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Vedolizumab Therapy is Ineffective for Primary Sclerosing Cholangitis in Patients With Inflammatory Bowel Disease: A GETAID Multicentre Cohort Study
- Source :
- Journal of Crohn's and Colitis, Journal of Crohn's and Colitis, Elsevier-Oxford University Press, 2019, 13 (10), pp.1239-1247. ⟨10.1093/ecco-jcc/jjz088⟩, Journal of Crohn's and Colitis, 2019, 13 (10), pp.1239-1247. ⟨10.1093/ecco-jcc/jjz088⟩
- Publication Year :
- 2019
- Publisher :
- Oxford University Press (OUP), 2019.
-
Abstract
- Background Whether vedolizumab may be effective as a treatment for primary sclerosing cholangitis [PSC] in patients with inflammatory bowel disease [IBD] remains controversial. Methods We performed a retrospective observational study of consecutive patients with IBD and PSC, treated with vedolizumab for at least 30 weeks in 22 centres of GETAID from January 2015 to June 2016. The outcomes included a decrease in the serum alkaline phosphatase [ALP] concentration of at least 50% from baseline to Week 30 or 54, a change in any serum liver enzymes concentrations, and an assessment of the efficacy and safety of vedolizumab in IBD. Results Among 75 patients with active IBD and PSC treated with vedolizumab, 21 patients discontinued vedolizumab before Week 30 [due to lack of efficacy in 19 and malignancy in two patients]. In the remaining 54 patients, a decrease in the serum ALP concentration of at least 50% from baseline to Weeks 30 and 54 was observed in four [7%] and four [11%] patients, respectively. No significant change was observed in serum liver enzyme concentrations at week 30 or 54. After a median follow-up period of 19.4 [14.0–29.9] months, nine cases of digestive neoplasia [colorectal neoplasia in seven and cholangiocarcinoma in two] were reported. Conclusions In patients with IBD and PSC, vedolizumab did not improve serum liver enzyme concentrations at week 30 or 54. Nine cases of digestive cancer occurred during the follow-up period, confirming the need for a tight surveillance programme in this population.
- Subjects :
- Adult
Male
Crohn’s disease
vedolizumab
medicine.medical_specialty
Adolescent
Cholangitis, Sclerosing
Population
Antibodies, Monoclonal, Humanized
Malignancy
Gastroenterology
Inflammatory bowel disease
Primary sclerosing cholangitis
Vedolizumab
Young Adult
03 medical and health sciences
0302 clinical medicine
Gastrointestinal Agents
inflammatory bowel disease
Internal medicine
medicine
Humans
education
ComputingMilieux_MISCELLANEOUS
Retrospective Studies
ulcerative colitis
education.field_of_study
Crohn's disease
business.industry
primary sclerosing cholangitis
[SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology
Retrospective cohort study
General Medicine
Inflammatory Bowel Diseases
medicine.disease
Ulcerative colitis
[SDV.MHEP.HEG] Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology
3. Good health
Treatment Outcome
030220 oncology & carcinogenesis
Female
030211 gastroenterology & hepatology
business
medicine.drug
Subjects
Details
- ISSN :
- 18764479 and 18739946
- Volume :
- 13
- Database :
- OpenAIRE
- Journal :
- Journal of Crohn's and Colitis
- Accession number :
- edsair.doi.dedup.....8bb8f28d932c2f4fd626f2ef7b2c574e
- Full Text :
- https://doi.org/10.1093/ecco-jcc/jjz088