Evidence map›Paper›PMID 25007944›Full record

Trial reportArthritis research & therapy2014

Low-dose oral imatinib in the treatment of systemic sclerosis interstitial lung disease unresponsive to cyclophosphamide: a phase II pilot study.

Paolo Fraticelli, Barbara Gabrielli, Giovanni Pomponio, Gabriele Valentini, Silvia Bosello, Piersandro Riboldi, Maria Gerosa, Paola Faggioli, Roberto Giacomelli, Nicoletta Del Papa and 8 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Arthritis research & therapy, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00573326 (Low-Dose Oral Imatinib in the Treatment of Scleroderma Pulmonary Involvement), which is not on this map. Cited by 43 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 4 pooled it
8.0field-weighted citation impact, top 2% 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.

NCT00573326 phase2unknown statusnot on this map

Low-Dose Oral Imatinib in the Treatment of Scleroderma Pulmonary Involvement: A Phase II Pilot Study

TypeinterventionalSponsorAzienda Ospedaliera Universitaria PoliclinicoRan2009 to 2010Enrolled30ConditionsSystemic SclerosisArmsImatinib
3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 4 syntheses or guidelines pooled it, 107 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pulmonary function tests as outcomes for systemic sclerosis interstitial lung disease.European respiratory review : an official journal of the European Respiratory Society · 2018
    Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Review
  8. Article
  9. The Role of Myofibroblasts in Physiological and Pathological Tissue Repair.Cold Spring Harbor perspectives in biology · 2023
    Review
  10. Article
  11. Article
  12. PDGF/PDGFR: A Possible Molecular Target in Scleroderma Fibrosis.International journal of molecular sciences · 2022
    Review
  13. Review
  14. Review
  15. Review
  16. Review
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  19. Article
  20. 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

18 authors at 11 institutions in 1 country.

Paolo Fraticelli
Barbara Gabrielli
Giovanni Pomponio
Gabriele Valentini
Silvia Bosello
Piersandro Riboldi
Maria Gerosa
Paola Faggioli
Roberto Giacomelli
Nicoletta Del Papa
Roberto Gerli
Claudio Lunardi
Stefano Bombardieri
Walter Malorni
Angelo Corvetta
Gianluca Moroncini
Armando Gabrielli
Imatinib in Scleroderma Italian Study Group
Ospedali Riuniti di Ancona · ITMedica (Italy) · ITUniversity of Milan · ITIstituto Superiore di Sanità · ITOspedale Civile di Giaveno · ITOspedale degli Infermi · ITUniversity of Campania "Luigi Vanvitelli" · ITUniversity of L'Aquila · ITUniversity of Perugia · ITUniversity of Pisa · ITUniversity of Verona · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPulmonary involvement represents a major cause of death of systemic sclerosis (SSc) patients. Recent data suggest that tyrosine kinase inhibitors, such as imatinib, may be a therapeutic option for SSc patients. However, preliminary published clinical trials were inconclusive about imatinib efficacy and showed side effects. The purpose of this study was to verify efficacy and tolerability of low-dose imatinib on interstitial lung disease in a cohort of SSc patients unresponsive to cyclophosphamide therapy.

methodsThirty consecutive SSc patients with active pulmonary involvement, unresponsive to cyclophosphamide, were treated with imatinib 200 mg/day for 6 months followed by a 6-month follow-up. A "good response" was defined as an increase of forced vital capacity (FVC) by more of 15% and/or increase of diffusing capacity of carbon monoxide (DLCO) >15% and PaO2 > 90% of initial value and high-resolution computed tomography (HRCT)-scan pattern unchanged or improved.

resultsTwenty-six patients completed the study. Three patients died and one patient was lost to follow-up. Four patients (15.32%) had a good response, 7 worsened and 15 had a stabilized lung disease. Overall, 19 (73.07%) patients had an improved or stabilized lung disease. After a 6-month follow-up, 12 (54.5%) of the 22 patients showed an improved or stabilized lung disease.

conclusionsLung function was stabilized in a large proportion of patients unresponsive to cyclophosphamide therapy and a beneficial outcome emerged from the analysis of HRCT lung scans. There was no significant improvement of skin involvement, and the low dose was well tolerated. These data provide useful suggestions to design future randomized clinical trials for SSc therapeutics.

trial registrationClinicalTrials.gov NCT00573326. Registered 13 December 2007.

Indexed as

Administration, OralAdultBenzamidesCyclophosphamideFemaleHumansImatinib MesylateImmunosuppressive AgentsLung Diseases, InterstitialMaleMiddle AgedPilot ProjectsPiperazinesProtein Kinase InhibitorsPyrimidinesRespiratory Function TestsBenzamidesCyclophosphamideImatinib MesylateImmunosuppressive AgentsPiperazinesProtein Kinase InhibitorsPyrimidines

Identifiers

PMID25007944
PMCPMC4227120
OpenAlexW2126719591

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.