Sjögren's disease & overlap diseases

Transcriptomic stratification predicts response to rituximab, abatacept, or the association of hydroxychloroquine and leflunomide in 3 randomised controlled clinical trials of Sjögren’s disease

Ann Rheum DisPublished Secondary analysis of 3 randomised controlled trials

Primary result · Response rate, active treatment vs placebo, by cluster (pooled)Result — go to the resultResponse rate 61.5% vs 32.6%

Authors' conclusion

Transcriptomic stratification of SjD patients revealed differential responses to HCQ-LEF and RTX.

Study context

Population
Sjögren's disease (SjD) patients from 3 RCTs: Hydroxychloroquine-leflunomide (HCQ-LEF) (RepurpSS-I), rituximab (RTX) (TRACTISS) and abatacept3 RCTs
Participants
81 / 24 / 80 / 6
Comparison
Response to active treatment vs placebo across 4 transcriptomic endotypes (clusters 1 to 4)
  • Cluster 1n = 81
  • Cluster 2n = 24
  • Cluster 3n = 80
  • Cluster 4n = 6
Primary endpoint
Therapeutic response by the Sjögren Tool for Assessing Response index, compared across clusters
Methodological detailspooled and individual trial analyses, whole-blood RNA sequencing, semisupervised UMAP with support vector machine model
  • Pooled and individual trial analyses
  • Whole-blood RNA sequencing
  • Semisupervised UMAP with support vector machine model

Primary result

As reported in the abstract

Response rate, active treatment vs placebo, by cluster (pooled)

Response rate

61.5% vs 32.6%

P = 0.016

Further findings

OutcomeP value
ESSDAI, clusters 3 and 4 vs clusters 1 and 2Significantly higher in clusters 3 and 4P = 0.003

ESSPRI scores across clusters

Comparable across clusters

Original publication

Transcriptomic stratification predicts response to rituximab, abatacept, or the association of hydroxychloroquine and leflunomide in 3 randomised controlled clinical trials of Sjögren’s disease. Ann Rheum Dis. Published 24 December 2025. doi:10.1016/j.ard.2025.11.017

Composed by AI from the published abstract and checked against it. How Briefs are made →

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