Vedolizumab use is not associated with increased malignancy incidence: GEMINI LTS study results and post-marketing data.
Adult
Adverse Drug Reaction Reporting Systems
/ statistics & numerical data
Aged
Aged, 80 and over
Antibodies, Monoclonal, Humanized
/ therapeutic use
Colitis, Ulcerative
/ drug therapy
Crohn Disease
/ drug therapy
Databases, Factual
/ statistics & numerical data
Female
Gastrointestinal Agents
/ therapeutic use
Humans
Incidence
Inflammatory Bowel Diseases
/ drug therapy
Longitudinal Studies
Male
Middle Aged
Neoplasms
/ chemically induced
Product Surveillance, Postmarketing
Young Adult
Journal
Alimentary pharmacology & therapeutics
ISSN: 1365-2036
Titre abrégé: Aliment Pharmacol Ther
Pays: England
ID NLM: 8707234
Informations de publication
Date de publication:
01 2020
01 2020
Historique:
received:
02
08
2019
revised:
01
09
2019
accepted:
23
09
2019
pubmed:
21
11
2019
medline:
20
8
2020
entrez:
21
11
2019
Statut:
ppublish
Résumé
Vedolizumab is a gut-selective antibody to α To analyse the incidence of malignancy with vedolizumab treatment in the GEMINI long-term safety (LTS) study and post-marketing (PM) setting. 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 1 year 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. Among 1785 patients with ≥1 year 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 observed to 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 1 year following vedolizumab initiation), in approximately 208 050 patient-years of vedolizumab exposure. Lower gastrointestinal malignancies were most common (59). 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.
Sections du résumé
BACKGROUND
Vedolizumab is a gut-selective antibody to α
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 1 year 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 ≥1 year 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 observed to 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 1 year following vedolizumab initiation), in approximately 208 050 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.
Identifiants
pubmed: 31747086
doi: 10.1111/apt.15538
pmc: PMC7050439
mid: NIHMS1557657
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Gastrointestinal Agents
0
vedolizumab
9RV78Q2002
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
149-157Subventions
Organisme : NIDDK NIH HHS
ID : K23 DK111995
Pays : United States
Organisme : Takeda Pharmaceutical Company Ltd
Pays : International
Organisme : National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC)
Pays : International
Informations de copyright
© 2019 John Wiley & Sons Ltd.
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