Effect of rituximab on a salivary gland ultrasound score in primary Sjögren’s syndrome: results of the TRACTISS randomised double-blind multicentre substudy

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Colleges, School and Institutes


Objectives: To compare the effects of rituximab versus placebo on salivary gland ultrasound (SGUS) in primary Sjögren’s syndrome (PSS), in a multicentre, multiobserver phase III trial substudy.

Methods: Subjects consenting to SGUS were randomised to rituximab or placebo given at weeks 0, 2, 24 and 26, and scanned at baseline and weeks 16 and 48. Sonographers completed a 0-11 total ultrasound score (TUS) comprising domains of echogenicity, homogeneity, glandular definition, glands involved, and hypoechoic foci size. Baseline-adjusted TUS values were analysed over time, modelling change from baseline at each time point. For each TUS domain we fitted a repeated measures logistic regression model to model the odds of a response in the rituximab arm (≥1 point improvement) as a function of the baseline score, age category, disease duration and time point.

Results: 52 patients (n=26 rituximab and n=26 placebo) from 9 centres completed baseline and one or more follow-up visits. Estimated between group differences (rituximab-placebo) in baseline adjusted TUS were -1.2 (95% CI -2.1 to -0.3; p=0.0099) and -1.2 (95% CI -2.0 to –0.5; p=0.0023) at weeks 16 and 48. Glandular definition improved in the rituximab arm with an OR of 6.8 (95% CI 1.1-43.0; p=0.043) at week 16 and 10.3 (95% CI 1.0-105.9; p=0.050) at week 48.

Conclusions: We demonstrated statistically significant improvement in TUS after rituximab compared with placebo. This encourages further research into both B cell depletion therapies in PSS and SGUS as an imaging biomarker.


Original languageEnglish
Pages (from-to)412-416
JournalAnnals of the Rheumatic Diseases
Issue number3
Early online date23 Dec 2017
Publication statusPublished - 12 Feb 2018


  • Sjögren’s syndrome, rituximab, ultrasound, salivary gland, B cells