Safety and tolerability of canakinumab, an IL-1β inhibitor, in type 2 diabetes mellitus patients: a pooled analysis of three randomised double-blind studies

Table 5 Adverse events of special interest including class effect (IL-1β inhibition) and disease effect (T2DM)

	Canakinumab pooled dose				Placebo
	Low dose	Intermediate dose	Medium dose	High dose	Placebo
	N = 20	N = 247	N = 268	N = 137	N = 354
Infections
n (%)	4 (20.0)	54 (21.9)	40 (14.9)	30 (21.9)	49 (13.8)
IR (%)	4.41	4.05	5.13	4.02	3.17
Hypersensitivity/allergy
n (%)	0	9 (3.6)	9 (3.4)	6 (4.4)	14 (4.0)
IR (%)	0	0.59	1.02	0.70	0.84
Thrombocytopenia
n (%)	1 (5.0)	7 (2.8)	5 (1.9)	4 (2.9)	4 (1.1)
IR (%)	1.04	0.46	0.56	0.46	0.23
Hypertension
n (%)	0	5 (2.0)	3 (1.1)	3 (2.2)	6 (1.7)
IR (%)	0	0.32	0.33	0.35	0.35
Major adverse cardiovascular events (MACE)
n (%)	0	3 (1.2)	4 (1.5)	2 (1.5)	9 (2.5)
IR (%)	0	0.19	0.44	0.23	0.53
Hepatic disorders
n (%)	0	1 (0.4)	2 (0.7)	6 (4.4)	2 (0.6)
IR (%)	0	0.06	0.22	0.70	0.12
Vertigo
n (%)	0	1 (0.4)	5 (1.9)	4 (2.9)	6 (1.7)
IR (%)	0	0.06	0.56	0.46	0.3
Injection-site reactions
n (%)	0	0	2 (0.7)	0	2 (0.6)
IR (%)	0	0	0.22	0	0.12
Hypoglycaemia
n (%)	0	0	2 (0.7)	0	1 (0.3)
IR (%)	0	0	0.22	0	0.06
Changes in renal function
n (%)	0	1 (0.4)	1 (0.4)	0	0
IR (%)	0	0.06	0.11	0	0
Lymphoid organ toxicity
n (%)	0	0	1 (0.4)	0	0
IR (%)	0	0	0.11	0	0
Malignancies
n (%)	0	0	0	1 (0.7)	0
IR (%)	0	0	0	0.11	0
Neutropenia
n (%)	0	1 (0.4)	0	0	0
IR (%)	0	0.06	0	0	0

n (%) are expressed as number (%) of patients; incidence rate (IR) is expressed as % per month.
Low dose: 0.03 mg/kg i.v. once; intermediate dose: 0.1 and 0.3 mg/kg i.v. once, 5 and 15 mg s.c. monthly; medium dose: 1.5 mg/kg i.v. once, 50 mg s.c. monthly and 150 mg s.c. once; high dose: 10 mg/kg i.v. once and 150 mg s.c. monthly.

ISSN: 1475-2840