U.S. flag

An official website of the United States government

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.

Clinical and Economic Review Report: Vedolizumab (ENTYVIO SC): Takeda Canada Inc. Indication: Crohn disease [Internet] Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2021 Apr.

Cover of Clinical and Economic Review Report: Vedolizumab (ENTYVIO SC)

Clinical and Economic Review Report: Vedolizumab (ENTYVIO SC): Takeda Canada Inc. Indication: Crohn disease [Internet]

Show details

References (from CADTH)

1.
The impact of inflammatory bowel disease in Canada: 2012 final report and recommendations Toronto (ON): Crohn’s and Colitis Foundation of Canada; 2012: http://www​.crohnsandcolitis​.ca/Crohns_and_Colitis​/documents/reports​/ccfc-ibd-impact-report-2012.pdf. Accessed 2020 Nov 30.
2.
2018 impact of inflammatory bowel disease in Canada. Toronto (ON): Crohn’s and Colitis Foundation of Canada; 2018: https:​//crohnsandcolitis​.ca/Crohns_and_Colitis​/documents/reports​/2018-Impact-Report-LR.pdf?ext=.pdf. Accessed 2020 Nov 30.
3.
Lichtenstein GR, Loftus EV, Isaacs KL, Regueiro MD, Gerson LB, Sands BE. ACG clinical guideline: management of Crohn’s disease in adults. Am J Gastroenterol. 2018;113(4):481–517. [PubMed: 29610508]
4.
Benchimol EI, Bernstein CN, Bitton A, et al. The impact of inflammatory bowel disease in Canada 2018: a scientific report from the Canadian Gastro-Intestinal Epidemiology Consortium to Crohn’s and Colitis Canada. J Can Assoc Gastroenterol. 2019; 2(Suppl 1):S1–S5. [PMC free article: PMC6512240] [PubMed: 31294380]
5.
Coward S, Clement F, Benchimol EI, et al. A29 The rising prevalence of inflammatory bowel disease in Canada: analyzing the past to predict the future. J Can Assoc Gastroenterol. 2018;1(Supl 1):47–48.
6.
Entyvio (vedolizumab): 108 mg / 0.68 mL solution for subcutaneous injection in a pre-filled syringe or pen [product monograph]. Toronto (ON): Takeda Canada Inc.; 2020 Nov 19.
7.
Clinical study report: MLN0002SC-3031. A phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of vedolizumab subcutaneous as maintenance therapy in subjects with moderately to severely active Crohn’s Disease who achieved clinical response following open-label vedolizumab intravenous therapy [CONFIDENTIAL internal sponsor’s report]. Deerfield (IL): Takeda Developkent Center Americas, Inc.; 2019 Oct 6.
8.
Network meta-analysis of evidence for vedolizumab and competing interventions for the treatment of Crohn’s disease: study report. In: CDR submission: Entyvio (vedolizumab), 108 mg, subcutaneous injection [CONFIDENTIAL sponsor’s submission]. Toronto (ON): Takeda Canada Inc; 2020 Jul 22.
9.
Interim clinical study report: MLN0002SC-3030. A phase 3b open-label study to determine the long-term safety and efficacy of vedolizumab subcutaneous in subjects with ulcerative colitis and Crohn’s disease [CONFIDENTIAL internal sponsor’s report]. Deerfield (IL): Takeda Development Center Americas, Inc.; ▬▬▬▬▬.
10.
Peyrin-Biroulet L, Panés J, Sandborn WJ, et al. Defining disease severity in inflammatory bowel diseases: current and future directions. Clin Gastroenterol Hepatol. 2016;14(3):348–354.e317. [PubMed: 26071941]
11.
Hashash J, Regueiro M. Overview of medical management of high-risk, adult patients with moderate to severe Crohn disease. In: Lamont JT, ed. UpToDate. Waltham (MA): UpToDate; 2020: www​.uptodate.com. Accessed 2020 Oct 27.
12.
