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

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 funct

SUBMITTER: Fisher BA 

PROVIDER: S-EPMC5867400 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature