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Diffuse Lung Disease |

Pirfenidone Post-Authorization Safety Registry (PASSPORT): Update and Concomitant Use of NAC and/or Corticosteroids

Vincent Cottin, MD; Toby Maher, PhD; Arata Azuma, PhD; Lesley Groves, PhD; Philip Hormel, MS; Magnus Sköld, PhD; Sara Tomassetti, MD; Dirk Koschel, MD
Author and Funding Information

Louis Pradel Hospital, Lyon, France; Royal Brompton Hospital, London, United Kingdom; Nippon Medical School, Tokyo, Japan; Genentech, South San Francisco, CA; Karolinska Institute, Stockholm, Sweden; G. B. Morgagni Hospital, Forli, Italy; Fachkrankenhaus Coswig, Coswig, Germany


Chest. 2015;148(4_MeetingAbstracts):364A. doi:10.1378/chest.2245542
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Abstract

SESSION TITLE: Diagnosis and Treatment of IPF

SESSION TYPE: Original Investigation Slide

PRESENTED ON: Monday, October 26, 2015 at 01:30 PM - 02:30 PM

PURPOSE: PASSPORT is a post-authorization safety registry for pirfenidone to collect real-world data in EU patients with idiopathic pulmonary fibrosis (IPF). This analysis assessed the safety of pirfenidone as monotherapy and in combination with N-acetylcysteine (NAC) and/or corticosteroids (CS).

METHODS: 109 EU sites dosed 1006 patients. Safety data were recorded at routine clinic visits for up to 2 years. Pirfenidone-associated adverse drug reactions (ADR) were collected.

RESULTS: At baseline, mean±SD age was 70±8.5 years and mean±SD time since IPF diagnosis was 1.6±2.5 years; 80% of patients were male; supplemental O2 was used by 27% of patients; mean±SD FVC was 2.56±0.78 L; mean±SD % predicted FVC was 66±16% (14% had <50% predicted FVC). The most common comorbidities (>10%) were hypertension, GERD, hypercholesterolemia, and coronary artery disease. At this interim analysis, median time on pirfenidone was 7.6 months and total exposure was 803 patient‑years. Overall, 67% of patients had ≥1 ADR, most commonly: nausea, 17%; fatigue, 15%; decreased appetite, 13%; decreased weight, 12%; rash, 10%; diarrhea, 9%. Of patients who had an ADR, 55% experienced their first ADR within the first 30 days of treatment. Around 5% of patients completed 2 years treatment, 55% are ongoing, 9% died and 21% discontinued due to pirfenidone-related ADRs, most commonly nausea, rash and decreased weight. 11% discontinued for other reasons. Patients with FVC <50% had a higher discontinuation rate than other patients (48% vs 39%, respectively). The imbalance was mainly driven by higher rates of death and lung transplantation. The discontinuation rate due to pirfenidone ADRs was similar among patients with FVC <50% and ≥50% (20.3% vs 20.9%, respectively). 62% of patients received pirfenidone alone; 11%, 8%, and 8% received pirfenidone plus NAC, CS, or NAC+CS, respectively. The remaining 11% had partial use of NAC and/or steroids. ADR incidence was generally consistent for these subgroups except weight decrease and ALT increase, which occurred more often in the pirfenidone+CS group.

CONCLUSIONS: In this real-world setting, pirfenidone was generally safe and well tolerated as monotherapy or combined with NAC and/or CS. The rate of discontinuation due to pirfenidone-related ADRs was similar regardless of disease severity.

CLINICAL IMPLICATIONS: No clinically important new safety findings have emerged from this analysis of real-world usage that would change the favorable risk-benefit profile for pirfenidone observed in clinical trials.

DISCLOSURE: Vincent Cottin: Consultant fee, speaker bureau, advisory committee, etc.: Actelion, Bayer, Boehringer Ingelheim, Gilead, GSK, Intermune / Roche, Novartis, Roche, Sanofi, Biogen Idec Toby Maher: Grant monies (from industry related sources): National Institute for Health Research, the Medical Research Council and the Biotechnology and Biological Research Council, University grant monies: from GlaxoSmithKline R&D, UCB and Novartis, Consultant fee, speaker bureau, advisory committee, etc.: Astra Zeneca, Bayer, Biogen Idec, Boehringer Ingelheim, Cipla, GlaxoSmithKline R&D, Lanthio, InterMune, ProMetic, Roche, Sanofi-Aventis, Takeda and UCB. Arata Azuma: Grant monies (from sources other than industry): Grant of Ministry of Health, Labor and Welfare of Japan, Grant monies (from sources other than industry): Grant of Ministry of Education, Culture, Sports, Science and Technology, Fiduciary position (of any organization, association, society, etc, other than ACCP: Board Member and President Elect of WASOG,, Fiduciary position (of any organization, association, society, etc, other than ACCP: Educational Committee Member of APSR, Fiduciary position (of any organization, association, society, etc, other than ACCP: Associate Editor of Respiratory Investigation, Respiratory Case Report (RCR), and Pulmonary Medicine, Fiduciary position (of any organization, association, society, etc, other than ACCP: A Member of Review Board of Drug related adverse events, in PMDA (Pharmaceuticals and Medical Devices Agency; http://www.pmda.go.jp/), Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim, Shionogi Co., Takeda Pharmaceutical Co., GSK United Kingdom, InterMune®, AFT Pharmaceuticals, , Other: Eizai Co., Pfizer Inc. Lesley Groves: Employee: Contract employee of Roche through Advanced Clinical, Inc Philip Hormel: Employee: Roche Genentech Magnus Sköld: Consultant fee, speaker bureau, advisory committee, etc.: InterMune, Boehringer Ingelheim, Novartis, Almirall, AstraZeneca, GlaxoSmithKline, Mundipharma, Chiesi, Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim, Intermune Novartis, GlaxoSmithKline, Nycomed, Grant monies (from industry related sources): Sandoz, Other: Boehringer Ingelheim, Intermune, Actelion Sara Tomassetti: Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim, InterMune and Chiesi Dirk Koschel: Consultant fee, speaker bureau, advisory committee, etc.: Almirall, Alk Abello, Bayer Vital, Berlin Chemie, Boehringer Ingelheim, Intermune, Janssen-Cilag, Mundipharma, Novartis and Roche

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