In patients with primary Sjogren’s syndrome, improvements in salivary gland ultrasound were demonstrated after treatment with rituximab, according to the results of the TRACTISS substudy published in the Annals of the Rheumatic Diseases.
Patients with primary Sjogren’s syndrome who consented to receiving salivary gland ultrasound were randomly assigned to receive rituximab or placebo, administered at 0, 2, 24, and 26 weeks. All participants were scanned at baseline and at 16 and 48 weeks. The sonographers compiled a total ultrasound score (0 to 11), which included domains of echogenicity, homogeneity, glands involved, glandular definition, and size of hypoechoic foci. Baseline-adjusted total ultrasound score values were assessed over time, considering the change from baseline at each time point.
A total of 52 patients (26 treated with rituximab and 26 treated with placebo) from 9 centers completed the baseline visit and ≥1 follow-up visit. The estimated differences between the rituximab and placebo groups in baseline-adjusted total ultrasound score were −1.2 (95% CI, −2.1 to −0.3; P =.0099) at 16 weeks and −1.2 (95% CI, −2.0 to −0.5; P =.0023) at 48 weeks. Glandular definition improved in the rituximab treatment group, with an odds ratio (OR) of 6.8 (95% CI, 1.1-43.0; P =.043) at 16 weeks and an OR of 10.3 (95% CI, 1.0-105.9; P =.050) at 48 weeks.
A statistically significant improvement in total ultrasound score was demonstrated after treatment with rituximab compared with placebo. The investigators concluded that these findings warrant further research into both B-cell depletion therapies in primary Sjogren’s syndrome and the use of salivary gland ultrasound as an imaging biomarker in this population.
Fisher BA, Everett CC, Rout J, et al. Effect of rituximab on a salivary gland ultrasound score in primary Sjögren’s syndrome: results of the TRACTISS randomised double-blind multicentre substudy. Ann Rheum Dis. 2018;77:412-416.