Indirect comparison of intravenous vs. subcutaneous C1-inhibitor placebo-controlled trials for routine prevention of hereditary angioedema attacks

Table 3 Efficacy endpoints with C1-INH(SC) and C1-INH(IV) in the placebo-controlled COMPACT and CHANGE studies, respectively

	COMPACT study^a C1-INH(SC) 60 IU/kg (N = 40)^c	CHANGE study^b C1-INH(IV) 1000 U (N = 22)	Adjusted difference^d	P-value
Monthly reduction in number of attacks vs. placebo
Least-squares mean (95% CI)	3.6 (2.9, 4.2)	2.3 (1.4, 3.3)	1.3 (0.1, 2.4)	0.034
Adjusted median (95% CI)	3.1 (2.3, 4.4)	2.2 (1.9, 3.6)	1.2 (− 0.9, 3.3)	0.251
Attack rate reduction vs. placebo (%)
Least-squares mean (95% CI)	84.0 (75.6, 92.4)	50.8 (30.4, 71.3)	32.8 (14.4, 51.2)	<0.001
Adjusted median (95% CI)	95.1 (86.4, 100.0)	53.1 (30.7, 88.3)	42.7 (11.6, 73.7)	0.008

Adjusted data for the crossover study design variables—means adjusted for period and sequence and medians for sequence within treatment (period not included for convergence reasons); may vary slightly from previously reported unadjusted data
CI confidence interval, IU international units, IV intravenous, SC subcutaneous, U units
^aObservation period of 14 weeks
^bObservation period of 12 weeks
^cFive of the 45 patients in COMPACT had missing attack values (3 during the placebo period and 2 during the C1-INH[SC] 60 IU/kg period) and were excluded from analyses
^dModel-based estimates for differences in outcomes

ISSN: 1710-1492