Remicade (infliximab): powder for solution, sterile, lyophilized, 100 mg/vial [product monograph]. Toronto (ON): Janssen Inc; 2017 Aug 4: https:​//crohnsandcolitis​.ca/Crohns_and_Colitis​/images/living-with-crohns-colitis/REMICADE-MONOGRAPH​.PDF. Accessed 2020 Nov 27.
13.
Inflectra (infliximab for injection): powder for solution, sterile, lyophilized, 100 mg/vial [product monograph]. Kirkland (QC): Pfizer Canada Inc; 2018: https://www​.pfizer.ca​/sites/default/files​/201809/INFLECTRA_PM​_E_218146_24Aug2018.pdf. Accessed 2020 Nov 30.
14.
Humira (adalimumab): 40 mg in 0.8 mL sterile solution (50 mg/mL) subcutaneous injection, 10 mg in 0.1 mL sterile solution (100 mg/mL) subcutaneous injection, 20 mg in 0.2 mL sterile solution (100 mg/mL) subcutaneous injection, 40 mg in 0.4 mL sterile solution (100 mg/mL) subcutaneous injection, 80 mg in 0.8 mL sterile solution (100 mg/mL) subcutaneous injection [product monograph]. St-Laurent (QC): AbbVie Corporation; 2019 Jun 25: https://pdf​.hres.ca/dpd_pm/00052133.PDF. Accessed 2020 Nov 27.
15.
Stelara (ustekinumab): 45 mg/0.5 mL, 90 mg/1.0 mL solution for subcutaneous injection, 130 mg/26 mL (5 mg/mL) solution for intravenous infusion[product monograph]. Toronto (ON): Janssen Inc; 2017 Aug 18: https:​//crohnsandcolitis​.ca/Crohns_and_Colitis​/images/living-with-crohns-colitis/STELARA_MONOGRAPH​.PDF. Accessed 2020 Nov 27.
16.
CDR submission: Entyvio (vedolizumab), 108 mg, subcutaneous injection [CONFIDENTIAL sponsor’s submission]. Toronto (ON): Takeda Canada Inc.; 2020 Jul 22.
17.
Common drug review pharmacoeconomic review report. Entyvio (vedolizumab). Ottawa (ON): CADTH; 2016: https://cadth​.ca/sites​/default/files/cdr​/pharmacoeconomic/SR0487​_Entyvio_PE_Report.pdf. Accessed 2020 Nov 30.
18.
Ontario Ministry of Health Long-Term Care. Ontario drug benefit formulary/comparative drug index. 2019; https://www​.formulary​.health.gov.on.ca/formulary/. Accessed 2020 Oct 1.
19.
Renflexis (infliximab): for injection, powder for solution, sterile, lyophilized, 100 mg /vial [product monograph]. Kirkland (QC): Merck Canada Inc; 2020 Feb 25: https://pdf​.hres.ca/dpd_pm/00055165.PDF. Accessed 2020 Nov 27.
20.
Government of Saskatchewan. Saskatchewan Drug Plan Formulary Search. 2020; http://formulary​.drugplan​.ehealthsask.ca/SearchFormulary. Accessed 2020 Oct 1.
21.
CADTH Canadian Drug Expert Committee (CDEC) final recommendation: ustekinumab (Stelara — Janssen Inc.). Otttawa (ON): CADTH; 2017 Mar 21: https://cadth​.ca/sites​/default/files/cdr​/complete/SR0501_complete​_Stelara_Mar-23-17.pdf. Accessed 2020 Nov 30.
22.
pan-Canadian Pharmaceutical Alliance. Stelara (ustekinumab). 2019; https://www​.pcpacanada​.ca/negotiation/20970. Accessed 2020 Nov 30.
23.
CADTH Canadian Drug Expert Committee (CDEC) final recommendation: vedolizumab (Entyvio — Takeda Canada Inc.). Ottawa (ON): CADTH; 2016 Oct 27: https://cadth​.ca/sites​/default/files/cdr​/complete/SR0487_complete​_Entyvio-Oct-31-16.pdf. Accessed 2020 Nov 30.
24.
Best WR, Becktel JM, Singleton JW, Kern F, Jr. Development of a Crohn’s disease activity index. National Cooperative Crohn’s Disease Study. Gastroenterology. 1976;70(3):439–444. [PubMed: 1248701]
25.
Yoshida EM. The Crohn’s Disease Activity Index, its derivatives and the Inflammatory Bowel Disease Questionnaire: a review of instruments to assess Crohn’s disease. Can J Gastroenterol. 1999;13(1):65–73. [PubMed: 10099817]
26.
