Vedolizumab provides clinical benefit over 1 year in patients with active inflammatory bowel disease – a prospective multicenter observational study

Alimentary Pharmacology and Therapeutics

Volumn 44, Issue 11-12, 2016, Pages 1199-1212

  Stallmach, A ^a   Langbein, C ^a   Atreya, R ^a   Bruns, T ^a   Dignass, A ^a   Ende, K ^a   Hampe, J ^a   Hartmann, F ^a   Neurath, M F ^a   Maul, J ^a   Preiss, J C ^a   Schmelz, R ^a   Siegmund, B ^a   Schulze, H ^a   Teich, N ^a   von Arnim, U ^a   Baumgart, D C ^a   Schmidt, C ^a  

^a NONE   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; AZATHIOPRINE; BUDESONIDE; C REACTIVE PROTEIN; CALGRANULIN; CYCLOSPORIN A; GOLIMUMAB; INFLIXIMAB; MERCAPTOPURINE; MESALAZINE; METHOTREXATE; TACROLIMUS; VEDOLIZUMAB; GASTROINTESTINAL AGENT; INTEGRIN; INTEGRIN ALPHA4BETA7; MONOCLONAL ANTIBODY;

ABDOMINAL ABSCESS; ADULT; AGED; ANAPHYLAXIS; ARTHRALGIA; ARTHRITIS; ARTICLE; BRONCHITIS; CLINICAL TRIAL; CROHN DISEASE; DRUG EFFICACY; DRUG RESPONSE; DRUG WITHDRAWAL; FATIGUE; FEMALE; HUMAN; HYPERSENSITIVITY; INFECTION; INFLAMMATORY BOWEL DISEASE; LOWER RESPIRATORY TRACT INFECTION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OBSERVATIONAL STUDY; PNEUMONIA; PRIORITY JOURNAL; REMISSION; TREATMENT OUTCOME; ULCERATIVE COLITIS; ADOLESCENT; ANTAGONISTS AND INHIBITORS; CHEMISTRY; COLITIS, ULCERATIVE; FECES; IMMUNOLOGY; METABOLISM; MIDDLE AGED; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; ANTIBODIES, MONOCLONAL, HUMANIZED; C-REACTIVE PROTEIN; COLITIS, ULCERATIVE; CROHN DISEASE; FECES; FEMALE; GASTROINTESTINAL AGENTS; HUMANS; INTEGRINS; LEUKOCYTE L1 ANTIGEN COMPLEX; MALE; MIDDLE AGED; YOUNG ADULT;

EID: 84991014384     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/apt.13813     Document Type: Article

References (35)

