Long-term Safety of Secukinumab Over Five Years in Patients with Moderate-to-severe Plaque Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis: Update on Integrated Pooled Clinical Trial and Post-marketing Surveillance Data


  • Alice B. Gottlieb Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, USA
  • Atul Deodhar Division of Arthritis & Rheumatic Diseases, Oregon Health & Science University, Portland, Oregon, USA
  • Iain B. Mcinnes Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK
  • Xenofon Baraliakos Rheumazentrum Ruhrgebiet Herne, Ruhr University Bochum, Bochum, Germany
  • Kristian Reich Translational Research in Inflammatory Skin Disease, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
  • Stefan Schreiber Department of Medicine I, University Hospital Schleswig-Holstein, Kiel, Germany
  • Weibin Bao Novartis Pharmaceuticals Corporation, East Hanover, US
  • Kwaku Marfo Novartis Pharma AG, Basel, Switzerland
  • Hanno B. Richards Novartis Pharma AG, Basel, Switzerland
  • Luminita Pricop Novartis Pharmaceuticals Corporation, East Hanover, US
  • Abhijit Shete Novartis Pharma AG, Basel, Switzerland
  • Vivek Trivedi Novartis Pharmaceuticals Corporation, East Hanover, US
  • Deborah Keefe Novartis Pharmaceuticals Corporation, East Hanover, US
  • Charis C. Papavassilis Novartis Pharma AG, Basel, Switzerland
  • Piotr Jagiello Novartis Pharma AG, Basel, Switzerland
  • Philemon Papanastasiou Novartis Pharma AG, Basel, Switzerland
  • Philip J. Mease Swedish Medical Center and University of Washington, Seattle, US
  • Mark Lebwohl Mount Sinai Hospital, New York, US




Ankylosing spondylitis, biologics, interleukin, psoriasis, psoriatic arthritis, safety


Secukinumab, a selective interleukin (IL)-17A inhibitor, is approved for use in adult and paediatric psoriasis, psoriatic arthritis, ankylosing spondylitis and non-radiographic 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 post-marketing 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 patient-years, 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.


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How to Cite

Gottlieb, A. B., Deodhar, A., Mcinnes, I. B., Baraliakos, X., Reich, K., Schreiber, S., Bao, W., Marfo, K. ., Richards, H. B., Pricop, L., Shete, A., Trivedi, V., Keefe, D., Papavassilis, C. C., Jagiello, P., Papanastasiou, P. ., Mease, P. J., & Lebwohl, M. (2022). Long-term Safety of Secukinumab Over Five Years in Patients with Moderate-to-severe Plaque Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis: Update on Integrated Pooled Clinical Trial and Post-marketing Surveillance Data. Acta Dermato-Venereologica, 102, adv00698. https://doi.org/10.2340/actadv.v102.563