P191  Secukinumab demonstrates a consistent safety profile in patients with psoriasis, psoriatic arthritis and ankylosing spondylitis over long term: updated pooled safety analyses

Conclusion Secukinumab was well tolerated in this long-term analysis of patients with PsO, PsA and AS across clinical trials and post-marketing surveillance, with a safety profile consistent with previous reports (Deodhar, 2019). P191 Table 1:Selected adverse events of interest with secukinumab across poo led clinical trialsVariablePsOPsAASSEC N = 8,819SEC N = 2,678SEC N = 1,140Exposure (days),mean (SD)623.9 (567.7)816.2 (580.7)1130.1 (583.0)Death, n (%)14 (0.2)11 (0.4)9 (0.8)Selected adverse events of interest, EAIR (95% CI)Serious infectionsa1.4 (1.2-1.6)1.8 (1.5-2.2)1.2 (0.9-1.6)Candida infectionsbb2.9 (2.7-3.2)1.5 (1.2-1.9)0.7 (0.5-1.1)IBDc0.01 (0.0-0.05)0.03 (0.0-0.1)0.03 (0.0-0.2)Crohns diseasecc0.1 (0.05-0.2)0.1 (0.04-0.2)0.4 (0.24-0.7)Ulcerative colitiscc0.1 (0.08-0.2)0.1 (0.04-0.2)0.2 (0.1-0.5)MACEdd0.4 (0.3-0.5)0.4 (0.3-0.6)0.7 (0.4-1.0)Uveitiscc0.01 (0.0-0.05)0.1 (0.04-0.2)1.2 (0.9-1.7)Malignancyee0.9 (0.7-1.0)1.0 (0.77-1.3)0.5 (0.3-0.8)aRates for system organ class;bRates for high level term;cRates for preferred term (PT; IBD for unspecified IBD);dRates for Novartis MedDRA Query term;eRates for standardised MedDRA Query term - ‘malignancies and unspecified tumour’. AS, ankylosing spondylitis; CI, confidence interval; EAIR, exposure-adjusted incidence rate per 100 patient-years; IBD, inflammatory bowel disease; MACE, major adverse cardiac events; MedDRA, Medical Dictionary for Regulatory Activities; N, number of patien ts in the analysis; PsA, psoriatic art...
Source: Rheumatology - Category: Rheumatology Source Type: research