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.

Entyvio (Vedolizumab) [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2016 Dec.

Cover of Entyvio (Vedolizumab)

Entyvio (Vedolizumab) [Internet].

Show details

REFERENCES

1.
The impact of inflammatory bowel disease in Canada: 2012 final report and recommendations [Internet]. Toronto: Crohn's and Colitis Foundation of Canada; 2012. [cited 2016 May 12]. Available from: http://www​.isupportibd​.ca/pdf/ccfc-ibd-impact-report-2012​.pdf.
2.
Fast facts: the impact of IBD in Canada 2012 [Internet]. Toronto: Crohn's and Colitis Foundation of Canada; 2012. [cited 2016 May 12]. Available from: http://www​.isupportibd​.ca/pdf/ccfc.ca-impact-report-fast-facts.pdf.
3.
Crohn's disease. Bethesda (MD): National Digestive Diseases Information Clearinghouse; 2014.
4.
Takeda. ClinicalTrials​.gov [Internet]. Bethesda (MD): U.S. National Library of Medicine; Jan 29, 2016. [cited 2016 May 12; last updated 2016 May 3]. Entyvio (Vedolizumab) long term safety study (Entyvio PASS) 2000 - . Available from: https://clinicaltrials.gov/ct2/show/NCT02674308 Identifier: NCT02674308.
5.
Entyvio™ (vedolizumab) powder for concentrate for solution in infusion 300 mg/vial [product monograph]. Oakville (ON): Takeda Canada; Mar 22, 2016.
6.
Indication: ulcerative colitis [Internet]. Ottawa: CADTH; Oct 28, 2015. [cited 2016 May 12]. Canadian Drug Expert Committee final recommendation: vedolizumab (Entyvio - Takeda Canada Inc.) (Common Drug Review). Available from: https://www​.cadth.ca​/sites/default/files​/cdr/complete/SR0421​_cdr_complete_Entyvio_Nov-2-15_e.pdf.
7.
Gregor JC, McDonald JW, Klar N, Wall R, Atkinson K, Lamba B, et al. An evaluation of utility measurement in Crohn's disease. Inflamm Bowel Dis. 1997;3(4):265–276. [PubMed: 23282873]
8.
Entyvio: EPAR - product information [Internet]. London: European Medicines Agency; Jun 16, 2014. [cited 2016 Jul 6]. updated 2016 Jun 9. (European public assessment report). Available from: http://www​.ema.europa​.eu/docs/en_GB/document_library​/EPAR_-_Product_Information​/human​/002782/WC500168528.pdf.
9.
Manufacturer's submission: Entyvio™ (vedolizumab) powder for concentrate for solution in infusion 300 mg/vial [CONFIDENTIAL manufacturer's submission]. Oakville (ON): Takeda; 2016. Common technical document section 5.3.5.3: integrated summary of safety.
10.
Takeda. ClinicalTrials​.gov [Internet]. Bethesda (MD): U.S. National Library of Medicine; Nov 19, 2015. [cited 2016 May 12; last updated 2016 Mar 2]. Efficacy and safety of vedolizumab subcutaneous (SC) as maintenance therapy in Crohn's disease. 2000 - . Available from: https:​//clinicaltrials​.gov/ct2/show/NCT02611817 Identifier: NCT02611817.
11.
Takeda. ClinicalTrials​.gov [Internet]. Bethesda (MD): U.S. National Library of Medicine; Nov 19, 2015. [cited 2016 May 12; last updated 2016 Apr 19]. Efficacy and safety of vedolizumab subcutaneously (SC) as maintenance therapy in ulcerative colitis. 2000 - . Available from: https:​//clinicaltrials​.gov/ct2/show/NCT02611830 Identifier: NCT02611830.
12.
Takeda. ClinicalTrials​.gov [Internet]. Bethesda (MD): U.S. National Library of Medicine; Nov 19, 2015. [cited 2016 May 24; last updated: 2016 Mar 2]. Vedolizumab subcutaneous long-term open-label extension study. 2000 - . Available from: https:​//clinicaltrials​.gov/ct2/show/NCT02620046 Identifier: NCT02620046.
