The Risk of Malignancy in Patients With Secukinumab-treated Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis

All EAIR values are presented with 95% confidence intervals. n = number of patients with event in time period. N = number of patients with at least one event. No. = total number of patients across indications entering treatment period. PsA, psoriatic arthritis; AS, ankylosing spondylitis.

All EAIR values are presented with 95% confidence intervals. n = number of patients with event in time period. ^aMore than five cases in total across indications. ^bBowen disease may also be referred to as squamous cell carcinoma in situ. PsA, psoriatic arthritis; AS, ankylosing spondylitis.

n = number of patients with an event in time period. PTY, patient treatment-years.

Authors and Disclosures

M. Lebwohl¹, A. Deodhar², C.E.M. Griffiths³, M.A. Menter⁴, D. Poddubnyy⁵, W. Bao⁶, V. Jehl⁷, K. Marfo⁷, P. Primatesta⁷, A. Shete⁷, V. Trivedi⁶ and P.J. Mease<sup>8

1</sup>Kimberly and Eric J. Waldman Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York City, NY, USA
²Oregon Health & Science University, Portland, OR, USA
³The Dermatology Centre, The University of Manchester, Manchester Academic Health Science Centre, Salford Royal NHS Foundation Trust, Manchester, UK
⁴Division of Dermatology, Baylor Scott & White Health, Dallas, TX, USA
⁵Division of Gastroenterology, Infectious Diseases and Rheumatology, Charité, Universitätsmedizin Berlin, Germany, and Epidemiology Unit, German Rheumatism Research Centre, Berlin, Germany
⁶Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
⁷Novartis Pharma AG, Basel, Switzerland
⁸Department of Rheumatology, Swedish Health Services/Providence St Joseph Health and University of Washington, Seattle, WA, USA

Correspondence
Mark Lebwohl. Email: lebwohl@aol.com

Conflicts of interest M.L. has participated in advisory boards and/or as an investigator and/or speaker and received grants and/or honoraria from the following companies: AbbVie, Amgen, Arcutis Biotherapeutics, AstraZeneca, Allergan, Almirall, Avotres Therapeutics, BirchBioMed Inc., Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Castle Biosciences, Corrona, Celgene, Clinuvel, Dermavant Sciences, Eli Lilly, Evelo Biosciences, Foundation for Research and Education in Dermatology, Inozyme Pharma, LEO Pharma, Incyte, Janssen Research & Development, LLC, Kadmon Corporation, Medimmune, Meiji Seika Pharma, Menlo (VYNE) Therapeutics, Mitsubishi, NeuroDerm, Novartis Pharma, Ortho Dermatologics, Pfizer, Promius Pharma/Dr Reddy’s Laboratories, Sciderm, Theravance, UCB, ViDac and Verrica Pharmaceuticals. A.D. has participated in advisory boards and/or acted as an investigator and/or speaker and received grants and/or honoraria from the following companies: AbbVie, Eli Lilly, GlaxoSmithKline, Novartis, Pfizer, UCB, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Gilead, and Janssen Biotech Inc. C.E.M.G. is supported in part by the National Institute for Health Research (NIHR) Manchester Biomedical Research Centre. He has received honoraria and/or research funding from the following companies: AbbVie, Almirall, BMS, Celgene, Eli Lilly, Janssen Biotech, Inc., LEO Pharma, Novartis, Pfizer, Sandoz, SUN Pharma and UCB. M.A.M. has received grants and/or honoraria and/or acted as consultant/advisor/investigator or speaker for the following companies: Abbott Laboratories, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen Biotech, Inc., LEO Pharma, Merck, Novartis Pharmaceuticals, SUN Pharma and UCB. D.P. has received research grants from and/or has acted as a consultant/speaker for the following companies: AbbVie, Bristol Myers Squibb, BIOCAD, Eli Lilly, Gilead, GlaxoSmithKline, Janssen Biotech Inc., MSD, Novartis Pharma, Pfizer, Samsung and UCB. P.J.M. has received grants from and/or has acted as consultant/speaker for the following companies: AbbVie, Amgen, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Galapagos, Genentech, Gilead, GlaxoSmithKline, Janssen Biotech Inc., Eli Lilly, Merck, Novartis Pharma, Pfizer, SUN Pharma and UCB. W.B., V.J., K.M., P.P., A.S. and V.T. are all employed by Novartis Pharma.

Sidebar 1

What is Already Known About This Topic?

• Secukinumab is approved for the treatment of moderate-to-severe psoriasis, psoriatic arthritis, ankylosing spondylitis and nonradiographic axial spondyloarthritis.

• Clinical studies in these indications have reported low exposure-adjusted incidence rates (EAIR) of malignancies at one year, but there is currently a lack of longer-term data on the incidence of malignancy in secukinumab-treated patients.

Sidebar 2

What Does This Study add?

• The cumulative EAIR of malignancy is 0·85 per 100 patient years [95% confidence interval (CI) 0·74–0·98] in secukinumab-treated patients across indications.

• The observed vs. expected number of malignancies were comparable, as indicated by a standardized incidence rate of 0·99 (95% CI 0·82–1·19).

• This assessment provides a broader understanding of the safety of secukinumab, and supports its long-term use in these chronic systemic immune-mediated conditions.