All-case post-marketing surveillance of 1371 patients treated with pirfenidone for idiopathic pulmonary fibrosis.

Abstract

BACKGROUND:

Idiopathic pulmonary fibrosis (IPF) is a chronic fibrotic lung disease with a median survival of 2-5 years and limited treatment options. In 2008, pirfenidone became the first drug to be approved for IPF treatment in Japan. The aim of this study was to assess the safety of pirfenidone for IPF treatment in a clinical setting.

METHODS:

We conducted a safety-oriented post-marketing surveillance of all patients with IPF who were administered pirfenidone in the first year after its launch in Japan. This was a prospective, non-interventional, observational study. Case report forms were used to collect survey data, comprising adverse events, acute exacerbations, patient demographics, concomitant drug use, and concurrent treatment data.

RESULTS:

Of the 1371 patients available for safety evaluation, two-thirds had stage III-IV disease. The incidence of total adverse drug reactions (ADRs) was 64.6%. ADRs with an incidence of ≥3% were decreased appetite, photosensitivity reaction, nausea, abdominal discomfort, malaise, somnolence, and hepatic function abnormal. This safety profile was consistent with the findings in phase II and III trials in Japan. The discontinuation rates due to adverse events at 12 months for each disease stage were similar; however, discontinuation caused by disease progression increased with disease severity. Treatment with pirfenidone stabilized both vital capacity and subjective symptoms in most patients (70-80%) treated for at least 6 months.

CONCLUSIONS:

This post-marketing surveillance in Japan showed that pirfenidone was generally well tolerated in patients with IPF, including those with severe lung function impairment.

• Authors: Takashi Ogura, Arata Azuma, Yoshikazu Inoue, Hiroyuki Taniguchi, Kingo Chida, Masashi Bando, Yuka Niimi, Shinichi Kakutani, Moritaka Suga, Yukihiko Sugiyama, Shoji Kudoh, Toshihiro Nukiwa
• Journal: Respiratory investigation (Respir Investig) Vol. 53 Issue 5 Pg. 232-41 (Sep 2015) ISSN: 2212-5353 [Electronic] Netherlands
• PMID: 26344613 (Publication Type: Journal Article, Observational Study, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2015 The Japanese Respiratory Society. Published by Elsevier B.V. All rights reserved.

Chemical References

• Pyridones
• pirfenidone

Topics

• Aged
• Disease Progression
• Female
• Humans
• Idiopathic Pulmonary Fibrosis (drug therapy, physiopathology)
• Male
• Middle Aged
• Product Surveillance, Postmarketing
• Prospective Studies
• Pyridones (adverse effects, therapeutic use)
• Severity of Illness Index
• Treatment Outcome
• Vital Capacity