Positionspapier der Arbeitsgruppe Chronisch Entzündliche Darmerkrankungen der ÖGGH zum Einsatz von Vedolizumab subkutan

Zusammenfassung

Der humanisierte monoklonale anti-α4β7-Integrin-Antikörper Vedolizumab ist eine von mehreren biologischen Therapieoptionen bei moderaten und schweren Verläufen von Colitis ulcerosa und Morbus Crohn. Im Zuge des VISIBLE-Studienprogramms wurde zusätzlich zur etablierten intravenösen Verabreichung eine subkutane Administrationsform von Vedolizumab erprobt. Die Arbeitsgruppe CED der Österreichischen Gesellschaft für Gastroenterologie und Hepatologie (ÖGGH) fasst in diesem Positionspapier die Datenlage zur subkutanen Applikation von Vedolizumab zusammen, ergänzt ein bestehendes Positionspapier zum Stellenwert von Vedolizumab als Erstlinientherapie bei chronisch entzündlichen Darmerkrankungen und bietet praxisnahe Empfehlungen zur praktischen Anwendung.

Abstract

The humanized monoclonal anti-α4β7-integrin-antibody vedolizumab is one of several biologic therapeutic options in moderate-to-severe ulcerative colitis and Crohn’s disease. Within the VISIBLE trial program, a novel subcutaneous application route was evaluated in addition to the already established intravenous form. In this position statement, the working group “Inflammatory Bowel Diseases” of the Austrian Society for Gastroenterology and Hepatology (OEGGH) summarizes the evidence regarding the subcutaneous application of vedolizumab. This work supplements a position paper on the value of vedolizumab as a first-line biologic that has already been published and offers useful recommendations for clinical practice.

