Safety of Secukinumab from 1 Million Patient-Years of Exposure: Experience from Post-Marketing Setting and Clinical Trials.

Autor: Sun R; Novartis Pharmaceuticals Corporation, Bannockburn, IL, USA., Bustamante M; Novartis Pharma, Barcelona, Spain., Gurusamy VK; Novartis Pharma AG, Basel, Switzerland., Lebwohl M; Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA., Gottlieb AB; Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA., Mease PJ; Department of Rheumatology, Swedish Medical Center/Providence St. Joseph Health, Seattle, WA, USA.; University of Washington, Seattle, WA, USA., Deodhar A; Oregon Health and Science University, Portland, OR, USA., Bao W; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA., Mendelson M; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA., Porter B; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA., Chand D; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.; University of Illinois College of Medicine-Peoria and Children's Hospital of Illinois, Peoria, IL, USA., Dong V; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. victor.dong@novartis.com.
Jazyk: angličtina
Zdroj: Dermatology and therapy [Dermatol Ther (Heidelb)] 2024 Mar; Vol. 14 (3), pp. 729-743. Date of Electronic Publication: 2024 Mar 07.
DOI: 10.1007/s13555-024-01122-2
Abstrakt: Introduction: Secukinumab is an anti-interleukin (IL)-17A monoclonal antibody indicated for multiple immunological disorders. Here, we aim to summarize secukinumab safety in clinical trials (CTs) and post-marketing setting (PMS) until 25 June 2022.
Methods: Adverse events (AEs) were summarized with crude reporting rate (RR) per 100 patient-years (PY) in PMS for all reported indications and with exposure-adjusted incident rates (EAIR) per 100 PY in pooled 47 CTs for approved indications.
Results: Secukinumab exposure totaled 1,159,260 PY in PMS and 27,765 PY in CTs. AEs were mostly (> 80%) non-serious in PMS. EAIR for serious AEs was 7.0/100 PY. Nasopharyngitis (RR 0.59/100 PY, EAIR 16.08/100 PY) and pneumonia (RR 0.14/100 PY, EAIR 0.17/100 PY) were the most common infection and serious infection, respectively. Candida infections (RR 0.20/100 PY, EAIR 2.16/100 PY) were the most common fungal infections. Inflammatory bowel disease (IBD) was observed in PMS (0.14/100 PY) and CTs (0.26/100 PY). Most (76%) patients with prior IBD did not report IBD flare during CTs. PMS monitoring identified paradoxical skin reactions including dyshidrotic eczema (RR 0.006/100 PY) and pyoderma gangrenosum (RR 0.003/100 PY).
Conclusion: Secukinumab safety profile with increased patient exposure remained favorable. Paradoxical skin reactions were identified in post-marketing monitoring.
(© 2024. The Author(s).)
Databáze: MEDLINE
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