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.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 Ann+Rheum+Dis
2018 ; 77
(3
): 412-416
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English Wikipedia
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.