Erfahrungen und unterstützende Hinweise zur Anwendung von Nintedanib bei Patienten mit idiopathischer Lungenfibrose

Zusammenfassung

Im Oktober 2016 fand in Frankfurt auf Einladung von Boehringer Ingelheim ein Treffen deutscher IPF-Experten mit der Zielsetzung statt, praxisrelevante Aspekte der Behandlung der idiopathischen Lungenfibrose (IPF) mit Nintedanib zu erörtern und unterstützende Hilfestellungen für den klinischen Behandlungsalltag zu formulieren. Die resultierenden Hinweise dieses Dokumentes beschränken sich auf praktische Fragen und Erfahrungen zur Anwendung von Nintedanib bei IPF. Die Wahl des Medikaments bei Vorliegen verschiedener Therapieoptionen wurde hier nicht diskutiert. Hierzu verweisen die teilnehmenden Experten auf die aktuellen Leitlinien zur Diagnose und Therapie der IPF.

Die Teilnehmer diskutierten anhand von 10 Themenbereichen ein umfassendes Spektrum klinischer Fragestellungen einer IPF-Behandlung mit Nintedanib. Hierzu zählten u. a. patientenbezogene Aspekte bei Therapiebeginn, die Behandlung antikoagulierter IPF-Patienten und der Umgang mit unerwünschten Arzneimittelwirkungen unter Nintedanib (z. B. gastrointestinale Nebenwirkungen, Leberenzymerhöhungen).

Weiterhin erörterten die Experten Therapiemaßnahmen unter fortschreitender Krankheitsprogression des IPF-Patienten, klinische Umstände, die einen Therapieabbruch mit Nintedanib rechtfertigen, sowie therapeutische Handlungsoptionen bei akuter Exazerbation oder schwerer Infektion. Abschließend diskutierten die Teilnehmer die Vorgehensweise vor/nach elektiven Eingriffen (z. B. Lungentransplantation) unter Therapie mit Nintedanib und die gegenwärtige Evidenz für den Einsatz einer antifibrotischen Kombinationstherapie bei IPF-Patienten.

In die zu jedem Themenbereich formulierten Hinweise einer IPF-Therapie mit Nintedanib ist die publizierte Evidenz aus klinischen Studien eingeflossen. Bei unzureichender oder fehlender Datenlage haben die Experten auf Grundlage eigener klinischer Erfahrungen und Einschätzungen Empfehlungen formuliert.

Abstract

In October 2016, a group of German IPF experts were invited by Boehringer Ingelheim to meet in Frankfurt with the aim, (a) to discuss relevant aspects of the management and treatment of idiopathic pulmonary fibrosis (IPF) using nintedanib; and, (b) to provide supportive advice for daily clinical practice with nintedanib. The resulting information compiled in this document is confined to practical issues regarding the use of nintedanib in patients with IPF. Where different therapeutic options were available, the choice of IPF medication was not discussed and the experts alluded to current guidelines for the diagnosis and treatment of IPF.

The participants discussed a comprehensive spectrum of clinical questions related to 10 different topics, including patient-related aspects at initiation of IPF therapy, the treatment of anticoagulated IPF patients, and the handling of nintedanib-related adverse events such as gastrointestinal side effects and elevated liver enzymes. In addition, the experts evaluated therapeutic options for IPF patients with continuous disease progression, clinical scenarios that justify discontinuation of nintedanib treatment, and therapeutic options for IPF patients with an acute exacerbation or severe infection. Finally, the participants discussed the handling of nintendanib before/after elective surgical intervention (e. g. lung transplantation) and the current evidence for antifibrotic combination therapy in patients with IPF.

For each topic discussed, the resulting information incorporates published evidence from clinical trials. In case of insufficient or lacking evidence, the experts have formulated recommendations based on their personal clinical experience and evaluation.

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