Stellungnahme zur Nutzenbewertung von Etrasimod (Colitis ulcerosa, ≥ 16 Jahre)

Deutsche Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten (DGVS)
Stellungnehmer: Prof. Dr. med. Oliver Bachmann, Pforzheim

Gesellschaft für Pädiatrische Gastroenterologie und Ernährung (GPGE)
Stellungnehmer: Prof. Dr. med. Jan Däbritz, Greifswald & Prof. Dr. med. Jan de Laffolie, Gießen

Publikationsverlauf

Artikel online veröffentlicht:
10. Oktober 2024

• Literatur

• 1 Le Berre C, Honap S, Peyrin-Biroulet L. Ulcerative colitis. Lancet 2023; 402: 571-584
• 2 Raine T. et al. ECCO Guidelines on Therapeutics in Ulcerative Colitis: Medical Treatment. J Crohns Colitis 2022; 16 (01) 2-17
• 3 Kucharzik T. et al. Aktualisierte S3-Leitlinie Colitis ulcerosa (Version 6.2). Z Gastroenterol 2024; 62 (05) 769-858
• 4 Turner D. et al. STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD. Gastroenterology 2021; 160 (05) 1570-1583
• 5 Chanchlani N. et al. Mechanisms and management of loss of response to anti-TNF therapy for patients with Crohn’s disease: 3-year data from the prospective, multicentre PANTS cohort study. Lancet Gastroenterol Hepatol 2024; 9 (06) 521-538
• 6 Solitano V. et al. Comparative Risk of Serious Infections With Biologic Agents and Oral Small Molecules in Inflammatory Bowel Diseases: A Systematic Review and Meta-Analysis. Clin Gastroenterol Hepatol 2023; 21 (04) 907-921
• 7 Dai N. et al. Colectomy rates in ulcerative colitis: A systematic review and meta-analysis. Dig Liver Dis 2023; 55 (01) 13-20
• 8 Spinelli A. et al. ECCO Guidelines on Therapeutics in Ulcerative Colitis: Surgical Treatment. J Crohns Colitis 2022; 16 (02) 179-189
• 9 Verstockt B. et al. Sphingosine 1-phosphate modulation and immune cell trafficking in inflammatory bowel disease. Nat Rev Gastroenterol Hepatol 2022; 19 (06) 351-366
• 10 Sandborn WJ. et al. Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies. Lancet 2023; 401: 1159-1171
• 11 Regueiro M. et al. Etrasimod for the Treatment of Ulcerative Colitis: Analysis of Infection Events From the ELEVATE UC Clinical Program. J Crohns Colitis 2024;
• 12 Faubion WA Jr. et al. The natural history of corticosteroid therapy for inflammatory bowel disease: a population-based study. Gastroenterology 2001; 121 (02) 255-260
• 13 Ho GT. et al. The efficacy of corticosteroid therapy in inflammatory bowel disease: analysis of a 5-year UK inception cohort. Aliment Pharmacol Ther 2006; 24 (02) 319-330
• 14 Sands BE. et al. Vedolizumab versus Adalimumab for Moderate-to-Severe Ulcerative Colitis. N Engl J Med 2019; 381 (13) 1215-1226
• 15 Verstockt B. et al. Results of the Seventh Scientific Workshop of ECCO: Precision Medicine in IBD-Disease Outcome and Response to Therapy. J Crohns Colitis 2021; 15 (09) 1431-1442
• 16 Noor NM. et al. A biomarker-stratified comparison of top-down versus accelerated step-up treatment strategies for patients with newly diagnosed Crohn’s disease (PROFILE): a multicentre, open-label randomised controlled trial. Lancet Gastroenterol Hepatol 2024; 9 (05) 415-427
• 17 Etrasimod (Colitis ulcerosa) – Nutzenbewertung gemäß § 35a SGB V – Dossierbewertung. 2024, Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen.
• 18 Rokkas T. et al. Comparative maintenance performance of all biologic agents and small molecules in ulcerative colitis: a network meta-analysis. Eur J Gastroenterol Hepatol 2024; 36 (05) 520-533
• 19 Vermeire S. et al. Impact of Prior Biologic or Janus Kinase Inhibitor Therapy on Efficacy and Safety of Etrasimod in the ELEVATE UC 52 and ELEVATE UC 12 Trials. J Crohns Colitis 2024;
• 20 Herrlinger KR, Stange EF. Prioritization in inflammatory bowel disease therapy. Expert Rev Gastroenterol Hepatol 2023; 17 (08) 753-767
• 21 Langholz E. et al. Incidence and prevalence of ulcerative colitis in Copenhagen county from 1962 to 1987. Scand J Gastroenterol 1991; 26 (12) 1247-1256
• 22 Peyrin-Biroulet L. et al. Efficacy and Safety of Etrasimod in Patients with Moderately to Severely Active Isolated Proctitis: Results From the Phase 3 ELEVATE UC Clinical Programme. J Crohns Colitis 2024;
• 23 Turner D. et al. Management of Paediatric Ulcerative Colitis, Part 1: Ambulatory Care-An Evidence-based Guideline From European Crohn’s and Colitis Organization and European Society of Paediatric Gastroenterology, Hepatology and Nutrition. J Pediatr Gastroenterol Nutr 2018; 67 (02) 257-291
• 24 Turner D. et al. Management of Paediatric Ulcerative Colitis, Part 2: Acute Severe Colitis-An Evidence-based Consensus Guideline From the European Crohn’s and Colitis Organization and the European Society of Paediatric Gastroenterology, Hepatology and Nutrition. J Pediatr Gastroenterol Nutr 2018; 67 (02) 292-310