Outcome measures for primary Sjögren's syndrome

Area of Science:

• Rheumatology
• Immunology
• Clinical Trials

Background:

• Primary Sjögren's syndrome (SS) is characterized by lymphocytic infiltration of epithelia, primarily affecting salivary and lachrymal glands, leading to dry eye and mouth.
• Clinical features include subjective symptoms like dryness, pain, fatigue, and systemic manifestations such as arthritis and vasculitis.
• Accurate outcome assessment in SS requires evaluating sicca symptoms, objective measures, fatigue, quality of life, disease activity, and damage.

Purpose of the Study:

• To review and critically analyze existing and developing outcome assessment tools for primary Sjögren's syndrome.
• To discuss the development and validation of two consensus disease activity indexes: the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) and the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI).

Main Methods:

• Review of literature on outcome measures for Sjögren's syndrome.
• Analysis of the development process for the EULAR-supported ESSPRI and ESSDAI.
• Evaluation of the feasibility, validity, and reliability of these new indexes based on recent studies.

Main Results:

• Existing tools like PROFAD and SSI assess patient-reported symptoms.
• The EULAR-supported ESSPRI and ESSDAI were developed as consensus indexes for disease activity and systemic manifestations.
• Preliminary studies indicate that ESSPRI and ESSDAI are feasible, valid, and reliable instruments for Sjögren's syndrome assessment.

Conclusions:

• ESSPRI and ESSDAI represent significant advancements in standardizing outcome assessment for Sjögren's syndrome.
• These indexes, upon final validation, are expected to serve as consensus criteria in clinical trials and practice.
• Improved outcome measures are crucial for evaluating therapeutic efficacy and managing Sjögren's syndrome effectively.