13.
PrRemicade® (infliximab): powder for solution, sterile, lyophilized, 100 mg/vial [product monograph]. Toronto: Janssen Inc; Apr 26, 2016.
14.
PrInflectra (infliximab): powder for solution, sterile, lyophilized, 100 mg/vial [product monograph]. Incheon, South Korea: Celltrion Healthcare Ltd; Jun 10, 2016.
15.
A phase 3, randomized, placebo-controlled, blinded, multicenter study of the induction and maintenance of clinical response and remission by vedolizumab (MLN0002) in patients with moderate to severe Crohn's disease [CONFIDENTIAL internal manufacturer's report]. Cambridge (MA): Millennium Pharmaceuticals Inc; Oct 10, 2012. Clinical study report: C13007.
16.
Pharmaceutical Benefits Advisory Committee. March 2015 PBAC meeting. Canberra: Australian Government; 2015. [cited 2016 May 12]. Vedolizumab, 300mg vial; Entyvio®; Takeda Pharmaceuticals Australia [Internet] (Public summary document). Available from: https://www​.pbs.gov.au​/industry/listing/elements​/pbac-meetings​/psd/2015-03/Files​/vedolizumab-1-psd-march-2015.docx.
17.
Pharmaceutical Benefits Advisory Committee. March 2015 PBAC meeting - positive recommendations [Internet]. Canberra: Australian Government; 2015. [cited 2016 May 12]. Available from: https://www​.pbs.gov.au​/industry/listing/elements​/pbac-meetings​/pbac-outcomes/2015-03​/2015-03-positive-recommendations​.docx.
18.
Vedolizumab. Pharmaceutical benefits scheme [Internet]. Canberra: Australian Government; 2016. [cited 2016 May 17]. Available from: http://www​.pbs.gov.au​/medicine/item/10384M-10390W-10398G-10415E.
19.
Takeda UK Ltd [Internet]. Glasgow (UK): Scottish Medicines Consortium; Jun 5, 2015. [cited 2016 May 12]. Vedolizumab 300mg powder for concentrate for solution for infusion (Entyvio®) Available from: https://www​.scottishmedicines​.org.uk/files​/advice/vedolizumab​_Entyvio_FINAL_June_2015_for_website​.pdf.
20.
Final appraisal determination [Internet]. London: National Institute for Health and Care Excellence (NICE); 2015. [cited 2016 May 12]. Vedolizumab for treating moderately to severely active Crohn's disease after prior therapy. Available from: https://www​.nice.org​.uk/guidance/TA352/documents​/crohns-disease-moderate-to-severe-vedolizumab-final-appraisal-determination-document2.
21.
A phase 3, randomized, placebo-controlled, blinded, multicenter study of the induction of clinical response and remission by vedolizumab in patients with moderate to severe Crohn's disease [CONFIDENTIAL internal manufacturer's report]. Cambridge (MA): Millennium Pharmaceuticals, Inc; Aug 30, 2012. Clinical study report: C13011.
22.
CDR submission: Entyvio™ (vedolizumab) powder for concentrate for solution in infusion 300 mg/vial [CONFIDENTIAL manufacturer's submission]. Oakville (ON): Takeda; 2016. Common technical document section 2.7.4: summary of clinical safety.
23.
Lichtenstein GR, Hanauer SB, Sandborn WJ. The Practice Parameters Committee of the American College of Gastroenterology. Management of Crohn's disease in adults. Am J Gastroenterol [Internet] 2009;104:465–483. [cited 2016 May 12]; Available from: http://s3​.gi.org/physicians​/guidelines/CrohnsDiseaseinAdults2009.pdf.
24.
PrHumira® (adalimumab): 40 mg in 0.8 mL sterile solution (50 mg/mL) subcutaneous injection [product monograph]. St. Laurent (QC): AbbVie Corporation; Apr 6, 2016.
25.
Common Drug Review. Adalimumab resubmission #3 (Humira® - Abbott Laboratories Ltd.) [Internet]. Ottawa: CADTH; Dec 19, 2007. [cited 2016 May 12]. CEDAC final recommendation and reason for recommendation. Available from: https://www​.cadth.ca​/sites/default/files​/cdr/complete/cdr_complete​_Humira-Resubmission-Crohns​_Dec-19-2007.pdf.
