Evidence map›Paper›PMID 36328401›Full record

Observational studyRMD open2022

Effectiveness and safety of tocilizumab in patients with systemic sclerosis: a propensity score matched controlled observational study of the EUSTAR cohort.

Simon Kuster, Suzana Jordan, Muriel Elhai, Ulrike Held, Klaus Steigmiller, Cosimo Bruni, Fabio Cacciapaglia, Serena Vettori, Elise Siegert, Simona Rednic and 30 more

Open access · goldAbstract readObservational Study
In one paragraph

Observational study in RMD open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 4 pooled it
4.4field-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.

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

22 citing papers in PubMed, 4 syntheses or guidelines pooled it, 31 citations in OpenAlex.

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  17. CD45+/ Col I+ Fibrocytes: Major source of collagen in the fibrotic lung, but not in passaged fibroblast cultures.Matrix biology : journal of the International Society for Matrix Biology · 2025
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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

40 authors at 20 institutions in 18 countries.

Simon KusterDepartment of Rheumatology; University Hospital Zurich, University of Zurich, Zurich, Switzerland.
Suzana JordanDepartment of Rheumatology; University Hospital Zurich, University of Zurich, Zurich, Switzerland.
Muriel ElhaiDepartment of Rheumatology; University Hospital Zurich, University of Zurich, Zurich, Switzerland.
Ulrike HeldDepartment of Biostatistics at Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.
Klaus SteigmillerDepartment of Biostatistics at Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.
Cosimo BruniDepartment of Rheumatology; University Hospital Zurich, University of Zurich, Zurich, Switzerland.
Fabio CacciapagliaRheumatology Unit, DETO, University Hospital Polyclinic of Bari, Bari, Italy.ORCID 0000-0001-7479-4462
Serena VettoriDepartment of Precision Medicine, University of Campania 'Luigi Vanvitelli', Naples, Italy.
Elise SiegertClinic for Rheumatology and Immunology, Bad Bramstedt, Germany.
Simona RednicClinica Reumatologie, University of Medicine and Pharmacy, Cluj-Napoca, Romania.
Veronica CodulloDepartment of Rheumatology, IRCCS Foundation Policlinico San Matteo, Pavia, Italy.ORCID 0000-0003-2557-8514
Paolo AiroUOC Rheumatology and Clinical Immunology, Spedali Civili di Brescia, Brescia, Italy.
Yolanda Braun-MoscoviciB. Shine Department of Rheumatology, Rambam Health Care Campus and Technion, Haifa, Israel.
Nicolas HunzelmannUniversity of Cologne, Cologne, Germany.
Maria Joao SalvadorDepartment of Rheumatology, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal.
Valeria RiccieriDepartment of Clinical Internal, Anesthesiological and Cardiovascular Sciences, Sapienza University of Rome, Rome, Italy.
Ana-Maria GheorghiuDepartment of Internal Medicine and Rheumatology, Cantacuzino Hospital, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.
Juan José Alegre SanchoDepartment of Rheumatology, Hospital Peset, Valencia, Spain.
Katarzyna Romanowska-ProchnickaDepartment of Biophysics, Physiology and Pathophysiology, Medical University of Warsaw, Warsaw, Poland.
Ivan CastellvíDepartment of Rheumatology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.ORCID 0000-0002-5410-5807
Ina KötterClinic for Rheumatology and Immunology, Bad Bramstedt, Germany.
Marie-Elise TruchetetDepartment of Rheumatology, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
F J López-LongoDepartment of Rheumatology, National Reference Center for Systemic Autoimmune Rare Diseases, Hopital Pellegrin, Bordeaux, France.
Pavel I NovikovDepartment of Rheumatology, National Reference Center for Systemic Autoimmune Rare Diseases, Hopital Pellegrin, Bordeaux, France.
Alessandro GiolloRheumatology Section, Department of Medicine, University of Verona, Verona, Italy.
Yuichiro ShiraiDepartment of Allergy and Rheumatology, Nippon Medical School, Tokyo, Japan.
Laura BelloliRheumatology Unit, ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy.
Elisabetta ZanattaRheumatology Unit, Department of Clinical and Experimental Medicine, University of Padova, Padova, Italy.
Eric HachullaReferral Centre for Rare Systemic Auto-immune Diseases for North and North-West of France, Department of Internal Medicine, Claude Huriez Hospital, University of Lille, Lille, France.
Vanessa SmithDepartment of Internal Medicine, Department of Rheumatology, Ghent University Hospital, Ghent, Belgium.ORCID 0000-0001-6271-7945
Chris DentonCentre for Rheumatology, University College London Medical School-Royal Free Campus, London, UK.
Ruxandra M IonescuInternal Medicine and Rheumatology Department-St. Maria Hospital, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.
Tim SchmeiserKrankenhaus St. Josef, Wuppertal-Elberfeld, Germany.ORCID 0000-0001-7342-0020
Joerg H W DistlerDepartment of Internal Medicine III, Erlangen University Hospital, Erlangen, Germany.
Armando GabrielliDipartimento di Scienze Cliniche e Molecolari, Università Politecnica delle Marche, Ancona, Italy.
Anna-Maria Hoffmann-VoldDepartment of Rheumatology, Rikshospitalet University Hospital Oslo, Oslo, Norway.ORCID 0000-0001-6467-7422
Masataka KuwanaDepartment of Allergy and Rheumatology, Nippon Medical School, Tokyo, Japan.ORCID 0000-0001-8352-6136
Yannick AllanoreDepartment of Rheumatology, Paris Descartes University, Cochin Hospital, APHP, Paris, France.
Oliver DistlerDepartment of Rheumatology; University Hospital Zurich, University of Zurich, Zurich, Switzerland Oliver.Distler@usz.ch.ORCID 0000-0002-0546-8310
EUSTAR collaborators
University of Zurich · CHCarol Davila University of Medicine and Pharmacy · RODélégation Paris 5 · FRHôpital Pellegrin · FRNippon Medical School · JPAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · ITAzienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda · ITGhent University Hospital · BEHai phong University Of Medicine and Pharmacy · VNHNO Bad Bramstedt · DEHospitais da Universidade de Coimbra · PTHospital de Sant Pau · ESHospital General Universitario Gregorio Marañón · ESHospital Universitario Doctor Peset · ESMarche Polytechnic University · ITMedical University of Warsaw · PLOslo University Hospital · NOPoliclinico San Matteo Fondazione · ITPolyclinic General Hospital · GRRambam Health Care Campus · IL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTocilizumab showed trends for improving skin fibrosis and prevented progression of lung fibrosis in systemic sclerosis (SSc) in randomised controlled clinical trials. We aimed to assess safety and effectiveness of tocilizumab in a real-life setting using the European Scleroderma Trial and Research (EUSTAR) database.

