International arthritis investigators this week at the 2012 Annual Meeting of the American College of Rheumatology held in Washington, DC presented data related to the 14-3-3η protein and its auto-antibodies, a promising set of new blood-based markers from Augurex, that alone or in combination with other markers, may aid in the diagnosis of Rheumatoid Arthritis (RA), a debilitating and chronic autoimmune disease that affects 1.5% of the population. Early diagnosis, assisted by proven RA markers, can lead to earlier treatment of RA, which is associated with significantly better outcomes for patients with this disease.
Dr. Walter Maksymowych, co-inventor of 14-3-3η, the principal investigator of several 14-3-3η studies and Medical Research Professor of Medicine and Rheumatologist at the University of Alberta, Canada says, “The data that we have previously presented over the past two years indicate that 14-3-3η on its own, and in combination with blood tests currently used, such as RF and anti-CCP, can increase the diagnosis rate of patients with RA. Also, in both RA and Psoriatic Arthritis, it marks joint damage which is an irreversible process contributing to the physical debilitation associated with these diseases.”
Because 14-3-3η is not normally found in the blood, when it is present in patients with RA, it appears that the body tries to clear it by mounting an immune response creating “auto-antibodies” to 14-3-3η which can be measured in blood. Dr. Anthony Marotta, Chief Scientific Officer of Augurex Life Sciences Corp, the company that has been investigating 14-3-3η says, “The data presented at ACR describes the measurement of 14-3-3η and its “auto-antibodies” for RA diagnosis. Further studies are planned to determine their clinical usefulness to assess the risk of aggressive disease and likely response to specific therapies.”
Dr. Paul-Peter Tak, Professor of Medicine at the Academic Medical Center, University of Amsterdam was the principal investigator of a 14-3-3η study in Psoriatic Arthritis that was presented at this meeting. “Similar to the 14-3-3η data in RA, we saw that the marker was particularly elevated in Psoriatic Arthritis patients with joint damage, and that its expression marked likelihood of response to a therapy called adalimumab. Now we are observing that when the levels of 14-3-3η decrease twelve weeks after the treatment is started, that it marks response to therapy. This is potentially very useful in the clinic since we need additional markers of joint damage and response to therapy to help us better manage these patients,” says Dr. Tak.
These data come recently after Augurex Life Sciences Corp announced in September 2012 that it had formed an exclusive license agreement with Quest Diagnostics for the development of a clinical laboratory-developed testing service based on 14-3-3η for the United States. Quest Diagnostics, the world’s leading diagnostic testing company serving approximately half of the physicians and hospitals in the United States, expects to launch the service in 2013.
“The novel biomarker 14-3-3η has the potential to provide the basis for a laboratory testing service that can aid in the early diagnosis of RA and help monitor disease activity,” said Stanley J. Naides, M.D., Medical Director, Immunology Research and Development and Interim Scientific Director, Immunology Research and Development, Quest Diagnostics, and an attendee of ACR. “Quest Diagnostics has a strong immunology expertise, and we look forward to developing a new testing service based on the Augurex marker to be added to our arthritis menu to advance rheumatologic practice.”