26.
Common Drug Review. Indication - Crohn's disease: overview of CDR clinical and pharmacoeconomic reports [Internet]. Ottawa: CADTH; 2008. [cited 2016 May 12]. Adalimumab (Humira® - Abbott Laboratories Limited) Available from: https://www​.cadth.ca​/sites/default/files​/cdr/relatedinfo/cdr​_trans_humira-resub3-crohns​_overview_Mar-07-08_e.pdf.
27.
Infliximab. Ottawa: CADTH; Mar 11, 2016. [cited 2016 May 17]. (Common Drug Review). Available from: https://www​.cadth.ca/infliximab-19.
28.
Sandborn WJ, Feagan BG, Rutgeerts P, Hanauer S, Colombel JF, Sands BE, et al. Vedolizumab as induction and maintenance therapy for Crohn's disease. N Engl J Med. 2013 Aug 22;369(8):711–721. [PubMed: 23964933]
29.
Sandborn WJ, Feagan BG, Rutgeerts P, Hanauer S, Colombel JF, Sands BE, et al. Vedolizumab as induction and maintenance therapy for Crohn's disease [Supplementary appendix] N Engl J Med. 2013 Aug 22;369(8):711–721. [PubMed: 23964933]
30.
Millennium Pharmaceuticals, Inc. ClinicalTrials​.gov [Internet]. Bethesda (MD): U.S. National Library of Medicine; Oct 31, 2008. [cited 2016 May 12; last updated 2014 Jun 19]. Study of vedolizumab (MLN0002) in patients with moderate to severe Crohn's disease (GEMINI II) 2000 - . Available from: https:​//clinicaltrials​.gov/ct2/show/NCT00783692 Identifier: NCT00783692.
31.
Sands BE, Feagan BG, Rutgeerts P, Colombel JF, Sandborn WJ, Sy R, et al. Effects of vedolizumab induction therapy for patients with Crohn's disease in whom tumor necrosis factor antagonist treatment failed. Gastroenterology. 2014 Sep;147(3):618–627. [PubMed: 24859203]
32.
Millennium Pharmaceuticals, Inc. ClinicalTrials​.gov [Internet]. Bethesda (MD): U.S. National Library of Medicine; Oct 18, 2010. [cited 2016 May 12; last updated 2014 Jun 19]. Study of vedolizumab in patients with moderate to severe Crohn's disease (GEMINI III) 2000 - . Available from: https:​//clinicaltrials​.gov/ct2/show/NCT01224171 Identifier: NCT01224171.
33.
Center for Drug Evaluation and Research, U.S. Food and Drug Administration. Entyvio (vedolizumab). Company: Takeda Pharmaceuticals U.S.A., Inc. Application no.: 125476. Approval date: 5/20/2014 [Internet]. Rockville (MD): FDA; May 20, 2014. [cited 2016 May 12]. Statistical review(s) (FDA drug approval package). Available from: http://www​.accessdata​.fda.gov/drugsatfda_docs​/nda/2014/125476Orig1s000StatR.pdf.
34.
CDR submission: Entyvio™ (vedolizumab) powder for concentrate for solution in infusion 300 mg/vial [CONFIDENTIAL manufacturer's submission]. Oakville (ON): Takeda; 2016. Common technical document section 2.7.3: summary of clinical efficacy - Crohn's disease.
35.
Center for Drug Evaluation and Research, U.S. Food and Drug Administration. Entyvio (vedolizumab). Company: Takeda Pharmaceuticals U.S.A., Inc. Application no.: 125476. Approval date: 5/20/2014 [Internet]. Rockville (MD): FDA; May 20, 2014. [cited 2016 May 12]. Medical review(s) (FDA drug approval package). Available from: http://www​.accessdata​.fda.gov/drugsatfda_docs​/nda/2014/125476Orig1s000MedR.pdf.
36.
