.653) | 0.251 (0.141 to 0.446) |
| Treatment effect, ratio | 0.632 | 0.793 | 0.478 | |
| (95% CI) | (0.332 to 1.202) | (0.440 to 1.432) | (0.240 to 0.954) | |
| p Value | 0.1619 | 0.4420 | 0.0363 | |
| Time to first confirmed relapse—patients free of confirmed relapses at week 24 | (n=121) | (n=108) | (n=114) | (n=119) |
| K-M estimate (95% CI) | 78.5 (70.98 to 85.96) | 85.6 (78.59 to 92.60) | 83.9 (76.90 to 90.96) | 90.6 (84.97 to 96.16) |
| Hazard ratio (95% CI) | 0.64 (0.33 to 1.22) | 0.79 (0.43 to 1.45) | 0.42 (0.20 to 0.87) | |
| p -Value | 0.1744 | 0.4529 | 0.0189 | |
| Mean cumulative number of new or enlarging non-enhancing T2 lesions from week 12 to 24‡,§ | (n=110) | (n=88) | (n=98) | (n=93) |
| Mean (SD) | 0.7 (1.89) | 0.5 (1.01) | 0.3 (1.22) | 0.5 (1.13) |
| Median (range) | 0.0 (0.0–12.0) | 0.0 (0.0–4.0) | 0.0 (0.0–11.0) | 0.0 (0.0–7.0) |
| Treatment effect, ratio | 0.694 | 0.443 | 0.657 | |
| (95% CI) | (0.353 to 1.367) | (0.223 to 0.883) | (0.336 to 1.284) | |
| p Value | 0.2914 | 0.0208 | 0.2194 | |
| Mean cumulative number of combined unique active lesions from week 12 to 24‡,§ | (n=110) | (n=88) | (n=98) | (n=93) |
| Mean (SD) | 6.9 (14.27) | 4.0 (7.77) | 1.4 (2.80) | 1.9 (3.75) |
| Median (range) | 2.0 (0.0–95.0) | 1.0 (0.0–45.0) | 0.0 (0.0–22.0) | 0.0 (0.0–22.0) |
| Treatment effect, ratio | 0.580 | 0.199 | 0.272 | |
| (95% CI) | (0.353 to 0.954) | (0.121 to 0.329) | (0.165 to 0.449) | |
| p Value | 0.0318 | <0.0001 | <0.0001 | |
| Brain volume, percentage change from baseline to week 24‡,§ | (n=107) | (n=85) | (n=94) | (n=89) |
| Mean (SD) | –0.26 (1.006) | 0.02 (0.718) | 0.05 (0.758) | 0.23 (1.053) |
| Median (range) | –0.20 (–5.13 to 4.70) | 0.04 (–2.23 to 1.82) | 0.04 (–1.92 to 2.62) | 0.17 (–3.80 to 5.18) |
*All-treated analysis set.
†Secondary endpoint.
‡Per-protocol analysis set.
§Exploratory MRI endpoint.
K-M, Kaplan–Meier.