메뉴 건너뛰기




Volumn 74, Issue 11, 2014, Pages 1293-1303

Vedolizumab: First global approval

Author keywords

[No Author keywords available]

Indexed keywords

CORTICOSTEROID; IMMUNOMODULATING AGENT; LDP 002; MLN 002; TUMOR NECROSIS FACTOR ALPHA INHIBITOR; UNCLASSIFIED DRUG; VEDOLIZUMAB; GASTROINTESTINAL AGENT; MONOCLONAL ANTIBODY;

EID: 84904742519     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.1007/s40265-014-0253-1     Document Type: Article
Times cited : (21)

References (44)
  • 1
    • 84894589499 scopus 로고    scopus 로고
    • Review article: Anti-adhesion therapies for inflammatory bowel disease
    • Lobaton T, Vermeire S, Van Assche G, et al. Review article: anti-adhesion therapies for inflammatory bowel disease. Aliment Pharmacol Ther. 2014;39(6):579-94.
    • (2014) Aliment Pharmacol Ther , vol.39 , Issue.6 , pp. 579-594
    • Lobaton, T.1    Vermeire, S.2    Van Assche, G.3
  • 2
    • 84867359637 scopus 로고    scopus 로고
    • Vedolizumab for the treatment of ulcerative colitis and Crohn's disease
    • McLean LP, Shea-Donohue T, Cross RK. Vedolizumab for the treatment of ulcerative colitis and Crohn's disease. Immunotherapy. 2012;4(9):883-98.
    • (2012) Immunotherapy , vol.4 , Issue.9 , pp. 883-898
    • McLean, L.P.1    Shea-Donohue, T.2    Cross, R.K.3
  • 3
    • 84879894997 scopus 로고    scopus 로고
    • Moving towards disease modification in inflammatory bowel disease therapy
    • Allen PB, Peyrin-Biroulet L. Moving towards disease modification in inflammatory bowel disease therapy. Curr Opin Gastroenterol. 2013;29(4):397-404.
    • (2013) Curr Opin Gastroenterol , vol.29 , Issue.4 , pp. 397-404
    • Allen, P.B.1    Peyrin-Biroulet, L.2
  • 4
    • 84893095796 scopus 로고    scopus 로고
    • When combination therapy isn't working: Emerging therapies for the management of inflammatory bowel disease
    • Krishnareddy S, Swaminath A. When combination therapy isn't working: emerging therapies for the management of inflammatory bowel disease. World J Gastroenterol. 2014;20(5):1139-46.
    • (2014) World J Gastroenterol , vol.20 , Issue.5 , pp. 1139-1146
    • Krishnareddy, S.1    Swaminath, A.2
  • 5
    • 84861318436 scopus 로고    scopus 로고
    • Targeting leukocyte migration and adhesion in Crohn's disease and ulcerative colitis
    • Thomas S, Baumgart DC. Targeting leukocyte migration and adhesion in Crohn's disease and ulcerative colitis. Inflammopharmacology. 2012;20(1):1-18.
    • (2012) Inflammopharmacology , vol.20 , Issue.1 , pp. 1-18
    • Thomas, S.1    Baumgart, D.C.2
  • 6
    • 84880667585 scopus 로고    scopus 로고
    • Integrin inhibitors go with the gut
    • Holmes D. Integrin inhibitors go with the gut. Nat Rev Drug Discov. 2013;12(6):411-2.
    • (2013) Nat Rev Drug Discov , vol.12 , Issue.6 , pp. 411-412
    • Holmes, D.1
  • 7
    • 84882785930 scopus 로고    scopus 로고
    • Inhibition of leukocyte trafficking in inflammatory bowel disease
    • Cominelli F. Inhibition of leukocyte trafficking in inflammatory bowel disease. N Engl J Med. 2013;369(8):775-6.
    • (2013) N Engl J Med , vol.369 , Issue.8 , pp. 775-776
    • Cominelli, F.1
  • 8
    • 84886788747 scopus 로고    scopus 로고
    • Vedolizumab, a monoclonal antibody to the gut homing alpha4beta7 integrin, does not affect cerebrospinal fluid T-lymphocyte immunophenotype
    • Milch C, Wyant T, Xu J, et al. Vedolizumab, a monoclonal antibody to the gut homing alpha4beta7 integrin, does not affect cerebrospinal fluid T-lymphocyte immunophenotype. J Neuroimmunol. 2013;264(1-2):123-6.
    • (2013) J Neuroimmunol , vol.264 , Issue.1-2 , pp. 123-126
    • Milch, C.1    Wyant, T.2    Xu, J.3
  • 11
    • 85081467669 scopus 로고    scopus 로고
