A prospective cohort study to assess the relevance of vedolizumab drug level monitoring in IBD patients

References

• Mosli MH, Rivera-Nieves J, Feagan BG. T-cell trafficking and anti-adhesion strategies in inflammatory bowel disease: current and future prospects. Drugs. 2014;74:297–311.
   PubMed Web of Science ®Google Scholar
• Soler D, Chapman T, Yang L-L, et al. The binding specificity and selective antagonism of vedolizumab, an anti-alpha4beta7 integrin therapeutic antibody in development for inflammatory bowel diseases. J Pharmacol Exp Ther. 2009;330:864–875.
   PubMed Web of Science ®Google Scholar
• Garnock-Jones KP. Vedolizumab: a review of its use in adult patients with moderately to severely active ulcerative colitis or Crohn’s disease. BioDrugs Clin Immunother Biopharm Gene Ther. 2015;29:57–67.
   Google Scholar
• Sandborn WJ, Feagan BG, Rutgeerts P, et al. Vedolizumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med. 2013;369:711–721.
   PubMed Web of Science ®Google Scholar
• Feagan BG, Rutgeerts P, Sands BE, et al. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013;369:699–710.
   PubMed Web of Science ®Google Scholar
• Baumgart DC, Bokemeyer B, Drabik A, et al. Vedolizumab induction therapy for inflammatory bowel disease in clinical practice – a nationwide consecutive German cohort study. Aliment Pharmacol Ther. 2016;43:1090–1102.
   PubMed Web of Science ®Google Scholar
• Stallmach A, Langbein C, Atreya R, et al. Vedolizumab provides clinical benefit over 1 year in patients with active inflammatory bowel disease – a prospective multicenter observational study. Aliment Pharmacol Ther. 2016;44:1199–1212.
   PubMed Web of Science ®Google Scholar
• Cornillie F, Hanauer SB, Diamond RH, et al. Postinduction serum infliximab trough level and decrease of C-reactive protein level are associated with durable sustained response to infliximab: a retrospective analysis of the ACCENT I trial. Gut. 2014;63: 1721–1727.
   PubMed Web of Science ®Google Scholar
• Mazor Y, Almog R, Kopylov U, et al. Adalimumab drug and antibody levels as predictors of clinical and laboratory response in patients with Crohn's disease. Aliment Pharmacol Ther. 2014; 40:620–628.
   PubMed Web of Science ®Google Scholar
• Roblin X, Marotte H, Leclerc M, et al. Combination of C-reactive protein, infliximab trough levels, and stable but not transient antibodies to infliximab are associated with loss of response to infliximab in inflammatory bowel disease. J Crohns Colitis. 2015;9:525–531.
   PubMed Web of Science ®Google Scholar
• Kobayashi T, Suzuki Y, Motoya S, et al. First trough level of infliximab at week 2 predicts future outcomes of induction therapy in ulcerative colitis – results from a multicenter prospective randomized controlled trial and its post hoc analysis. J Gastroenterol. 2016;51:241–251.
   PubMed Web of Science ®Google Scholar
• Dignass A, Eliakim R, Magro F, et al. Second European evidence-based consensus on the diagnosis and management of ulcerative colitis. Part 1: definitions and diagnosis. J Crohns Colitis. 2012; 6:965–990.
   PubMed Web of Science ®Google Scholar
• Gomollón F, Dignass A, Annese V, et al. 3rd European evidence-based consensus on the diagnosis and management of Crohn’s disease 2016: Part 1: diagnosis and medical management. ECCOJC. 2017;11:3–25.
   Web of Science ®Google Scholar
• Lewis JD, Chuai S, Nessel L, et al. Use of the non-invasive components of the mayo score to assess clinical response in ulcerative colitis. Inflamm Bowel Dis. 2008;14:1660–1666.
   PubMed Web of Science ®Google Scholar
• Harvey RF, Bradshaw JM. A simple index of Crohn’s-disease activity. Lancet Lond Engl. 1980;1:514.
   PubMed Web of Science ®Google Scholar
• Yarur AJ, Kubiliun MJ, Czul F, et al. Concentrations of 6-thioguanine nucleotide correlate with trough levels of infliximab in patients with inflammatory bowel disease on combination therapy. Clin Gastroenterol Hepatol Off Clin Pract J Am Gastroenterol Assoc. 2015;13:1118–1124.e3.
   PubMed Web of Science ®Google Scholar
• Gilissen LPL, Wong DR, Engels LGJB, et al. Therapeutic drug monitoring of thiopurine metabolites in adult thiopurine tolerant IBD patients on maintenance therapy. J Crohns Colitis. 2012;6:698–707.
