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10.1136/annrheumdis-2017-212268

http://scihub22266oqcxt.onion/10.1136/annrheumdis-2017-212268
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suck abstract from ncbi


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pmid29275334
      Ann+Rheum+Dis 2018 ; 77 (3 ): 412-416
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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 #MMPMID29275334
  • 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
  • Ann Rheum Dis 2018[Mar]; 77 (3 ): 412-416 PMID29275334 show ga
  • 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.
  • |Adult [MESH]
  • |Aged [MESH]
  • |Double-Blind Method [MESH]
  • |Female [MESH]
  • |Humans [MESH]
  • |Immunologic Factors/*therapeutic use [MESH]
  • |Male [MESH]
  • |Middle Aged [MESH]
  • |Rituximab/*therapeutic use [MESH]
  • |Salivary Glands/diagnostic imaging/*drug effects [MESH]
  • |Sjogren's Syndrome/diagnostic imaging/*drug therapy [MESH]
  • |Treatment Outcome [MESH]


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