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 4 Summary of secukinumab post-marketing safety: cumulative and across five PSUR periods

Reporting period	26 Dec 2014–25 June 2015	26 June 2015–25 Dec 2015	26 Dec 2015–25 June 2016	26 June 2016–25 Dec 2016	26 Dec 2016–25 June 2017	Cumulative rate
Exposure	1838	7450	16,871	28,549	41,346	96,054
Infections and infestations/serious infections and infestations
Cases (n)	178/89	495/149	712/232	1136/475	1730/573	4483/1688
EARR (per 100 PY)	9.7/4.8	6.6/2.0	4.2/1.4	4.0/1.7	4.2/1.4	4.7/1.8
Neutropenia
Cases (n)	0	11	12	22	24	66
EARR (per 100 PY)	0	0.2	0.07	0.08	0.06	0.07
Hypersensitivity
Cases (n)	82	293	425	573	752	2293
EARR (per 100 PY)	4.5	3.9	2.5	2.0	1.8	2.4
Malignant or unspecified tumors
Cases (n)	2	15	21	50	76	173
EARR (per 100 PY)	0.1	0.2	0.1	0.2	0.2	0.2
Total IBD
Cases (n)	4	12	37	46	93	195
EARR (per 100 PY)	0.2	0.2	0.2	0.2	0.2	0.2
MACE
Cases (n)	6	15	16	39	58	148
EARR (per 100 PY)	0.3	0.2	0.09	0.1	0.1	0.2
SIB
Cases (n)	1	3	6	8	12	35
EARR (per 100 PY)	0.05	0.04	0.04	0.03	0.03	0.04

Approximation was not done if EARR is less than 0.1
EARR exposure-adjusted reporting rates, IBD inflammatory bowel disease, MACE major adverse cardiovascular events, PSUR periodic safety update report, PY patient-treatment years, SIB suicidal ideation and behavior

ISSN: 1478-6362