Evidence map›Paper›PMID 32551397›Full record

ArticleContemporary clinical trials communications2020

Safety and efficacy of abatacept in patients with treatment-resistant SARCoidosis (ABASARC) - protocol for a multi-center, single-arm phase IIa trial.

Björn C Frye, Ina Caroline Rump, Annette Uhlmann, Fabian Schubach, Gabriele Ihorst, Bodo Grimbacher, Gernot Zissel, Joachim Müller Quernheim

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials communications, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.2field-weighted citation impact, top 22% 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

5 citing papers in PubMed, 16 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. [Sarcoidosis and berylliosis].Der Internist · 2022
    Review
  5. 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

8 authors at 1 institution in 1 country.

Björn C FryeDepartment of Pneumology, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany.
Ina Caroline RumpDepartment of Pneumology, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany.
Annette UhlmannInstitute for Immunodeficiency, Center for Chronic Immunodeficiency (CCI), Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany.
Fabian SchubachClinical Trials Unit, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany.
Gabriele IhorstClinical Trials Unit, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany.
Bodo GrimbacherInstitute for Immunodeficiency, Center for Chronic Immunodeficiency (CCI), Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany.
Gernot ZisselDepartment of Pneumology, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany.
Joachim Müller QuernheimDepartment of Pneumology, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany.
University of Freiburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSarcoidosis is a granulomatous systemic disease that becomes chronic in approximately one third of affected patients resulting in quality of life and functional impairment. Immunosuppressive drugs other than steroids represent alternative therapeutic options, but side effects like liver and bone marrow toxicity or increased susceptibility to infections limit their use. Pathophysiological studies in sarcoidosis patients demonstrate altered regulatory T-cell functions with a reduced expression of CTLA-4 (CD152) and prolonged inflammation. Therefore, interfering with CTLA-4 using abatacept might be a therapeutic option in sarcoidosis similar to rheumatoid arthritis therapy. METHODS/

designThis is a multicenter prospective open-labeled single arm phase II study addressing the safety of abatacept in sarcoidosis patients. 30 patients with chronic sarcoidosis requiring immunosuppressive therapy beyond 5 mg prednisolone equivalent will be treated with abatacept in combination with corticosteroids for one year in two centers.The primary endpoint is the number and characterization of severe infectious complications under treatment with abatacept.Secondary endpoints are the rate of all infections, patient-related outcomes (assessed by questionnaires), lung function and immunological parameters including alveolar inflammation assessed by bronchoaveolar lavage. DISCUSSION: This is the first trial of abatacept in patients with sarcoidosis. It is hypothesized that administration of abatacept is safe in patients with chronic sarcoidosis and can limit ongoing inflammation. Patients' wellbeing is assessed by established questionnaires. Immunological work-up will highlight the effect of abatacept on inflammatory pathways in sarcoidosis.

trial registrationThe trial has been registered at the German Clinical Trial Registry (

Indexed as

18FDG-PET-CT, 18Fluor-Desoxy-Glucose positron-emission tomography combined with computer tomographyAbataceptBAL, bronchoalveolar lavageChronic sarcoidosisCMV, cytomegaly-virusEBV, Epstein-Barr-VirusFVC, forced vital capacityGHS, general health scoreIFN-γ, Interferon-γIL, interleukinKing's sarcoidosis questionnaireKSQ, King's sarcoidosis questionnairePatient-reported outcomeRegulatory T-cellsTherapyTLC, total lung capacityTNF, tumor-necrosis factorTReg, regulatory T-cells

Identifiers

PMID32551397
PMCPMC7292904
OpenAlexW3031721497

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.