Evidence map›Paper›PMID 35973804›Full record

ArticleAnnals of the rheumatic diseases2022

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

Yannick Allanore, Madelon C Vonk, Oliver Distler, Arata Azuma, Maureen D Mayes, Martina Gahlemann, Alexandra James, Veronika Kohlbrenner, Margarida Alves, Dinesh Khanna and 2 more

Open access · hybridAbstract read
In one paragraph

Article in Annals of the rheumatic diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 3 pooled it
5.9field-weighted citation impact, top 3% 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

27 citing papers in PubMed, 3 syntheses or guidelines pooled it, 41 citations in OpenAlex.

  1. Guideline
  2. Pooled it
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  4. Trial
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  12. Combination antifibrotic and immunosuppressive therapy in progressive fibrosing ILD.Sarcoidosis, vasculitis, and diffuse lung diseases : official journal of WASOG · 2026
    Article
  13. Progressive pulmonary fibrosis: the importance of identification and intervention.European respiratory review : an official journal of the European Respiratory Society · 2026
    Review
  14. Review
  15. Article
  16. Article
  17. Article
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  19. Review
  20. Nintedanib in systemic sclerosis treatment: a case report.Journal of medical case reports · 2024
    Article
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

12 authors at 9 institutions in 6 countries.

Yannick AllanoreDepartment of Rheumatology A, Descartes University, APHP, Cochin Hospital, Paris, France yannick.allanore@me.com.ORCID http://orcid.org/0000-0002-6149-0002
Madelon C VonkDepartment of Rheumatology, Radboud University Medical Center, Nijmegen, The Netherlands.ORCID http://orcid.org/0000-0002-2266-9907
Oliver DistlerDepartment of Rheumatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.ORCID http://orcid.org/0000-0002-0546-8310
Arata AzumaDepartment of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.
Maureen D MayesDivision of Rheumatology and Clinical Immunogenetics, University of Texas McGovern Medical School, Houston, Texas, USA.
Martina GahlemannInflammation Medicine, Boehringer Ingelheim (Schweiz) GmbH, Basel, Switzerland.
Alexandra JamesElderbrook Solutions GmbH, Bietigheim-Bissingen, Germany.
Veronika KohlbrennerInflammation Medicine, Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, Connecticut, USA.
Margarida AlvesInflammation Medicine, Boehringer Ingelheim International GmbH, Ingelheim, Germany.
Dinesh KhannaDepartment of Medicine, University of Michigan Scleroderma Program, University of Michigan, Ann Arbor, Michigan, USA.ORCID http://orcid.org/0000-0003-1412-4453
Kristin B HighlandPulmonary Medicine, Cleveland Clinic, Cleveland, Ohio, USA.
SENSCIS-ON trial investigators
Boehringer Ingelheim (Germany) · DEBoehringer Ingelheim (Switzerland) · CHBoehringer Ingelheim (United States) · USCleveland Clinic · USDélégation Paris 5 · FRNippon Medical School · JPRadboud University Nijmegen · NLUniversity of Michigan · USUniversity of Zurich · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesIn the SENSCIS trial in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD), nintedanib reduced the rate of decline in forced vital capacity (FVC) versus placebo, with adverse events that were manageable for most patients. An open-label extension trial, SENSCIS-ON, is assessing safety and FVC decline during longer term nintedanib treatment.

methodsPatients who completed the SENSCIS trial or a drug-drug interaction (DDI) study of nintedanib and oral contraceptive on treatment were eligible to enter SENSCIS-ON. Adverse events and changes in FVC over 52 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 and initiated nintedanib in SENSCIS-ON or who received nintedanib for ≤28 days in the DDI study ('initiated nintedanib' group).

resultsThere were 197 patients in the continued nintedanib group and 247 in the initiated nintedanib group. Diarrhoea was reported in 68.0% and 68.8% of patients in these groups, respectively. Adverse events led to discontinuation of nintedanib in 4.6% and 21.5% of the continued nintedanib and initiated nintedanib groups, respectively. Mean (SE) changes in FVC from baseline to week 52 of SENSCIS-ON were -58.3 (15.5) mL in the continued nintedanib group and -44.0 (16.2) mL in the initiated nintedanib group.

conclusionsThe safety profile of nintedanib over 52 weeks of SENSCIS-ON was consistent with that reported in SENSCIS. The change in FVC over 52 weeks of SENSCIS-ON was similar to that observed in the nintedanib group of SENSCIS.

Indexed as

Idiopathic Pulmonary FibrosisScleroderma, SystemicDisease ProgressionHumansIndolesTreatment OutcomeVital CapacityIndolesnintedanibAutoimmune DiseasesPulmonary FibrosisScleroderma, Systemic

Identifiers

PMID35973804
PMCPMC9664126
OpenAlexW4291993875

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.