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

被引:72
作者
Ogura, Takashi [1 ]
Azuma, Arata [2 ]
Inoue, Yoshikazu [3 ]
Taniguchi, Hiroyuki [4 ]
Chida, Kingo [5 ]
Bando, Masashi [6 ]
Niimi, Yuka [7 ]
Kakutani, Shinichi [8 ]
Suga, Moritaka [9 ]
Sugiyama, Yukihiko [6 ]
Kudoh, Shoji [10 ]
Nukiwa, Toshihiro [10 ]
机构
[1] Kanagawa Cardiovasc & Resp Ctr, Dept Resp Med, Kanazawa Ku, 6-16-1 Tomioka Higashi, Yokohama, Kanagawa 2360051, Japan
[2] Nippon Med Sch, Dept Pulm Med & Oncol, Bunkyo Ku, Tokyo 1138602, Japan
[3] Kinki Chuo Chest Med Ctr, Natl Hosp Org, Clin Res Ctr, Kita Ku, Sakai, Osaka 5918555, Japan
[4] Tosei Gen Hosp, Dept Resp Med & Allergy, Seto, Aichi 4898642, Japan
[5] Hamamatsu Toyooka Hosp, Kita Ku, Hamamatsu, Shizuoka 4338103, Japan
[6] Jichi Med Univ, Dept Med, Div Pulm Med, Shimotsuke, Tochigi 3290498, Japan
[7] Shionogi & Co Ltd, Dept Pharmacovigilance, Chuo Ku, Osaka 5410045, Japan
[8] Shionogi & Co Ltd, Dept Biostat, Kita Ku, Osaka 5300012, Japan
[9] Saiseikai Kumamoto Hosp, Ctr Prevent Med, Minami Ku, Kumamoto 8614193, Japan
[10] Japan AntiTB Assoc, Chiyoda Ku, Tokyo 1010061, Japan
关键词
Idiopathic pulmonary fibrosis; Pirfenidone; Post-marketing surveillance; Safety;
D O I
10.1016/j.resinv.2015.06.001
中图分类号
R56 [呼吸系及胸部疾病];
学科分类号
摘要
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. Copyright (C) 2015 The Japanese Respiratory Society. Published by Elsevier B.V. All rights reserved.
引用
收藏
页码:232 / 241
页数:10
相关论文
共 29 条
[1]  
Amer Thoracic Soc, 2000, AM J RESP CRIT CARE, V161, P646
[2]   Predictors of the clinical effects of pirfenidone on idiopathic pulmonary fibrosis [J].
Arai, Toru ;
Inoue, Yoshikazu ;
Sasaki, Yumiko ;
Tachibana, Kazunobu ;
Nakao, Keiko ;
Sugimoto, Chikatoshi ;
Okuma, Tomohisa ;
Akira, Masanori ;
Kitaichi, Masanori ;
Hayashi, Seiji .
RESPIRATORY INVESTIGATION, 2014, 52 (02) :136-143
[3]   Double-blind, placebo-controlled trial of pirfenidone in patients with idiopathic pulmonary fibrosis [J].
Azuma, A ;
Nukiwa, T ;
Tsuboi, E ;
Suga, M ;
Abe, S ;
Nakata, K ;
Taguchi, Y ;
Nagai, S ;
Itoh, H ;
Ohi, M ;
Sato, A ;
Kudoh, S ;
Raghu, G .
AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE, 2005, 171 (09) :1040-1047
[4]   Exploratory analysis of a phase III trial of pirfenidone identifies a subpopulation of patients with idiopathic pulmonary fibrosis as benefiting from treatment [J].
Azuma, Arata ;
Taguchi, Yoshio ;
Ogura, Takashi ;
Ebina, Masahito ;
Taniguchi, Hiroyuki ;
Kondoh, Yasuhiro ;
Suga, Moritaka ;
Takahashi, Hiroki ;
Nakata, Koichiro ;
Sato, Atsuhiko ;
Kudoh, Shoji ;
Nukiwa, Toshihiro .
RESPIRATORY RESEARCH, 2011, 12
[5]   Clinical experience with pirfenidone for the treatment of idiopathic pulmonary fibrosis [J].
Bonella, F. ;
Wessendorf, T. E. ;
Costabel, U. .
DEUTSCHE MEDIZINISCHE WOCHENSCHRIFT, 2013, 138 (11) :518-523
[6]  
Chiba H, 2012, EPIDEMIOLOGICAL SURV, P125
[7]   Changes in clinical and physiologic variables predict survival in idiopathic pulmonary fibrosis [J].
Collard, HR ;
King, TE ;
Bartelson, BB ;
Vourlekis, JS ;
Schwarz, MI ;
Brown, KK .
AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE, 2003, 168 (05) :538-542
[8]  
FLETCHER CM, 1952, P ROY SOC MED, V45, P577
[9]  
Japanese Respiratory Society's Committee formulating diagnosis and treatment guideline for diffuse lung diseases, 2011, CLIN DIAGN TREATM GU, P111
[10]   A Phase 3 Trial of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis [J].
King, Talmadge E., Jr. ;
Bradford, Williamson Z. ;
Castro-Bernardini, Socorro ;
Fagan, Elizabeth A. ;
Glaspole, Ian ;
Glassberg, Marilyn K. ;
Gorina, Eduard ;
Hopkins, Peter M. ;
Kardatzke, David ;
Lancaster, Lisa ;
Lederer, David J. ;
Nathan, Steven D. ;
Pereira, Carlos A. ;
Sahn, Steven A. ;
Sussman, Robert ;
Swigris, Jeffrey J. ;
Noble, Paul W. .
NEW ENGLAND JOURNAL OF MEDICINE, 2014, 370 (22) :2083-2092