Evidence map›Paper›PMID 38652570›Full record

Trial reportRheumatology (Oxford, England)2025

Brentuximab vedotin for skin involvement in refractory diffuse cutaneous systemic sclerosis, an open-label trial.

Andreu Fernández-Codina, Tatiana Nevskaya, Murray Baron, C Thomas Appleton, Matthew J Cecchini, Amanda Philip, Maha El-Shimy, Louise Vanderhoek, Iago Pinal-Fernández, Janet E Pope

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Rheumatology (Oxford, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03198689 (A Pilot Study of Adcetris Treatment in Active Diffuse Cutaneous Systemic Sclerosis), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
5.5field-weighted citation impact, top 4% 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.

NCT03198689 phase2completednot on this map

A Pilot Study of Adcetris Treatment in Active Diffuse Cutaneous Systemic Sclerosis (Diffuse Scleroderma)

TypeinterventionalSponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sRan2019 to 2023Enrolled11ConditionsDiffuse Cutaneous Systemic SclerosisArmsBrentuximab Vedotin
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 17 citations in OpenAlex.

  1. Antibody-Empowered Nanomedicine for Precise Biomedical Applications.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 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

10 authors at 3 institutions in 3 countries.

Andreu Fernández-CodinaDivision of Rheumatology, Western University, London, ON, Canada.ORCID 0000-0001-7939-7837
Tatiana NevskayaDivision of Rheumatology, Western University, London, ON, Canada.
Murray BaronDivision of Rheumatology, Jewish General Hospital, McGill University, Montreal, QC, Canada.
C Thomas AppletonDivision of Rheumatology, Western University, London, ON, Canada.ORCID 0000-0001-7148-0767
Matthew J CecchiniDivision of Pathology, Western University, London, ON, Canada.
Amanda PhilipDivision of Rheumatology, Western University, London, ON, Canada.
Maha El-ShimyDivision of Rheumatology, Western University, London, ON, Canada.
Louise VanderhoekDivision of Rheumatology, Western University, London, ON, Canada.
Iago Pinal-FernándezMuscle Unit, National Institute of Arthritis and Musculoskeletal and Skin Diseases, Bethesda, MD, USA.
Janet E PopeDivision of Rheumatology, Western University, London, ON, Canada.ORCID 0000-0003-1479-5302
Western University · CAJewish General Hospital · CAJohns Hopkins University · US

Funding

AstraZenecaSeagen
6 · The paper itself

Abstract

objectiveWe explored the efficacy and safety of brentuximab vedotin, a chimeric anti-CD30 antibody drug conjugate, in patients with severe active diffuse cutaneous systemic sclerosis (dcSSc).

methodsThis phase II proof-of-concept, single centre, open-label, single arm, investigator-initiated trial included patients ≥18 years, with dcSSc, modified Rodnan skin score (mRSS) ≥15 with <5 years since the first non-Raynaud's symptom and/or skin worsening despite immunosuppression who were treated with intravenous brentuximab vedotin 0.6 mg/kg q3 weeks for 45 weeks. The primary end point was a decrease in mRSS of ≥8 points at 48 weeks.

resultsEleven patients were treated with brentuximab vedotin, with nine completing the study. The mean mRSS reduction at week 48 was 11.3 (95% CI 6.9, 15.8; P = 0.001), meeting the primary end point in the intention to treat analysis (7/11 had a decrease in mRSS ≥8). The % forced vital capacity increased by 7.8% (12.5). The Composite Response Index in dcSSc (CRISS) suggested a beneficial treatment effect (86% ≥0.6). Most adverse events were mild. No SAEs were attributed to brentuximab vedotin.

conclusionIn dcSSc, brentuximab vedotin improved skin and FVC without safety concerns. A placebo-controlled trial is warranted to corroborate these initial findings.

trial registrationClinicalTrials.gov, http://clinicaltrials.gov, NCT03198689.

Indexed as

ImmunoconjugatesScleroderma, DiffuseAdultAgedBrentuximab VedotinFemaleHumansMaleMiddle AgedProof of Concept StudyTreatment OutcomeBrentuximab VedotinImmunoconjugatesbiologicbrentuximabskinSystemic sclerosistreatment

Identifiers

PMID38652570
PMCPMC11879290
OpenAlexW4395025680

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.