The American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) have developed, validated, and approved a unified and definitive set of classification criteria for Sjögren’s syndrome. As many as 4 million Americans live with the disease, with women representing 90% of those affected.
The classification criteria will be used to determine patient suitability for participation in clinical trials related to the disease. The new criteria supersede previous sets, including the 2012 criteria provisionally approved by the ACR and the American European Consensus Group criteria published in 2012.
“The landscape of Sjögren’s syndrome has changed in recent years, due to both the recently validated disease activity indices and the availability of new therapeutic agents,” said lead author Caroline Shiboski, DDS, PhD, MPG, Leland A. and Gladys K. Barber distinguished professor in dentistry and chair of the department of orofacial sciences in the University of California San Francisco School of Dentistry.
“Using methodology consistent with recent ACR/EULAR-approved classification criteria for other rheumatic diseases, we developed a single set of data-driven consensus classification criteria for primary Sjögren’s syndrome, which performed well in validation and are well suited as entry criteria for new clinical trials,” said Shiboski.
The white blood cells of patients with Sjögren’s syndrome attack the glands that produce tears and saliva, resulting in dry mouth, dry eyes, fatigue, and chronic pain. The lack of saliva often can lead to tooth decay. The disease also can involve other parts of the body, including the lungs, kidneys, blood vessels, and nervous system.
The study announcing the unified criteria and the process that led to their adoption, “2016 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Primary Sjögren’s Syndrome,” was published by Arthritis & Rheumatology and the Annals of the Rheumatic Diseases.