   PubMed Web of Science ®Google Scholar
• Levesque BG, Greenberg GR, Zou G, et al. A prospective cohort study to determine the relationship between serum infliximab concentration and efficacy in patients with luminal Crohn’s disease. Aliment Pharmacol Ther. 2014;39:1126–1135.
   PubMed Web of Science ®Google Scholar
• Cellier C, Sahmoud T, Froguel E, et al. Correlations between clinical activity, endoscopic severity, and biological parameters in colonic or ileocolonic Crohn's disease. A prospective multicentre study of 121 cases. The Groupe d'Etudes Thérapeutiques des Affections Inflammatoires Digestives. Gut. 1994;35:231–235.
   PubMed Web of Science ®Google Scholar
• Falvey JD, Hoskin T, Meijer B, et al. Disease activity assessment in IBD: clinical indices and biomarkers fail to predict endoscopic remission. Inflamm Bowel Dis. 2015;21:824–831.
   PubMed Web of Science ®Google Scholar
• Hibi T, Sakuraba A, Watanabe M, et al. C-reactive protein is an indicator of serum infliximab level in predicting loss of response in patients with Crohn's disease. J Gastroenterol. 2014;49: 254–262.
   PubMed Web of Science ®Google Scholar
• Descos L, André F, André C, et al. Assessment of appropriate laboratory measurements to reflect the degree of activity of ulcerative colitis. Digestion. 1983;28:148–152.
   PubMed Web of Science ®Google Scholar
• Kumar S, Ghoshal UC, Aggarwal R, et al. Severe ulcerative colitis: prospective study of parameters determining outcome. J Gastroenterol Hepatol. 2004;19:1247–1252.
   PubMed Web of Science ®Google Scholar
• Bergamaschi G, Di Sabatino A, Albertini R, et al. Prevalence and pathogenesis of anemia in inflammatory bowel disease. Influence of anti-tumor necrosis factor-alpha treatment. Haematologica. 2010;95:199–205.
   PubMed Web of Science ®Google Scholar
• Samuel S, Bruining DH, Loftus EV, et al. Validation of the ulcerative colitis colonoscopic index of severity and its correlation with disease activity measures. Clin Gastroenterol Hepatol Off Clin Pract J Am Gastroenterol Assoc. 2013;11:49–54*.e1.
   PubMed Web of Science ®Google Scholar
• Williet N, Boschetti G, Fovet M, et al. Association between low trough levels of vedolizumab during induction therapy for inflammatory bowel diseases and need for additional doses within 6 months. Clin Gastroenterol Hepatol Off Clin Pract J Am Gastroenterol Assoc. 2017;15:1750–1757.e3.
   PubMed Web of Science ®Google Scholar
• Ungar B, Kopylov U, Yavzori M, et al. Association of vedolizumab level, anti-drug antibodies, and α4β7 occupancy with response in patients with inflammatory bowel diseases. Clin Gastroenterol Hepatol Off Clin Pract J Am Gastroenterol Assoc. 2017. [Epub ahead of print]. doi: 10.1016/j.cgh.2017.11.050
   Google Scholar
• Rosario M, Wyant T, Leach T, et al. Vedolizumab pharmacokinetics, pharmacodynamics, safety, and tolerability following administration of a single, ascending, intravenous dose to healthy volunteers. Clin Drug Investig. 2016;36:913–923.
   PubMed Web of Science ®Google Scholar
• Rosario M, Dirks NL, Gastonguay MR, et al. Population pharmacokinetics-pharmacodynamics of vedolizumab in patients with ulcerative colitis and Crohn’s disease. Aliment Pharmacol Ther. 2015;42:188–202.
   PubMed Web of Science ®Google Scholar
• Byrareddy SN, Arthos J, Cicala C, et al. Sustained virologic control in SIV + macaques after antiretroviral and α4β7 antibody therapy. Science. 2016;354:197–202.
   PubMed Web of Science ®Google Scholar
• Schoepfer AM, Beglinger C, Straumann A, et al. Fecal calprotectin more accurately reflects endoscopic activity of ulcerative colitis than the Lichtiger Index, C-reactive protein, platelets, hemoglobin, and blood leukocytes. Inflamm Bowel Dis. 2013;19:332–341.
   PubMed Web of Science ®Google Scholar
• Halpin SJ, Ford AC. Prevalence of symptoms meeting criteria for irritable bowel syndrome in inflammatory bowel disease: systematic review and meta-analysis. Am J Gastroenterol. 2012;107: 1474–1482.
   PubMed Web of Science ®Google Scholar
• Vivinus-Nébot M, Frin-Mathy G, Bzioueche H, et al. Functional bowel symptoms in quiescent inflammatory bowel diseases: role of epithelial barrier disruption and low-grade inflammation. Gut. 2014;63:744–752.
   PubMed Web of Science ®Google Scholar