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

From: 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

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
  1. Approximation was not done if EARR is less than 0.1
  2. 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