    • Accessed 5 June 2014
    • Takeda Pharmaceuticals America Inc. Prescribing information ENTYVIO (vedolizumab) for injection, for intravenous use. 2014. http://general. takedapharm.com/content/file.aspx?filetypecode=ENTYVIOPI&CountryCode= US&LanguageCode=EN&cacheRandomizer=452533ef-ab7b-4140-922a-a97734127102. Accessed 5 June 2014.
    • (2014) Prescribing Information ENTYVIO (Vedolizumab) for Injection, for Intravenous Use
  • 12
    • 85081470888 scopus 로고    scopus 로고
    • Accessed 5 June 2014
    • US Food and Drug Administration. BLA approval (BLA125476/0). 2014. http://www.accessdata.fda.gov/drugsatfda-docs/appletter/2014/125476Orig1s000ltr. pdf. Accessed 5 June 2014.
    • (2014) BLA Approval (BLA125476/0)
  • 17
    • 84889872074 scopus 로고    scopus 로고
    • In vitro assessment of the effects of vedolizumab binding on peripheral blood lymphocytes
    • Wyant T, Yang L, Fedyk E. In vitro assessment of the effects of vedolizumab binding on peripheral blood lymphocytes. mAbs. 2013;5(6):842-50.
    • (2013) mAbs , vol.5 , Issue.6 , pp. 842-850
    • Wyant, T.1    Yang, L.2    Fedyk, E.3
  • 19
    • 84863984524 scopus 로고    scopus 로고
    • Vedolizumab for the treatment of active ulcerative colitis: A randomized controlled phase 2 dose-ranging study
    • Parikh A, Leach T, Wyant T, et al. Vedolizumab for the treatment of active ulcerative colitis: a randomized controlled phase 2 dose-ranging study. Inflamm Bowel Dis. 2012;18(8):1470-9.
    • (2012) Inflamm Bowel Dis , vol.18 , Issue.8 , pp. 1470-1479
    • Parikh, A.1    Leach, T.2    Wyant, T.3
  • 20
    • 57249089077 scopus 로고    scopus 로고
    • Treatment of active Crohn's disease with MLN0002, a humanized antibody to the alpha4beta7 integrin
    • erratum appears in Clin Gastroenterol Hepatol. 2009;7(4):494
    • Feagan BG, Greenberg GR, Wild G, et al. Treatment of active Crohn's disease with MLN0002, a humanized antibody to the alpha4beta7 integrin (erratum appears in Clin Gastroenterol Hepatol. 2009;7(4):494). Clin Gastroenterol Hepatol. 2008;6(12):1370-7.
    • (2008) Clin Gastroenterol Hepatol , vol.6 , Issue.12 , pp. 1370-1377
    • Feagan, B.G.1    Greenberg, G.R.2    Wild, G.3
  • 21
    • 84882769357 scopus 로고    scopus 로고
    • Vedolizumab as induction and maintenance therapy for ulcerative colitis
    • Feagan BG, Rutgeerts P, Sands BE, et al. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013;369(8):699-710.
    • (2013) N Engl J Med , vol.369 , Issue.8 , pp. 699-710
    • Feagan, B.G.1    Rutgeerts, P.2    Sands, B.E.3
  • 22
    • 84882749768 scopus 로고    scopus 로고
    • Vedolizumab as induction and maintenance therapy for Crohn's disease
    • Sandborn WJ, Feagan BG, Rutgeerts P, et al. Vedolizumab as induction and maintenance therapy for Crohn's disease. N Engl J Med. 2013;369(8):711-21.
    • (2013) N Engl J Med , vol.369 , Issue.8 , pp. 711-721
    • Sandborn, W.J.1    Feagan, B.G.2    Rutgeerts, P.3
  • 23
    • 84904747073 scopus 로고    scopus 로고
    • Vedolizumab affects antibody responses to immunisation selectively in the gastrointestinal tract: Randomised controlled trial results
    • doi:10.1136/gutjnl-2014-307127
    • Wyant T, Leach T, Sankoh S, et al. Vedolizumab affects antibody responses to immunisation selectively in the gastrointestinal tract: randomised controlled trial results. Gut. 2014;. doi:10.1136/gutjnl-2014-307127.
    • (2014) Gut
    • Wyant, T.1    Leach, T.2    Sankoh, S.3
  • 24
    • 84884538154 scopus 로고    scopus 로고
    • Long-term clinical experience with vedolizumab in patients with inflammatory bowel disease
    • Parikh A, Fox I, Leach T, et al. Long-term clinical experience with vedolizumab in patients with inflammatory bowel disease. Inflamm Bowel Dis. 2013;19(8):1691-9.
