TY - JOUR
T1 - Long-term Safety of Secukinumab Over Five Years in Patients with Moderate-to-severe Plaque Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis
T2 - Update on Integrated Pooled Clinical Trial and Post-marketing Surveillance Data
AU - Gottlieb, Alice B.
AU - Deodhar, Atul
AU - McInnes, Iain B.
AU - Baraliakos, Xenofon
AU - Reich, Kristian
AU - Schreiber, Stefan
AU - Bao, Weibin
AU - Marfo, Kwaku
AU - Richards, Hanno B.
AU - Pricop, Luminita
AU - Shete, Abhijit
AU - Trivedi, Vivek
AU - Keefe, Deborah
AU - Papavassilis, Charis C.
AU - Jagiello, Piotr
AU - Papanastasiou, Philemon
AU - Mease, Philip J.
AU - Lebwohl, Mark
N1 - Funding Information:
The authors thank the patients who participated in these studies and the study investigators. The authors thank Sandeep Subramaniam, Avinash Thakur and Vivek Sanker (Novartis Healthcare Private limited, Hyderabad, India), and Trudy Mcgarry (Novartis Ireland Limited, Dublin, Ireland) for editorial and medical writing support, which was funded by Novartis Pharma AG, Switzerland, in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3).
Publisher Copyright:
© 2022, Medical Journals/Acta D-V. All rights reserved.
PY - 2022
Y1 - 2022
N2 - Secukinumab, a selective interleukin (IL)-17A inhibitor, is approved for use in adult and paediatric psoriasis, psoriatic arthritis, ankylosing spondylitis and nonradiographic axial spondyloarthritis. The aim of this study was to report the long-term safety of secukinumab in pooled data from 28 clinical trials and a postmarketing safety surveillance in psoriasis, psoriatic arthritis and ankylosing spondylitis patients. Analyses included 12,637 secukinumab-treated patients, corresponding to 15,063, 5,985 and 3,527 patient-years of exposure in psoriasis, psoriatic arthritis and ankylosing spondylitis patients, respectively. Incidences of serious adverse events were low, with no identifiable patterns across indications. Active tuberculosis or latent tuberculosis infections were rare. The incidence of opportunistic infections was < 0.2/100 patient-years, the incidence of malignancy was ≤ 1/100 patient-years, and the incidence of major adverse cardiovascular events was < 0.7/100 patientyears, with no apparent increases over time. Secukinumab demonstrated a favourable safety profile for up to 5 years of treatment across the 3 indications, and no new safety signals were identified.
AB - Secukinumab, a selective interleukin (IL)-17A inhibitor, is approved for use in adult and paediatric psoriasis, psoriatic arthritis, ankylosing spondylitis and nonradiographic axial spondyloarthritis. The aim of this study was to report the long-term safety of secukinumab in pooled data from 28 clinical trials and a postmarketing safety surveillance in psoriasis, psoriatic arthritis and ankylosing spondylitis patients. Analyses included 12,637 secukinumab-treated patients, corresponding to 15,063, 5,985 and 3,527 patient-years of exposure in psoriasis, psoriatic arthritis and ankylosing spondylitis patients, respectively. Incidences of serious adverse events were low, with no identifiable patterns across indications. Active tuberculosis or latent tuberculosis infections were rare. The incidence of opportunistic infections was < 0.2/100 patient-years, the incidence of malignancy was ≤ 1/100 patient-years, and the incidence of major adverse cardiovascular events was < 0.7/100 patientyears, with no apparent increases over time. Secukinumab demonstrated a favourable safety profile for up to 5 years of treatment across the 3 indications, and no new safety signals were identified.
KW - ankylosing spondylitis
KW - biologics
KW - interleukin
KW - psoriasis
KW - psoriatic arthritis
KW - safety
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U2 - 10.2340/actadv.v102.563
DO - 10.2340/actadv.v102.563
M3 - Article
C2 - 35146532
AN - SCOPUS:85129149156
VL - 102
JO - Acta Dermato-Venereologica
JF - Acta Dermato-Venereologica
SN - 0001-5555
M1 - adv00698
ER -