Long‐Term Real‐World Safety Profile of Secukinumab Assessed Through a 9‐Year Experience in Patients Affected by Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis: Results From a Multicentric Retrospective Study
Secukinumab is a biologic agent known for its durable efficacy in chronic plaque psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS). Monitoring the safety of secukinumab is a priority to ensure its long‐term usage. We aimed to provide an extended safety assessment of secukinumab treatment in a real‐world setting. This bicentric observational study enrolled 332 patients with PsO, PsA and AS who received subcutaneous injections of secukinumab for up to 9 years. Adverse events (AEs) were reported annually as exposure‐adjusted incidence rates (EAIRs) per 100 patient‐years (pt‐y). The total secukinumab exposure was 1129 pt‐y. The retention rate was 73%, with 16 (4.8%) of patients discontinuing due to AEs. Despite most AEs being reported within the first 2 years, their incidence was low and decreased over time. The EAIR of any AEs was the highest in the initial 6 months (32.72/100 pt‐y), followed by year 1 (7.62/100 pt‐y), and year 2 of treatment (3.01/100 pt‐y). Common AEs included respiratory and urinary tract infections, candidiasis, and diarrhoea. Secukinumab showed sustained safety over an extended 9‐year treatment period, supporting its use for the long‐term management of these immune‐inflammatory disorders.
Authors
- Andrea Chiricozzi (ORCID: https://orcid.org/0000-0002-6739-0387)
- Giusy Peluso (ORCID: https://orcid.org/0000-0001-8298-2287)
- Giacomo Caldarola (ORCID: https://orcid.org/0000-0002-8837-9232)
- Tiago Torres (ORCID: https://orcid.org/0000-0003-0404-0870)
- Clara De Simone (ORCID: https://orcid.org/0000-0002-0898-0045)
- Arianna Guaita (ORCID: https://orcid.org/0000-0003-3151-1236)
- Maria Antonietta D’Agostino (ORCID: https://orcid.org/0000-0002-5347-0060)
- Augusta Ortolan (ORCID: https://orcid.org/0000-0002-3131-0939)
- Gennaro Marco Falco (ORCID: https://orcid.org/0009-0001-1219-9008)
- Eleonora De Luca (ORCID: https://orcid.org/0000-0003-3893-2869)
- Ketty Peris (ORCID: https://orcid.org/0000-0003-1957-6600)
- Elena Ippoliti (ORCID: https://orcid.org/0009-0009-6455-0531)
Institutions
- Università Cattolica del Sacro Cuore (IT)
- University of Padua (IT)
- Universidade do Porto (PT)
- Agostino Gemelli University Polyclinic (IT)
- Centro de Genética Clínica (PT)
- University of the Sacred Heart (JP)
- i3S - Instituto de Investigação e Inovação em Saúde, Universidade do Porto (PT)
Publication Details
- Journal
- Dermatologic Therapy
- Published
- 2025-01-01
- DOI
- https://doi.org/10.1155/dth/9618241
- Primary Topic
- Spondyloarthritis Studies and Treatments
- Type
- article
- Field-Weighted Citation Impact
- 0.00