    • (2013) Inflamm Bowel Dis , vol.19 , Issue.8 , pp. 1691-1699
    • Parikh, A.1    Fox, I.2    Leach, T.3
  • 25
    • 84904727989 scopus 로고    scopus 로고
    • Pharmacokinetic/pharmacodynamic relationship and immunogenicity of vedolizumab in adults with inflammatory bowel disease: Additional results from GEMINI 1 and 2
    • abstract no. P-140
    • Rosario M, Fox I, Milch C, et al. Pharmacokinetic/pharmacodynamic relationship and immunogenicity of vedolizumab in adults with inflammatory bowel disease: additional results from GEMINI 1 and 2 (abstract no. P-140). Inflamm Bowel Dis. 2013;19(suppl):S80.
    • (2013) Inflamm Bowel Dis , vol.19 , Issue.SUPPL.
    • Rosario, M.1    Fox, I.2    Milch, C.3
  • 26
    • 84904747135 scopus 로고    scopus 로고
    • Pharmacokinetic and pharmacodynamic relationship and immunogenicity of vedolizumab in adults with inflammatory bowel disease: Additional results from the GEMINI 1 and 2 studies
    • abstract no. DOP058
    • Rosario M, Wyant T, Milch C, et al. Pharmacokinetic and pharmacodynamic relationship and immunogenicity of vedolizumab in adults with inflammatory bowel disease: additional results from the GEMINI 1 and 2 studies (abstract no. DOP058). J Crohns Colitis. 2014;8(suppl 1):S42-S43.
    • (2014) J Crohns Colitis , vol.8 , Issue.SUPPL. 1
    • Rosario, M.1    Wyant, T.2    Milch, C.3
  • 27
    • 84904753968 scopus 로고    scopus 로고
    • Population pharmacokinetic modelling of vedolizumab in patients with ulcerative colitis or Crohn's disease
    • abstract no. P385
    • Rosario M, Dirks N, Gastonguay M, et al. Population pharmacokinetic modelling of vedolizumab in patients with ulcerative colitis or Crohn's disease (abstract no. P385). J Crohns Colitis. 2014;8(suppl 1):S225-6.
    • (2014) J Crohns Colitis , vol.8 , Issue.SUPPL. 1
    • Rosario, M.1    Dirks, N.2    Gastonguay, M.3
  • 28
    • 84904748929 scopus 로고    scopus 로고
    • Population pharmacokinetic modeling of vedolizumab in patients with ulcerative colitis or Crohn's disease
    • abstract no. M01225
    • Dirks NL, Rosario M, Gastonguay MR, et al. Population pharmacokinetic modeling of vedolizumab in patients with ulcerative colitis or Crohn's disease (abstract no. M01225). Gastroenterology. 2014;1(suppl):S-591.
    • (2014) Gastroenterology , vol.1 , Issue.SUPPL.
    • Dirks, N.L.1    Rosario, M.2    Gastonguay, M.R.3
  • 29
    • 84904744110 scopus 로고    scopus 로고
    • Vedolizumab exposure-response relationship during induction therapy in adults with Crohn's disease
    • abstract no. Mo1231
    • French J, Rosario M, Dirks NL, et al. Vedolizumab exposure-response relationship during induction therapy in adults with Crohn's disease (abstract no. Mo1231). Gastroenterology. 2014;1(suppl):S592-3.
    • (2014) Gastroenterology , vol.1 , Issue.SUPPL.
    • French, J.1    Rosario, M.2    Dirks, N.L.3
  • 30
    • 84904744110 scopus 로고    scopus 로고
    • Exposure-response relationship of vedolizumab treatment in adults with ulcerative colitis
    • abstract no. Mo1229
    • French J, Rosario M, Dirks NL, et al. Exposure-response relationship of vedolizumab treatment in adults with ulcerative colitis (abstract no. Mo1229). Gastroenterology. 2014;1(suppl):S-592.
    • (2014) Gastroenterology , vol.1 , Issue.SUPPL.
    • French, J.1    Rosario, M.2    Dirks, N.L.3
  • 31
    • 84904724660 scopus 로고    scopus 로고
    • Exposure response relationship during vedolizumab induction therapy in adults with ulcerative colitis
    • abstract no. P489
