Background Ultrasound (US) is a non-invasive tool validated to identify structural abnormalities of salivary glands and to diagnose primary Sjögren 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 (<10 years) biologically active pSS and/or systemic pSS. 28 pSS patients had ultrasonographic examination before the first infusion (placebo or RTX) and at 24 weeks follow up. Both parotid and submandibular glands were assessed. The echostructure of each gland was scored using a semi quantitative scoring (0 to 4). We also evaluated the size of each glands and the vascularisation using the resistive index of the transverse facial artery of the parotid glands before and after stimulation with lemon juice. Concerning the echostructural scoring of each gland, we considered an improvement if the score of the glands was improved by one point or more and the comparison between the RTX and placebo group were obtained using the Fisher’s exact test. Difference of size (mm) and resistive index before and after treatment (RTX or placebo) were evaluated using the non parametric Wilcoxon test.
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.
Cornec D, Jousse-Joulin S, Pers JO, Marhadour T, et al. Contribution of salivary gland ultrasonography to the diagnosis of Sjögren’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