University of Sussex
Browse
412.full.pdf (282.83 kB)

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

Download (282.83 kB)
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 Bowman
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.

History

Publication status

  • Published

File Version

  • Published version

Journal

Annals of the Rheumatic Diseases

ISSN

0003-4967

Publisher

BMJ Publishing Group

Issue

3

Volume

77

Page range

412-416

Department affiliated with

  • Clinical and Experimental Medicine Publications

Full text available

  • Yes

Peer reviewed?

  • Yes

Legacy Posted Date

2018-02-20

First Open Access (FOA) Date

2018-02-20

First Compliant Deposit (FCD) Date

2018-02-20

Usage metrics

    University of Sussex (Publications)

    Categories

    No categories selected

    Licence

    Exports

    RefWorks
    BibTeX
    Ref. manager
    Endnote
    DataCite
    NLM
    DC