Fisher, Benjamin A, Everett, Colin C, Rout, John, O’Dwyer, John L, Emery, Paul, Pitzalis, Costantino, Ng, Wan-Fai, Carr, Andrew, Pease, Colin T, Price, Elizabeth J, Sutcliffe, Nurhan, Makdissi, Jimmy, Tappuni, Anwar R, Gendi, Nagui S T, Hall, Frances C, Ruddock, Sharon P, Fernandez, Catherine, Hulme, Claire T, Davies, Kevin, Edwards, Christopher John, Lanyon, Peter C, Moots, Robert J, Roussou, Euthalia, Richards, Andrea, Sharples, Linda D, Bombardieri, Michele and Bowman, Simon J (2018) 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

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Abstract

Abstract
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.

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

Item Type:	Article
Schools and Departments:	Brighton and Sussex Medical School > Clinical and Experimental Medicine
Subjects:	R Medicine > R Medicine (General)
Depositing User:	Lisa Costick
Date Deposited:	20 Feb 2018 16:32
Last Modified:	20 Feb 2018 16:32
URI:	http://srodev.sussex.ac.uk/id/eprint/73742

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