Adalimumab in der Behandlung der Colitis ulcerosa – ein Konsensus der Arbeitsgruppe Chronisch Entzündliche Darmerkrankungen der Österreichischen Gesellschaft für Gastroenterologie und Hepatologie

Zusammenfassung

TNF-alpha-Antikörper haben den Verlauf der mittelschweren bis schweren aktiven Colitis ulcerosa wesentlich verbessert. Adalimumab ist der erste vollständig humane, monoklonale TNF-alpha-Antikörper, den Patienten selbst subkutan applizieren können. Adalimumab ist seit April 2012 zur Behandlung der mittelschweren bis schweren, aktiven Colitis ulcerosa bei Patienten zugelassen, bei denen mit einer adäquaten Therapie mit einem Glukokortikoid und einem Immunsuppressivum kein ausreichendes Ansprechen erzielt werden konnte, oder die eine entsprechende Unverträglichkeit aufweisen oder bei denen diese Therapien kontraindiziert sind. Mit Adalimumab können verglichen mit Placebo bei Patienten mit mittelschwerer bis schwerer aktiver Colitis ulcerosa häufiger eine klinische Remission und eine mukosale Heilung induziert und aufrechterhalten werden, die Zahl der Colitis ulcerosa-bedingten Krankenhausaufenthalte verringert sowie die gesundheitsbezogene Lebensqualität verbessert werden. Der Wirkungseintritt kann bereits nach 2 Wochen der Therapie erfolgen. Die Sicherheitsdaten von Adalimumab entsprechen weitgehend jenen anderer TNF-alpha-Blocker. In den bisher publizierten Studien zum Einsatz von Adalimumab bei Colitis ulcerosa wurden keine neuen Sicherheitsfragen aufgeworfen. Der vorliegende Konsensusbericht der Arbeitsgruppe Chronisch Entzündliche Darmerkrankungen der Österreichischen Gesellschaft für Gastroenterologie und Hepatologie (ÖGGH) fasst die aktuelle Datenlage zu Adalimumab in der Behandlung der Colitis ulcerosa zusammen und soll als praktischer Leitfaden für die Anwendung von Adalimumab bei Patienten mit Colitis ulcerosa dienen.

Abstract

TNF alpha antibodies have clearly improved the outcome of moderately to severely active ulcerative colitis. Adalimumab is the first fully human, monoclonal TNF alpha antibody, which is administered subcutaneously. Since April 2012 adalimumab is approved for the treatment of moderately to severely active ulcerative colitis in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant or who are intolerant to or have medical contraindications for such therapies. Adalimumab can induce and maintain clinical remission and mucosal healing compared to placebo in moderately to severely active ulcerative colitis, can reduce the rate of ulcerative colitis related hospitalisations and improve health-related quality of life. The response can be observed after two weeks of treatment. The safety profile of adalimumab is comparable to those of other TNF alpha inhibitors. Studies on the treatment of ulcerative colitis with adalimumab did not reveal new safety aspects. The present consensus report by the Working Group Inflammatory Bowel Diseases of the Austrian Society of Gastroenterology and Hepatology presents the existing evidence of adalimumab for the treatment of ulcerative colitis and is aimed to assist as code of its practice.

Schlüsselwörter

Colitis ulcerosa - chronisch entzündliche Darmerkrankung - TNF-alpha-Blocker

Key words

ulcerative colitis - chronic inflammatory bowel disease - TNF alpha inhibitor

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