Sandborn WJ, Feagan BG, Hanauer SB, et al. A review of activity indices and efficacy endpoints for clinical trials of medical therapy in adults with Crohn’s disease. Gastroenterology. 2002;122(2):512–530. [PubMed: 11832465]
27.
Bryant RV, Sandborn WJ, Travis SP. Introducing vedolizumab to clinical practice: who, when, and how? J Crohns Colitis. 2015;9(4):356–366. [PubMed: 25687206]
28.
Mahadevan U. Clinical trial design and endpoints in biologic therapy for Crohn’s disease: interpretation of the results. Medscape. New York (NY): WebMD: www​.medscape.com. Accessed 2020 Oct 13.
29.
Best WR. Rederived values of the eight coefficients of the Crohn’s Disease Activity Index (CDAI) Gastroenterology. 1979. [PubMed: 467941]
30.
de Dombal FT, Softley A. IOIBD report no 1: observer variation in calculating indices of severity and activity in Crohn’s disease. International Organisation for the Study of Inflammatory Bowel Disease. Gut. 1987;28(4):474–481. [PMC free article: PMC1432811] [PubMed: 3583074]
31.
Guyatt G, Mitchell A, Irvine EJ, et al. A new measure of health status for clinical trials in inflammatory bowel disease. Gastroenterology. 1989;96(3):804–810. [PubMed: 2644154]
32.
Irvine EJ. Development and subsequent refinement of the inflammatory bowel disease questionnaire: a quality-of-life instrument for adult patients with inflammatory bowel disease. J Pediatr Gastroenterol Nutr. 1999;28(4):S23–27. [PubMed: 10204520]
33.
Pallis AG, Mouzas IA, Vlachonikolis IG. The inflammatory bowel disease questionnaire: a review of its national validation studies. Inflamm Bowel Dis. 2004;10(3):261–269. [PubMed: 15290922]
34.
Gregor JC. An evaluation of utility measurement in Crohn’s disease. Inflamm Vowel Dis. 1997;3(4):265–276. [PubMed: 23282873]
35.
EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990;16(3):199–208. [PubMed: 10109801]
36.
Brooks R. EuroQol: the current state of play. Health Policy. 1996;37(1):53–72. [PubMed: 10158943]
37.
Sinnott PL, Joyce VR, Barnett PG. Guidebook: preference measurement in economic analysis. Menlo Park (CA): Health Economics Research Center; 2007: https://www​.herc.research​.va.gov/files/BOOK_419.pdf. Accessed 2020 Oct 13.
38.
Stark RG, Reitmeir P, Leidl R, König HH. Validity, reliability, and responsiveness of the EQ-5D in inflammatory bowel disease in Germany. Inflamm Bowel Dis. 2010;16(1):42–51. [PubMed: 19475674]
39.
Coteur G, Feagan B, Keininger DL, Kosinski M. Evaluation of the meaningfulness of health-related quality of life improvements as assessed by the SF-36 and the EQ-5D VAS in patients with active Crohn’s disease. Aliment Pharmacol Ther. 2009;29(9):1032–1041. [PubMed: 19222413]
Copyright © 2021 Canadian Agency for Drugs and Technologies in Health.

The copyright and other intellectual property rights in this document are owned by CADTH and its licensors. These rights are protected by the Canadian Copyright Act and other national and international laws and agreements. Users are permitted to make copies of this document for non-commercial purposes only, provided it is not modified when reproduced and appropriate credit is given to CADTH and its licensors.

Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/

Bookshelf ID: NBK572474

Views

Other titles in this collection

Related information

  • PMC
    PubMed Central citations
  • PubMed
    Links to PubMed

Recent Activity

Your browsing activity is empty.

Activity recording is turned off.

Turn recording back on

See more...