methodsPatients with SSc fulfilling the American College of Rheumatology (ACR)/EULAR 2013 classification criteria, with baseline and follow-up visits at 12±3 months, receiving tocilizumab or standard of care as the control group, were selected. Propensity score matching was applied. Primary endpoints were the modified Rodnan skin score (mRSS) and FVC at 12±3 months compared between the groups. Secondary endpoints were the percentage of progressive/regressive patients for skin and lung at 12±3 months.

resultsNinety-three patients with SSc treated with tocilizumab and 3180 patients with SSc with standard of care fulfilled the inclusion criteria. Comparison between groups did not show significant differences, but favoured tocilizumab across all predefined primary and secondary endpoints: mRSS was lower in the tocilizumab group (difference -1.0, 95% CI -3.7 to 1.8, p=0.48). Similarly, FVC % predicted was higher in the tocilizumab group (difference 1.5 (-6.1 to 9.1), p=0.70). The percentage of progressive/regressive patients favoured tocilizumab over controls. These results were robust regarding the sensitivity analyses. Safety analysis confirmed previously reported adverse event profiles.

conclusionAlthough this large, observational, controlled, real-life EUSTAR study did not show significant effectiveness of tocilizumab on skin and lung fibrosis, the consistency of direction of all predefined endpoints generates hypothesis for potential effectiveness in a broader SSc population.

Indexed as

Pulmonary FibrosisScleroderma, SystemicAntibodies, Monoclonal, HumanizedHumansPropensity ScoreUnited StatesAntibodies, Monoclonal, Humanizedtocilizumabautoimmune diseasesbiological therapysystemic sclerosis

Identifiers

PMID36328401
PMCPMC9639158
OpenAlexW4308451842

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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.