Schlüsselwörter

Chronisch entzündliche Darmerkrankung - Colitis ulcerosa - Morbus Crohn

Keywords

Inflammatory Bowel Disease - Ulcerative Colitis - Crohn's Disease

Publikationsverlauf

Eingereicht: 30. April 2023

Angenommen nach Revision: 03. August 2023

Artikel online veröffentlicht:
20. September 2023

• Literatur

• 1 Blesl A, Högenauer C, Koch R. et al. Stellenwert von Vedolizumab als Erstlinienbiologikum bei chronisch-entzündlichen Darmerkrankungen (CED). Journal für Gastroenterologische und Hepatologische Erkrankungen 2019; 17: 10-17
• 2 Vermeire S, Danese S, Kisfalvi K. et al. S0653 Long-Term Treatment With Vedolizumab SC in Ulcerative Colitis: Interim Results From VISIBLE OLE. Official journal of the American College of Gastroenterology | ACG 2020; 115
• 3 Sandborn WJ, Wolf DC, D‘Haens GR. et al. Sa1880 DOSE ESCALATION OF SUBCUTANEOUS VEDOLIZUMAB IN PATIENTS WITH ULCERATIVE COLITIS: A POST HOC ANALYSIS OF THE VISIBLE TRIAL DATA. Gastroenterology 2020; 158: S-463
• 4 Wolf D, Danese S, Matthews B. et al. 634 Transitioning From Vedolizumab IV to Vedolizumab SC in Patients With Ulcerative Colitis: Results From the VISIBLE Program. Official journal of the American College of Gastroenterology | ACG 2019; 114: S369-S370
• 5 Novacek G, Dejaco C, Gröchenig HP. et al. Vedolizumab in der Behandlung der Colitis ulcerosa und des Morbus Crohn – ein Konsensus der Arbeitsgruppe „Chronisch Entzündliche Darmerkrankungen“ der Österreichischen Gesellschaft für Gastroenterologie und Hepatologie. Z Gastroenterol 2016; 54: 456-467
• 6 Sandborn WJ, Baert F, Danese S. et al. Efficacy and Safety of Vedolizumab Subcutaneous Formulation in a Randomized Trial of Patients With Ulcerative Colitis. Gastroenterology 2020; 158: 562-572 e512
• 7 Vermeire S, D’Haens G, Baert F. et al. Efficacy and Safety of Subcutaneous Vedolizumab in Patients With Moderately to Severely Active Crohn’s Disease: Results From the VISIBLE 2 Randomised Trial. J Crohns Colitis 2022; 16: 27-38
• 8 Vaughn BP, Yarur AJ, Graziano E. et al. Vedolizumab Serum Trough Concentrations and Response to Dose Escalation in Inflammatory Bowel Disease. J Clin Med 2020; 9
• 9 Outtier A, Wauters L, Rahier JF. et al. Effect of vedolizumab dose intensification on serum drug concentrations and regain of response in inflammatory bowel disease patients with secondary loss of response. GastroHep 2021; 3: 63-71
• 10 Wang Z, Verstockt B, Sabino J. et al. Therapeutic Drug Monitoring Can Guide the Intravenous-to-Subcutaneous Switch of Infliximab and Vedolizumab: A Simulation Study. Clin Gastroenterol Hepatol 2023;
• 11 Feuerstein JD, Ho EY, Shmidt E. et al. AGA Clinical Practice Guidelines on the Medical Management of Moderate to Severe Luminal and Perianal Fistulizing Crohn’s Disease. Gastroenterology 2021; 160: 2496-2508
• 12 Torres J, Bonovas S, Doherty G. et al. ECCO Guidelines on Therapeutics in Crohn’s Disease: Medical Treatment. J Crohns Colitis 2020; 14: 4-22
• 13 Kucharzik T, Dignass AU, Atreya R. et al. Aktualisierte S3-Leitlinie Colitis ulcerosa – Living Guideline. Z Gastroenterol 2020; 58: e241-e326
• 14 Sturm A, Atreya R, Bettenworth D. et al. Aktualisierte S3-Leitlinie „Diagnostik und Therapie des Morbus Crohn“ der Deutschen Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten (DGVS)AWMF. 2021
• 15 Raine T, Bonovas S, Burisch J. et al. ECCO Guidelines on Therapeutics in Ulcerative Colitis: Medical Treatment. Journal of Crohn’s and Colitis 2021; 16: 2-17
• 16 Lamb CA, Kennedy NA, Raine T. et al. British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults. Gut 2019; 68: s1-s106
• 17 Vickers AD, Ainsworth C, Mody R. et al. Systematic Review with Network Meta-Analysis: Comparative Efficacy of Biologics in the Treatment of Moderately to Severely Active Ulcerative Colitis. PLOS ONE 2016; 11: e0165435
• 18 Cholapranee A, Hazlewood GS, Kaplan GG. et al. Systematic review with meta-analysis: comparative efficacy of biologics for induction and maintenance of mucosal healing in Crohn’s disease and ulcerative colitis controlled trials. Alimentary pharmacology & therapeutics 2017; 45: 1291-1302
• 19 Sands BE, Peyrin-Biroulet L, Loftus EV. et al. Vedolizumab versus Adalimumab for Moderate-to-Severe Ulcerative Colitis. New England Journal of Medicine 2019; 381: 1215-1226
• 20 Bressler B, Yarur A, Kopylov U. et al. 638 Clinical Effectiveness of First-Line Anti-TNF Therapies and Second-Line Anti-TNF Therapy Post-Vedolizumab Discontinuation in Patients With Ulcerative Colitis or Crohn’s Disease. Official journal of the American College of Gastroenterology | ACG 2019; 114: S373
• 21 Terjung B, Schmelz R, Ehehalt R. et al. Safety of vedolizumab in the treatment of pregnant women with inflammatory bowel disease: a targeted literature review. Therapeutic advances in gastroenterology 2020; 13: 1756284820952592
• 22 Chambers C, Adams J, Johnson D. et al. 717 The Vedolizumab Pregnancy Exposure Registry: An OTIS Pregnancy Study Update. Official journal of the American College of Gastroenterology | ACG 2019; 114
• 23 Torres J, Chaparro M, Julsgaard M. et al. European Crohn’s and Colitis Guidelines on Sexuality, Fertility, Pregnancy, and Lactation. Journal of Crohn’s and Colitis 2022; 17: 1-27
• 24 Mahadevan U, Robinson C, Bernasko N. et al. Inflammatory Bowel Disease in Pregnancy Clinical Care Pathway: A Report From the American Gastroenterological Association IBD Parenthood Project Working Group. Gastroenterology 2019; 156: 1508-1524
• 25 Rath E, Bonelli M, Duftner C. et al. National consensus statement by the Austrian Societies for Rheumatology, Pulmonology, Infectiology, Dermatology and Gastroenterology regarding the management of latent tuberculosis and the associated utilization of biologic and targeted synthetic disease modifying antirheumatic drugs (DMARDs). Wien Klin Wochenschr 2022;
• 26 Takeda. Fachinformation Vedolizumab Subkutan. 2022
• 27 Ventress E, Young D, Rahmany S. et al. Transitioning from Intravenous to Subcutaneous Vedolizumab in Patients with Inflammatory Bowel Disease [TRAVELESS]. Journal of Crohn‘s and Colitis 2021; 16: 911-921