Skip to main content
Top
Published in: Digestive Diseases and Sciences 6/2017

01-06-2017 | Original Article

Predictors of Clinical Response and Remission at 1 Year Among a Multicenter Cohort of Patients with Inflammatory Bowel Disease Treated with Vedolizumab

Published in: Digestive Diseases and Sciences | Issue 6/2017

Login to get access

Abstract

Background

Vedolizumab (VDZ) has demonstrated long-term efficacy in Crohn’s disease (CD) and ulcerative colitis (UC) in phase III trials.

Aims

Our aim was to evaluate the efficacy of VDZ at week 54 in inflammatory bowel disease (IBD) in a multicenter cohort of patients.

Methods

Adult patients completing induction therapy with VDZ were eligible for this study. Clinical response and remission was assessed using the Harvey–Bradshaw Index (HBI) for CD, the Simple Clinical Colitis Activity Index for UC and physician assessment.

Results

Among 136 total patients (96 CD and 40 UC), 76 (56%) demonstrated clinical response or remission at week 54. In univariate analysis, for patients with CD concomitant initiation of immunomodulator therapy (2.71, 95% CI 1.11–6.57), the addition of an immunomodulator (OR 11.49, 3.16–41.75) and CRP < 3 (4.92, 95% CI 1.99–12.15) was associated with increased odds of clinical response or remission at week 54. For UC patients, hospitalization after VDZ induction was associated with decreased odds of response or remission at week 54 (OR 0.22, 95% CI 0.05–0.88). On multivariate analysis in CD, addition of an immunomodulator (OR 8.33, 95% CI 2.15–32.26) remained significant predictors of clinical response or remission at week 54.

