Clinical end points according to study group for the all-time on-study population
| Characteristics* | Group A (n=10) | Group B (PLP10) (n=10) | Group C (n=9) | Placebo (n=12) | p Value of Group B versus placebo |
|---|---|---|---|---|---|
| Annual relapse rate over 1 year† | 0.80 | 0.40 | 0.78 | 0.83 | |
| Total number of relapses† | 8 | 4 | 7 | 10 | |
| Primary end points | |||||
| Annual relapse rate over 2 years (95% CI)† | 0.85 | 0.40 (0.15–0.87) | 0.72 | 1.04 | 0.024 |
| Total number of relapses† | 17 | 8 | 13 | 25 | |
| Excluding patients on natalizumab | (n=9) | (n=10) | (n=9) | (n=10) | |
| Annual relapse rate over 2 years (95% CI) | 0.83 | 0.40 (0.10–0.79) | 0.72 | 0.95 | 0.016 |
| Total number of relapses | 15 | 8 | 13 | 19 | |
| Secondary end points | |||||
| Cumulative probability of sustained progression increase by 1 point on EDSS, confirmed after 6 months, over 2 years %† | 43 | 10 (1/10) | 24 | 58 (7/12) | 0.019 |
| Excluding patients on natalizumab | |||||
| Cumulative probability of sustained progression increase by 1 point on EDSS, confirmed after 6 months, over 2 years % | 33 | 10 (1/10) | 24 | 70 (7/10) | 0.006 |
| Exploratory results | |||||
| Patient proportion with ≤1 relapse over 2 years %† | 50 (5/10) | 90 (9/10) | 56 (5/9) | 42 (5/12) | 0.030 |
| MRI | |||||
| Patient proportion with new or enlarging T2 lesions %† | – | 29 (2/7) | – | 67 (4/6) | |
| Excluding patients on natalizumab | |||||
| Patient proportion with no new or enlarging T2 lesions % | – | 29 (2/7) | – | 80 (4/5) | |
| DMT (interferons, glatiramer acetate) and natalizumab | |||||
| Patient proportion on DMT and natalizumab at the end of 2 years %† | 80 (8/10)‡ | 60 (6/10) | 67 (6/9) | 75 (9/12)§ | 0.747 |
*CI denotes confidence interval.
†Including patients on natalizumab.
‡1 of 10 on natalizumab.
§2 of 12 on natalizumab.
DMT, disease-modifying treatment.