Clinical profiles and outcomes in patients with ulcerative colitis receiving standard and higher-than-standard doses of vedolizumab: findings from a real-world study in Europe

References

• Ford AC, Moayyedi P, Hanauer SB. Ulcerative colitis. BMJ. 2013;346:f432. doi: 10.1136/bmj.f432.
   PubMedGoogle Scholar
• Ng SC, Shi HY, Hamidi N, et al. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. Lancet. 2017;390(10114):2769–2778. doi: 10.1016/S0140-6736(17)32448-0.
   PubMed Web of Science ®Google Scholar
• Ordas I, Eckmann L, Talamini M, et al. Ulcerative colitis. Lancet. 2012;380(9853):1606–1619. doi: 10.1016/S0140-6736(12)60150-0.
   PubMed Web of Science ®Google Scholar
• Raine T, Bonovas S, Burisch J, et al. ECCO guidelines on therapeutics in ulcerative colitis: medical treatment. J Crohns Colitis. 2022;16(1):2–17. doi: 10.1093/ecco-jcc/jjab178.
   PubMed Web of Science ®Google Scholar
• Spinelli A, Bonovas S, Burisch J, et al. ECCO guidelines on therapeutics in ulcerative colitis: surgical treatment. J Crohns Colitis. 2022;16(2):179–189. doi: 10.1093/ecco-jcc/jjab177.
   PubMed Web of Science ®Google Scholar
• Roda G, Jharap B, Neeraj N, et al. Loss of response to anti-TNFs: definition, epidemiology, and management. Clin Transl Gastroenterol. 2016;7(1):e135. doi: 10.1038/ctg.2015.63.
   PubMed Web of Science ®Google Scholar
• Wyant T, Fedyk E, Abhyankar B. An overview of the mechanism of action of the monoclonal antibody vedolizumab. J Crohns Colitis. 2016;10(12):1437–1444. doi: 10.1093/ecco-jcc/jjw092.
   PubMed Web of Science ®Google Scholar
• Poole RM. Vedolizumab: first global approval. Drugs. 2014;74(11):1293–1303. doi: 10.1007/s40265-014-0253-1.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. EMA recommends approval of a locally targeted treatment for ulcerative colitis and Crohn’s disease. [Press release]. 2014 [cited 2014 March 21]. Available from: https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-approval-locally-targeted-treatment-ulcerative-colitis-crohns_en.pdf.
   Google Scholar
• Harbord M, Eliakim R, Bettenworth D, et al. Third European evidence-based consensus on diagnosis and management of ulcerative colitis. Part 2: current management. J Crohns Colitis. 2017;11(7):769–784. doi: 10.1093/ecco-jcc/jjx009.
   PubMed Web of Science ®Google Scholar
• Dassopoulos T, Cohen RD, Scherl EJ, et al. Ulcerative colitis care pathway. Gastroenterology. 2015;149(1):238–245. doi: 10.1053/j.gastro.2015.05.036.
   PubMed Web of Science ®Google Scholar
• Macaluso FS, Ventimiglia M, Orlando A. Effectiveness and safety of vedolizumab in inflammatory bowel disease: a comprehensive meta-analysis of observational studies. J Crohns Colitis. 2023;17(8):1217–1227. doi: 10.1093/ecco-jcc/jjad043.
   PubMedGoogle Scholar
• Gemayel NC, Rizzello E, Atanasov P, et al. Dose escalation and switching of biologics in ulcerative colitis: a systematic literature review in real-world evidence. Curr Med Res Opin. 2019;35(11):1911–1923. doi: 10.1080/03007995.2019.1631058.
   PubMed Web of Science ®Google Scholar
• Long MD, Cohen RD, Smith TW, et al. Retrospective database analysis: dose escalation and adherence in patients initiating biologics for ulcerative colitis. Dig Dis. 2022;40(5):553–564. doi: 10.1159/000521299.
   PubMedGoogle Scholar
• Guberna L, Nyssen OP, Chaparro M, et al. Frequency and effectiveness of empirical anti-TNF dose intensification in inflammatory bowel disease: systematic review with meta-analysis. J Clin Med. 2021;10(10):2132.
   PubMed Web of Science ®Google Scholar
• Chaparro M, Garre A, Ricart E, et al. Short and long-term effectiveness and safety of vedolizumab in inflammatory bowel disease: results from the ENEIDA registry. Aliment Pharmacol Ther. 2018;48(8):839–851. doi: 10.1111/apt.14930.
   PubMed Web of Science ®Google Scholar
• Wolf D, D'Haens G, Sandborn WJ, et al. Escalation to weekly dosing recaptures response in adalimumab-treated patients with moderately to severely active ulcerative colitis. Aliment Pharmacol Ther. 2014;40(5):486–497. doi: 10.1111/apt.12863.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. Entyvio: EPAR – Product Information, Annex 1 – SUMMARY OF PRODUCT CHARACTERISTICS. 2014.
   Google Scholar
• European Pharmaceutical Market Research Association (EPhMRA). Code of Conduct. 2022 [cited 2023 Jan 18]. Available from: https://www.ephmra.org/sites/default/files/2022-08/EPHMRA%202022%20Code%20of%20Conduct.pdf.
