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Lookup NU author(s): Professor Fai NgORCiD
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
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.
Author(s): Fisher BA, Everett CC, Rout J, O'Dwyer JL, Emery P, Pitzalis C, Ng WF, Carr A, Pease CT, Price EJ, Sutcliffe N, Makdissi J, Tappuni AR, Gendi NST, Hall FC, Ruddock SP, Fernandez C, Hulme CT, Davies KA, Edwards CJ, Lanyon PC, Moots RJ, Roussou E, Richards A, Sharples LD, Bombardieri M, Bowman SJ
Publication type: Article
Publication status: Published
Journal: Annals of the Rheumatic Diseases
Year: 2018
Volume: 77
Issue: 3
Pages: 412-416
Print publication date: 01/03/2018
Online publication date: 23/12/2017
Acceptance date: 01/12/2017
Date deposited: 20/11/2018
ISSN (print): 0003-4967
ISSN (electronic): 1468-2060
Publisher: BMJ Publishing Group
URL: https://doi.org/10.1136/annrheumdis-2017-212268
DOI: 10.1136/annrheumdis-2017-212268
PubMed id: PMC5867400
Notes: TRIAL REGISTRATION NUMBER: 65360827, 2010-021430-64; Results
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