
| 10.1136/annrheumdis-2017-212268
http://scihub22266oqcxt.onion/10.1136/annrheumdis-2017-212268
 C5867400!5867400!29275334
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Ann+Rheum+Dis 2018 ; 77 (3): 412-6 Nephropedia Template TP
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Effect of rituximab on a salivary gland ultrasound score in primary Sj�gren?s syndrome: results of the TRACTISS randomised double-blind multicentre substudy #MMPMID29275334Fisher 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 SJAnn Rheum Dis 2018[Mar]; 77 (3): 412-6 PMID29275334show ga
Objectives: To compare the effects of rituximab versus placebo on salivary gland ultrasound (SGUS) in primary Sj�gren?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.�
  
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