THU0267 Ultrasonographic Salivary Glands Response to Rituximab in Primary SjöGren Syndrome Patients (Tears Sononographic Study)

Background Ultrasound (US) is a non-invasive tool validated to identify structural abnormalities of salivary glands and to diagnose primary Sjogren Syndrome patients (pSS) (1). However, no previous study evaluated the follow up and the potential improvement of treated pSS patients using ultrasonography. Objectives We conducted a multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of Rituximab (RTX) in active pSS patients (TEARS study: Tolerance and EfficAcy of Rituximab in pSS)) and we evaluated in a single centre (Brest, France) the echostructural and vascularisation changes in this population. Methods The TEARS study included pSS patients with scores above 50 mmon at least two of four visual analog scales (VASs) evaluating dryness, pain, fatigue, and global disease. They were randomly assigned (1:1) to RTX (1 gat weeks 0 and 2) or placebo. Patient had recent-onset ( Results Using this methodology, parotid echostructural scoring was improved in 50% of pSS patients in the RTX group versus 7% in the placebo group (p=0.03). The US submandibular scoring was also improved in 35% of pSS patients in the RTX group compared to 16% in the placebo but the difference was not statistically significant (p= 0.16). There were no changes concerning the size of each gland in RTX or placebo groups. Regarding the modifications between week 0 and week 24 of lemon stimulation response, measured by resistive index variation before and after stimulation, the two groups were not different. Conclusions In our pSS population treated by RTX or placebo, ultrasound evaluation showed a more important improvement of the echo structure of the salivary glands in treated patients than in the placebo group. In contrast, RTX did not modify neither sizes of the salivary glands nor vascularisation inside the glands. References Cornec D, Jousse-Joulin S, Pers JO, Marhadour T, et al. Contribution of salivary gland ultrasonography to the diagnosis of Sjogren’s syndrome: Toward new diagnostic criteria?Arthritis Rheum. 2013 ;65:216-25. Acknowledgements Financial support for this study was received from the Programme Hospitalier de Recherche Clinique (PHRC) 2010. Rituximab was donated free of charge by Roche. Disclosure of Interest S. Jousse-Joulin: None Declared, V. Devauchelle-Pensec Grant/research support from: Roche, D. Cornec: None Declared, T. Marhadour: None Declared, L. Bressolette: None Declared, J.-O. Pers: None Declared, E. Nowak: None Declared, A. Saraux Grant/research support from: Roche, Speakers bureau: Roche