Standardisation of labial salivary gland histopathology in clinical trials in primary Sjögren’s syndrome

Research output: Contribution to journalArticlepeer-review


  • Roland Jonsson
  • Troy Daniels
  • Michele Bombardieri
  • Rachel Brown
  • Peter Morgan
  • Stefano Bombardieri
  • Wan-fai Ng
  • Athanasios Tzioufas
  • Claudio Vitali
  • Pepe Shirlaw
  • Erlin Haacke
  • Sebastian Costa
  • Hendrika Bootsma
  • Valerie Devauchelle-Pensec
  • Timothy Radstake
  • Xavier Mariette
  • Andrea Richards
  • Rebecca Stack

Colleges, School and Institutes


Labial salivary gland (LSG) biopsy is used in the classification of primary Sjögren’s syndrome (PSS) and in patient stratification in clinical trials. It may also function as a biomarker. The acquisition of tissue and histological interpretation is variable and needs to be standardized for use in clinical trials.
A modified EULAR consensus guideline development strategy was used. The steering committee of the ad hoc working group identified key outstanding points of variability in LSG acquisition and analysis. A two day workshop was held to develop consensus where possible and identify points where further discussion/data was needed. These points were reviewed by a subgroup of experts on PSS histopathology and then circulated via an online survey to 50 stakeholder experts consisting of rheumatologists, histopathologists and oral medicine specialists, to assess level of agreement (0-10 scale) and comments. Criteria for agreement were a mean score ≥6/10 and 75% of respondents scoring ≥6/10.
39 (78%) experts responded and 16 points met criteria for agreement. These points are focused on tissue requirements, identification of the characteristic focal lymphocytic sialadenitis, calculation of the focus score, identification of germinal centres, assessment of the area of leukocyte infiltration, reporting standards, and use of pre-study samples for clinical trials.
We provide standardized consensus guidance for the use of labial salivary gland histopathology in the classification of PSS and in clinical trials and identify areas where further research is required to achieve evidence-based consensus.


Original languageEnglish
Pages (from-to)1161-1168
JournalAnnals of the Rheumatic Diseases
Issue number7
Early online date13 Dec 2016
Publication statusE-pub ahead of print - 13 Dec 2016


  • focal lymphocytic sialadentitis, biomarkers, Sjögren’s syndrome, salivary gland, outcome measures, histology, focus score