Evidence map›Paper›PMID 38580347›Full record

Trial reportRMD open2024

Induction of regulatory T cells and efficacy of low-dose interleukin-2 in systemic sclerosis: interventional open-label phase 1-phase 2a study.

François Barde, Roberta Lorenzon, Eric Vicaut, Sébastien Rivière, Patrice Cacoub, Carlotta Cacciatore, Michelle Rosenzwajg, Anne Daguenel-Nguyen, Olivier Fain, David Klatzmann and 1 more

Open access · goldAbstract readClinical Trial, Phase IIClinical Trial, Phase I
In one paragraph

Trial report in RMD open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
6.8field-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

8 citing papers in PubMed, 16 citations in OpenAlex.

  1. Regulatory T cells in cancer and inflammation.Signal transduction and targeted therapy · 2026
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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 at 2 institutions in 1 country.

François Barde *Service de médecine interne, AP-HP, Hôpital Saint Antoine, Sorbonne Universite, Paris, France.ORCID 0000-0002-5652-225X
Roberta Lorenzon *Clinical Investigation Center for Biotherapies and Inflammation-Immunopathology-Biotherapy Department (i2B), AP-HP, Hôpital Pitié-Salpêtrière, Sorbonne Universite, Paris, France.
Eric VicautUnité de recherche clinique, AP-HP, Hôpital Lariboisière, Paris Cité University, Paris, France.
Sébastien RivièreService de médecine interne, AP-HP, Hôpital Saint Antoine, Sorbonne Universite, Paris, France.
Patrice CacoubService de médecine interne et immunologie clinique, AP-HP, Hôpital Pitié-Salpêtrière, Sorbonne Universite, Paris, France.
Carlotta CacciatoreService de médecine interne, AP-HP, Hôpital Saint Antoine, Sorbonne Universite, Paris, France.
Michelle RosenzwajgCentre d'Investigation Clinique intégré en Biothérapies et immunologie (i2B), Sorbonne Universite, Paris, France.ORCID 0000-0001-5312-6203
Anne Daguenel-NguyenService de pharmacie, AP-HP, Hôpital Saint-Antoine, Sorbonne Universite, Paris, France.
Olivier FainService de médecine interne, AP-HP, Hôpital Saint Antoine, Sorbonne Universite, Paris, France.
David KlatzmannCentre d'Investigation Clinique intégré en Biothérapies et immunologie (i2B), Sorbonne Universite, Paris, France.
Arsène MekinianService de médecine interne, AP-HP, Hôpital Saint Antoine, Sorbonne Universite, Paris, France arsene.mekinian@aphp.fr.ORCID 0000-0003-2849-3049
Sorbonne Université · FRUniversité Paris Cité · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSystemic sclerosis (SSc) is a chronic autoimmune disease, with impaired immune response, increased fibrosis and endothelial dysfunction. Regulatory T cells (Tregs), which are essential to control inflammation, tissue repair and autoimmunity, have a decreased frequency and impaired function in SSc patients. Low-dose interleukin-2 (IL-2

objectiveWe aimed to assess the safety and biological efficacy of IL-2

methodsAs part of the TRANSREG open-label phase IIa basket trial in multiple autoimmune diseases, we studied nine patients with SSc without severe organ involvement. Patients received 1 million international units (MIU)/day of IL-2 for 5 days, followed by fortnightly injections for 6 months. Laboratory and clinical evaluations were performed between baseline and month 6.

resultsAt day 8, the primary endpoint (Treg frequency) was reached with a 1.8±0.5-fold increase of Treg levels among CD4

conclusionIL-2

Indexed as

Interleukin-2Scleroderma, SystemicT-Lymphocytes, RegulatoryAutoimmune DiseasesHumansQuality of LifeInterleukin-2Autoimmune DiseasesScleroderma, SystemicT-Lymphocyte subsets

Identifiers

PMID38580347
PMCPMC11002342
OpenAlexW4393982991

What OpenQuestion holds

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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.