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.

中文翻译：

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利妥昔单抗对原发性干燥综合征唾液腺超声评分的影响：TRACTISS 随机双盲多中心子研究的结果

目的 在一项多中心、多观察者 III 期试验子研究中，比较利妥昔单抗与安慰剂对原发性干燥综合征 (PSS) 中唾液腺超声 (SGUS) 的影响。方法 同意接受 SGUS 的受试者在第 0、2、24 和 26 周随机接受利妥昔单抗或安慰剂，并在基线和第 16 周和第 48 周进行扫描。超声医师完成了 0-11 的总超声评分 (TUS)，包括回声性、均匀性领域，腺体的定义，所涉及的腺体和低回声病灶大小。随着时间的推移分析基线调整的 TUS 值，模拟每个时间点的基线变化。对于每个 TUS 域，我们拟合了一个重复测量逻辑回归模型，以将利妥昔单抗组的反应几率（改善≥1 分）建模为基线评分、年龄类别、疾病持续时间和时间点的函数。结果 来自九个中心的 52 名患者（n=26 rituximab 和 n=26 安慰剂）完成了基线和一次或多次随访。基线调整 TUS 的估计组间差异（利妥昔单抗-安慰剂）分别为 -1.2（95% CI -2.1 至 -0.3；P=0.0099）和 -1.2（95% CI -2.0 至 -0.5；P=0.0023）第 16 周和第 48 周。利妥昔单抗组的腺体定义改善，第 16 周的 OR 为 6.8（95% CI 1.1 至 43.0；P=0.043），第 48 周的 OR 为 10.3（95% CI 1.0 至 105.9；P=0.050）。结论 我们证明，与安慰剂相比，利妥昔单抗治疗后 TUS 有统计学显着改善。这鼓励进一步研究 PSS 和 SGUS 中 B 细胞耗竭疗法作为成像生物标志物。试用注册号65360827、2010-021430-64；结果。