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Effect of rituximab on a salivary gland ultrasound score in primary Sjögren’s syndrome: results of the TRACTISS randomised double-blind multicentre substudy
journal contribution
posted on 2023-06-09, 12:17 authored by 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, Nurhan Sutcliffe, Jimmy Makdissi, Anwar R Tappuni, Nagui S T Gendi, Frances C Hall, Sharon P Ruddock, Catherine Fernandez, Claire T Hulme, Kevin DaviesKevin Davies, Christopher John Edwards, Peter C Lanyon, Robert J Moots, Euthalia Roussou, Andrea Richards, Linda D Sharples, Michele Bombardieri, Simon J BowmanObjectives 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.
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Publication status
- Published
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- Published version
Journal
Annals of the Rheumatic DiseasesISSN
0003-4967Publisher
BMJ Publishing GroupExternal DOI
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3Volume
77Page range
412-416Department affiliated with
- Clinical and Experimental Medicine Publications
Full text available
- Yes
Peer reviewed?
- Yes
Legacy Posted Date
2018-02-20First Open Access (FOA) Date
2018-02-20First Compliant Deposit (FCD) Date
2018-02-20Usage metrics
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