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Vedolizumab use is not associated with increased malignancy incidence: GEMINI LTS study results and post-marketing data

Card, Timothy; Ungaro, Ryan; Bhayat, Fatima; Blake, Aimee; Hantsbarger, Gary; Travis, Simon

Authors

Dr TIM CARD tim.card@nottingham.ac.uk
Clinical Associate Professor

Ryan Ungaro

Fatima Bhayat

Aimee Blake

Gary Hantsbarger

Simon Travis



Abstract

© 2019 John Wiley & Sons Ltd Background: Vedolizumab is a gut-selective antibody to α4β7integrin approved to treat moderate-to-severe Crohn's disease and ulcerative colitis in adults. Inflammatory bowel disease (IBD) and immunosuppressant use are associated with increased risk of malignancy. Aim: To analyse the incidence of malignancy with vedolizumab treatment in the GEMINI long-term safety (LTS) study and post-marketing (PM) setting. Methods: Malignancy data from the LTS study (May 2009 to May 2018), and data from the vedolizumab Global Safety Database (20 May 2014 to 19 May 2018), were identified using Medical Dictionary for Regulatory Activities coding. The number of patients experiencing malignancies in the LTS study (excluding malignancies within 1year following vedolizumab initiation) was indirectly standardised against the number expected, using age- and sex-specific rates in patients with IBD from Optum's Clinformatics™ Data Mart (CDM) database. Results: Among 1785 patients with ≥1year of follow-up post-vedolizumab initiation in the LTS study (total 5670 patient-years), observed numbers of malignancies were similar to those expected compared with CDM data (31 vs 29; ratio of observedto expected events=1.08; P=0.71; 95% confidence intervals [CI] 0.73, 1.53). The most common malignancies were renal and bladder (6). PM, 293 patients reported 299 malignancies (including malignancies within 1year following vedolizumab initiation), in approximately 208050 patient-years of vedolizumab exposure. Lower gastrointestinal malignancies were most common (59). Conclusions: The number of malignancies in the LTS study was similar to that expected from an IBD population with no statistically significant differences, although few confounders could be corrected for. Limitations of PM safety reporting require consideration; however, the number of malignancies with vedolizumab appeared low.

Citation

Card, T., Ungaro, R., Bhayat, F., Blake, A., Hantsbarger, G., & Travis, S. (2020). Vedolizumab use is not associated with increased malignancy incidence: GEMINI LTS study results and post-marketing data. Alimentary Pharmacology and Therapeutics, 51(1), 149-157. https://doi.org/10.1111/apt.15538

Journal Article Type Article
Acceptance Date Sep 23, 2019
Online Publication Date Nov 20, 2019
Publication Date 2020-01
Deposit Date Sep 27, 2019
Publicly Available Date Nov 21, 2020
Journal Alimentary Pharmacology and Therapeutics
Print ISSN 0269-2813
Electronic ISSN 1365-2036
Publisher Wiley
Peer Reviewed Peer Reviewed
Volume 51
Issue 1
Pages 149-157
DOI https://doi.org/10.1111/apt.15538
Public URL https://nottingham-repository.worktribe.com/output/2664462
Publisher URL https://onlinelibrary.wiley.com/doi/full/10.1111/apt.15538

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Card Et Al PV Malignancy Manuscript For Resubmission R1 17-Sept-19 (525 Kb)
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Card Et Al. PV Malignacy Manuscript Figure 1 For Resubmission 17-Sept-19 (309 Kb)
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Card Et Al. PV Malignancy Manuscript Appendices For Resubmission 17-Sept-19 (128 Kb)
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