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. 2018 Dec 11;24(1):56–63. doi: 10.1111/jns.12291

Table 3.

Primary efficacy outcome‐estimated means of MMRC 10‐sum score 13 to 26 weeks after the start of administration for each product, linear mixed model—mITT and PPS

Population Covariate Least square means: estimate [95% CI] Differences: estimate [95% CI] P value
mITT
N = 22
Product
IqYmune® 94.5 [93.5, 95.6] −0.01 [−0.51, 0.48] 0.96
Kiovig® 94.5 [93.6, 95.5]
Perioda
1 94.4 [93.4, 95.4] −0.24 [−0.73, 0.25] 0.32
2 94.7 [93.7, 95.6]
Sequencea
A 95.0 [93.9, 96.0] 0.90 [−0.85, 2.65] 0.30
B 94.1 [92.58, 95.61]
Non‐inferiority IqYmune® vs Kiovig® <0.001
PPS
N = 21
Product
IqYmune® 94.4 [93.3, 95.6] −0.14 [−0.60, 0.31] 0.51
Kiovig® 94.6 [93.6, 95.5]
Perioda
1 94.3 [93.2, 95.5] −0.37 [−0.83, 0.08] 0.10
2 94.7 [93.7, 95.6]
Sequencea
A 94.9 [93.8, 96.0] 0.80 [−1.06, 2.67] 0.38
B 94.1 [92.5, 95.7]
Non‐inferiority IqYmune® versus Kiovig® <0.001

Abbreviations: CI, confidence interval; MMRC, Modified Medical Research Council.

Range of mean MMRC 10‐sum score result: 0 (complete paralysis) to 100 (full strength). Modified‐intent‐to‐treat (mITT), and per protocol set (PPS) populations.

a

In sequence A, participants were first treated with Kiovig® for 21‐25 weeks (period 1) then with IqYmune® for 21‐25 weeks (period 2). In sequence B, participants were first treated with IqYmune® then with Kiovig®.