    • Rosario M, French J, Dirks N, et al. Exposure response relationship during vedolizumab induction therapy in adults with ulcerative colitis (abstract no. P489). J Crohns Colitis. 2014;8 (suppl 1):S270-S271.
    • (2014) J Crohns Colitis , vol.8 , Issue.SUPPL. 1
    • Rosario, M.1    French, J.2    Dirks, N.3
  • 32
    • 84904724660 scopus 로고    scopus 로고
    • Exposure response relationship of vedolizumab after 6 weeks of treatment in adults with Crohn's disease
    • abstract no. P488
    • Rosario M, French J, Dirks N, et al. Exposure response relationship of vedolizumab after 6 weeks of treatment in adults with Crohn's disease (abstract no. P488). J Crohns Colitis. 2014;8 (suppl 1):S270.
    • (2014) J Crohns Colitis , vol.8 , Issue.SUPPL. 1
    • Rosario, M.1    French, J.2    Dirks, N.3
  • 33
    • 84904726610 scopus 로고    scopus 로고
    • Efficacy of vedolizumab in ulcerative colitis by prior treatment failure in GEMINI I, a randomized, placebo-controlled, double-blind, multicenter trial
    • abstract no. O-1b
    • Feagan B, Sands B, Sankoh S, et al. Efficacy of vedolizumab in ulcerative colitis by prior treatment failure in GEMINI I, a randomized, placebo-controlled, double-blind, multicenter trial (abstract no. O-1b). Inflamm Bowel Dis. 2012;18(Suppl. 1):S1-2.
    • (2012) Inflamm Bowel Dis , vol.18 , Issue.SUPPL. 1
    • Feagan, B.1    Sands, B.2    Sankoh, S.3
  • 34
    • 84967180715 scopus 로고    scopus 로고
    • Effects of continued vedolizumab therapy for ulcerative colitis in week 6 induction therapy nonresponders
    • abstract no. P501
    • Feagan B, Sandborn WJ, Smyth M, et al. Effects of continued vedolizumab therapy for ulcerative colitis in week 6 induction therapy nonresponders (abstract no. P501). J Crohns Colitis. 2014;8(suppl):S276-7.
    • (2014) J Crohns Colitis , vol.8 , Issue.SUPPL.
    • Feagan, B.1    Sandborn, W.J.2    Smyth, M.3
  • 35
    • 84904726322 scopus 로고    scopus 로고
    • Reductions in corticosteroid use in patients with ulcerative colitis or Crohn's disease treated with vedolizumab
    • abstract no. 1676
    • Sands B, Hanauer S, Colombel JF, et al. Reductions in corticosteroid use in patients with ulcerative colitis or Crohn's disease treated with vedolizumab (abstract no. 1676). Am J Gastroenterol. 2013;108(suppl):S503.
    • (2013) Am J Gastroenterol , vol.108 , Issue.SUPPL.
    • Sands, B.1    Hanauer, S.2    Colombel, J.F.3
  • 36
    • 84904758654 scopus 로고    scopus 로고
    • Health-related quality of life in patients with ulcerative colitis after treatment with vedolizumab: Results from the GEMINI 1 study
    • abstract no. Mo1223
    • Feagan BG, Colombel JF, Rubin DT, et al. Health-related quality of life in patients with ulcerative colitis after treatment with vedolizumab: results from the GEMINI 1 study (abstract no. Mo1223). Gastroenterology. 2014;1(suppl):S-590.
    • (2014) Gastroenterology , vol.1 , Issue.SUPPL.
    • Feagan, B.G.1    Colombel, J.F.2    Rubin, D.T.3
  • 37
    • 85028097647 scopus 로고    scopus 로고
    • Efficacy of continued vedolizumab therapy in patients with Crohn's disease who did not respond to vedolizumab induction therapy at week 6
    • abstract no. P497
    • Sandborn WJ, Feagan B, Reinisch W, et al. Efficacy of continued vedolizumab therapy in patients with Crohn's disease who did not respond to vedolizumab induction therapy at week 6 (abstract no. P497). J Crohns Colitis. 2014;8(suppl):S274-S275.
    • (2014) J Crohns Colitis , vol.8 , Issue.SUPPL.
    • Sandborn, W.J.1    Feagan, B.2    Reinisch, W.3
  • 38
    • 84889798701 scopus 로고    scopus 로고
    • Vedolizumab maintenance therapy for Crohn's disease: Results of GEMINI II, a randomized, placebo-controlled, double-blind, multicenter phase 3 trial
    • abstract no. 1522
