Table 2.

CIDP improvement and CIDP stability during IgPro10 restabilization period in relation to results of IVIG withdrawal period (PSDS population)

IgPro10 restabilization period	Number (%) of subjects, N = 207
	IVIG withdrawal period
	CIDP deterioration bya		No CIDP deterioration or withdrawal fromstudy,b
	INCAT total score, N = 151	I‐RODS total score or mean grip strength, N = 49	N = 7
Improvement by adjusted INCAT scorec	137 (91)	10 (20)	4 (57)
No improvement by adjusted INCAT scorec	14 (9)	39 (80)	3 (43)
Improvement and CIDP stability achieved (based on adjusted INCAT score)c , d	120 (80)	9 (18)	4 (57)
No improvement but CIDP stability achieved (based on adjusted INCAT score)c , d	4 (3)	32 (65)	2 (29)

Abbreviations: CIDP, chronic inflammatory demyelinating polyneuropathy; INCAT, inflammatory neuropathy cause and treatment; I‐RODS, inflammatory Rasch‐built overall disability scale; IVIG, intravenous immunoglobulin; N, number of subjects; PSDS, pre‐randomization safety data set.

^aCIDP deterioration was defined as an increase in adjusted INCAT total score by ≥1 point, a decrease in I‐RODS total score by ≥4 points, or a decrease in mean grip strength by ≥8 kPa.

^bSubjects who did not demonstrate CIDP deterioration during the IVIG withdrawal period but entered IgPro10 restabilization period (N = 3) with an additional four subjects who had shown CIDP deterioration but withdrew consent.

^cImprovement was defined as a decrease in adjusted INCAT score by ≥1 point, an increase in I‐RODS centile score by ≥4 points, an increase in mean grip strength by ≥8 kPa, and an increase in MRC sum score by ≥3 points, as compared to the Reference Visit.

^dCIDP stability occurred when CIDP status did not show a clinically meaningful difference at the last two consecutive visits during the IgPro10 restabilization period. In addition, to be considered CIDP stable, the CIDP status had to recover back to at least the status at Screening (as assessed by adjusted INCAT score).