Long-term safety of secukinumab in patients with moderate-to-severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis: integrated pooled clinical trial and post-marketing surveillance data

Table 3 Selected AEs with secukinumab across pooled clinical trials

Variable	PsO studies	PsA studies	AS studies
	Any secukinumab N = 5181	Any secukinumab N = 1380	Any secukinumab N = 794
	EAIR per 100 patient-years (95% CI)
Serious infections¹	1.4 (1.2, 1.6)	1.9 (1.5, 2.4)	1.2 (0.8, 1.8)
Candida infections²	2.2 (1.9, 2.5)	1.5 (1.1, 2.0)	0.7 (0.4, 1.2)
IBD³	0.01 (0.00, 0.05)	0.05 (0.01, 0.2)	0.1 (0.0, 0.3)
Crohn’s disease³	0.05 (0.02, 0.1)	0.08 (0.02, 0.2)	0.4 (0.2, 0.8)
Ulcerative colitis³	0.1 (0.07, 0.2)	0.08 (0.02, 0.2)	0.2 (0.1, 0.5)
MACE⁴	0.3 (0.2, 0.5)	0.4 (0.3, 0.7)	0.6 (0.3, 1.1)
Neutropenia³	0.3 (0.2, 0.4)	0.2 (0.1, 0.4)	0.5 (0.3, 1.0)
Uveitis³	0.02 (0.0, 0.07)	0.1 (0.0, 0.2)	1.4 (0.9, 2.0)
Malignancy⁵	0.8 (0.6, 1.0)	1.1 (0.8, 1.5)	0.5 (0.2, 0.9)

Approximation was not done if EAIR is less than 0.1
¹Values are based on system organ class: infections and infestations
²Values are based on the high-level term
³Values are based on the preferred term
⁴Values are based on Novartis MedDRA query, which comprises (1) any MI, (2) any CVA, and (3) all other CV events that are fatal, out of a listing of 2200+ terms
⁵Values are based on standardized MedDRA query
AE adverse event, AS ankylosing spondylitis, CI confidence interval, CV cardiovascular, CVA CV accident, EAIR exposure-adjusted incidence rate per 100 patient-years, IBD inflammatory bowel disease, MACE major adverse cardiovascular event, MedDRA Medical Dictionary for Regulatory Activities, MI myocardial infarction, N number of patients in the analysis, n number of patients with a response, PsA psoriatic arthritis, PsO psoriasis

ISSN: 1478-6362