Safety and effectiveness of tocilizumab in systemic sclerosis: a multicentre French-Italian study
Year: 2026
Type: article
Study design: Observational 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.
Source: RMD Open
Authors: Giulia Buonsante, Giacomo De Luca, Elena Marazzi, Fabio Cacciapaglia, Maria Grazia Lazzaroni, Marco De Pinto, Devis Benfaremo, Valentina Longo, Carlo Iandoli, Giovanna Cuomo, Anna Cuberli, Elisabetta Zanatta, Alain Lescoat, Silvia Bellando-Randone, Giorgia Trignani, Serena Guiducci, Lorenzo Beretta, Gianluca Moroncini, Dilia Giuggioli, Paolo Airò, Florenzo Iannone, Veronica Codullo, Silvia Laura Bosello, Nicoletta Del Papa, Marie-Elise Truchetet, Jerome Avouac, Lorenzo Dagna, Marco Matucci-Cerinic, Yannick Allanore, Corrado Campochiaro
Institutions: Vita-Salute San Raffaele University, Université Paris Cité, IRCCS Ospedale San Raffaele, Institut Cochin, University of Pavia, University of Bari Aldo Moro, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, University of Modena and Reggio Emilia, Marche Polytechnic University, Azienda Ospedaliero-Universitaria delle Marche, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Campania "Luigi Vanvitelli", University of Padua, Centre Hospitalier Universitaire de Rennes, University of Florence, University of Milan, Istituto Ortopedico Gaetano Pini, Università Cattolica del Sacro Cuore, Centre Hospitalier Universitaire de Bordeaux, Hôpital Pellegrin
Language: English
Subfield: Rheumatology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,391
Awards: G1483213741, G1798610363
OpenAlex ID: W7164012819