Guyatt G, Mitchell A, Irvine EJ, Singer J, Williams N, Goodacre R, et al. A new measure of health status for clinical trials in inflammatory bowel disease. Gastroenterology. 1989 Mar;96(3):804–810. [PubMed: 2644154]
37.
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 Apr;28(4):S23–S27. [PubMed: 10204520]
38.
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 May 1;29(9):1032–1041. [PubMed: 19222413]
39.
EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199–208. [PubMed: 10109801]
40.
Brooks R. EuroQol: the current state of play. Health Policy. 1996 Jul;37(1):53–72. [PubMed: 10158943]
41.
European public assessment report: Entyvio [Internet]. London: European Medicines Agency; Mar 20, 2014. [cited 2016 May 12]. Committee for Medicinal Products for Human Use. Available from: http://www​.ema.europa​.eu/docs/en_GB/document_library​/EPAR_-_Public​_assessment_report​/human/002782/WC500168530.pdf.
42.
Guideline on the development of new medicinal products for the treatment of Crohn's disease [Internet]. London: European Medicines Agency; Jul 24, 2008. [cited 2016 May 12]. Committee for Medicinal Products for Human Use. Available from: http://www​.ema.europa​.eu/docs/en_GB/document_library​/Scientific_guideline​/2009/09/WC500003265.pdf.
43.
Millennium Pharmaceuticals, Inc. ClinicalTrials​.gov [Internet]. Bethesda (MD): U.S. National Library of Medicine; Oct 31, 2008. [cited 2016 May 12; last updated 2014 Jun 19]. Study of vedolizumab (MLN0002) in patients with moderate to severe ulcerative colitis (GEMINI I) 2000 - . Available from: https:​//clinicaltrials​.gov/ct2/show/NCT00783718 Identifier: NCT00783718.
44.
Sadowski DC, Bernstein CN, Bitton A, Croitoru K, Fedorak RN, Griffiths A, et al. Canadian Association of Gastroenterology clinical practice guidelines: the use of tumour necrosis factor-alpha antagonist therapy in Crohn's disease. Can J Gastroenterol [Internet] 2009 Mar;23(3):185–202. [cited 2016 May 12]; Available from: https://www​.cag-acg.org​/images/publications​/cag_cpg_crohnsmar2009.pdf. [PMC free article: PMC2694654] [PubMed: 19319383]
45.
Prescribing information: Cimzia (certolizumab pegol) injection, for subcutaneous use [Internet]. Smyrna (GA): UCB Pharma S.A.; 2016. [cited 2016 May 13]. Available from: http://www​.accessdata​.fda.gov/drugsatfda_docs​/label/2016/125160s241lbl.pdf.
46.
PrCimzia® (certolizumab pegol): solution for injection in a single-use pre-filled glass syringe, 200 mg/mL [product monograph]. Oakville (ON): UCB Canada Inc; Jun 2, 2016.
47.
Questions and answers on recommendation for the refusal of the marketing authorisation for Cimzia [Internet]. London: European Medicines Agency; Mar 19, 2008. [cited 2016 May 12]. Available from: http://www​.ema.europa​.eu/docs/en_GB/document_library​/Summary​_of_opinion_-_Initial_authorisation​/human​/000740/WC500070614.pdf.
48.
Summary of the risk management plan (RMP) for Entyvio (vedolizumab) [Internet]. London: European Medicines Agency; 2014. [cited 2016 May 13]. Available from: http://www​.ema.europa​.eu/docs/en_GB/document_library​/EPAR_-_Risk-management-plan_summary​/human/002782/WC500163289.pdf.
49.
Millennium Pharmaceuticals, Inc. ClinicalTrials​.gov [Internet]. Bethesda (MD): U.S. National Library of Medicine; Nov 5, 2008. [cited 2016 May 12; last updated 2014 Dec 22]. An open-label study of vedolizumab (MLN0002) in patients with ulcerative colitis and Crohn's disease (GEMINI LTS) 2000 - . Available from: https:​//clinicaltrials​.gov/ct2/show/NCT00790933 Identifier: NCT00790933.
50.
