Karin Melsens1,2, Els Vandecasteele3, Ellen Deschepper4, Valérie Badot5, Daniel Blockmans6, Guy Brusselle7, Ellen De Langhe8, Michel De Pauw3, Claire Debusschere1,2, Saskia Decuman2, Liselotte Deroo9, Frédéric Houssiau10, Jan Lenaerts8, Yves Piette1, Kristof Thevissen1, Marie Vanthuyne10, René Westhovens8, Sara Wijnant9, Filip De Keyser1,2, Vanessa Smith1,2. 1. a Department of Rheumatology , Universitair Ziekenhuis Gent , Ghent , Belgium. 2. b Faculty of Medicine and Health Sciences, Department of Internal Medicine , Universiteit Gent , Ghent , Belgium. 3. c Department of Cardiology , Universitair Ziekenhuis Gent , Ghent , Belgium. 4. d Department of Public Health, Biostatistics Unit , Universiteit Gent , Ghent , Belgium. 5. e Department of Rheumatology , Hopital Erasme, Université Libre de Bruxelles , Brussels , Belgium. 6. f Department of General Internal Medicine , universitaire ziekenhuizen leuven , Leuven , Belgium. 7. g Department of Respiratory Medicine , Universitair Ziekenhuis Gent , Ghent , Belgium. 8. h Department of Rheumatology , universitaire ziekenhuizen leuven , Leuven , Belgium. 9. i Faculty of Medicine and Health Sciences , Universiteit Gent , Ghent , Belgium. 10. j Department of Rheumatology , Cliniques Universitaires Saint-Luc , Brussels , Belgium.
Abstract
OBJECTIVES: Following results in open-label studies of rituximab in patients with systemic sclerosis, a Belgian three-centre initiative was launched to explore safety and efficacy of rituximab in early, diffuse cutaneous systemic sclerosis (dcSSc). METHODS: Open-label study of 17 patients with early dcSSc, treated with two courses of rituximab, at month 0 and 6. Clinical examination, lung function testing, echocardiography, disease activity score (DAS) and functional status were performed at baseline and over 24 months of follow-up. RESULTS: Modified Rodnan skin score (MRSS) changed significantly over time, with a mean of 25.5 (standard deviation [SD] 6.0) at baseline to 12.6 (SD 5.1) at month 24 (Mixed Model Analysis [MMA] p < 0.0001), which is a decrease of 51% at month 24 vs. baseline. DAS showed significant decrease over the total study period, with a score of 4.1 (SD 1.7) at baseline to 1.5 (SD 1.8) at month 24 (MMA p < 0.0001). Additionally, this was significant at all time points vs. baseline, both for MRSS and DAS. Internal organ status remained clinically stable throughout the study period. No statistically significant differences compared to baseline were found at the follow-up time points. Seven serious adverse events took place, all except for one, considered unrelated to study medication. CONCLUSIONS: This is the first multicentre Belgian collaboration investigating potential efficacy of rituximab in early dcSSc. Rituximab appears to be safe and tolerable and it may have beneficial effects on skin involvement, on overall disease activity and on stabilization of internal organ status in early dcSSc.
OBJECTIVES: Following results in open-label studies of rituximab in patients with systemic sclerosis, a Belgian three-centre initiative was launched to explore safety and efficacy of rituximab in early, diffuse cutaneous systemic sclerosis (dcSSc). METHODS: Open-label study of 17 patients with early dcSSc, treated with two courses of rituximab, at month 0 and 6. Clinical examination, lung function testing, echocardiography, disease activity score (DAS) and functional status were performed at baseline and over 24 months of follow-up. RESULTS: Modified Rodnan skin score (MRSS) changed significantly over time, with a mean of 25.5 (standard deviation [SD] 6.0) at baseline to 12.6 (SD 5.1) at month 24 (Mixed Model Analysis [MMA] p < 0.0001), which is a decrease of 51% at month 24 vs. baseline. DAS showed significant decrease over the total study period, with a score of 4.1 (SD 1.7) at baseline to 1.5 (SD 1.8) at month 24 (MMA p < 0.0001). Additionally, this was significant at all time points vs. baseline, both for MRSS and DAS. Internal organ status remained clinically stable throughout the study period. No statistically significant differences compared to baseline were found at the follow-up time points. Seven serious adverse events took place, all except for one, considered unrelated to study medication. CONCLUSIONS: This is the first multicentre Belgian collaboration investigating potential efficacy of rituximab in early dcSSc. Rituximab appears to be safe and tolerable and it may have beneficial effects on skin involvement, on overall disease activity and on stabilization of internal organ status in early dcSSc.
Entities:
Keywords:
Systemic sclerosis; anti-CD20 therapy; clinical outcome; clinical trial; early severe diffuse scleroderma; rituximab
Authors: Marina Maria Vieira de Figueiredo Caldas; Francisco Alves Bezerra Neto; Kesley Pablo Morais de Azevedo; Isac Davidson Santiago Fernandes Pimenta; Ana Katherine Da Silveira Gonçalves De Oliveira; Grasiela Piuvezam Journal: Medicine (Baltimore) Date: 2019-09 Impact factor: 1.817