Effect of rituximab on a salivary gland ultrasound score in primary Sjögren's syndrome: results of the TRACTISS randomised double-blind multicentre substudy. Issue 3 (23rd December 2017)

• Record Type: Journal Article
• Authors: 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 A; Edwards, Christopher John; Lanyon, Peter C; Moots, Robert J; Roussou, Euthalia; Richards, Andrea; Sharples, Linda D; Bombardieri, Michele; Bowman, Simon J
• Is Part Of: Annals of the rheumatic diseases. Volume 77:Issue 3(2018)
• Page Start: 412
• Page End: 416
• Publication Date: 2017-12-23
• Subjects: sjøgren's syndrome -- ultrasonography -- B cells; Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2017-212268
• Languages: English
• ISSNs: 0003-4967

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.