Outcomes of patients with systemic sclerosis treated with rituximab in contemporary practice: A prospective cohort study

Elhai M, Boubaya M, Distler O, Smith V, Matucci-Cerinic M, Alegre Sancho JJ, Truchetet ME, Braun-Moscovici Y, Iannone F, Novikov PI, Lescoat A, Siegert E, Castellví I, Airó P, Vettori S, De Langhe E, Hachulla E, Erler A, Ananieva L, Krusche M, López-Longo FJ, Distler J, Hunzelmann N, Hoffmann-Vold AM, Riccieri V, Hsu VM, Pozzi MR, Ancuta C, Rosato E, Mihai C, Kuwana M, Saketkoo LA, Chizzolini C, Hesselstrand R, Ullman S, Yavuz S, Rednic S, Caimmi C, Bloch-Queyrat C, Allanore Y (2019)

Publication Type: Journal article

Publication year: 2019


DOI: 10.1136/annrheumdis-2018-214816


Objective: To assess the safety and efficacy of rituximab in systemic sclerosis (SSc) in clinical practice. Methods: We performed a prospective study including patients with SSc from the European Scleroderma Trials and Research (EUSTAR) network treated with rituximab and matched with untreated patients with SSc. The main outcomes measures were adverse events, skin fibrosis improvement, lung fibrosis worsening and steroids use among propensity score-matched patients treated or not with rituximab. Results: 254 patients were treated with rituximab, in 58% for lung and in 32% for skin involvement. After a median follow-up of 2 years, about 70% of the patients had no side effect. Comparison of treated patients with 9575 propensity-score matched patients showed that patients treated with rituximab were more likely to have skin fibrosis improvement (22.7 vs 14.03 events per 100 person-years; OR: 2.79 [1.47-5.32]; p=0.002). Treated patients did not have significantly different rates of decrease in forced vital capacity (FVC)>10% (OR: 1.03 [0.55-1.94]; p=0.93) nor in carbon monoxide diffusing capacity (DLCO) decrease. Patients having received rituximab were more prone to stop or decrease steroids (OR: 2.34 [1.56-3.53], p<0.0001). Patients treated concomitantly with mycophenolate mofetil had a trend for better outcomes as compared with patients receiving rituximab alone (delta FVC: 5.22 [0.83-9.62]; p=0.019 as compared with controls vs 3 [0.66-5.35]; p=0.012). Conclusion: Rituximab use was associated with a good safety profile in this large SSc-cohort. Significant change was observed on skin fibrosis, but not on lung. However, the limitation is the observational design. The potential stabilisation of lung fibrosis by rituximab has to be addressed by a randomised trial.

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Involved external institutions

Hôpitaux Universitaires Paris Seine-Saint-Denis FR France (FR) University of Paris 5 - René Descartes / Université Paris V René Descartes FR France (FR) Geneva University Hospitals / Hôpitaux universitaires de Genève (HUG) CH Switzerland (CH) Azienda Ospedaliera San Gerardo (ASST Monza) IT Italy (IT) Avicenne Hospital / Hôpital Avicienne FR France (FR) University of Verona / Università degli Studi di Verona IT Italy (IT) Università degli studi "La Sapienza" IT Italy (IT) Carol Davila University of Medicine and Pharmacy / Universitatea de Medicină și Farmacie „Carol Davila” (UMF București) RO Romania (RO) Universität zu Köln DE Germany (DE) Katholieke Universiteit Leuven (KUL) / Catholic University of Leuven BE Belgium (BE) Universitätsklinikum Carl Gustav Carus Dresden DE Germany (DE) Hospital de la Santa Creu i Sant Pau ES Spain (ES) Nippon Medical School JP Japan (JP) Centre Hospitalier Universitaire de Bordeaux / CHU Bordeaux FR France (FR) Technion - Israel Institute of Technology IL Israel (IL) Università degli studi della Campania Luigi Vanvitelli IT Italy (IT) Università degli Studi di Firenze / University of Florence IT Italy (IT) Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia IT Italy (IT) Oslo University Hospital / Oslo Universitetssykehus Rikshospitalet NO Norway (NO) Lund University / Lunds universitet SE Sweden (SE) Center of Experimental Rheumatology CH Switzerland (CH) Copenhagen University Hospital DK Denmark (DK) Tulane University US United States (USA) (US) Charité - Universitätsmedizin Berlin DE Germany (DE) V.A. Nasonova Research Institute of Rheumatology RU Russian Federation (RU) Hospital General Universitario Gregorio Marañón ES Spain (ES) Rutgers, The State University of New Jersey US United States (USA) (US) University of Bari Aldo Moro / Università degli Studi di Bari Aldo Moro IT Italy (IT) Marmara University TR Turkey (TR) Grigore T. Popa University of Medicine and Pharmacy / Universitatea de Medicină și Farmacie "Grigore T. Popa" (UMF Iași) RO Romania (RO) I.M. Sechenov First Moscow State Medical University RU Russian Federation (RU) LIRIC Lille Inflammation Research International Center FR France (FR) Centre hospitalier universitaire de Rennes / CHU Rennes FR France (FR) Hospital Universitario Dr. Peset Aleixandre ES Spain (ES) University Hospital Ghent BE Belgium (BE)

How to cite


Elhai, M., Boubaya, M., Distler, O., Smith, V., Matucci-Cerinic, M., Alegre Sancho, J.J.,... Allanore, Y. (2019). Outcomes of patients with systemic sclerosis treated with rituximab in contemporary practice: A prospective cohort study. Annals of the Rheumatic Diseases. https://doi.org/10.1136/annrheumdis-2018-214816


Elhai, Muriel, et al. "Outcomes of patients with systemic sclerosis treated with rituximab in contemporary practice: A prospective cohort study." Annals of the Rheumatic Diseases (2019).

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