Vedolizumab induction therapy for inflammatory bowel disease in clinical practice - A nationwide consecutive German cohort study

Alimentary Pharmacology and Therapeutics

Volumn 43, Issue 10, 2016, Pages 1090-1102

  Baumgart, D C ^a   Bokemeyer, B ^b   Drabik, A ^c   Stallmach, A ^d   Schreiber, S ^e   Atreya, Raya ^f   Bachmann, Oliver ^f   Busse, Karin ^f   Bläker, Michael ^f   Börner, Norbert ^f   Büning, Jürgen ^f   Dignass, Axel ^f   Ehehalt, Robert ^f   Ende, Karin ^f   Fischer, Andreas ^f   Jessen, Petra ^f   Hartmann, Franz ^f   Hartmann, Heinz ^f   Hartmann, Petra ^f   Maul, Jochen ^f   Krupka, Niklas ^f   Krummenerl, Thomas ^f   Kühbacher, Tanja ^f   Lügering, Andreas ^f   Mross, Michael ^f   Neurath, Markus ^f   Nikolaus, Susanna ^f   Preiss, Jan ^f   Reinshagen, Max ^f   Schmelz, Renate ^f   Schmidt, Carsten ^f   Siegmund, Britta ^f   Teich, Niels ^f   Von Arnim, Ulrike ^f   more..

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^b KLINIKUM MINDEN   (Germany)

^c Biostatistics Consulting   (Germany)

^d JENA UNIVERSITY HOSPITAL   (Germany)

^e UNIVERSITY HOSPITAL SCHLESWIG HOLSTEIN   (Germany)

^f NONE

Author keywords

[No Author keywords available]

Indexed keywords

5 ACETAMIDOSALICYLIC ACID; C REACTIVE PROTEIN; CALGRANULIN; HEMOGLOBIN; IMMUNOMODULATING AGENT; STEROID; VEDOLIZUMAB; MONOCLONAL ANTIBODY; TUMOR NECROSIS FACTOR;

ABDOMINAL PAIN; ACNE; ACUTE GENERALIZED EXANTHEMATOUS PUSTULOSIS; ACUTE KIDNEY FAILURE; ADULT; ANUS FISSURE; APHTHOUS STOMATITIS; ARTHRALGIA; ARTHRITIS; ARTICLE; CLINICAL TRIAL; CLOSTRIDIUM DIFFICILE INFECTION; COUGHING; CROHN DISEASE; DIGESTIVE SYSTEM DISEASE ASSESSMENT; DRUG EFFICACY; DRUG RESPONSE; DRUG WITHDRAWAL; DRY SKIN; ERYTHEMA NODOSUM; FATIGUE; FEMALE; FEVER; GERMAN (CITIZEN); HARVEY BRADSHAW INDEX; HEADACHE; HELICOBACTER INFECTION; HERPETIC STOMATITIS; HUMAN; INFECTION; INFLAMMATORY BOWEL DISEASE; MAJOR CLINICAL STUDY; MALE; MALNUTRITION; MEMORY DISORDER; MULTICENTER STUDY; NAUSEA; PARESTHESIA; PARTIAL MAYO SCORE; PRIORITY JOURNAL; PRURITUS; RASH; REMISSION; RHINOPHARYNGITIS; ULCERATIVE COLITIS; COHORT ANALYSIS; COLITIS, ULCERATIVE; GERMANY; PROSPECTIVE STUDY; SMOKING;

ADULT; ANTIBODIES, MONOCLONAL, HUMANIZED; COHORT STUDIES; COLITIS, ULCERATIVE; CROHN DISEASE; FEMALE; GERMANY; HUMANS; LEUKOCYTE L1 ANTIGEN COMPLEX; MALE; PROSPECTIVE STUDIES; REMISSION INDUCTION; SMOKING; TUMOR NECROSIS FACTOR-ALPHA;

EID: 84962635821     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/apt.13594     Document Type: Article

References (43)

