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. 2024 Mar;14(3):729-743.
doi: 10.1007/s13555-024-01122-2. Epub 2024 Mar 7.

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

Rui Sun  1 , Mercedes Bustamante  2 , Venkatesh Kumar Gurusamy  3 , Mark Lebwohl  4 , Alice B Gottlieb  4 , Philip J Mease  5   6 , Atul Deodhar  7 , Weibin Bao  8 , Meryl Mendelson  8 , Brian Porter  8 , Deepa Chand  8   9 , Victor Dong  10
Affiliations

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

Rui Sun et al. Dermatol Ther (Heidelb). 2024 Mar.

Abstract

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.

Keywords: Clinical trials; IL-17A; Patient-year; Post-marketing setting; Safety; Secukinumab.

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Conflict of interest statement

Mark Lebwohl is an employee of Mount Sinai and receives research funds from Abbvie, Amgen, Arcutis, Avotres, Boehringer Ingelheim, Cara therapeutics, Dermavant Sciences, Eli Lilly, Incyte, Inozyme, Janssen Research & Development, LLC, Ortho Dermatologics, Pfizer, Sanofi-Regeneron, and UCB, Inc., and is a consultant for Almirall, AltruBio Inc., Anaptys Bio, Apogee, Arcutis, Inc., AstraZeneca, Atomwise, Avotres Therapeutics, Brickell Biotech, Boehringer Ingelheim, Bristol Myers Squibb, Castle Biosciences, Celltrion, Corevitas, Dermavant Sciences, EPI, Evommune, Inc., Facilitation of International Dermatology Education, Forte biosciences, Foundation for Research and Education in Dermatology, Galderma, Genentech, Incyte, LEO Pharma, Meiji Seika Pharma, Mindera, Pfizer, Sanofi-Regeneron, Seanergy, Strata, Takeda, Trevi, and Verrica. Alice B Gottlieb has received research/educational grants from Anaptyps Bio, Highlights Therapeutics, Moonlake Immunotherapeutics AG, Janssen, Novartis, Bristol Myers Squibb, and UCB Pharma, (all paid to Mount Sinai School of Medicine); has received honoraria as an advisory board member and consultant for Amgen, Anaptyps Bio, Avotres Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Dice Therapeutics, Eli Lilly, Highlights Therapeutics, Janssen, Novartis, Sanofi, UCB, and Xbiotech. Philip J Mease has received grant/research support from AbbVie, Amgen, Bristol Myers Squibb, Celgene, Crescendo Bioscience, Genentech, Janssen, Eli Lilly, Merck, Novartis, Pfizer and UCB; is a consultant for: AbbVie, Amgen, BMS, Celgene, Crescendo Bioscience, Genentech, Janssen, Eli Lilly, Merck, Novartis, Pfizer, and UCB; Speakers bureau: AbbVie, Amgen, Bristol Myers Squibb, Celgene, Crescendo Bioscience, Genentech, Janssen, Eli Lilly, Merck, Novartis, Pfizer, and UCB. Atul Deodhar has received honoraria for consulting or speaking for, or has received research grants from AbbVie, Bristol Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer, and UCB. Venkatesh Kumar Gurusamy is employee of Novartis. Rui Sun, Mercedes Bustamante, Weibin Bao, Meryl Mendelson, Brian Porter, Deepa Chand, and Victor Dong are employees and own shares of Novartis.

Figures

Fig. 1
Fig. 1
Post-marketing reporting rate per 100 PY. The bar graph demonstrates the decreasing reporting rate of safety events (left y-axis) as the cumulative exposure of secukinumab increases (right y-axis), as reported by periodic safety update reports from 25 December 2018, 25 December 2020, and 25 June 2022. PY patient-years, RR reporting rate
See this image and copyright information in PMC

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