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

Rui Sun; Mercedes Bustamante; Venkatesh Kumar Gurusamy; Mark Lebwohl; Alice B Gottlieb; Philip J Mease; Atul Deodhar; Weibin Bao; Meryl Mendelson; Brian Porter; Deepa Chand; Victor Dong

doi:10.1007/s13555-024-01122-2

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

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

Authors

Rui Sun¹, Mercedes Bustamante², Venkatesh Kumar Gurusamy³, Mark Lebwohl⁴, Alice B Gottlieb⁴, Philip J Mease^{5

6}, Atul Deodhar⁷, Weibin Bao⁸, Meryl Mendelson⁸, Brian Porter⁸, Deepa Chand^{8

9}, Victor Dong¹⁰

Affiliations

¹ Novartis Pharmaceuticals Corporation, Bannockburn, IL, USA.
² Novartis Pharma, Barcelona, Spain.
³ Novartis Pharma AG, Basel, Switzerland.
⁴ Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
⁵ Department of Rheumatology, Swedish Medical Center/Providence St. Joseph Health, Seattle, WA, USA.
⁶ University of Washington, Seattle, WA, USA.
⁷ Oregon Health and Science University, Portland, OR, USA.
⁸ Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
⁹ University of Illinois College of Medicine-Peoria and Children's Hospital of Illinois, Peoria, IL, USA.
¹⁰ Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. victor.dong@novartis.com.

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.