Titre :

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

Auteur(s) :

Kuster, S. [Auteur]
Jordan, S. [Auteur]
Elhai, Muriel [Auteur]
Hôpital Cochin [AP-HP]
Held, U. [Auteur]
Steigmiller, K. [Auteur]
Bruni, C. [Auteur]
Cacciapaglia, F. [Auteur]
Vettori, S. [Auteur]
Siegert, E. [Auteur]
Rednic, S. [Auteur]
Codullo, V. [Auteur]
Airo, P. [Auteur]
Braun-Moscovici, Y. [Auteur]
Hunzelmann, N. [Auteur]
Joao Salvador, M. [Auteur]
Riccieri, V. [Auteur]
Gheorghiu, A. M. [Auteur]
Alegre Sancho, J. J. [Auteur]
Romanowska-Prochnicka, K. [Auteur]
Castellví, I. [Auteur]
Kötter, I. [Auteur]
Truchetet, M. E. [Auteur]
López-Longo, F. J. [Auteur]
Novikov, Pavel I. [Auteur]
Hôpital Pellegrin
Giollo, A. [Auteur]
Shirai, Y. [Auteur]
Belloli, L. [Auteur]
Zanatta, E. [Auteur]
Hachulla, Eric [Auteur]
Centre National de Référence des Maladies Auto-Immunes Systémiques Rares du Nord et Nord-Ouest de France [CeRAINO]
Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286
Smith, V. [Auteur]
Denton, C. [Auteur]
Ionescu, R. M. [Auteur]
Schmeiser, T. [Auteur]
Distler, J. H. W. [Auteur]
Gabrielli, A. [Auteur]
Hoffmann-Vold, A. M. [Auteur]
Kuwana, M. [Auteur]
Allanore, Y. [Auteur]
Distler, O. [Auteur]

Titre de la revue :

RMD Open

Nom court de la revue :

RMD Open

Numéro :

8

Date de publication :

2022-11-05

ISSN :

2056-5933

Discipline(s) HAL :

Sciences du Vivant [q-bio]

Résumé en anglais : [en]

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 ...
Lire la suite >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.Lire moins >

Langue :

Anglais

Audience :

Internationale

Vulgarisation :

Non

Établissement(s) :

Université de Lille
Inserm
CHU Lille

Collections :

• Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286

Date de dépôt :

2024-01-12T00:08:48Z
2024-03-25T15:49:07Z