New Sjögren’s Antibody Discovery Improves Diagnosis

With the approach of the new year also comes new hope for those with Sjögren’s syndrome. A recent discovery of a new autoantibody associated with Sjögren’s syndrome is leading to the development of a new diagnostic test that will more accurately identify a diagnosis of Sjögren’s early in the disease process. This finding will pave the way to improved identification and treatment of this devastating autoimmune illness. Many of our PROSE patients with Sjögren’s syndrome have been through a long journey of diagnosis and maintain hope that future Sjögren’s sufferers won’t have to endure a similar path.

Sjögren’s syndrome is a chronic autoimmune disease in which the body’s own cells attack moisture producing glands as well as other organ systems resulting in dry eyes and mouth, fatigue, and organ dysfunction. This disease affects as many as 4 million Americans with an estimated additional 3 million more cases undiagnosed. At present, there is no single definitive diagnostic test for diagnosing Sjögren’s, only a set of diagnostic criteria, which makes diagnosis an often difficult and lengthy process for patients. When patients do not get an accurate diagnosis upon early onset of symptoms, effective treatment is delayed. This delay can seriously impact a patient’s quality of life, cause undue stress and anxiety, and result in irreversible damage to organs and glands. Due to the significant impact of a delayed diagnosis, the Sjögren’s Syndrome Foundation (SSF), a leading Sjögren’s patient support and advocacy group, has set their sights on reducing the time to diagnosis by 50% in the next 5 years.

With this new antibody discovery published in the December issue of the Journal of Clinical Immunology, the SSF sees one very large step toward their stated goal. Researchers at the University at Buffalo in cooperation with Immco Diagnostics, Inc., have uncovered a new antibody that is present in patients much earlier in the disease process than previously identified antibodies used as disease indicators. Physicians have previously relied on two antibody markers, Ro and La, as part of the diagnostic criteria for Sjögren’s. These markers often do not appear until quite late in the disease process when irreversible damage may have already occurred. In this new study, these new antibodies were found in 45% of patients who met the current clinical criteria for diagnosis but did not test positive for the current antibodies used for diagnosis. At least one of the newly discovered antibodies was found in 76% of patients who were symptomatic for less than two years, yet lacked the disease markers Ro or La. These findings reveal the effectiveness of the newly discovered antibodies to reveal Sjögren’s syndrome at an earlier stage.

The University at Buffalo has filed a patent on the biomarker-based method and licensed the technology to Immco Diagnostics, which has created a new diagnostic tool based on the research. The company aims to make to test available to physicians in early 2013. Because initial symptoms of Sjögren’s may be identified by physicians of different disciplines, including dentists, oral surgeons, ophthalmologists, and rheumatologists, the new test will be marketed to these different groups of physicians to broaden the impact of this new test.

We will keep our eye on the launch and use of this new diagnostic tool and hope to report even more positive news for our Sjögren’s patients in 2013. Best wishes for a happy and healthy new year!