1. Baumgart DC, Sandborn WJ,. Crohn's disease. Lancet 2012; 380: 1590-605.
2. Ordás I, Eckmann L, Talamini M, Baumgart DC, Sandborn WJ,. Ulcerative colitis. Lancet 2012; 380: 1606-19.
3. Baumgart DC, le Claire M,. The Expenditures for Academic Inpatient Care of Inflammatory Bowel Disease Patients Are Almost Double Compared with Average Academic Gastroenterology and Hepatology Cases and Not Fully Recovered by Diagnosis-Related Group (DRG) Proceeds. PLoS One. 2016 Jan 19; 11 (1): e0147364.
4. Selby WS, Janossy G, Bofill M, Jewell DP,. Intestinal lymphocyte subpopulations in inflammatory bowel disease: an analysis by immunohistological and cell isolation techniques. Gut 1984; 25: 32-40.
5. Thomas S, Baumgart DC,. Targeting leukocyte migration and adhesion in Crohn's disease and ulcerative colitis. Inflammopharmacology 2012; 20: 1-18.
6. Streeter PR, Berg EL, Rouse BT, Bargatze RF, Butcher EC,. A tissue-specific endothelial cell molecule involved in lymphocyte homing. Nature 1988; 331: 41-6.
7. Hu MC, Crowe DT, Weissman IL, Holzmann B,. Cloning and expression of mouse integrin beta p(beta 7): a functional role in Peyer's patch-specific lymphocyte homing. Proc Natl Acad Sci USA 1992; 89: 8254-8.
8. Berlin C, Berg EL, Briskin MJ, et al,. Alpha 4 beta 7 integrin mediates lymphocyte binding to the mucosal vascular addressin MAdCAM-1. Cell 1993; 74: 185-95.
9. Briskin MJ, McEvoy LM, Butcher EC,. MAdCAM-1 has homology to immunoglobulin and mucin-like adhesion receptors and to IgA1. Nature 1993; 363: 461-4.
10. Erle DJ, Briskin MJ, Butcher EC, Garcia-Pardo A, Lazarovits AI, Tidswell M,. Expression and function of the MAdCAM-1 receptor, integrin alpha 4 beta 7, on human leukocytes. J Immunol 1994; 153: 517-28.
11. Wagner N, Lohler J, Kunkel EJ, et al,. Critical role for beta7 integrins in formation of the gut-associated lymphoid tissue. Nature 1996; 382: 366-70.
12. Briskin M, Winsor-Hines D, Shyjan A, et al,. Human mucosal addressin cell adhesion molecule-1 is preferentially expressed in intestinal tract and associated lymphoid tissue. Am J Pathol 1997; 151: 97-110.
13. Binion DG, West GA, Ina K, Ziats NP, Emancipator SN, Fiocchi C,. Enhanced leukocyte binding by intestinal microvascular endothelial cells in inflammatory bowel disease. Gastroenterology 1997; 112: 1895-907.
14. Krupka N, Baumgart DC,. Designing biologic selectivity for inflammatory bowel disease-role of vedolizumab. Drug Des Devel Ther 2015; 9: 147-54.
15. Soler D, Chapman T, Yang LL, 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: 864-75.
16. 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.
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. 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: 1002-7
19. 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): 5-36.
20. Lewis JD, Chuai S, Nessel L, Lichtenstein GR, Aberra FN, Ellenberg JH,. Use of the noninvasive components of the Mayo score to assess clinical response in ulcerative colitis. Inflamm Bowel Dis 2008; 14: 1660-6.
21. Harvey RF, Bradshaw JM,. A simple index of Crohn's-disease activity. Lancet 1980; 1: 514.
22. Vermeire S, Schreiber S, Sandborn WJ, Dubois C, Rutgeerts P,. Correlation between the Crohn's disease activity and Harvey-Bradshaw indices in assessing Crohn's disease severity. Clin Gastroenterol Hepatol 2010; 8: 357-63.
23. Medical Dicitionary for Regulatory Activities (MedDRA) The MSSO-Maintenance and Support Services Organization, Chantilly, VA, USA, 2013.
24. 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 failed. Gastroenterology 2014; 147: 618-27 e3.