CDR submission: Entyvio™ (vedolizumab) powder for concentrate for solution in infusion 300 mg/vial [CONFIDENTIAL manufacturer's submission]. Oakville (ON): Takeda Canada; Apr 21, 2016. Systematic literature review and indirect treatment comparisons in Crohn's disease.
51.
Singh S, Garg SK, Pardi DS, Wang Z, Murad MH, Loftus EV Jr. Comparative efficacy of biologic therapy in biologic-naive patients with Crohn disease: a systematic review and network meta-analysis. Mayo Clin Proc. 2014 Dec;89(12):1621–1635. [PubMed: 25441399]
52.
Hazlewood GS, Rezaie A, Borman M, Panaccione R, Ghosh S, Seow CH, et al. Comparative effectiveness of immunosuppressants and biologics for inducing and maintaining remission in Crohn's disease: a network meta-analysis. Gastroenterology. 2015 Feb;148(2):344–354. [PubMed: 25448924]
53.
Vedolizumab for treating moderately to severely active Crohn's disease after prior therapy [Internet]. London: National Institute for Health and Care Excellence (NICE); 2015. [cited 2016 May 16]. Crohn's disease (moderate to severe) - vedolizumab: committee papers part 2. (NICE technology appraisal guidance TA352). Available from: https://www​.nice.org​.uk/guidance/TA352/documents​/crohns-disease-moderate-to-severe-vedolizumab-committee-papers3.
54.
Sandborn WJ, Hanauer SB, Rutgeerts P, Fedorak RN, Lukas M, MacIntosh DG, et al. Adalimumab for maintenance treatment of Crohn's disease: results of the CLASSIC II trial. Gut [Internet] 2007 Sep;56(9):1232–1239. [cited 2016 May 17]; Available from: http://www​.ncbi.nlm.nih​.gov/pmc/articles/PMC2701613. [PMC free article: PMC2701613] [PubMed: 17299059]
55.
CDR submission: Entyvio™ (vedolizumab) powder for concentrate for solution in infusion 300 mg/vial [CONFIDENTIAL manufacturer's submission]. Oakville (ON): Takeda Canada; Mar, 2016. Entyvio™ (vedolizumab) - clinical summary.
56.
Entyvio biologics safety and efficacy assessment report [CONFIDENTIAL internal report]. Ottawa: Health Canada; 2016. (BSEAR report).
57.
A phase 3, open-label study to determine the long-term safety and efficacy of vedolizumab (MLN0002) in subjects with ulcerative colitis and Crohn's disease [CONFIDENTIAL internal manufacturer's report]. Deerfield (IL): Takeda; Mar 23, 2016. Interim clinical study report 3: MLN0002-C13008 (results through 21 May 2015)
58.
Sands B, Dubinsky M, Vermeire S, Sankoh S, Rosario M, Milch C. Effects of increased vedolizumab dosing frequency on disease activity in ulcerative colitis and Crohn's disease [abstract] Am J Gastroenterol. 2014 Oct;109(S2):S478–S479. Abstract 1618. (Presented at 79th Annual Scientific Meeting of the American College of Gastroenterology; 2014 Oct 17–22; Philadelphia, PA).
59.
Mendoza Ladd AH, Scott FI, Grace R, Bownik H, Lichtenstein GR. Dose escalation of vedolizumab from every 8 weeks to every 4 or 6 weeks enables patients with inflammatory bowel disease to recapture response [abstract] Gastroenterology. 2016 Apr;150(4 Suppl 1):S235–S236. (Presented at Digestive Disease Week; 2016 May 21–24; San Diego, CA).
60.
Prescribing information: Entyvio (vedolizumab) for injection, for intravenous use [Internet]. Deerfield (IL): Takeda Pharmaceuticals America; May, 2014. [cited 2016 Jul 6]. Available from: http://www​.accessdata​.fda.gov/drugsatfda_docs​/label/2014/125476s000lbl.pdf.
61.
Miligkos M, Papamichael K, Casteele NV, Mantzaris GJ, Gils A, Levesque BG, et al. Efficacy and safety profile of anti-tumor necrosis factor-alpha versus anti-integrin agents for the treatment of Crohn's disease: a network meta-analysis of indirect comparisons. Clin Ther. 2016 Jun;38(6):1342–1358. [PubMed: 27091732]
62.
