Aktualisierung der Colitis ulcerosa Leitlinie 2020

Um dem Konzept der sogenannten „living guidelines“ Rechnung zu tragen, findet in jährlichen Abständen eine Überarbeitung der 2018 publizierten Colitis-ulcerosa-Leitlinie statt. Hintergrund des Konzepts ist der Wunsch, eine hohe Aktualität der Empfehlungen zu gewährleisten und neue diagnostische und therapeutische Aspekte, die nach Publikation der Leitlinie aufgetreten sind, zu berücksichtigen. Seit der letzten Aktualisierung der Leitlinie im Herbst 2019 hat die Steuergruppe als wesentliche Neuerung die Studiendaten zu Ustekinumab bei Colitis ulcerosa identifiziert, die im Herbst 2019 zur Zulassung der Substanz bei der Colitis ulcerosa mit mittel- bis hochgradiger Entzündungsaktivität und Versagen einer konventionellen Therapie geführt haben. Ustekinumab ist ein monoklonaler Antikörper, der gegen die p40-Untereinheit von Interleukin-12 und -23 gerichtet ist und der bereits eine gute Wirksamkeit und Verträglichkeit bei Patienten mit Morbus Crohn gezeigt hat. Das der Zulassung zugrunde liegende UNIFI-Studienprogramm konnte nun eine signifikante Überlegenheit gegenüber Placebo sowohl in der Induktions- als auch in der Erhaltungstherapie bei Patienten mit mittel- bis hochgradiger Entzündungsaktivität nachweisen [1]. Subanalysen der UNIFI-Studie konnten zeigen, dass bereits 2 Wochen nach Beginn der Induktionstherapie eine Reduktion der Stuhlfrequenz und der Blutbeimengungen sowie eine Reduktion von Calprotectin zu beobachten sind. Kürzlich konnte auch eine gute Langzeitwirkung von Ustekinumab nach 2 Jahren mit geringem Wirkverlust gezeigt werden [2]. Die bisherigen Real-World-Erfahrungen bei Patienten mit Colitis ulcerosa [3] sowie Studiendaten aus der Therapie von CED-Patienten und Daten aus dem PSOLAR-Register bei Psoriasis konnten bisher keine relevanten Signale für unerwünschte Nebenwirkungen, insbesondere das vermehrte Auftreten schwerer Infektionen, kardiovaskulärer Nebenwirkungen oder Hinweise auf Malignität identifizieren [4] [5].

Publication History

Article published online:
01 December 2020

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