Table 3

Section A reports the 2-year primary end point of relapses based on the study design as reported by the dropout patients by treatment arm and section B reports the comparison of the 24-month pretreatment ARR (baseline) with the 24-month on-treatment ARR for the total randomised population by treatment arm

Section A Characteristics	Group A (N=8)		Group B*(N=7)		Group C (N=10)		Placebo (N=7)
End point	X	Y	X	Y	X	Y	X	Y
Number of relapses	20	14	14	14	27	26	20	13
Annual relapse rate	1.25	0.88	1.00	1.00	1.35	1.30	1.42	0.92

Section B Characteristics	Group A (N=20)		Group B*(N=20)		Group C (N=20)		Placebo (N=20)
End point	X	Y	X	Y	X	Y	X	Y
Number of relapses	45	34	49	30	46	41	43	41
Annual relapse rate	1.13	0.85	1.23	0.75	1.15	1.03	1.08	1.03
ARR reduction % (Y to X)†		−25		−39		−10		−5
p Value against baseline		0.120		0.005		0.475		0.652
Percentage of reduction of the ARR compared with placebo (Ys)†		−18		−27		0.0		N/A
p Value against placebo		0.447		0.121		0.996

Section A: The most dropout patients who transferred to disease-modified therapy (DMT) were from group A and the placebo group, with three and two patients, respectively, on natalizumab. These parameters justify the decreased number of relapses recorded within the group A and placebo dropouts and could affect the ITT analysis in favour of the placebo when the total 2-year recorded data are used. For the PLP10 group, 14 relapses were reported at baseline, which remained the same during the 2-year study period. For the placebo group, 20 relapses were reported at baseline and decreased to 13 during the 2-year study period. These results are expected because for the PLP10 group, 43% of the dropouts were under DMT at entry baseline and remained the same until the end of the study, with no patient on natalizumab, but the 57% of the placebo group dropouts who were under DMT at entry baseline increased to 86% at the end of the study, including two patients on natalizumab.
Section B: The ARR of the PLP10 group was 1.23 at baseline and 0.75 at the end of the study (39% reduction, p=0.005), and that for the placebo group was 1.08 at baseline and 1.03 at the end of the study (5% reduction, p=0.652). No significant difference was calculated for the other two treatment arms. During the 24-month on-treatment, the PLP10 group presented a 27% reduction in the ARR versus the placebo group (p=0.121), with all groups lacking statistically significant results
X: total number of relapses for the 24-month pretreatment (baseline).
Y: total number of relapses for the 24-month on-treatment.
*PLP10 group.
†Unadjusted estimate.