Evidence map›Paper›PMID 31329360›Full record

Trial reportRespirology (Carlton, Vic.)2020

Long-term treatment with nintedanib in Asian patients with idiopathic pulmonary fibrosis: Results from INPULSIS®-ON.

Jin Woo Song, Takashi Ogura, Yoshikazu Inoue, Zuojun Xu, Manuel Quaresma, Susanne Stowasser, Wibke Stansen, Bruno Crestani

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Respirology (Carlton, Vic.), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 2 pooled it
3.0field-weighted citation impact, top 8% 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.

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

29 citing papers in PubMed, 2 syntheses or guidelines pooled it, 38 citations in OpenAlex.

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  18. Disease progression in idiopathic pulmonary fibrosis under anti-fibrotic treatment.Sarcoidosis, vasculitis, and diffuse lung diseases : official journal of WASOG · 2023
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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

8 authors at 6 institutions in 5 countries.

Jin Woo SongDepartment of Pulmonary and Critical Care Medicine, ASAN Medical Centre, University of Ulsan College of Medicine, Seoul, South Korea.ORCID 0000-0001-5121-3522
Takashi OguraDepartment of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Centre, Yokohama, Japan.ORCID 0000-0002-7445-270X
Yoshikazu InoueClinical Research Center, National Hospital Organization Kinki-Chuo Chest Medical Centre, Osaka, Japan.ORCID 0000-0003-3994-874X
Zuojun XuPeking Union Medical College Hospital, Beijing, China.
Manuel QuaresmaBoehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
Susanne StowasserBoehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
Wibke StansenBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.
Bruno CrestaniService de Pneumologie A, DHU FIRE, APHP, Hôpital Bichat, Paris, France.
Boehringer Ingelheim (Germany) · DEChinese Academy of Medical Sciences & Peking Union Medical College · CNInserm · FRKanagawa Cardiovascular and Respiratory Center · JPNHO Kinki Chuo Chest Medical Center · JPUlsan College · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveThe efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis (IPF) were investigated in the placebo-controlled INPULSIS® trials. All patients who completed an INPULSIS® trial could receive open-label nintedanib in the extension trial INPULSIS®-ON.

methodsWe assessed the long-term efficacy and safety of nintedanib in patients of Asian race who were treated in INPULSIS®-ON. Analyses were descriptive.

resultsA total of 215 Asian patients were treated in INPULSIS®-ON, of whom 121 continued nintedanib in INPULSIS®-ON and 94 initiated nintedanib in INPULSIS®-ON having received placebo in an INPULSIS® trial. At baseline of INPULSIS®-ON, the mean (SD) age of Asian patients was 66.3 (7.5) years, 80.5% were males and mean (SD) forced vital capacity (FVC) was 78.9 (19.3) % predicted. Median total exposure to nintedanib in both INPULSIS® and INPULSIS®-ON was 42.2 months; maximum exposure was 64.1 months. In INPULSIS®, the annual rate (SE) of decline in FVC over 52 weeks in Asian patients was -124 (20) mL/year in the nintedanib group and -218 (24) mL/year in the placebo group. In INPULSIS®-ON, the annual rate (SE) of decline in FVC over 192 weeks in Asian patients was -127 (11) mL/year. Diarrhoea was reported in Asian patients at event rates of 58.8 and 82.5 events per 100 patient exposure-years in patients who continued and initiated nintedanib in INPULSIS®-ON, respectively.

conclusionThe effect of nintedanib on slowing disease progression in Asian patients with IPF is sustained over the long term. Long-term treatment with nintedanib has an acceptable safety and tolerability profile.

Indexed as

AgedAsian PeopleDiarrheaDisease ProgressionFemaleHumansIdiopathic Pulmonary FibrosisIndolesMaleMiddle AgedProtein Kinase InhibitorsTime FactorsTreatment OutcomeVital CapacityIndolesnintedanibProtein Kinase Inhibitorsclinical trialsinterstitial lung diseaselung fibrosisnintedanib

Identifiers

PMID31329360
PMCPMC7154738
OpenAlexW2963389474

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.