1. Lakatos PL. Recent trends in the epidemiology of inflammatory bowel diseases: up or down? World J Gastroenterol 2006; 12: 6102–8.
2. Hanauer SB, Feagan BG, Lichtenstein GR, et al. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet 2002; 359: 1541–9.
3. Rutgeerts P, Sandborn WJ, Feagan BG, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med 2005; 353: 2462–76.
4. Sandborn WJ, Feagan BG, Stoinov S, et al. Certolizumab pegol for the treatment of Crohn's disease. N Engl J Med 2007; 357: 228–38.
5. 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.
6. 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: 257–65 e1–3.
7. Sandborn WJ, Feagan BG, Marano C, et al. Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology 2014; 146: 85–95; quiz e14–5.
8. Yanai H, Hanauer SB. Assessing response and loss of response to biological therapies in IBD. Am J Gastroenterol 2011; 106: 685–98.
9. Gisbert JP, Panes J. Loss of response and requirement of infliximab dose intensification in Crohn's disease: a review. Am J Gastroenterol 2009; 104: 760–7.
10. 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 Crohns Colitis 2010; 4: 355–66.
11. Ben-Horin S. Loss of response to anti-tumor necrosis factors: what is the next step? Dig Dis 2014; 32: 384–8.
12. Billioud V, Sandborn WJ, Peyrin-Biroulet L. Loss of response and need for adalimumab dose intensification in Crohn's disease: a systematic review. Am J Gastroenterol 2011; 106: 674–84.
13. Roda G, Jharap B, Neeraj N, et al. Loss of response to anti-TNFs: definition, epidemiology, and management. Clin Transl Gastroenterol 2016; 7: e135.
14. Soler D, Chapman T, Yang LL, 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: 864–75.
15. Fischer A, Zundler S, Atreya R, et al. Differential effects of alpha4beta7 and GPR15 on homing of effector and regulatory T cells from patients with UC to the inflamed gut in vivo. Gut 2016; 65: 1642–64.
16. Stallmach A, Schmidt C, Teich N. Vedolizumab for the treatment of ulcerative colitis. Expert Rev Gastroenterol Hepatol 2016; 10: 165–75.
17. 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.
18. Sandborn WJ, Feagan BG, Rutgeerts P, et al. Vedolizumab as induction and maintenance therapy for Crohn's disease. N Engl J Med 2013; 369: 711–21.
19. Gies N, Kroeker KI, Wong K, et al. Treatment of ulcerative colitis with adalimumab or infliximab: long-term follow-up of a single-centre cohort. Aliment Pharmacol Ther 2010; 32: 522–8.
20. 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: 2879–85.
21. Vivio EE, Kanuri N, Gilbertsen JJ, et al. Vedolizumab effectiveness and safety over the first year of use in an IBD clinical practice. J Crohns Colitis 2016; 10: 402–9.
22. Amiot A, Grimaud JC, Peyrin-Biroulet L, et al. Effectiveness and safety of vedolizumab induction therapy for patients with inflammatory bowel disease. Clin Gastroenterol Hepatol 2016; doi: 10.1016/j.cgh.2016.02.016 [Epub ahead of print].
23. 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: 1090–102.
24. 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: 1147–55.
25. Silverberg MS, Satsangi J, Ahmad T, et al. Toward an integrated clinical, molecular and serological classification of inflammatory bowel disease: report of a Working Party of the 2005 Montreal World Congress of Gastroenterology. Can J Gastroenterol 2005; 19(Suppl A): 5A–36A.
26. Lewis JD, Chuai S, Nessel L, et al. Use of the noninvasive components of the Mayo score to assess clinical response in ulcerative colitis. Inflamm Bowel Dis 2008; 14: 1660–6.
27. Harvey RF, Bradshaw JM. A simple index of Crohn's-disease activity. Lancet 1980; 1: 514.
28. Wolfe F. Fatigue assessments in rheumatoid arthritis: comparative performance of visual analog scales and longer fatigue questionnaires in 7760 patients. J Rheumatol 2004; 31: 1896–902.
29. Brandse JF, Vos LM, Jansen J, et al. Serum Concentration of Anti-TNF Antibodies, Adverse Effects and Quality of Life in Patients with Inflammatory Bowel Disease in Remission on Maintenance Treatment. J Crohns Colitis 2015; 9: 973–81.
30. Kopylov U, Yung D, Engel T, et al. Fecal calprotectin for the prediction of small-bowel Crohn's disease by capsule endoscopy: a systematic review and meta-analysis. Eur J Gastroenterol Hepatol 2016; 28: 1137–44.
31. Papoutsaki M, Talamonti M, Giunta A, et al. The impact of methodological approaches for presenting long-term clinical data on estimates of efficacy in psoriasis illustrated by three-year treatment data on infliximab. Dermatology 2010; 221(Suppl. 1): 43–7.
32. Jürgens M, Mahachie John JM, Cleynen I, et al. Levels of C-reactive protein are associated with response to infliximab therapy in patients with Crohn's disease. Clin Gastroenterol Hepatol 2011; 9: 421–7 e1.
33. De Vos M, Dewit O, D'Haens G, et al. Fast and sharp decrease in calprotectin predicts remission by infliximab in anti-TNF naive patients with ulcerative colitis. J Crohns Colitis 2012; 6: 557–62.
34. Reinisch W, Wang Y, Oddens BJ, et al. C-reactive protein, an indicator for maintained response or remission to infliximab in patients with Crohn's disease: a post-hoc analysis from ACCENT I. Aliment Pharmacol Ther 2012; 35: 568–76.
35. Boschetti G, Garnero P, Moussata D, et al. Accuracies of serum and fecal S100 proteins (calprotectin and calgranulin C) to predict the response to TNF antagonists in patients with Crohn's disease. Inflamm Bowel Dis 2015; 21: 331–6.