ArticleAlimentary pharmacology & therapeutics2020
Vedolizumab use is not associated with increased malignancy incidence: GEMINI LTS study results and post-marketing data.
Article in Alimentary pharmacology & therapeutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.
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Who cites it
26 citing papers in PubMed.
- SMARCA4-Deficient Undifferentiated Tumor of the Right Colon in a Patient With Ulcerative Colitis.Cureus · 2026Article
- Cytotoxic T-Lymphocyte-Associated Protein 4 Deficiency Colitis Masked by Recurrent Cytomegalovirus Colitis Successfully Treated With Vedolizumab.ACG case reports journal · 2026Article
- Risk of extraintestinal cancer in patients with inflammatory bowel disease: a multicenter retrospective cohort study in Japan.Journal of gastroenterology · 2026Article
- Positioning and sequencing of advanced therapies in inflammatory bowel disease: A guide for clinical practice.World journal of gastroenterology · 2025Review
- A Guide to the Patient-Centric Use of Vedolizumab for Crohn's Disease.Inflammatory bowel diseases · 2025Review
- Real-World Safety of Vedolizumab in Inflammatory Bowel Disease: A Retrospective Cohort Study Supported by FAERS Signal Analysis.Pharmaceuticals (Basel, Switzerland) · 2025Article
- B-cell Acute Lymphoblastic Leukemia in a Patient With Crohn's Disease After Anti-TNF-Alpha Treatment.Cureus · 2025Article
- Dynamic Presentations of Recurrent Post-Transplant Lymphoproliferative Disorder in a Heart Transplant Recipient: A Rare Case Study.ACG case reports journal · 2024Article
- Inflammatory Bowel Disease and Colorectal Cancer.Cancers · 2024Review
- Choosing Therapy for Moderate to Severe Crohn's Disease.Journal of the Canadian Association of Gastroenterology · 2024Article
- Choosing Therapies in Ulcerative Colitis.Journal of the Canadian Association of Gastroenterology · 2024Article
- Real-World Evidence of Effectiveness and Safety of Vedolizumab for Inflammatory Bowel Disease in Taiwan: A Prospective Nationwide Registry (VIOLET) Study.Inflammatory bowel diseases · 2023Article
- The 2023 Impact of Inflammatory Bowel Disease in Canada: Special Populations-IBD in Seniors.Journal of the Canadian Association of Gastroenterology · 2023Review
- Crohn's disease and breast cancer: a literature review of the mechanisms and treatment.Internal and emergency medicine · 2023Review
- Review
- Concurrent immune checkpoint inhibition and selective immunosuppressive therapy in patients with immune-related enterocolitis.Journal for immunotherapy of cancer · 2023Article
- The Optimal Management of Inflammatory Bowel Disease in Patients with Cancer.Journal of clinical medicine · 2023Review
- Risk of Cancer in Patients with Inflammatory Bowel Diseases and Keys for Patient Management.Cancers · 2023Review
- Therapeutic Management of Adults with Inflammatory Bowel Disease and Malignancies: A Clinical Challenge.Cancers · 2023Review
- Personalize, participate, predict, and prevent: 4Ps in inflammatory bowel disease.Frontiers in medicine · 2023Review
Corrections and comments
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Authors and funding
6 authors.
Funding
Abstract
backgroundVedolizumab is a gut-selective antibody to α
aimTo analyse the incidence of malignancy with vedolizumab treatment in the GEMINI long-term safety (LTS) study and post-marketing (PM) setting.
methodsMalignancy 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.
resultsAmong 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).
conclusionsThe 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.
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