Evidence map›Paper›PMID 39988350›Full record

Trial reportRMD open2025

Continued nintedanib in patients with systemic sclerosis-associated interstitial lung disease: 3-year data from SENSCIS-ON.

Yannick Allanore, Madelon C Vonk, Oliver Distler, Arata Azuma, Maureen D Mayes, Alexandra James, Veronika Kohlbrenner, Margarida Alves, Dinesh Khanna, Kristin B Highland and 1 more

Abstract readClinical Trial, Phase III
In one paragraph

Trial report in RMD open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–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

9 citing papers in PubMed.

  1. Review
  2. Article
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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

11 authors.

Yannick AllanoreDepartment of Rheumatology A, Université Paris Cité, APHP, Cochin Hospital, Paris, France yannick.allanore@aphp.fr.ORCID 0000-0002-6149-0002
Madelon C VonkDepartment of Rheumatology, Radboud University Medical Center, Nijmegen, The Netherlands.ORCID 0000-0002-2266-9907
Oliver DistlerDepartment of Rheumatology, University Hospital Zurich, University of Zurich, Zürich, Switzerland.ORCID 0000-0002-0546-8310
Arata AzumaClinical Research Center, Mihara General Hospital, Saitama, Japan.
Maureen D MayesDivision of Rheumatology and Clinical Immunogenetics, University of Texas McGovern Medical School, Houston, Texas, USA.
Alexandra JamesElderbrook Solutions GmbH, Bietigheim-Bissingen, Germany.
Veronika KohlbrennerBoehringer Ingelheim Pharmaceuticals Inc, Ridgefield, Connecticut, USA.
Margarida AlvesBoehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
Dinesh KhannaScleroderma Program, Department of Medicine, University of Michigan, Ann Arbor, Michigan, USA.ORCID 0000-0003-1412-4453
Kristin B HighlandCleveland Clinic, Cleveland, Ohio, USA.
SENSCIS-ON trial investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveWe assessed adverse events and changes in forced vital capacity (FVC) in patients treated with open-label nintedanib over 148 weeks of SENSCIS-ON, the extension of the SENSCIS trial.

methodsAdverse events and changes in FVC over 148 weeks of SENSCIS-ON were assessed in patients who received nintedanib in SENSCIS and continued nintedanib in SENSCIS-ON ('continued nintedanib' group) and in patients who received placebo in SENSCIS or received nintedanib for ≤28 days in a drug-drug interaction study and then received nintedanib in SENSCIS-ON ('initiated nintedanib' group).

resultsThe continued nintedanib group comprised 197 patients, and the initiated nintedanib group comprised 247 patients (231 from SENSCIS). Diarrhoea was the most frequent adverse event, reported in 152 (77.2%) and 183 (74.1%) patients in the continued nintedanib and initiated nintedanib groups, respectively. Among patients in the continued and initiated nintedanib groups, respectively, 53 (26.9%) and 148 (59.9%) had ≥1 dose reduction, 72 (36.5%) and 131 (53.0%) had ≥1 treatment interruption and 29 (14.7%) and 72 (29.1%) had adverse events that led to treatment discontinuation. Mean (SE) changes in FVC (mL) at week 148 were -189.1 (29.5) in the continued nintedanib group and -126.4 (26.4) in the initiated nintedanib group.

conclusionThe safety profile of nintedanib over 148 weeks of SENSCIS-ON was consistent with that reported in SENSCIS. Changes in FVC during SENSCIS and SENSCIS-ON supported a continued effect of nintedanib on slowing the decline in lung function, but showed continued progression of SSc-ILD.

Indexed as

IndolesLung Diseases, InterstitialProtein Kinase InhibitorsScleroderma, SystemicAdultAgedFemaleHumansMaleMiddle AgedTreatment OutcomeVital CapacityIndolesnintedanibProtein Kinase InhibitorsConnective Tissue DiseasesPulmonary FibrosisScleroderma, Systemic

Identifiers

PMID39988350
PMCPMC11848673

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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.