Short summary

Sjogren's Syndrome, SS, is characterized by debilitating dryness of eyes and mouth in some patients associated with constitutional and more severe symptoms. The syndrome is difficult to diagnose and treatment is mainly concentrated on symptoms. This project aims to characterize a cohort of 50 Danish SS-patients by using a new classifications tool and ultrasound of the salivary glands. 

Rationale

A diagnosis of SS traditionally is based on the classification criteria provided by the American-European Consensus Group (AECG), proposed in 2002. New criteria have been proposed in the 2016 ACR/EULAR classification criteria for primary SS. Recent scientific studies indicate that ultrasound (US) investigation of the major salivary glands may be a valuable supplement in the diagnostic and maybe also in risk stratification and monitoring of treatment response in SS. US is not so far introduced as a tool in routine care for SS patients in Denmark. In the present study we wish to characterize a Danish cohort of 50 patients with SS by interview, patient reported outcome (ESSPRI), disease activity score (ESSPRI), measurement of tear and salivary production (Schirmers´s test, salivary test), ultrasound of the salivary glands and blood sampling (for a biobank). Saliva will also be saved in the biobank. Subsequently analysis of biomarkers of inflammation will be analyzed in blood and saliva.

The results provide the opportunity to evaluate US findings in relation to patient reported outcomes, disease activity score and saliva production.

SS patients have not been characterized like this before in Denmark. Furthermore, the introduction of US for disease evaluation will add important clinical information about the disease. The biobank allows future studies of potential biomarkers for the disease.

Description of the cohort

Patients that are registered at the Department of Rheumatology, Odense University Hospital, with the diagnoses of M35.0 and M35.9 according to the International Classification of Diseases (ICD-10). 

Data and biological material

Clinical data will be obtained during interviews and from medical records. Disease manifestations and AECG and 2016 ACR/EULAR classification criteria will be registered. Sjögren's syndrome disease activity index (ESSDAI) is calculated via systemic clinical examination and laboratory evaluations, and the EULAR Sjögren's syndrome patient-reported index (ESSPRI) assessed via a survey of patient responses. 

Blood and urine samples will be analyzed during patient visits. A blood and saliva sample will be stores in a biobank for subsequent analysis of biomarkers of inflammation. 

Collaborating researchers and departments

Department of Rheumatology, Copenhagen University Hospital at Glostrup

• Consultant Lene Terslev, MD, PhD
• Consultant Vitoria Fana, MD,

Department of Clinical Immunology, Odense University Hospital

• Associate Professor, Søren Lillevang, MD, PhD
• Anna Christine Nilsson, MD