An Open-label Study With Pirfenidone on Chronic Hypersensitivity Pneumonitis.
Adult
Alveolitis, Extrinsic Allergic
/ chemically induced
Anti-Inflammatory Agents
/ pharmacology
Anti-Inflammatory Agents, Non-Steroidal
/ therapeutic use
Azathioprine
/ pharmacology
Carbon Monoxide
/ pharmacology
Double-Blind Method
Female
Humans
Idiopathic Pulmonary Fibrosis
/ chemically induced
Immunosuppressive Agents
/ pharmacology
Lung
Male
Middle Aged
Prednisone
/ pharmacology
Prospective Studies
Pyridones
/ therapeutic use
Quality of Life
Treatment Outcome
Vital Capacity
/ drug effects
Fibrosis pulmonar
Hypersensitivity pneumonitis
Neumonitis por hipersensibilidad
Pirfenidona
Pirfenidone
Pulmonary fibrosis
Journal
Archivos de bronconeumologia
ISSN: 2173-5751
Titre abrégé: Arch Bronconeumol (Engl Ed)
Pays: Spain
ID NLM: 101777538
Informations de publication
Date de publication:
Mar 2020
Mar 2020
Historique:
received:
11
07
2019
revised:
31
07
2019
accepted:
27
08
2019
pubmed:
1
12
2019
medline:
27
5
2021
entrez:
1
12
2019
Statut:
ppublish
Résumé
Chronic hypersensitivity pneumonitis (cHP) represents a severe lung disease often evolving to fibrosis with the subsequent destruction of the lung parenchyma. There are no approved therapies with confirmed efficacy to deal with this disease. We performed an open-label, proof of concept study, to evaluate the efficacy and safety of pirfenidone added to immunosuppressive drugs on the treatment of cHP. We included 22 patients assigned to two groups: Group 1, nine patients that received prednisone plus azathioprine and Group 2, thirteen patients, received prednisone plus azathioprine and pirfenidone (ClinicalTrials.gov identifier NCT02496182). There were no significant imbalances in clinically relevant baseline characteristics between two study groups. After 1 year of treatment, inclusion of pirfenidone was not associated with improved forced vital capacity (primary end-point). A not significant tendency to show higher improvement of diffusion capacity of the lung for carbon monoxide (D These findings suggest that the addition of pirfenidone to the anti-inflammatory treatment in patients with chronic HP may improve the outcome with acceptable safety profile. However, prospective randomized double-blind, placebo-controlled trials in largest cohorts are needed to validate its efficacy.
Sections du résumé
BACKGROUND
Chronic hypersensitivity pneumonitis (cHP) represents a severe lung disease often evolving to fibrosis with the subsequent destruction of the lung parenchyma. There are no approved therapies with confirmed efficacy to deal with this disease.
METHODS
We performed an open-label, proof of concept study, to evaluate the efficacy and safety of pirfenidone added to immunosuppressive drugs on the treatment of cHP. We included 22 patients assigned to two groups: Group 1, nine patients that received prednisone plus azathioprine and Group 2, thirteen patients, received prednisone plus azathioprine and pirfenidone (ClinicalTrials.gov identifier NCT02496182). There were no significant imbalances in clinically relevant baseline characteristics between two study groups.
RESULTS
After 1 year of treatment, inclusion of pirfenidone was not associated with improved forced vital capacity (primary end-point). A not significant tendency to show higher improvement of diffusion capacity of the lung for carbon monoxide (D
CONCLUSIONS
These findings suggest that the addition of pirfenidone to the anti-inflammatory treatment in patients with chronic HP may improve the outcome with acceptable safety profile. However, prospective randomized double-blind, placebo-controlled trials in largest cohorts are needed to validate its efficacy.
Identifiants
pubmed: 31784348
pii: S0300-2896(19)30381-3
doi: 10.1016/j.arbres.2019.08.019
pii:
doi:
Substances chimiques
Anti-Inflammatory Agents
0
Anti-Inflammatory Agents, Non-Steroidal
0
Immunosuppressive Agents
0
Pyridones
0
Carbon Monoxide
7U1EE4V452
pirfenidone
D7NLD2JX7U
Azathioprine
MRK240IY2L
Prednisone
VB0R961HZT
Banques de données
ClinicalTrials.gov
['NCT02496182']
Types de publication
Clinical Trial
Journal Article
Langues
eng
spa
Sous-ensembles de citation
IM
Pagination
163-169Informations de copyright
Copyright © 2020 SEPAR. Publicado por Elsevier España, S.L.U. All rights reserved.