Efficacy and safety of tafolecimab in Chinese patients with heterozygous familial hypercholesterolemia: a randomized, double-blind, placebo-controlled phase 3 trial (CREDIT-2)

Table 3 Treatment-emergent adverse events and laboratory abnormalities in the double-blind treatment period

	150 mg Q2W		450 mg Q4W
	Tafolecimab (n = 52)	Placebo (n = 23)	Tafolecimab (n = 48)	Placebo (n = 25)
Adverse events
Any	36 (69.2)	13 (56.5)	23 (47.9)	15 (60.0)
Serious	2 (3.8)	0	2 (4.2)	0
Deaths	1 (1.9)	0	0	0
Leading to treatment discontinuation	2 (3.8)	0	0	0
Most common adverse events in participants receiving tafolecimab^a
Upper respiratory tract infection	11 (21.2)	1 (4.3)	2 (4.2)	3 (12.0)
Blood creatine phosphokinase increased	3 (5.8)	0	3 (6.3)	1 (4.0)
Alanine aminotransferase increased	4 (7.7)	0	0	0
Aspartate aminotransferase increased	4 (7.7)	0	0	0
Hypertension	4 (7.7)	0	0	0
Muscle-related adverse events^b	5 (9.6)	1 (4.3)	0	2 (8.0)
Hypersensitivity^c	5 (9.6)	1 (4.3)	0	2 (8.0)
Potential injection-site adverse events^d	2 (3.8)	0	1 (2.1)	0
Laboratory results
ALT or AST >3× ULN (any post-baseline value)	1 (1.9)	0	1 (2.1)	0
Creatine kinase >5× ULN (any post-baseline value)	0	1 (4.3)	2 (4.2)	0

Data are number of participants (%)
ALT alanine aminotransferase, AST aspartate aminotransferase, MedDRA The Medical Dictionary for Regulatory Activities, Q2W every 2 weeks, Q4W every 4 weeks, ULN upper limit of normal
^aBy MedDRA (version 24.0) preferred term
^bDefined using statin-associated muscle events (ACC/AHA guideline on the management of blood cholesterol [2018])
^cDefined as acute systemic reactions characterized by pruritus, generalized flush, urticaria, angioedema, respiratory distress or hypotension
^dDefined as events characterized by injection site swelling, injection site erythema, injection site haemorrhage, injection site pruritus, injection site induration or injection site pain

ISSN: 1741-7015