Colombel JF, Sands BE, Rutgeerts P, Sandborn W, Danese S, D'Haens G, et al. The safety of vedolizumab for ulcerative colitis and Crohn's disease. Gut [Internet] 2016 Feb 18; [cited 2016 May 30]; Available from: http://gut​.bmj.com/content​/early/2016/02​/18/gutjnl-2015-311079.full.pdf+html. [PMC free article: PMC5531223] [PubMed: 26893500]
63.
Prescribing information: Tysabri (natalizumab) injection, for intravenous use [Internet]. Cambridge (MA): Biogen Idec Inc; 2015. [cited 2016 May 13]. Available from: http://www​.accessdata​.fda.gov/drugsatfda_docs​/label/2015/125104s950lbl.pdf.
64.
PrTysabri® (natalizumab): concentrate for solution for intravenous infusion 300 mg/15 mL [product monograph]. Mississauga (ON): Biogen Canada Inc; Mar 10, 2016.
65.
Questions and answers on recommendation for the refusal of the marketing authorisation for Natalizumab Elan Pharma [Internet]. London: European Medicines Agency; Nov 15, 2007. [cited 2016 May 12]. Available from: http://www​.ema.europa​.eu/docs/en_GB/document_library​/Summary​_of_opinion_-_Initial_authorisation​/human​/000624/WC500070716.pdf.
66.
CDR submission: Entyvio™ (vedolizumab) powder for concentrate for solution in infusion 300 mg/vial [CONFIDENTIAL manufacturer's submission]. Oakville (ON): Takeda Canada; Apr 21, 2016. Entyvio™ (vedolizumab) - executive summary.
67.
Hanauer SB, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S, Colombel JF, et al. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet. 2002 May 4;(9317):359. 1541–1549. [PubMed: 12047962]
68.
Takeda. ClinicalTrials​.gov [Internet]. Bethesda (MD): U.S. National Library of Medicine; Jan 15, 2014. [cited 2016 May 24; last updated: 2015 Aug 11]. Phase III study of MLN0002 (300 mg) in treatment of Crohn's disease. 2000 - . Available from: https:​//clinicaltrials​.gov/ct2/show/NCT02038920 Identifier: NCT02038920.
69.
Amiot A, Grimaud JC, Peyrin-Biroulet L, Filippi J, Pariente B, Roblin X, et al. Effectiveness and safety of vedolizumab induction therapy for patients with inflammatory bowel disease. Clin Gastroenterol Hepatol. 2016 Feb 22; [PubMed: 26917043]
70.
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 Mar;70(3):439–444. [PubMed: 1248701]
71.
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 Jan;13(1):65–73. [PubMed: 10099817]
72.
Sandborn WJ, Feagan BG, Hanauer SB, Lochs H, Lofberg R, Modigliani R, et al. A review of activity indices and efficacy endpoints for clinical trials of medical therapy in adults with Crohn's disease. Gastroenterology. 2002 Feb;122(2):512–530. [PubMed: 11832465]
73.
Mahadevan U. Medscape [Internet]. New York: WebMD; 2006. [cited 2016 Jul 11]. Clinical trial design and endpoints in biologic therapy for Crohn's disease: interpretation of the results. Available from: http://www​.medscape.com​/viewarticle/543353 Free registration required.
74.
Best WR, Becktel JM, Singleton JW. Rederived values of the eight coefficients of the Crohn's Disease Activity Index (CDAI). Gastroenterology. 1979 Oct;77(4 Pt 2):843–846. [PubMed: 467941]
75.
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 [Internet] 1987 Apr;28(4):474–481. [cited 2016 Jul 11]; Available from: http://www​.ncbi.nlm.nih​.gov/pmc/articles/PMC1432811. [PMC free article: PMC1432811] [PubMed: 3583074]
76.
Pallis AG, Mouzas IA, Vlachonikolis IG. The inflammatory bowel disease questionnaire: a review of its national validation studies. Inflamm Bowel Dis. 2004 May;10(3):261–269. [PubMed: 15290922]
77.
