Marco Vincenzo Lenti1, Scott Levison2, Elena Eliadou2, Robert Willert2, Karen Kemp2, Anna Carter2, Catherine Stansfield3, Arash Assadsangabi3, Salil Singh4, Ben Crooks4, Suzanne Tattersall4, Francesca Fairhurst4, Catherine Kenneth5, Sreedhar Subramanian6, Chris Probert6, Daniel Storey6, Belle Gregg6, Paul Smith7, Eleanor Liu7, Jimmy K Limdi8, Alex Johnston9, Peter John Hamlin9, Christian P Selinger10. 1. Department of Gastroenterology, Leeds Teaching Hospitals, Leeds, UK; First Department of Internal Medicine, San Matteo Hospital Foundation, University of Pavia, Pavia, Italy. 2. Department of Gastroenterology, Manchester Royal Infirmary, Central Manchester University Hospitals, Manchester, United Kingdom. 3. Department of Gastroenterology, Salford Royal Hospitals, Salford, United Kingdom. 4. Department of Gastroenterology, Bolton NHS Trust, Bolton, United Kingdom. 5. Department of Gastroenterology, Bradford Teaching Hospital, Bradford, United Kingdom. 6. Gastroenterology & Liver Services, The Royal Liverpool and Broadgreen University Hospitals, Liverpool, United Kingdom. 7. Department of Gastroenterology, Wrightington, Wigan and Leigh NHS Trust, Wigan, United Kingdom. 8. Department of Gastroenterology, The Pennine Acute Hospitals NHS Trust, Manchester, United Kingdom. 9. Department of Gastroenterology, Leeds Teaching Hospitals, Leeds, UK. 10. Department of Gastroenterology, Leeds Teaching Hospitals, Leeds, UK. Electronic address: Christian.selinger@web.de.
Abstract
BACKGROUND: Real-life data on vedolizumab effectiveness in inflammatory bowel disease (IBD) are still emerging. Data on the comparative safety of the gut selective profile are of particular interest. AIMS: To assess clinical outcome and safety in IBD patients treated with vedolizumab. METHODS: We retrospectively collected data of patients treated with vedolizumab at eight UK hospitals (August 2014-January 2018). Clinical response and remission at 14 and 52 weeks evaluated through Physician Global Assessment (PGA) and adverse events were recorded. Possible predictors of clinical response were examined. RESULTS: Two hundred and three IBD patients (mean treatment 16 ± 8 months) were included. Of these, 135 patients (mean age 40.6 ± 16.0 years; F:M 1.9:1) had CD and 68 (mean age 44.5 ± 18.1 years; F:M 1:1.2) had UC. According to PGA, 106/135 (78.5%) CD and 62/68 (91.2%) UC patients (p = 0.02) had a clinical response/remission at 14 weeks, whereas 76/119 (63.9%) CD and 52/63 (82.5%) UC patients (p < 0.01) showed a sustained response or remission at 52 weeks, with a high adherence rate (97%). No predictors of clinical response were found. The cumulative incidence of infectious diseases was 11.9 per 100 person-years. CONCLUSION: Vedolizumab is an effective therapy for inducing and maintaining remission of IBD, with better results for UC, and with a good safety profile.
BACKGROUND: Real-life data on vedolizumab effectiveness in inflammatory bowel disease (IBD) are still emerging. Data on the comparative safety of the gut selective profile are of particular interest. AIMS: To assess clinical outcome and safety in IBDpatients treated with vedolizumab. METHODS: We retrospectively collected data of patients treated with vedolizumab at eight UK hospitals (August 2014-January 2018). Clinical response and remission at 14 and 52 weeks evaluated through Physician Global Assessment (PGA) and adverse events were recorded. Possible predictors of clinical response were examined. RESULTS: Two hundred and three IBDpatients (mean treatment 16 ± 8 months) were included. Of these, 135 patients (mean age 40.6 ± 16.0 years; F:M 1.9:1) had CD and 68 (mean age 44.5 ± 18.1 years; F:M 1:1.2) had UC. According to PGA, 106/135 (78.5%) CD and 62/68 (91.2%) UC patients (p = 0.02) had a clinical response/remission at 14 weeks, whereas 76/119 (63.9%) CD and 52/63 (82.5%) UC patients (p < 0.01) showed a sustained response or remission at 52 weeks, with a high adherence rate (97%). No predictors of clinical response were found. The cumulative incidence of infectious diseases was 11.9 per 100 person-years. CONCLUSION:Vedolizumab is an effective therapy for inducing and maintaining remission of IBD, with better results for UC, and with a good safety profile.
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