Evidence map›Paper›PMID 32026347›Full record

ArticlePulmonary therapy2017

Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis: Experience from 92 Sites in an Open-Label US Expanded Access Program.

Lisa Lancaster, Lake Morrison, Alexander Auais, Beiying Ding, Ahmar Iqbal, Boris Polman, Kevin R Flaherty

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pulmonary therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02141087 (A Treatment Protocol to Allow Patients in the US With Idiopathic Pulmonary Fibrosis Access to Pirfenidone), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02141087 approved for marketingnot on this map

A Treatment Protocol to Allow Patients in the US With Idiopathic Pulmonary Fibrosis Access to Pirfenidone

Typeexpanded_accessSponsorGenentech, Inc.ConditionsIdiopathic Pulmonary FibrosisArmsPirfenidone
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Fibrosis following Acute Skeletal Muscle Injury: Mitigation and Reversal Potential in the Clinic.Journal of sports medicine (Hindawi Publishing Corporation) · 2020
    Review
  6. Pirfenidone prevents and reverses hepatic insulin resistance and steatohepatitis by polarizing M2 macrophages.Laboratory investigation; a journal of technical methods and pathology · 2019
    Article
  7. Article
  8. Article
  9. Pirfenidone safety and adverse event management in idiopathic pulmonary fibrosis.European respiratory review : an official journal of the European Respiratory Society · 2017
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 1 country.

Lisa LancasterDepartment of Medicine, Vanderbilt University, Nashville, TN, USA. lisa.lancaster@vanderbilt.edu.
Lake MorrisonDepartment of Medicine, Duke University, Durham, NC, USA.
Alexander AuaisGenentech, Inc., South San Francisco, CA, USA.
Beiying DingGenentech, Inc., South San Francisco, CA, USA.
Ahmar IqbalGenentech, Inc., South San Francisco, CA, USA.
Boris PolmanGenentech, Inc., South San Francisco, CA, USA.
Kevin R FlahertyDepartment of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
Duke University · USUniversity of Michigan–Ann Arbor · USVanderbilt University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIn phase 3 clinical trials, pirfenidone significantly slowed disease progression with a well-defined and medically manageable safety profile in patients with idiopathic pulmonary fibrosis (IPF). This study examined safety events related to pirfenidone in patients with IPF in an expanded access program in the US.

methodsThe Expanded Access Program allowed patients with IPF access to pirfenidone prior to US Food and Drug Administration approval. Patients had an IPF diagnosis including a definite or possible usual interstitial pneumonia (UIP) pattern, predicted forced vital capacity ≥50%, and predicted diffusing capacity for carbon monoxide ≥30%. Clinical laboratory data and adverse drug reactions (ADRs) deemed causally related to pirfenidone were analyzed using descriptive summary statistics.

resultsOf the 1620 patients treated, 1221 (75.4%) completed the program: 66.5% had definite UIP, and 33.2% had possible UIP. Mean (SD) pirfenidone exposure was 22.8 (9.6) weeks, and mean (SD) daily dose during the course of treatment was 2058.7 (399.2) mg. ADRs occurred in 64.9% of patients: 3.3% were severe and 0.2% life threatening. The most common ADRs were nausea (22.6%) and fatigue (19.6%); 13.0% of patients discontinued due to ADRs. Serious ADRs occurred in 24 patients (1.5%), which were primarily related to elevated liver function enzymes (ten patients, 0.6%). No ADRs led to death.

conclusionsIn this open-label study of 1620 patients with IPF, including those with possible UIP, the safety profile of pirfenidone was consistent with that of earlier clinical trials, and no new safety signals were identified. NCT02141087.

fundingGenentech, Inc., a member of the Roche group.

Indexed as

Idiopathic pulmonary fibrosisPirfenidoneSafety

Identifiers

PMID32026347
PMCPMC6964201
OpenAlexW2751886337

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.