Objectives Here, we present the reported incidence rates of inflammatory bowel disease (IBD) in patients receiving treatment with secukinumab for psoriasis (PsO), psoriatic arthritis (PsA) or ankylosing spondylitis (AS), in a pooled analysis of 21 clinical trials.
Methods Data from all patients who had received at least one dose of secukinumab were included. Safety analyses were conducted to evaluate cumulative IBD rates as well as per-year rates, by indication. Crohn’s disease (CD), ulcerative colitis (UC) and IBD unclassified (IBDU) events were analysed using exposure-adjusted incidence rates (patient incidence rates per 100 patient-years (PY)).
Results A total of 7355 patients with a cumulative exposure of 16 226.9 PY were included in the pooled analysis. Among 5181 patients with PsO, there were 14 cases of UC, 5 cases of CD and 1 case of IBDU, with exposure adjusted incidence rates (EAIRs) of 0.13, 0.05 and 0.01, respectively. Of these 20 cases, 14 were new-onset. In 1380 patients with PsA, there were 3 cases of UC, 3 cases of CD and 2 cases of IBDU (EAIRs 0.08, 0.08 and 0.05); 7 of these represented new-onset cases. Among 794 patients with AS, there were 4 cases of UC, 8 cases of CD and 1 case of IBDU (EAIRs 0.2, 0.4 and 0.1); 9 were new-onset cases. In the per year analysis, the EAIRs for each indication did not increase over time with secukinumab treatment.
Conclusions In this pooled secukinumab safety analysis of 7355 patients across 21 clinical trials, cases of IBD events (including CD, UC and IBDU) were uncommon.
- inflammatory bowel disease
- crohn’s disease
- ulcerative colitis
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Handling editor Josef S Smolen
Contributors All authors provided a substantial contribution to the conception, design and interpretation of the work. Drafted the work or revised it critically for important intellectual content. Provided final approval of the submission version of the manuscript. ADG undertook the statistical data analysis.
Funding Funding for the clinical trials was provided by Novartis Pharma AG, Switzerland.
Competing interests SS has served as a consultant for Abbvie, AstraZeneca/Medimmune, Boehringer, Celltrion, Ferring, Jansen, Novartis, MSD, Pfizer, Sanofi, Takeda, UCB and as a paid speaker for Abbvie, Celltrion, Ferring, MSD and Takeda. J-FC has served as a consultant or advisory board member for Abbvie, Amgen, Boehringer-Ingelheim, Celgene Corporation, Celltrion, Enterome, Ferring, Genentech, Janssen and Janssen, Eli Lilly and Company, Medimmune, Merck & Co, Pfizer, Protagonist, Second Genome, Seres, Shire, Takeda and Theradiag; has been a speaker for Abbvie and Ferring; has been a member of the speaker's bureau for Amgen. BGF has received grant/research support from Millennium Pharmaceuticals, Merck, Tillotts Pharma AG, AbbVie, Novartis Pharmaceuticals, Centocor Inc, Elan/Biogen, UCB Pharma, Bristol-Myers Squibb, Genentech, ActoGenix and Wyeth Pharmaceuticals Inc.; consulting fees from Millennium Pharmaceuticals, Merck, Centocor Inc, Elan/Biogen, Janssen-Ortho, Teva Pharmaceuticals, Bristol-Myers Squibb, Celgene, UCB Pharma, AbbVie, Astra Zeneca, Serono, Genentech, Tillotts Pharma AG, Unity Pharmaceuticals, Albireo Pharma, Given Imaging Inc, Salix Pharmaceuticals, Novonordisk, GSK, Actogenix, Prometheus Therapeutics and Diagnostics, Athersys, Axcan, Gilead, Pfizer, Shire, Wyeth, Zealand Pharma, Zyngenia, GiCare Pharma Inc, and Sigmoid Pharma and speakers fees from UCB, AbbVie and J&J/Janssen. KR has served as a consultant and/or paid speaker for, and/or participated in clinical trials sponsored by, companies that manufacture drugs used for the treatment of psoriasis, including AbbVie, Amgen, Biogen-Idec, Celgene, Centocor, Covagen, Eli Lilly, Forward Pharma, GSK, Janssen-Cilag, Leo Pharma, Medac, MSD, Novartis, Pfizer, Vertex, Takeda and Xenoport. AAD has served as a consultant for AbbVie, Amgen, Boehringer Ingelheim, Janssen, Novartis, Pfizer, UCB and has received grant/research support from AbbVie, Amgen, Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB. IBM has received research grants, consultation fees or speaker honoraria from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Novartis, Pfizer and UCB. BP and TF are employees of Novartis Pharma AG (Switzerland). ADG is an employee of Novartis Healthcare Pvt. Ltd (India). LP is an employee of Novartis Pharmaceuticals Corporation (USA).
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement All data relevant to the study are included in the article or uploaded as supplementary information.
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