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

Benjamin A Fisher; Colin C Everett; John Rout; John L O'Dwyer; Paul Emery; Costantino Pitzalis; Wan-Fai Ng; Andrew Carr; Colin T Pease; Elizabeth J Price; +17 more... Nurhan Sutcliffe; Jimmy Makdissi; Anwar R Tappuni; Nagui ST Gendi; Frances C Hall; Sharon P Ruddock; Catherine Fernandez; Claire T Hulme; Kevin A Davies; Christopher John Edwards; Peter C Lanyon; Robert J Moots; Euthalia Roussou; Andrea Richards; Linda D Sharples ORCID logo; Michele Bombardieri; Simon J Bowman; (2017) Effect of rituximab on a salivary gland ultrasound score in primary Sjögren's syndrome: results of the TRACTISS randomised double-blind multicentre substudy. Annals of the rheumatic diseases, 77 (3). pp. 412-416. ISSN 0003-4967 DOI: 10.1136/annrheumdis-2017-212268
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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 nine 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 to 43.0; P=0.043) at week 16 and 10.3 (95% CI 1.0 to 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. TRIAL REGISTRATION NUMBER: 65360827, 2010-021430-64; Results.


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