    • Hanauer S, Colombel JF, Feagan B, et al. Vedolizumab maintenance therapy for Crohn's disease: results of GEMINI II, a randomized, placebo-controlled, double-blind, multicenter phase 3 trial (abstract no. 1522). Am J Gastroenterol. 2012;107(suppl): S620-1.
    • (2012) Am J Gastroenterol , vol.107 , Issue.SUPPL.
    • Hanauer, S.1    Colombel, J.F.2    Feagan, B.3
  • 39
    • 84904756040 scopus 로고    scopus 로고
    • Vedolizumab induction therapy for patients with Crohn's disease and prior anti-TNF antagonist failure: A randomized, placebo-controlled, doubleblind, multicenter trial
    • abstract no. P-26
    • Sands B, Feagan B, Rutgeerts P, et al. Vedolizumab induction therapy for patients with Crohn's disease and prior anti-TNF antagonist failure: a randomized, placebo-controlled, doubleblind, multicenter trial (abstract no. P-26). Inflamm Bowel Dis. 2012;18(Suppl):S24-5.
    • (2012) Inflamm Bowel Dis , vol.18 , Issue.SUPPL.
    • Sands, B.1    Feagan, B.2    Rutgeerts, P.3
  • 40
    • 0000788815 scopus 로고    scopus 로고
    • An ascending dose trial of a humanized A4B7 antibody in ulcerative colitis
    • abstract no. 4851
    • Feagan BG, McDonald JW, Wild G, et al. An ascending dose trial of a humanized A4B7 antibody in ulcerative colitis (abstract no. 4851). Gastroenterology. 2000;118 (suppl 4 part 1):A874.
    • (2000) Gastroenterology , vol.118 , Issue.SUPPL. 4 PART 1
    • Feagan, B.G.1    McDonald, J.W.2    Wild, G.3
  • 41
    • 84904763666 scopus 로고    scopus 로고
    • No association between vedolizumab exposure and serum JC virus levels
    • abstract
    • Parikh A, Paolino J, Fedy ER, et al. No association between vedolizumab exposure and serum JC virus levels (abstract). J Crohns Colitis. 2011;5 (suppl 1):S109-10.
    • (2011) J Crohns Colitis , vol.5 , Issue.SUPPL. 1
    • Parikh, A.1    Paolino, J.2    Fedy, E.R.3
  • 42
    • 84898757747 scopus 로고    scopus 로고
    • Millennium Pharmaceuticals. (ClinicalTrials.gov identifier NCT00790933). US National Institutes of Health, ClinicalTrials. gov Accessed 9 June 2014
    • Millennium Pharmaceuticals. An open-label study of vedolizumab (MLN0002) in patients with ulcerative colitis and Crohn's disease (GEMINI LTS) (ClinicalTrials.gov identifier NCT00790933). US National Institutes of Health, ClinicalTrials. gov. 2008. http://clinicaltrials.gov/ct2/show/NCT00790933?term= NCT00790933&rank=1. Accessed 9 June 2014.
    • (2008) An Open-label Study of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn's Disease (GEMINI LTS)
  • 43
    • 85081462999 scopus 로고    scopus 로고
    • Takeda (ClinicalTrials.gov identifier NCT02039505). US National Institutes of Health, ClinicalTrials.gov Accessed 9 June 2014
    • Takeda. Phase III study of MLN0002 (300 mg) in the treatment of ulcerative colitis (ClinicalTrials.gov identifier NCT02039505). US National Institutes of Health, ClinicalTrials.gov. 2014. http://clinicaltrials.gov/ct2/ show/NCT02039505?term=NCT02039505&rank=1. Accessed 9 June 2014.
    • (2014) Phase III Study of MLN0002 (300 Mg) in the Treatment of Ulcerative Colitis
  • 44
    • 85081462999 scopus 로고    scopus 로고
    • (ClinicalTrials.gov identifier NCT02038920). US National Institutes of Health, ClinicalTrials.gov Accessed 9 June 2014
    • Takeda. Phase III study of MLN0002 (300 mg) in treatment of Crohn's disease (ClinicalTrials.gov identifier NCT02038920). US National Institutes of Health, ClinicalTrials.gov. 2014. http://clinicaltrials.gov/ct2/show/ NCT02038920?term=NCT02038920&rank=1. Accessed 9 June 2014.
    • (2014) Phase III Study of MLN0002 (300 Mg) in Treatment of Crohn's Disease


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.