PMID- 35078170
OWN - NLM
STAT- MEDLINE
DCOM- 20220603
LR  - 20220712
IS  - 1423-0356 (Electronic)
IS  - 0025-7931 (Linking)
VI  - 101
IP  - 6
DP  - 2022
TI  - Nintedanib in IPF: Post hoc Analysis of the Italian FIBRONET Observational Study.
PG  - 577-584
LID - 10.1159/000521138 [doi]
AB  - BACKGROUND: The FIBRONET study was an observational study of patients with 
      idiopathic pulmonary fibrosis (IPF) in Italy. OBJECTIVES: In this post hoc 
      descriptive analysis, we describe changes in lung function, anxiety/depression, 
      coughing, exacerbations, and adverse events (AEs) in patients receiving 
      nintedanib treatment. METHODS: Patients with IPF from 20 centers in Italy, aged 
      >/=40 years who received nintedanib for >/=7 months, were followed up for 12 months 
      from study enrollment, attending clinic visits every 3 months. Outcomes included 
      change in forced vital capacity (FVC)% predicted from baseline to 12 months, 
      anxiety/depression measured by the Hospital Anxiety and Depression Scale (HADS), 
      and the proportion of patients with cough, AEs, and exacerbations. RESULTS: In 
      total, 52 patients received nintedanib (mean duration of 11.6 months). Ten 
      patients had dose reductions from 150 mg to 100 mg twice daily, due to AEs. FVC% 
      predicted was unchanged in the overall nintedanib population (78.7% at baseline; 
      79.8% at 12 months) and those with a reduced dose (77.7% at baseline; 81.0% at 12 
      months). HADS score was low at baseline and throughout the study. The proportion 
      of patients with cough decreased from 50.0% to 21.2% over 12 months. Two patients 
      experienced exacerbations, 2 patients discontinued treatment, and 27 (51.9%) 
      reported AEs. The most common AE was diarrhea (34.6%). CONCLUSIONS: In patients 
      with IPF who received nintedanib in the FIBRONET study, FVC% predicted was stable 
      over 12 months, and the proportion of patients with cough decreased. The safety 
      profile was consistent with the known safety profile for nintedanib in IPF.
CI  - (c) 2022 The Author(s). Published by S. Karger AG, Basel.
FAU - Harari, Sergio
AU  - Harari S
AD  - Department of Clinical Sciences and Community Health, University of Milan, Milan, 
      Italy.
AD  - U.O. di Pneumologia e Terapia Semi-Intensiva Respiratoria, Ospedale San Giuseppe, 
      IRCCS MultiMedica, Milan, Italy.
FAU - Pesci, Alberto
AU  - Pesci A
AD  - Department of Medicine, Respiratory Unit, University of Milano-Bicocca, ASST 
      Monza, Monza, Italy.
FAU - Albera, Carlo
AU  - Albera C
AD  - SC Pneumologia U, A.O.U. Citta Della Scienza e della Salute (Molinette), 
      University of Torino, Turin, Italy.
FAU - Poletti, Venerino
AU  - Poletti V
AD  - Department of Diseases of the Thorax, Ospedale GB Morgagni, Forli, Italy.
AD  - Department of Respiratory Diseases & Allergy, Aarhus University Hospital, Aarhus, 
      Denmark.
FAU - Amici, Christian
AU  - Amici C
AD  - MediNeos Observational Research, Modena, Italy.
FAU - Crespi, Giovanna
AU  - Crespi G
AD  - Boehringer Ingelheim, Milan, Italy.
FAU - Campolo, Benedetta
AU  - Campolo B
AD  - Boehringer Ingelheim, Milan, Italy.
FAU - Vancheri, Carlo
AU  - Vancheri C
AD  - Regional Referral Centre for Rare Lung Diseases, University-Hospital "Policlinico 
      G. Rodolico", Department of Clinical and Experimental Medicine, University of 
      Catania, Catania, Italy.
CN  - FIBRONET study group
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20220125
PL  - Switzerland
TA  - Respiration
JT  - Respiration; international review of thoracic diseases
JID - 0137356
RN  - 0 (Indoles)
RN  - G6HRD2P839 (nintedanib)
SB  - IM
MH  - Cough/drug therapy
MH  - Humans
MH  - *Idiopathic Pulmonary Fibrosis/drug therapy
MH  - Indoles/adverse effects
MH  - Treatment Outcome
MH  - Vital Capacity
OTO - NOTNLM
OT  - Antifibrotic treatment
OT  - Idiopathic pulmonary fibrosis
OT  - Lung function
OT  - Nintedanib
OT  - Observational study
EDAT- 2022/01/26 06:00
MHDA- 2022/06/07 06:00
CRDT- 2022/01/25 20:18
PHST- 2021/05/26 00:00 [received]
PHST- 2021/11/22 00:00 [accepted]
PHST- 2022/01/26 06:00 [pubmed]
PHST- 2022/06/07 06:00 [medline]
PHST- 2022/01/25 20:18 [entrez]
AID - 000521138 [pii]
AID - 10.1159/000521138 [doi]
PST - ppublish
SO  - Respiration. 2022;101(6):577-584. doi: 10.1159/000521138. Epub 2022 Jan 25.