   Google Scholar
• Ladd AHM, Scott FI, Grace R, et al. Sa1086 dose escalation of vedolizumab from every 8 weeks to every 4 or 6 weeks enables patients with inflammatory bowel disease to recapture response. Gastroenterology. 2016;150(4):S235–S236. doi: 10.1016/S0016-5085(16)30859-9.
   Web of Science ®Google Scholar
• Amiot A, Grimaud JC, Peyrin-Biroulet L, et al. Effectiveness and safety of vedolizumab induction therapy for patients with inflammatory bowel disease. Clin Gastroenterol Hepatol. 2016;14(11):1593–1601 e2. doi: 10.1016/j.cgh.2016.02.016.
   PubMed Web of Science ®Google Scholar
• Amiot A, Serrero M, Peyrin-Biroulet L, et al. One-year effectiveness and safety of vedolizumab therapy for inflammatory bowel disease: a prospective multicentre cohort study. Aliment Pharmacol Ther. 2017;46(3):310–321. doi: 10.1111/apt.14167.
   PubMed Web of Science ®Google Scholar
• Vaughn BP, Yarur AJ, Graziano E, et al. Vedolizumab serum trough concentrations and response to dose escalation in inflammatory bowel disease. J Clin Med. 2020;9(10):3142. doi: 10.3390/jcm9103142.
   PubMed Web of Science ®Google Scholar
• Sands BE, Feagan BG, Rutgeerts P, et al. Effects of vedolizumab induction therapy for patients with Crohn’s disease in whom tumor necrosis factor antagonist treatment failed. Gastroenterology. 2014;147(3):618.e3–627.e3. doi: 10.1053/j.gastro.2014.05.008.
   Web of Science ®Google Scholar
• Amiot A, Serrero M, Peyrin-Biroulet L, et al. Three-year effectiveness and safety of vedolizumab therapy for inflammatory bowel disease: a prospective multi-centre cohort study. Aliment Pharmacol Ther. 2019;50(1):40–53. doi: 10.1111/apt.15294.
   PubMed Web of Science ®Google Scholar
• Bergqvist V, Holmgren J, Klintman D, et al. Real‐world data on switching from intravenous to subcutaneous vedolizumab treatment in patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2022;55(11):1389–1401. doi: 10.1111/apt.16927.
   PubMed Web of Science ®Google Scholar
• Atreya R, Redondo I, Hill J, et al. P261 burden of bowel urgency across specific treatment groups among ulcerative colitis patients – real world global study analyses. J Crohns Colitis. 2022;16(Suppl 1):i302–i303. doi: 10.1093/ecco-jcc/jjab232.388.
   Google Scholar
• Singh H, Wilson L, Tencer T, et al. Systematic literature review of real-world evidence on dose escalation and treatment switching in ulcerative colitis. Clinicoecon Outcomes Res. 2023;15:125–138. doi: 10.2147/CEOR.S391413.
   PubMed Web of Science ®Google Scholar
• Attauabi M, Madsen GR, Bendtsen F, et al. Vedolizumab as the first line of biologic therapy for ulcerative colitis and Crohn’s disease - a systematic review with meta-analysis. Dig Liver Dis. 2022;54(9):1168–1178. doi: 10.1016/j.dld.2021.11.014.
   PubMedGoogle Scholar
• Long MD, Martin CF, Chen W, et al. Changes in patient-reported outcomes with vedolizumab therapy in patients with inflammatory bowel diseases (IBD): results from the IBD partners patient powered research network. Crohns Colitis 360. 2019;1(2):otz020. doi: 10.1093/crocol/otz020.
   Google Scholar
• Sands BE, Peyrin-Biroulet L, Loftus EV, et al. Vedolizumab versus adalimumab for moderate-to-severe ulcerative colitis. N Engl J Med. 2019;381(13):1215–1226. doi: 10.1056/NEJMoa1905725.
   PubMed Web of Science ®Google Scholar
• Sandborn WJ, Colombel JF, Panaccione R, et al. Deep remission with vedolizumab in patients with moderately to severely active ulcerative colitis: a GEMINI 1 post hoc analysis. J Crohns Colitis. 2019;13(2):172–181. doi: 10.1093/ecco-jcc/jjy149.
   PubMed Web of Science ®Google Scholar
• Afzali A, Armuzzi A, Bouhnik Y, et al. P482 patient and physician perspectives on the management of inflammatory bowel disease: disease remission and durability of treatment. J Crohns Colitis. 2020;14(Suppl 1):S424–S424. doi: 10.1093/ecco-jcc/jjz203.611.
   Google Scholar
• Armuzzi A, Hart A, Cappelleri JC, et al. Characteristics, clinical outcomes and patient-reported outcomes of patients with ulcerative colitis receiving tofacitinib: a real-world survey in the United States and five European countries. BMC Gastroenterol. 2023;23(1):17. doi: 10.1186/s12876-023-02640-7.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. EMA recommends measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders. 2022 [cited 2023 July 06]; Available from: https://www.ema.europa.eu/en/news/ema-recommends-measures-minimise-risk-serious-side-effects-janus-kinase-inhibitors-chronic.
   Google Scholar
• Zurba Y, Gros B, Shehab M. Exploring the pipeline of novel therapies for inflammatory bowel disease; state of the art review. Biomedicines. 2023;11(3):747. doi: 10.3390/biomedicines11030747.
   PubMed Web of Science ®Google Scholar