Conclusions

Among a multicenter cohort of patients with IBD demonstrating primary response to VDZ, the addition of combination therapy with an immunomodulator is a significant predictor of clinical response or remission at week 54 in patients with CD.
Literature
1.
go back to reference Allez M, Karmiris K, Louis E, et al. Report of the ECCO pathogenesis workshop on anti-TNF therapy failures in inflammatory bowel diseases: definitions, frequency and pharmacological aspects. J Crohn’s Colitis. 2010;4:355–366.CrossRef Allez M, Karmiris K, Louis E, et al. Report of the ECCO pathogenesis workshop on anti-TNF therapy failures in inflammatory bowel diseases: definitions, frequency and pharmacological aspects. J Crohn’s Colitis. 2010;4:355–366.CrossRef
2.
go back to reference Hanauer SB, Feagan BG, Lichtenstein GR, et al. Maintenance infliximab for Crohn’s disease: the ACCENT I randomised trial. Lancet. 2002;359:1541–1549.CrossRefPubMed Hanauer SB, Feagan BG, Lichtenstein GR, et al. Maintenance infliximab for Crohn’s disease: the ACCENT I randomised trial. Lancet. 2002;359:1541–1549.CrossRefPubMed
3.
go back to reference Rutgeerts P, Sandborn WJ, Feagan BG, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005;353:2462–2476.CrossRefPubMed Rutgeerts P, Sandborn WJ, Feagan BG, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005;353:2462–2476.CrossRefPubMed
4.
go back to reference Colombel JF, Sandborn WJ, Rutgeerts P, et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn’s disease: the CHARM trial. Gastroenterology. 2007;132:52–65.CrossRefPubMed Colombel JF, Sandborn WJ, Rutgeerts P, et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn’s disease: the CHARM trial. Gastroenterology. 2007;132:52–65.CrossRefPubMed
5.
go back to reference Sandborn WJ, Van Assche G, Reinisch W, et al. Adalimumab induces and maintains clinical remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2012;142:257.e3–265.e3.CrossRef Sandborn WJ, Van Assche G, Reinisch W, et al. Adalimumab induces and maintains clinical remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2012;142:257.e3–265.e3.CrossRef
6.
go back to reference Sandborn WJ, Rutgeerts P, Enns R, et al. Adalimumab induction therapy for Crohn disease previously treated with infliximab. Ann Intern Med. 2007;146:829.CrossRefPubMed Sandborn WJ, Rutgeerts P, Enns R, et al. Adalimumab induction therapy for Crohn disease previously treated with infliximab. Ann Intern Med. 2007;146:829.CrossRefPubMed
7.
go back to reference Soler D, Chapman T, Yang L-L, Wyant T, Egan R, Fedyk ER. 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.CrossRefPubMed Soler D, Chapman T, Yang L-L, Wyant T, Egan R, Fedyk ER. 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.CrossRefPubMed
8.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
9.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
11.
go back to reference Harvey RF, Bradshaw JM. A simple index of Crohn’s-disease activity. Lancet. 1980;315:514.CrossRef Harvey RF, Bradshaw JM. A simple index of Crohn’s-disease activity. Lancet. 1980;315:514.CrossRef
13.
go back to reference Shelton E, Allegretti JR, Stevens B, et al. Efficacy of vedolizumab as induction therapy in refractory IBD patients: a multicenter cohort. Inflamm Bowel Dis. 2015;21:2879–2885.CrossRefPubMedPubMedCentral Shelton E, Allegretti JR, Stevens B, et al. Efficacy of vedolizumab as induction therapy in refractory IBD patients: a multicenter cohort. Inflamm Bowel Dis. 2015;21:2879–2885.CrossRefPubMedPubMedCentral
14.
go back to reference Colombel J-F, Loftus EV, Siegel CA, et al. P528. Efficacy of vedolizumab with concomitant corticosteroid or immunomodulator use in patients with Crohn’s disease in GEMINI 2. J Crohn’s Colitis. 2015;9:S344.CrossRef Colombel J-F, Loftus EV, Siegel CA, et al. P528. Efficacy of vedolizumab with concomitant corticosteroid or immunomodulator use in patients with Crohn’s disease in GEMINI 2. J Crohn’s Colitis. 2015;9:S344.CrossRef
15.
go back to reference Colombel J-F, Loftus EV, Siegel CA, et al. P433. Efficacy of vedolizumab with concomitant corticosteroid or immunomodulator use in patients with ulcerative colitis from GEMINI 1. J Crohn’s Colitis. 2015;9:S296–S297. Colombel J-F, Loftus EV, Siegel CA, et al. P433. Efficacy of vedolizumab with concomitant corticosteroid or immunomodulator use in patients with ulcerative colitis from GEMINI 1. J Crohn’s Colitis. 2015;9:S296–S297.
16.
go back to reference 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.CrossRefPubMedPubMedCentral 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.CrossRefPubMedPubMedCentral
17.
go back to reference Dulai PS, Singh S, Jiang X, et al. The real-world effectiveness and safety of vedolizumab for moderate–severe Crohn’s disease: results from the US VICTORY consortium. Am J Gastroenterol. 2016;111:1147–1155.CrossRefPubMed Dulai PS, Singh S, Jiang X, et al. The real-world effectiveness and safety of vedolizumab for moderate–severe Crohn’s disease: results from the US VICTORY consortium. Am J Gastroenterol. 2016;111:1147–1155.CrossRefPubMed
18.
go back to reference 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. 2015;13:1118.e3–1124.e3.CrossRef 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. 2015;13:1118.e3–1124.e3.CrossRef
19.
go back to reference 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 had failed. Gastroenterology. 2014;147:618.e3–627.e3.CrossRef 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 had failed. Gastroenterology. 2014;147:618.e3–627.e3.CrossRef
20.
go back to reference Ha C, Ullman TA, Siegel CA, Kornbluth A. Patients enrolled in randomized controlled trials do not represent the inflammatory bowel disease patient population. Clin Gastroenterol Hepatol. 2012;10:1002–1007. (quiz e78).CrossRefPubMed Ha C, Ullman TA, Siegel CA, Kornbluth A. Patients enrolled in randomized controlled trials do not represent the inflammatory bowel disease patient population. Clin Gastroenterol Hepatol. 2012;10:1002–1007. (quiz e78).CrossRefPubMed
21.
go back to reference Hazlewood GS, Rezaie A, Borman M, et al. Comparative effectiveness of immunosuppressants and biologics for inducing and maintaining remission in Crohn’s disease: a network meta-analysis. Gastroenterology. 2015;148:344–354.CrossRefPubMed Hazlewood GS, Rezaie A, Borman M, et al. Comparative effectiveness of immunosuppressants and biologics for inducing and maintaining remission in Crohn’s disease: a network meta-analysis. Gastroenterology. 2015;148:344–354.CrossRefPubMed
22.
go back to reference McLean LP, Cross RK. Integrin antagonists as potential therapeutic options for the treatment of Crohn’s disease. Expert Opin Investig Drugs. 2016;25:263–273.CrossRefPubMedPubMedCentral McLean LP, Cross RK. Integrin antagonists as potential therapeutic options for the treatment of Crohn’s disease. Expert Opin Investig Drugs. 2016;25:263–273.CrossRefPubMedPubMedCentral
23.
go back to reference Dulai PS, Mosli M, Khanna R, Levesque BG, Sandborn WJ, Feagan BG. Vedolizumab for the treatment of moderately to severely active ulcerative colitis. Pharmacotherapy. 2015;35:412–423.CrossRefPubMed Dulai PS, Mosli M, Khanna R, Levesque BG, Sandborn WJ, Feagan BG. Vedolizumab for the treatment of moderately to severely active ulcerative colitis. Pharmacotherapy. 2015;35:412–423.CrossRefPubMed
24.
go back to reference Hanauer SB. Positioning biologic agents in the treatment of Crohn’s disease. Inflamm Bowel Dis. 2009;15:1570–1582.CrossRefPubMed Hanauer SB. Positioning biologic agents in the treatment of Crohn’s disease. Inflamm Bowel Dis. 2009;15:1570–1582.CrossRefPubMed
Metadata
Title
Predictors of Clinical Response and Remission at 1 Year Among a Multicenter Cohort of Patients with Inflammatory Bowel Disease Treated with Vedolizumab
Publication date
01-06-2017
Published in
Digestive Diseases and Sciences / Issue 6/2017
Print ISSN: 0163-2116
Electronic ISSN: 1573-2568
DOI
https://doi.org/10.1007/s10620-017-4549-3

Other articles of this Issue 6/2017

Digestive Diseases and Sciences 6/2017 Go to the issue