All-case post-marketing surveillance of 1371 patients treated with pirfenidone for idiopathic pulmonary fibrosis.
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.
Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, 6-16-1 Tomioka-higashi, Kanazawa-ku, Yokohama, Kanagawa 236-0051, Japan. Electronic address: ogura201407@yahoo.co.jp.
Takashi
T
Ogura
Department of Pulmonary Medicine and Oncology, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo 113-8602, Japan. Electronic address: azuma_arata@yahoo.co.jp.
Arata
A
Azuma
Clinical Research Center, National Hospital Organization, Kinki-Chuo Chest Medical Center, 1180 Nagasone-cho, Kita-ku, Sakai, Osaka 591-8555, Japan. Electronic address: giichi@kch.hosp.go.jp.
Yoshikazu
Y
Inoue
Department of Respiratory Medicine and Allergy, Tosei General Hospital, 160 Nishioiwake-cho, Seto, Aichi 489-8642, Japan. Electronic address: hiro-tosei-lung@kkd.biglobe.ne.jp.
Hiroyuki
H
Taniguchi
Hamamatsu Toyooka Hospital, 110 Toyooka-cho, Kita-ku, Hamamatsu, Shizuoka 433-8103, Japan. Electronic address: chidak9211@gmail.com.
Kingo
K
Chida
Division of Pulmonary Medicine, Department of Medicine, Jichi Medical University, 3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan. Electronic address: bando034@jichi.ac.jp.
Masashi
M
Bando
Department of Pharmacovigilance, Shionogi & Co., Ltd., 1-8, Doshomachi 3-chome, Chuo-ku, Osaka 541-0045, Japan. Electronic address: yuka.niimi@shionogi.co.jp.
Yuka
Y
Niimi
Department of Biostatistics, Shionogi & Co., Ltd., 12F, Hankyu Terminal Building, 1-4, Shibata 1-chome, Kita-ku, Osaka 530-0012, Japan. Electronic address: shinichi.kakutani@shionogi.co.jp.
Shinichi
S
Kakutani
Center for Preventive Medicine, Saiseikai Kumamoto Hospital, 5-3-1, Chikami, Minami-ku, Kumamoto 861-4193,Japan. Electronic address: suga-taka-0825@rose.odn.ne.jp.
Moritaka
M
Suga
Division of Pulmonary Medicine, Department of Medicine, Jichi Medical University, 3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan. Electronic address: sugiyuki@jichi.ac.jp.
Yukihiko
Y
Sugiyama
Japan Anti-Tuberculosis Association, 1-3-12, Misakicho, Chiyoda-ku, Tokyo 101-0061, Japan. Electronic address: skudou@jatahq.org.
Shoji
S
Kudoh
Japan Anti-Tuberculosis Association, 1-3-12, Misakicho, Chiyoda-ku, Tokyo 101-0061, Japan. Electronic address: toshinkw47@gmail.com.
Toshihiro
T
Nukiwa
D000368:Aged; D018450:Disease Progression; D005260:Female; D006801:Humans; D054990:Idiopathic Pulmonary Fibrosis / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D011728:Pyridones / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014797:Vital Capacity
D011728:Pyridones; C093844:pirfenidone
Idiopathic pulmonary fibrosis; Pirfenidone; Post-marketing surveillance; Safety