Sjögren's disease & overlap diseases

Machine learning to classify the focus score and Sjögren's disease using digitalised salivary gland biopsies: a retrospective cohort study

Lancet RheumatolPublished Retrospective cohort study

Authors' conclusion

This study showed that deep learning can reliably classify the focus score and Sjögren's disease using minor salivary gland biopsy exclusively. The study identified that CD8+ T-cell infiltration in acini was associated with Sjögren's disease.

Study context

Population
Participants with sicca without SjD and patients with SjD (ACR-EULAR 2016 criteria) with focus score ≥1 or <1, six expert centres (UK, Greece, Portugal, France), European H2020 NECESSITY consortium490 (90%) female
Participants
545 participants
Outcome
AUROC to classify the focus score and SjD
Methodological detailsmulticentre (six expert centres), deep learning model trained on five centres, externally validated on the sixth, Shapley values for explainability, Conducted Oct 13, 2021, to Sept 5, 2024
  • Multicentre (six expert centres)
  • Deep learning model trained on five centres, externally validated on the sixth
  • Shapley values for explainability
  • Conducted Oct 13, 2021, to Sept 5, 2024

Main finding

As reported in the abstract

after external validation

Area under the receiver operator curve (AUROC), focus score classification

0.88

95% CI 0.82–0.94

AUROC, Sjögren's disease classification

0.89

0.82–0.94

Observational data: associations, not effects.

Further findings

Sjögren's disease classification in anti-Sjögren's syndrome-related antigen A negative patients (subgroup)

Performance of Sjögren's disease classification
0.92 (0.87-1.00)

Histological patterns identified by the model

New pattern of CD8+ T cells around acinar epithelial cells associated with Sjögren's disease diagnosis

Original publication

Machine learning to classify the focus score and Sjögren's disease using digitalised salivary gland biopsies: a retrospective cohort study. Lancet Rheumatol. Published 29 September 2025. doi:10.1016/s2665-9913(25)00181-x

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