PuSH - Publikationsserver des Helmholtz Zentrums München

Bonella, F.* ; Kreuter, M.* ; Hagmeyer, L.* ; German Nintedanib Compassionate Use Consortium (Neurohr, C. ; Milger, K.) ; Keller, C.* ; Kohlhaeufl, M.J.* ; Mueller-Quernheim, J.* ; Prasse, A.*

Insights from the German compassionate use program of nintedanib for the treatment of idiopathic pulmonary fibrosis.

Respiration 92, 98-106 (2016)
Verlagsversion Forschungsdaten DOI
Open Access Hybrid
Creative Commons Lizenzvertrag
Background: Nintedanib is approved for the treatment of idiopathic pulmonary fibrosis(IPF) and has been shown to slow disease progression by reducing annual lung function decline. Objective: To evaluate the results of a large cohort of IPF patients treated with nintedanib within a compassionate use program(CUP) in Germany(9 centers). Methods: Patients ( >= 40 years) were required to have a confirmed diagnosis of IPF, a forced vital capacity(FVC) >= 50% predicted ( pred.) and a carbon monoxide diffusing capacity(DLCO) 30-79% pred. and not to be eligible for pirfenidone treatment. Clinical data, pulmonary function tests and adverse events were recorded up to July 2015. Results: Sixty-two patients (48 male/14 female) with moderate IPF (FVC 64 +/- 17% pred. and DLCO 40 +/- 10% pred.) were treated with nintedanib. 77% of patients switched from pirfenidone (mean treatment duration 14 +/- 2 months) mostly due to disease progression (mean decline in FVC 7.4 +/- 3% pred. in the 6 months prior to nintedanib intake). Initiation of nintedanib treatment occurred 69 +/- 29 months after IPF diagnosis, and mean treatment duration was 8 +/- 4 months. Most patients (63%) stabilized 6 months after treatment start (mean FVC decline 3 +/- 1 vs. -17 +/- 2% in patients with disease progression; p < 0.01). The most common adverse events were diarrhea (63%) and weight loss (50%). Dose reduction occurred in 34% of cases and treatment discontinuation in 10%. Conclusion: Nintedanib treatment was generally well tolerated and was associated with FVC stabilization in the majority of IPF patients in this CUP setting where most patients were not treatment naive. Our data are in agreement with the previously published data.
Impact Factor
Scopus SNIP
Web of Science
Times Cited
Scopus
Cited By
Altmetric
2.651
1.155
49
54
Tags
Anmerkungen
Besondere Publikation
Auf Hompepage verbergern

Zusatzinfos bearbeiten
Eigene Tags bearbeiten
Privat
Eigene Anmerkung bearbeiten
Privat
Auf Publikationslisten für
Homepage nicht anzeigen
Als besondere Publikation
markieren
Publikationstyp Artikel: Journalartikel
Dokumenttyp Wissenschaftlicher Artikel
Schlagwörter Idiopathic Pulmonary Fibrosis ; Nintedanib ; Compassionate Use; Management; Efficacy; Pirfenidone; Diagnosis; Safety; Ipf
Sprache englisch
Veröffentlichungsjahr 2016
HGF-Berichtsjahr 2016
ISSN (print) / ISBN 0025-7931
e-ISSN 1423-0356
Zeitschrift Respiration
Quellenangaben Band: 92, Heft: 2, Seiten: 98-106 Artikelnummer: , Supplement: ,
Verlag Karger
Verlagsort Basel
Begutachtungsstatus Peer reviewed
POF Topic(s) 30503 - Chronic Diseases of the Lung and Allergies
Forschungsfeld(er) Lung Research
PSP-Element(e) G-501691-001
Erfassungsdatum 2016-12-31