Safety and Efficacy of Pirfenidone in Advanced Idiopathic Pulmonary Fibrosis: A Nationwide Post-Marketing Surveillance Study in Korean Patients View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2020-04-15

AUTHORS

Man Pyo Chung, Moo Suk Park, In Jae Oh, Heung Bum Lee, Young Whan Kim, Jong Sun Park, Soo Taek Uh, Yun Seong Kim, Yangjin Jegal, Jin Woo Song

ABSTRACT

AIM: The efficacy and safety of pirfenidone have been previously demonstrated in patients with mild-to-moderate idiopathic pulmonary fibrosis (IPF). However, the effect of pirfenidone in patients with advanced IPF remains unclear. Here, we investigated the effects of pirfenidone against advanced IPF in a real-world setting. METHODS: A prospective nationwide post-marketing study was conducted on 258 patients from 10 Korean institutions. Patients with a predicted forced vital capacity (FVC) less than 50% or a diffusing capacity of the lung for carbon monoxide (DLco) less than 35% at baseline were classified as the advanced IPF group. RESULTS: Of 219 patients included in the analysis, the majority were male (76.3%); the mean age was 67.3 years, and the advanced group accounted for 17.8% of the patients. The median treatment duration was 298 days. Among the subjects, 86.3% experienced adverse events (AEs), of which a decreased appetite (32.4%) and a photosensitivity reaction (13.7%) were the most frequent. The incidence of AEs was similar between the advanced and non-advanced groups (92.3% vs. 85.0%, respectively; p = 0.229). Although the overall discontinuation rate was higher in the advanced group than in the non-advanced group (74.4% vs. 50.0%, respectively; p = 0.006), the percentages of the patients who discontinued treatment as a result of AEs were similar in both groups (20.5% vs. 23.3%, respectively; p = 0.704). In all patients, the rates of decline in the predicted FVC and DLco over 48 weeks were - 4.3 ± 1.3% and - 4.4 ± 1.7%, respectively. There was no between-group difference in the rate of lung function decline. CONCLUSIONS: Pirfenidone used for the treatment of patients with IPF in a real-world setting was well tolerated, with an acceptable safety profile and a consistent therapeutic effect, regardless of the disease severity. TRIAL REGISTRATION: ClinicalTrials.gov NCT03761082; the trial was retrospectively registered on December 3, 2018. More... »

PAGES

2303-2316

Journal

TITLE

Advances in Therapy

ISSUE

5

VOLUME

37

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s12325-020-01328-8

DOI

http://dx.doi.org/10.1007/s12325-020-01328-8

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1126703747

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/32297284


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