Assessment of sensitivity to change of the European Scleroderma Study Group activity index

Assessment of sensitivity to change of the European Scleroderma Study Group activity index ■

Karin Melsens, Filip De Keyser, Saskia Decuman, Guy Brusselle, Michel De Pauw, Ellen Deschepper, Katelijne De Wilde, Dirk Elewaut, Yves Piette, Els Vandecasteele, Vanessa Smith

Abstract ■

Objective. The European Scleroderma Study Group (EScSG) activity index meets nearly all the OMERACT-standards of truth, discrimination and feasibility. The sensitivity to change remains to be attested. This study assesses sensitivity to change of the EScSG activity index in patients with early and severe diffuse cutaneous Systemic Sclerosis (dcSSc) treated with rituximab. Methods. 12-months follow-up (open-label study) of 14 consecutive patients with early dcSSc. Patients received an infusion of two times 1000mg rituximab at month 0 and 6, together with 100mg methylprednisolone. Clinical read outs (modified Rodnan skin score [mRSS], lung function and echocardiography) and EScSG activity index were performed at month 0, 3, 6 and 12. Mixed models analyses (MMA) were used to evaluate changes in parameters over time. Results. There was a clinically significant change in skin score with a mean (SD) mRSS of 24.8 (4.44) at baseline and 10.4 (3.12) at month 12 (MMA p