Two years follow-up of an open-label pilot study of treatment with rituximab in patients with early diffuse cutaneous systemic sclerosis

Two years follow-up of an open-label pilot study of treatment with rituximab in patients with early diffuse cutaneous systemic sclerosis ■

Karin Melsens, Els Vandecasteele, Ellen Deschepper, Valérie Badot, Daniel Blockmans, Guy Brusselle, Ellen De Langhe, Michel De Pauw, Claire Debusschere, Saskia Decuman, Liselotte Deroo, Frédéric Houssiau, Jan Lenaerts, Yves Piette, Kristof Thevissen, Marie Vanthuyne, René Westhovens, Sara Wijnant, Filip De Keyser, Vanessa Smith

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