Table 3.
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.
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®.