Stellungnahme zum Nutzenbewertungsverfahren zum Wirkstoff Upadacitinib (Neues Anwendungsgebiet: Colitis ulcerosa, vorbehandelt) – Stellungnahme zu allgemeinen Aspekten

Allgemeine Anmerkung

Upadacitinib (RINVOQ) als Januskinase-Inhibitor (JAKi) wurde schon 2019 für die rheumatoide Arthritis (RA) sowie später auch für weitere rheumatologische Indikationen und jetzt auch am 22.07.2022 für die Colitis ulcerosa (CU) in Deutschland zugelassen. Das Anwendungsgebiet für die CU ist in der Fachinformation folgendermaßen beschrieben:

Publication History

Article published online:
03 February 2023

• Literatur

• 1 Selinger CP, Parkes GC, Bassi A. et al. A multi-centre audit of excess steroid use in 1176 patients with inflammatory bowel disease. Alimentary Pharmacology & Therapeutics 2017; 46 (10) 964-973
• 2 Blumenstein I, Luegering A, Fischer I. et al. Steroid use in a high proportion of IBD patients – first results from the German cohort of the IBD-DICE study (P0436). UEG Journal 2022; 10 (58) 749
• 3 Bokemeyer B. Addressing unmet needs in inflammatory bowel disease. Drug Discov Today 2015; 20 (09) 1037-1039
• 4 Danese S, Vermeire S, Zhou W. et al. Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, multicentre, double-blind, randomised trials. Lancet 2022; 399: 2113-2128
• 5 Napolitano M, D'Amico F, Ragaini E. et al. Evaluating Upadacitinib in the Treatment of Moderate-to-Severe Active Ulcerative Colitis: Design, Development, and Potenzial Position in Therapy. Drug Des Devel Ther 2022; 16: 1897-1913
• 6 https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-24-27-october-2022
• 7 Høivik ML, Bernklev T, Solberg IC. IBSEN Study Group. et al. Patients with Crohn's disease experience reduced general health and vitality in the chronic stage: ten-year results from the IBSEN study. J Crohns Colitis 2012; 6 (04) 441-453
• 8 Høivik ML, Moum B, Solberg IC. IBSEN Group. et al. Work disability in inflammatory bowel disease patients 10 years after disease onset: results from the IBSEN Study. Gut 2013; 62 (03) 368-375
• 9 Bokemeyer B, Picker N, Wilke T. et al. Inadequate Response, Treatment Patterns, Health Care Utilization, and Associated Costs in Patients With Ulcerative Colitis: Retrospective Cohort Study Based on German Claims Data. Inflamm Bowel Dis 2022; 28 (11) 1647-1657
• 10 Kucharzik T, Dignass AU, Atreya R. et al. Aktualisierte S3-Leitlinie Colitis ulcerosa – Living Guideline. Z Gastroenterol. 2020, 58(12):e241-e326. doi: 10.1055/a-1296-3444. PMID: 33260237 und Konsultationsfassung Juli 2022 der Aktualisierten S3-Leitlinie Colitis ulcerosa (Version 4.0) Juli 2022 – AWMF-Registriernummer: 021-009.
• 11 Raine T, Bonovas S, Burisch J. et al. ECCO Guidelines on Therapeutics in Ulcerative Colitis: Medical Treatment. Journal of Crohn's and Colitis 2022; 16 (01) 2-17
• 12 Chowla N, Tariq R, Aggarwal M. et al. Upadacitinib in the Treatment of Ulcerative Colitis. Initial Real-World Experience From a Tertiary Care Center. The American Journal of Gastroenterology 2022; 117: 26
• 13 Juillerat P, Grueber MM, Ruetsch R. et al. Positioning biologics in the treatment of IBD: A practical guide – Which mechanism of action for whom?. Curr Res Pharmacol Drug Discov 2022; 28 (03) 100104
• 14 Eftychi C, Schwarzer R, Vlantis K. et al. Temporally distinct functions of the cytokines il-12 and il-23 drive chronic colon inflammation in response to intestinal barrier impairment.  Immunity 2019; 51 (02) 367-380
• 15 Veny M, Esteller M, Ricart E. et al. Late crohn's disease patients present an increase in peripheral th17 cells and cytokine production compared with early patients. Aliment. Pharmacol. Ther 2010; 31 (05) 561-572
• 16 Solitano V, D'Amico F, Zacharopoulou E. et al. Early Intervention in Ulcerative Colitis: Ready for Prime Time. J Clin Med 2020; 9 (08) 2646