@article{5e6ab1865a774631944c4952953f1bd3,
title = "The risk of malignancy in patients with secukinumab-treated psoriasis, psoriatic arthritis and ankylosing spondylitis: analysis of clinical trial and postmarketing surveillance data with up to five years of follow-up",
abstract = "Background: Data on the use of biologic therapy and malignancy risk are inconsistent due to limited long-term robust studies. Objectives: To assess the malignancy risk in patients with secukinumab-treated psoriasis, psoriatic arthritis (PsA) and ankylosing spondylitis (AS). Methods: This integrated safety analysis from both the secukinumab clinical trial programme and postmarketing safety surveillance data included any patient receiving at least one approved dose of secukinumab with a maximum of 5 years of follow-up. Safety analyses evaluated the rate of malignancy using exposure-adjusted incidence rates [EAIR; incidence rates per 100 patient treatment-years (PTY)]. Standardized incidence ratios (SIRs) were reported using the Surveillance, Epidemiology, and End Results Program (SEER) database as a reference population. Crude incidence of malignancy was also reported using postmarketing surveillance data. Results: Safety data from 49 clinical trials with secukinumab-treated patients were included: 10 685 patients with psoriasis, 2523 with PsA and 1311 with AS. Across indications over a 5-year period, the EAIR of malignancy was 0·85 per 100 PTY [95% confidence interval (CI) 0·74–0·98] in secukinumab-treated patients, corresponding to 204 patients per 23 908 PTY. Overall, the observed vs. expected number of malignancies from secukinumab clinical trial data were comparable, as indicated by an SIR of 0·99 (95% CI 0·82–1·19) across indications. The estimated crude cumulative incidence reporting rate per 100 PTY for malignancy was 0·27 in the postmarketing surveillance data across indications with a cumulative exposure of 285 811 PTY. Conclusions: In this large safety analysis, the risk of malignancy was low for up to 5 years of secukinumab treatment. These data support the long-term use of secukinumab in these indications.",
author = "M. Lebwohl and A. Deodhar and Griffiths, {C. E.M.} and Menter, {M. A.} and D. Poddubnyy and W. Bao and V. Jehl and K. Marfo and P. Primatesta and A. Shete and V. Trivedi and Mease, {P. J.}",
note = "Funding Information: This research was funded by Novartis Pharma AG, Basel, Switzerland. Funding sources Funding Information: Novartis Pharma were involved with the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review or approval of the manuscript; and decision to submit the manuscript for publication. The authors thank Trudy McGarry, PhD (Novartis Ireland Ltd), and Daniella Taylor, MA (Novartis Pharmaceuticals UK Ltd), for providing medical writing support/editorial support, which was funded by Novartis Pharma AG, Basel, Switzerland in accordance with Good Publication Practice (GPP3) guidelines ( http://www.ismpp.org/gpp3 ). Funding Information: 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{\textquoteright}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. Publisher Copyright: {\textcopyright} 2021 British Association of Dermatologists",
year = "2021",
month = nov,
doi = "10.1111/bjd.20136",
language = "English (US)",
volume = "185",
pages = "935--944",
journal = "British Journal of Dermatology",
issn = "0007-0963",
publisher = "Wiley-Blackwell",
number = "5",
}