Safety and effectiveness of tocilizumab in systemic sclerosis: a multicentre French-Italian study
Abstract
BACKGROUND: Tocilizumab (TCZ) has shown beneficial effects on interstitial lung disease (ILD) in systemic sclerosis (SSc). We aimed to assess the real-life safety and effectiveness of TCZ on several SSc-related domains using data from a French-Italian multicentre cohort. METHODS: We conducted a retrospective analysis of patients with SSc treated with TCZ across 15 referral centres. The following clinical data were collected at 12 months before TCZ initiation, at baseline and at 12 and 24 months of treatment: modified Rodnan skin score (mRSS), pulmonary function tests, Disease Activity Score in 28 joints using C reactive protein, digital ulcers and cardiac biomarkers. ILD progression was defined as a decline ≥5 in %predicted forced vital capacity (%pFVC) over 12±3 months. RESULTS: 197 patients were included (88% female; median age 57 years; median disease duration 9 years); 67% were antitopoisomerase I positive. TCZ monotherapy was used in 29% of cases, methotrexate was the most frequent combined treatment (35%). In SSc-associated ILD, %pFVC declined significantly from -12 months to baseline (81% to 77%; p=0.003). On TCZ introduction, %pFVC stabilised and the proportion of progressors declined from 43% to 24% (p=0.015). Among diffuse cutaneous patients, mRSS decreased significantly at 12 and 24 months. Digital ulcers, arthritis activity and cardiac biomarkers also improved. Infections were the most frequent adverse events (22.8%). TCZ was discontinued in 32% of patients, mainly for inefficacy. Pulmonary arterial hypertension and older age predicted TCZ failure, whereas elevated CRP predicted better response. CONCLUSIONS: In this large real-life cohort, TCZ was safe and associated with consistent benefits across different domains, supporting its role as a potential disease-modifying treatment in selected patients with SSc.
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BibTeX
@article{buonsante2026safety,
title = {{Safety and effectiveness of tocilizumab in systemic sclerosis: a multicentre French-Italian study}},
author = {Giulia Buonsante and Giacomo de Luca and Elena Marazzi and Fabio Cacciapaglia and Maria-Grazia Lazzaroni and Marco de Pinto and Devis Benfaremo and Valentina Longo and Carlo Iandoli and Giovanna Cuomo and Anna Cuberli and Elisabetta Zanatta and Alain Lescoat and Silvia Bellando-Randone and Giorgia Trignani and Serena Guiducci and Lorenzo Beretta and Gianluca Moroncini and Dilia Giuggioli and Paolo Airò and Florenzo Iannone and Veronica Codullo and Silvia Laura Bosello and Nicoletta del Papa and Marie-Elise Truchetet and Jérôme Avouac and Lorenzo Dagna and Marco Matucci-Cerinic and Yannick Allanore and Corrado Campochiaro},
journal = {RMD Open : Rheumatic \& Musculoskeletal Diseases},
year = {2026},
month = nov,
doi = {10.1136/rmdopen-2025-006688},
url = {https://hal.science/hal-05851685v1},
note = {CC BY-NC},
}
RIS
TY - JOUR
TI - Safety and effectiveness of tocilizumab in systemic sclerosis: a multicentre French-Italian study
AU - Giulia Buonsante
AU - Giacomo de Luca
AU - Elena Marazzi
AU - Fabio Cacciapaglia
AU - Maria-Grazia Lazzaroni
AU - Marco de Pinto
AU - Devis Benfaremo
AU - Valentina Longo
AU - Carlo Iandoli
AU - Giovanna Cuomo
AU - Anna Cuberli
AU - Elisabetta Zanatta
AU - Alain Lescoat
AU - Silvia Bellando-Randone
AU - Giorgia Trignani
AU - Serena Guiducci
AU - Lorenzo Beretta
AU - Gianluca Moroncini
AU - Dilia Giuggioli
AU - Paolo Airò
AU - Florenzo Iannone
AU - Veronica Codullo
AU - Silvia Laura Bosello
AU - Nicoletta del Papa
AU - Marie-Elise Truchetet
AU - Jérôme Avouac
AU - Lorenzo Dagna
AU - Marco Matucci-Cerinic
AU - Yannick Allanore
AU - Corrado Campochiaro
PY - 2026
DA - 2026/11/04
JO - RMD Open : Rheumatic & Musculoskeletal Diseases
DO - 10.1136/rmdopen-2025-006688
UR - https://hal.science/hal-05851685v1
AB - BACKGROUND: Tocilizumab (TCZ) has shown beneficial effects on interstitial lung disease (ILD) in systemic sclerosis (SSc). We aimed to assess the real-life safety and effectiveness of TCZ on several SSc-related domains using data from a French-Italian multicentre cohort. METHODS: We conducted a retrospective analysis of patients with SSc treated with TCZ across 15 referral centres. The following clinical data were collected at 12 months before TCZ initiation, at baseline and at 12 and 24 months of treatment: modified Rodnan skin score (mRSS), pulmonary function tests, Disease Activity Score in 28 joints using C reactive protein, digital ulcers and cardiac biomarkers. ILD progression was defined as a decline ≥5 in %predicted forced vital capacity (%pFVC) over 12±3 months. RESULTS: 197 patients were included (88% female; median age 57 years; median disease duration 9 years); 67% were antitopoisomerase I positive. TCZ monotherapy was used in 29% of cases, methotrexate was the most frequent combined treatment (35%). In SSc-associated ILD, %pFVC declined significantly from -12 months to baseline (81% to 77%; p=0.003). On TCZ introduction, %pFVC stabilised and the proportion of progressors declined from 43% to 24% (p=0.015). Among diffuse cutaneous patients, mRSS decreased significantly at 12 and 24 months. Digital ulcers, arthritis activity and cardiac biomarkers also improved. Infections were the most frequent adverse events (22.8%). TCZ was discontinued in 32% of patients, mainly for inefficacy. Pulmonary arterial hypertension and older age predicted TCZ failure, whereas elevated CRP predicted better response. CONCLUSIONS: In this large real-life cohort, TCZ was safe and associated with consistent benefits across different domains, supporting its role as a potential disease-modifying treatment in selected patients with SSc.
SN - 2056-5933
ER -