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The FNIH (Foundation for the National Institutes of Health) Biomarkers Consortium Inflammation and Immunity Steering Committee (IISC) identified Sjögren’s as a priority to address in its 2018 strategic plan. Fast-forward to summer 2019, and a dedicated Sjögren’s Working Group has been established and is working to prioritize challenges and develop a project plan for a partnership addressing the major needs of the Sjögren’s drug development community.

Key priorities under consideration for this working group are the evaluation of new potential clinical tools to support the clinical development of novel therapies in Sjögren’s.

Key challenges to address, as identified by the Sjögren’s Working Group, include:

  • Defining eligible patient subpopulations: The clinical, serological and immunologic patient heterogeneity and the understanding that clinical phenotypes don’t necessarily reflect the complexities of underlying immune mechanisms is a significant challenge in Sjögren’s. Larger studies are needed to more precisely define and characterize disease subsets from a molecular perspective.
  • Understanding disease progression: This category focuses on supporting multidimensional longitudinal profiling of patients to inform the development and validation of diagnostic, prognostic and disease monitoring biomarkers of Sjögren’s to improve clinical trials and better understand disease driving mechanisms of action.
  • Biomarker development and characterization: The need for patient phenotyping using molecular biomarkers to characterize different subgroups, treatment effects and measures for symptoms that are highly subjective or not currently evaluated is essential. Characterization of salivary gland biology in patients with systemic manifestations could help reveal more specific peripheral markers. Additionally, standardized imaging techniques to obtain pre- and post-treatment information associated with disease severity and progression are promising. Markers that predict long-term organ-specific changes or adverse systemic outcomes would be crucial for improving patient care. These studies should integrate biomarkers from genetic, epigenetic, transcriptional and proteomic data that can be developed as new clinical tools.
  • Identifying and harmonizing appropriate endpoints: Aligning current outcome measures in Sjögren’s, the ESSDAI and ESSPRI, with new endpoints being standardized through other consortia, will aid the efficiency and effectiveness of clinical trials. Emphasis is placed on collecting “real world evidence” outcomes to help understand what matters most to patients and gauge how physicians currently diagnose and manage Sjögren’s patients so that the precise tools developed for measurement are meaningful.

FNIH Biomarkers Consortium Overarching Goal

The Biomarkers Consortium is helping facilitate, catalyze and support a new era of precision medicine, with more highly predictive drug development tools that have an impact during a patient’s illness or lifespan. Its goal is to combine the forces of the public and private sectors to accelerate the development of biomarker-based technologies, medicines, and therapies for the prevention, early detection, diagnosis and treatment of disease.

What is a biomarker and what are they used for?

Biomarkers are biological molecules found in body fluids, including blood, or tissues that are signs of a normal or abnormal process, or of a condition of disease.

Biomarkers can be critical for diagnosis, identification of patient susceptibility and risk, disease management, categorizing patient subsets and measuring therapeutic response in clinical trials and increasing our understanding of disease etiology.