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Table 3 Selected AEs with secukinumab across pooled clinical trials

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

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)
  1. Approximation was not done if EAIR is less than 0.1
  2. 1Values are based on system organ class: infections and infestations
  3. 2Values are based on the high-level term
  4. 3Values are based on the preferred term
  5. 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
  6. 5Values are based on standardized MedDRA query
  7. 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