Irvine EJ, Feagan B, Rochon J, Archambault A, Fedorak RN, Groll A, et al. Quality of life: a valid and reliable measure of therapeutic efficacy in the treatment of inflammatory bowel disease. Canadian Crohn's Relapse Prevention Trial Study Group. Gastroenterology. 1994 Feb;106(2):287–296. [PubMed: 8299896]
78.
Ware J, Kosinski M, Bjorner JB, Turner-Bowker DM, Gandek B, Maruish ME. User's manual for the SF-36v2 health survey. 2nd ed. Lincoln (RI): Quality Metric Inc; 2007. Determining important differences in scores.
79.
Bernklev T, Jahnsen J, Lygren I, Henriksen M, Vatn M, Moum B. Health-related quality of life in patients with inflammatory bowel disease measured with the short form-36: psychometric assessments and a comparison with general population norms. Inflamm Bowel Dis. 2005 Oct;11(10):909–918. [PubMed: 16189421]
80.
Sinnott PL, Joyce VR, Barnett PG. Guidebook: preference measurement in economic analysis [Internet]. Menlo Park (CA): Health Economics Research Center; 2007. [cited 2016 Jul 11]. Available from: http://www​.herc.research​.va.gov/files/BOOK_419.pdf.
81.
Stark RG, Reitmeir P, Leidl R, Konig HH. Validity, reliability, and responsiveness of the EQ-5D in inflammatory bowel disease in Germany. Inflamm Bowel Dis. 2010 Jan;16(1):42–51. [PubMed: 19475674]
82.
Targan SR, Hanauer SB, van Deventer SJ, Mayer L, Present DH, Braakman T, et al. A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn's disease. Crohn's Disease cA2 Study Group. N Engl J Med. 1997 Oct 9;337(15):1029–1035. [PubMed: 9321530]
83.
Hanauer SB, Sandborn WJ, Rutgeerts P, Fedorak RN, Lukas M, MacIntosh D, et al. Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn's disease: the CLASSIC-I trial. Gastroenterology. 2006 Feb;130(2):323–333. [PubMed: 16472588]
84.
Sandborn WJ, Rutgeerts P, Enns R, Hanauer SB, Colombel JF, Panaccione R, et al. Adalimumab induction therapy for Crohn disease previously treated with infliximab: a randomized trial. Ann Intern Med. 2007 Jun 19;146(12):829–838. [PubMed: 17470824]
85.
Watanabe M, Hibi T, Lomax KG, Paulson SK, Chao J, Alam MS, et al. Adalimumab for the induction and maintenance of clinical remission in Japanese patients with Crohn's disease. J Crohns Colitis. 2012 Mar;6(2):160–173. [PubMed: 22325170]
86.
Colombel JF, Sandborn WJ, Rutgeerts P, Enns R, Hanauer SB, Panaccione R, et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial. Gastroenterology. 2007 Jan;132(1):52–65. [PubMed: 17241859]
87.
Jansen JP, Fleurence R, Devine B, Itzler R, Barrett A, Hawkins N, et al. Interpreting indirect treatment comparisons and network meta-analysis for health-care decision making: report of the ISPOR Task Force on Indirect Treatment Comparisons Good Research Practices: part 1. Value Health. 2011 Jun;14(4):417–428. [PubMed: 21669366]
88.
Vedolizumab for treating moderately to severely active Crohn's disease after prior therapy [Internet]. London: National Institute for Health and Care Excellence (NICE); 2015. [cited 2016 May 16]. Crohn's disease (moderate to severe) - vedolizumab: committee papers part 1. (NICE technology appraisal guidance TA352). Available from: https://www​.nice.org​.uk/guidance/TA352/documents​/crohns-disease-moderate-to-severe-vedolizumab-committee-papers3.
89.
Schoenfeld P, Cook D, Hamilton F, Laine L, Morgan D, Peterson W. An evidence-based approach to gastroenterology therapy. Evidence-Based Gastroenterology Steering Group. Gastroenterology. 1998 Jun;114(6):1318–1325. [PubMed: 9609770]
Copyright © CADTH 2016.

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: NBK424374

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...