Section A Characteristics | Group A (N=10) | Group B*(N=10) | Group C (N=9) | Placebo (N=12) | ||||
---|---|---|---|---|---|---|---|---|
End point | X | Y | X | Y | X | Y | X | Y |
Total number of relapses | 22 | 17 | 27 | 8 | 16 | 13 | 20 | 25 |
Annual relapse rate (ARR) | 1.10 | 0.85 | 1.35 | 0.40 | 0.88 | 0.72 | 0.83 | 1.04 |
Percentage of reduction compared with placebo (primary end point)† | −18 | −62 | −30 | N/A | ||||
p Value against placebo | 0.468 | 0.024 | 0.578 | |||||
ARR change % (Y to X)† | −23 | −70 | −18 | +25 | ||||
p Value against baseline | 0.425 | 0.003 | 0.578 | 0.500 |
Section B Excluding patients on natalizumab | Group A (N=9) | Group B* (N=10) | Group C (N=9) | Placebo (N=10) | ||||
---|---|---|---|---|---|---|---|---|
End point | X | Y | X | Y | X | Y | X | Y |
Total number of relapses | 16 | 15 | 27 | 8 | 16 | 13 | 13 | 19 |
ARR | 0.88 | 0.83 | 1.35 | 0.40 | 0.88 | 0.72 | 0.65 | 0.95 |
Percentage reduction compared with placebo (primary end point)† | −13 | −58 | −24 | N/A | ||||
p Value against placebo | 0.493 | 0.016 | 0.412 | |||||
ARR change % (Y to X)† | −6 | −70 | −18 | +46 | ||||
p Value against baseline | 0.857 | 0.003 | 0.578 | 0.354 |
Section A: During the 24-month period on-treatment, the ARR of group A was 0.85, with an 18% decrease compared with placebo (p=0.468); that of the PLP10 group was 0.40, with a 62% decrease (p=0.024); and that of group C was 0.72, with a 30% decrease (p=0.578). This section also reports the comparison of the 24-month pretreatment ARR (baseline ARR) with the 24-month on-treatment ARR of the all-time on-study population, including patients on natalizumab.
X: total number of relapses for the 24 months pretreatment (baseline).
Y: total number of relapses for the 24 months on-treatment.
*PLP10 group.
†Unadjusted estimate.