Evidence map›Paper›PMID 26393389›Full record

Trial reportAmerican journal of respiratory and critical care medicine2016

Efficacy of Nintedanib in Idiopathic Pulmonary Fibrosis across Prespecified Subgroups in INPULSIS.

Ulrich Costabel, Yoshikazu Inoue, Luca Richeldi, Harold R Collard, Inga Tschoepe, Susanne Stowasser, Arata Azuma

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in American journal of respiratory and critical care medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 111 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
111citing papers in PubMed, 5 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

111 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
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  4. Health-related quality of life of patients with idiopathic pulmonary fibrosis: a systematic review and meta-analysis.European respiratory review : an official journal of the European Respiratory Society · 2020
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  6. Dual αAmerican journal of respiratory and critical care medicine · 2025
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  9. A Phase 2 Study of Atezolizumab for Pretreated NSCLC With Idiopathic Interstitial Pneumonitis.Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2020
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51 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors.

Ulrich Costabel1 Ruhrlandklinik, University Hospital, University of Duisburg-Essen, Essen, Germany.
Yoshikazu Inoue2 Clinical Research Center, National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka, Japan.
Luca Richeldi3 National Institute for Health Research Southampton Respiratory Biomedical Research Unit and Clinical and Experimental Sciences, University of Southampton, Southampton, United Kingdom.
Harold R Collard4 Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of California San Francisco, San Francisco, California.
Inga Tschoepe5 Boehringer Ingelheim France S.A.S., Reims, France.
Susanne Stowasser6 Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany; and.
Arata Azuma7 Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

rationaleIn the two replicate, placebo-controlled, 52-week, phase III INPULSIS trials, nintedanib 150 mg twice daily significantly reduced the annual rate of decline in FVC, the primary endpoint, in subjects with idiopathic pulmonary fibrosis (IPF). It is unknown if this effect was uniform across all subjects treated with nintedanib.

objectivesTo investigate the potential association of demographic and clinical variables with the effect of nintedanib in subjects with IPF.

methodsSubgroup analyses of pooled data from the INPULSIS trials were prespecified. Subgroups were analyzed by sex, age (<65, ≥65 yr), race (white, Asian), baseline FVC percentage predicted (≤70%, >70%), baseline St. George's Respiratory Questionnaire (SGRQ) total score (≤40, >40), smoking status (never, ex/current), systemic corticosteroid use (yes/no), and bronchodilator use (yes/no). MEASUREMENTS AND MAIN

resultsA total of 1,061 subjects were treated (nintedanib n = 638, placebo n = 423). There was no statistically significant difference in the effect of nintedanib for the primary endpoint or the key secondary endpoints of change from baseline in SGRQ total score or time to first acute exacerbation in any subgroup. Treatment effects for the key secondary endpoints seemed more pronounced in subjects with baseline FVC ≤70% predicted, because the majority of acute exacerbations and a greater deterioration in SGRQ total score occurred in placebo-treated subjects in this subgroup.

conclusionsPooled data from the INPULSIS trials support a consistent effect of nintedanib across a range of IPF phenotypes by slowing disease progression across a number of prespecified subgroups.

Indexed as

Disease ProgressionEnzyme InhibitorsFemaleHumansIdiopathic Pulmonary FibrosisIndolesMaleMiddle AgedVital CapacityEnzyme InhibitorsIndolesnintedanibdisease progressionforced vital capacityquality of life

Identifiers

PMID26393389

What OpenQuestion holds

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Registered trials

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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.