25. Parkes GC, Whelan K, Lindsay JO,. Smoking in inflammatory bowel disease: impact on disease course and insights into the aetiology of its effect. J Crohns Colitis 2014; 8: 717-25.
26. Lunney PC, Leong RW,. Review article: ulcerative colitis, smoking and nicotine therapy. Aliment Pharmacol Ther 2012; 36: 997-1008.
27. Mosli MH, MacDonald JK, Bickston SJ, et al,. Vedolizumab for induction and maintenance of remission in ulcerative colitis: a Cochrane systematic review and meta-analysis. Inflamm Bowel Dis 2015; 21: 1151-9.
28. Baumgart DC, Grittner U, Steingraber A, Azzaro M, Philipp S,. Frequency, phenotype, outcome, and therapeutic impact of skin reactions following initiation of adalimumab therapy: experience from a consecutive cohort of inflammatory bowel disease patients. Inflamm Bowel Dis 2011; 17: 2512-20.
29. Palucka AK, Blanck JP, Bennett L, Pascual V, Banchereau J,. Cross-regulation of TNF and IFN-alpha in autoimmune diseases. Proc Natl Acad Sci USA 2005; 102: 3372-7.
30. Tillack C, Ehmann LM, Friedrich M, et al,. Anti-TNF antibody-induced psoriasiform skin lesions in patients with inflammatory bowel disease are characterised by interferon-gamma-expressing Th1 cells and IL-17A/IL-22-expressing Th17 cells and respond to anti-IL-12/IL-23 antibody treatment. Gut 2014; 63: 567-77.
31. Hirsch A, Colman RJ, Lang GD, Rubin DT,. Successful treatment of ulcerative colitis with vedolizumab in a patient with an infliximab-associated psoriasiform rash. ACG Case Rep J 2015; 2: 236-8.
32. Wyant T, Leach T, Sankoh S, et al,. Vedolizumab affects antibody responses to immunisation selectively in the gastrointestinal tract: randomised controlled trial results. Gut 2015; 64: 77-83.
33. Luthra P, Peyrin-Biroulet L, Ford AC,. Systematic review and meta-analysis: opportunistic infections and malignancies during treatment with anti-integrin antibodies in inflammatory bowel disease. Aliment Pharmacol Ther 2015; 41: 1227-36.
34. Boland BS, Dulai PS, Chang M, Sandborn WJ, Levesque BG,. Pseudomonas meningitis during vedolizumab therapy for Crohn's disease. Am J Gastroenterol 2015; 110: 1631-2.
35. 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.
36. Vivio E, Kanuri ND, Dey N, Chen CH, Gutierrez A, Ciorba MA,. Vedolizumab efficacy and safety in a tertiary care IBD clinical practice. Gastroenterology 2015; 148: S871-2.
37. Christensen B, Goeppinger SR, Colman RJ, et al,. Vedolizumab in the treatment of IBD: the University of Chicago experience. Gastroenterology 2015; 148: S866.
38. Eriksson C, Almer S, Bjoerk JA, et al,. Vedolizumab in inflammatory bowel disease, the first experience from the Swedish IBD Registry (SWIBREG). Gastroenterology 2015; 148: S871.
39. Amiot A, Grimaud JC, Treton X, et al,. The French real-life experience of vedolizumab efficacy and safety in Crohn's disease: a prospective, observational multicenter cohort study. United Eur Gastroenterol J 2015; 3: A16.
40. Amiot A, Peyrin-Biroulet L, Stefanescu L, et al,. The French real-life experience of vedolizumab efficacy and safety in ulcerative colitis: a prospective, observational multicenter cohort study. United Eur Gastroenterol J 2015; 3: A16.
41. 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; 89: 1621-35.
42. Vermeire S, O'Byrne S, Keir M, et al,. Etrolizumab as induction therapy for ulcerative colitis: a randomised, controlled, phase 2 trial. Lancet 2014; 384: 309-18.
43. Vermeire S, Ghosh S, Panes J, et al,. The mucosal addressin cell adhesion molecule antibody PF-00547,659 in ulcerative colitis: a randomised study. Gut 2011; 60: 1068-75.