The Sjögren’s International Collaborative Clinical Alliance has presented new classification criteria for research on Sjögren’s syndrome. Previously, research classifications for the autoimmune disease, which affects several areas of the body such as the eyes, salivary glands, and joints, had been subjective. The new objective criteria will help to standardize clinical trial enrollment and comparability of research data, researchers said.
Organizations within the National Institutes of Health, including the National Institute of Dental and Craniofacial Research, National Eye Institute, and Office for Research on Women’s Health, supported the Sjögren’s International Collaborative Clinical Alliance (SICCA).
SICCA criteria are the first that the American College of Rheumatology (ACR) has accepted, signaling the need for rheumatologists to collaborate with ophthalmologists and oral medicine practitioners to better diagnose the condition.
“The next step will be to present our criteria to representatives of the European League Against Rheumatism, the European equivalent of ACR, with a goal of achieving a single international standard,” Caroline Shiboski, DDS, PhD, professor at the University of California San Francisco (UCSF), School of Dentistry, said in a press release.
SICCA is a research alliance that spans seven countries and shares its scientific resources, allowing for the development of an international Sjögren’s syndrome patient registry.
Ophthalmologists, rheumatologists, and oral medicine/pathology clinicians chose 1,400 people from the registry to participate in clinical evaluations to assess the various disease components. Data were used to develop a preliminary set of classification criteria, and then compared with existing classification approaches, such as the American-European Consensus Group criteria.
The new SICCA criteria require patients to be positive in at least two of three diagnostic tests to be classified with Sjögren’s syndrome.
“Uniform classification criteria based on objective tests are important to help ensure that participants in clinical studies and treatment trials on Sjögren’s syndrome are correctly classified … ,” Shiboski said. “This is especially important … to avoid exposing individuals to new investigational drugs and any potential toxicity if they don’t have Sjögren’s syndrome.”
“Dry mouth and eyes long have been associated with Sjögren’s syndrome,” Troy Daniels, DDS, professor at UCSF, School of Dentistry, said in the release. “But our data showed that although patients may complain of dry mouth and eyes, these symptoms lack a statistically significant association with positive antibodies, ocular staining, and/or salivary biopsy. This shows the tremendous complexity of Sjögren’s syndrome and the true value of assembling more objective classification criteria moving forward.”