Themen – Stellungnahme zur Nutzenbewertung von Risankizumab (Morbus Crohn, vorbehandelte Patient*innen) vom 24. April 2023

• Literatur

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• 2 Holstiege J, Klimke K, Akmatov MK. et al Bundesweite Verordnungstrends biologischer Arzneimittel bei häufigen Autoimmunerkrankungen, 2012 bis 2018. Versorgungsatlas 2021; Bericht Nr. 21/03.
• 3 Burisch J, Kiudelis G, Kupcinskas L. et al. Natural disease course of Crohnʼs disease during the first 5 years after diagnosis in a European population-based inception cohort: an Epi-IBD study. Gut 2019; 68: 423-433
• 4 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) – August 2021 – AWMF-Registernummer: 021-004. Z Gastroenterol 2022; 60 (03) 332-418
• 5 Germer CT. Chirurgische Interventionen bei Morbus Crohn. Chirurg 2021; 92: 1-2
• 6 Ko Y, Paramsothy S, Yau Y. et al. Superior treatment persistence with ustekinumab in Crohn's disease and vedolizumab in ulcerative colitis compared with anti-TNF biological agents: real-world registry data from the Persistence Australian National IBD Cohort (PANIC) study. Aliment Pharmacol Ther 2021; 54: 292-301
• 7 Blesl A, Binder L, Högenauer C. et al. Limited long-term treatment persistence of first anti-TNF therapy in 538 patients with inflammatory bowel diseases: a 20-year real-world study. Aliment Pharmacol Ther 2021; 54 (05) 667-677
• 8 Cheng D, Kochar BD, Cai T. et al.  Risk of Infections With Ustekinumab and Tofacitinib Compared to Tumor Necrosis Factor α Antagonists in Inflammatory Bowel Diseases.  Clin Gastroenterol Hepatol 2022; 20: 2366-2372
• 9 DʼHaens G, Panaccione R, Baert F. et al. Risankizumab as induction therapy for Crohn’s disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. Lancet 2022; 399: 2015-2030
• 10 Ferrante M, Panaccione R, Baert F. et al. Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Lancet 2022; 399: 2031-2046
• 11 Ferrante M, Peyrin-Biroulet L, Dignass A. et al. Clinical and Endoscopic Improvements with Risankizumab Induction and Maintenance Dosing Versus Placebo are Observed Irrespective of Number of Prior Failed Biologics. UEGW 2022, OP128. The American Journal of GASTROENTEROLOGY 2022; 117 SUPPLEMENT.
• 12 Panaccione R, Lee WL, Clark R. et al. Dose Escalation Patterns of Advanced Therapies in Crohn’s Disease and Ulcerative Colitis: A Systematic Literature Review. Adv Ther
• 13 Fumery M, Defrance A, Roblin X. et al. Effectiveness and safety of risankizumab induction therapy for 100 patients with Crohnʼs disease: A GETAID multicentre cohort study. Aliment Pharmacol Ther 2023; 57: 426-434