Kuster, Simon, Jordan, Suzana ORCID: 0000-0002-8114-8239, Elhai, Muriel ORCID: 0000-0001-8627-5758, Held, Ulrike ORCID: 0000-0003-3105-5840, Steigmiller, Klaus, Bruni, Cosimo, Cacciapaglia, Fabio, Vettori, Serena, Siegert, Elise ORCID: 0000-0002-9594-0446, Rednic, Simona, Codullo, Veronica, Airo, Paolo, Braun-Moscovici, Yolanda, Hunzelmann, Nicolas, Salvador, Maria Joao, Riccieri, Valeria, Gheorghiu, Ana-Maria, Sancho, Juan Jose Alegre, Romanowska-Prochnicka, Katarzyna, Castellvi, Ivan, Koetter, Ina, Truchetet, Marie-Elise, Lopez-Longo, Fj, Novikov, Pavel, I, Giollo, Alessandro ORCID: 0000-0001-9355-7673, Shirai, Yuichiro, Belloli, Laura, Zanatta, Elisabetta, Hachulla, Eric, Smith, Vanessa, Denton, Chris, Ionescu, Ruxandra M., Schmeiser, Tim, Distler, Joerg H. W., Gabrielli, Armando, Hoffmann-Vold, Anna-Maria, Kuwana, Masataka, Allanore, Yannick and Distler, Oliver (2022). Effectiveness and safety of tocilizumab in patients with systemic sclerosis: a propensity score matched controlled observational study of the EUSTAR cohort. RMD Open, 8 (2). LONDON: BMJ PUBLISHING GROUP. ISSN 2056-5933

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Abstract

Objectives Tocilizumab 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. Methods Patients 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. Results Ninety-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. Conclusion Although 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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Kuster, SimonUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jordan, SuzanaUNSPECIFIEDorcid.org/0000-0002-8114-8239UNSPECIFIED
Elhai, MurielUNSPECIFIEDorcid.org/0000-0001-8627-5758UNSPECIFIED
Held, UlrikeUNSPECIFIEDorcid.org/0000-0003-3105-5840UNSPECIFIED
Steigmiller, KlausUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bruni, CosimoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cacciapaglia, FabioUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vettori, SerenaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Siegert, EliseUNSPECIFIEDorcid.org/0000-0002-9594-0446UNSPECIFIED
Rednic, SimonaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Codullo, VeronicaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Airo, PaoloUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Braun-Moscovici, YolandaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hunzelmann, NicolasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Salvador, Maria JoaoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Riccieri, ValeriaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gheorghiu, Ana-MariaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sancho, Juan Jose AlegreUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Romanowska-Prochnicka, KatarzynaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Castellvi, IvanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Koetter, InaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Truchetet, Marie-EliseUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lopez-Longo, FjUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Novikov, Pavel, IUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Giollo, AlessandroUNSPECIFIEDorcid.org/0000-0001-9355-7673UNSPECIFIED
Shirai, YuichiroUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Belloli, LauraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zanatta, ElisabettaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hachulla, EricUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Smith, VanessaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Denton, ChrisUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ionescu, Ruxandra M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schmeiser, TimUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Distler, Joerg H. W.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gabrielli, ArmandoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hoffmann-Vold, Anna-MariaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kuwana, MasatakaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Allanore, YannickUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Distler, OliverUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-698953
DOI: 10.1136/rmdopen-2022-002477
Journal or Publication Title: RMD Open
Volume: 8
Number: 2
Date: 2022
Publisher: BMJ PUBLISHING GROUP
Place of Publication: LONDON
ISSN: 2056-5933
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
2013 CLASSIFICATION CRITERIA; RHEUMATOLOGY/EUROPEAN LEAGUE; RHEUMATOID-ARTHRITIS; AMERICAN-COLLEGE; INTERLEUKIN-6; MORTALITY; PATHOGENESIS; DISEASEMultiple languages
RheumatologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/69895

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