UB Research Makes Early Diagnosis of Sjogren’s Syndrome a Reality

Their breakthrough means that people with Sjogren’s syndrome, a condition characterized by painfully dry eyes and mouth, will receive treatment when they’re more likely to benefit from it.

The research team observed the novel antibodies in 45 percent of patients who met most of the clinical criteria for Sjogren’s syndrome except the two antibodies currently required for a diagnosis.

These two antibodies—called “Ro” and “La”—appear late in the disease.

The researchers team found at least one of the new antibodies in 76 percent of patients with symptoms lasting less than two years, but without the Ro and La antibodies.

Their findings were published as a highlighted article in Clinical Immunology with an editorial by Robert I. Fox, MD, considered one of the world’s top Sjogren’s scientists.

Although Sjogren’s syndrome is one of the three most common autoimmune diseases, it is not well known.

The condition often takes years to diagnose, according to Julian L. Ambrus Jr., MD, professor of medicine and senior author on the paper.

“Sjogren’s patients get diagnosed too late,” he says, noting that 90 percent of patients are women.

“They go to the doctor because their eyes are dry or they can’t swallow, but by that time, their salivary or tear glands are already dead. They’re way past the point where they can generally benefit from treatment.”

The discovery of the novel antibodies grew out of a collaboration between UB and Immco that in 2006 resulted in a superior animal model for Sjogren’s syndrome now being used in labs worldwide.

“Our animal model has completely changed how people think about this disease,” Ambrus says.

“Sjogren’s disease in our animal model marches along in exactly the same way that the human disease does, reproducing every stage of the disease.”

Once scientists detected the new antibodies in mice, they started testing patients at Buffalo General Medical Center, finding the same antibodies, even at early stages of the disease.

UB has filed a patent on the biomarker-based method and licensed the technology to Immco, which has developed a new diagnostic tool based on the research that has significant proprietary value.

 "We will be the only company in the world to offer and market this test across any platform,” says Immco CEO William Maggio.

Once the assay undergoes New York State Department of Health validation this year, physicians will be able to start using it.

Because Sjogren’s syndrome presents with various symptoms, the test will be marketed to several different types of physicians, including oral surgeons, ophthalmologists, rheumatologists and dentists.

Immco will test patient samples from around the country. The company also is developing a diagnostic kit to market internationally.

“This is a very good example of how research and industry collaborate to produce something that will bring a lot of good to the health care industry—and it’s happening here in Buffalo,” Maggio says.

In addition to the chronic pain resulting from an inability to produce tears or saliva, Sjogren’s syndrome is associated with mild kidney and lung disease. Five to 10 percent of people with Sjogren’s develop lymphoma.

“Sjogren's patients are miserable,” says co-author Lakshmanan Suresh, DDS, Immco’s vice president for research and development and a clinical associate professor of oral diagnostic sciences in the UB School of Dental Medicine.

“They cannot taste anything, they often have serious tooth decay, and they feel as though they have sandpaper or grit in their eyes all the time.

“If we can find the antibodies early, then we can start to develop therapies to target them. The first step, though, is to make the diagnosis.”

The UB researchers recently received a $450,000 grant from the National Institutes of Health to study how the immune system becomes dysfunctional in Sjogren’s syndrome.

Last summer, the project received financial support from UB's Center for Advanced Biomedical and Bioengineering Technology, one of 15 centers funded by the Empire State Development's Division of Science, Technology and Innovation to encourage university-industry collaboration in research, education and technology transfer.

First author on the Clinical Immunology paper is Long Shen, PhD, research assistant professor of medicine at UB.

Along with Ambrus and Suresh, co-authors are, from UB:

•  Jingxiu Xuan, PhD, research assistant professor of medicine

From Immco:

• Matthew Lindemann, PhD, director of assay development
• Przemek Kowal, PhD, director of biopolymers
• Kishore Malyavantham, PhD, director of scientific initiatives