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In-office test for Sjögren’s syndrome involves OD in systemic care
By testing suspect dry eye patients, optometrists can make the diagnosis earlier in the disease process.
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Diagnosing Sjögren’s syndrome early provides the opportunity for physicians to address and possibly prevent associated complications.
“Early restoration of salivary function can relieve symptoms of dry mouth and may prevent or slow the progress of the oral complications of Sjögren’s syndrome, including dental caries, oral candidiasis and periodontal disease,” Kassan and colleagues reported in Archives of Internal Medicine. “Untreated severe dry eye can result in corneal perforation in the patient with Sjögren’s syndrome, which may eventually lead to loss of the eye.
“Early diagnosis may contribute to prompt recognition and treatment of serious systemic complications of Sjögren’s syndrome such as malignant lymphoma and interstitial lung disease,” they continued. “Additionally, an extensive delay in diagnosis can affect the patient’s psychological well-being because of the anxiety that accompanies an undiagnosed illness.”
Optometrists can now identify Sjögren’s patients earlier in their dry eye population with a new advanced diagnostic test.
Sjö, the laboratory test designed for early detection of Sjögren’s syndrome, has been available from Nicox for use by eye care professionals since November 2013. The test, which is currently only available in the U.S., utilizes the combination of four traditional biomarkers and three novel, propriety biomarkers to improve its sensitivity.
“The benefit of the Sjö test is that in addition to testing standard biomarkers for Sjögren’s syndrome – anti-Ro and anti-La – they test for three new markers: salivary protein 1 (SP-1), which has high expression in lacrimal and submandibular glands; carbonic anhydrase 6 (CA6), which has high expression in acinar cells of the submandibular and parotid glands; and parotid secretory protein (PSP), which is expressed in the acinar cells of the salivary glands,” Mile Brujic, OD, BS, FAAO, explained to Primary Care Optometry News. “The benefit to these markers is that they are expressed earlier in the disease process, thus, allowing for earlier detection than with standard laboratory testing.
Mile Brujic
“Ultimately, this places optometry in a unique position to identify patients earlier,” he added.
Performing the test
According to Nicox, the test is performed with a single-use lancet. Patients have their fingers pricked with the lancet, and drops of blood are collected on a Whatman card. After the card has dried, the test is sent along with the patient’s information to the testing laboratory for analysis. Results are received online or via fax.
“The test is easy to administer and is performed by technicians,” Scott B. Han, OD, FAAO, told PCON. “I have been surprised how many of my patients have underlying autoimmune conditions that we have helped uncover.”
Scott B. Han
“I recommend making sure that optometrists have team members who are well versed in the test and who can reliably perform it,” Brujic said. “The test does require education in the exam room from the optometrist, but a team member would actually perform it on the patient. Additionally, contacting the patient when results are received, with either an office visit or a phone call, is important to plan for next steps of patient care.”
Brujic said the skin prick test may be outside optometrists’ scope of practice in some states, but in those cases, patients could prick their own skin and collect the blood on the card.
Brujic said there is no CPT code for this test; Han noted that the lab bills the patient’s insurance directly.
According to the Sjögren’s Syndrome Foundation it can take, on average, 4.7 years for a patient to be diagnosed after the initial presentation of key symptoms.
Sjö has demonstrated 89% cumulative sensitivity and 78.2% cumulative specificity, according to Nicox.
“We have already diagnosed some patients who would not have been identified if we didn’t run the test,” Brujic said. “Who knows how long some of these patients would have gone without a proper diagnosis? Optometry is increasingly demonstrating its importance in overall health care, and the Sjö test is simply one more tool we now have to help improve the lives of our patients and increase our presence in the health care arena.”
Prevalence, relationship to dry eye
Sjögren’s syndrome is one of the most prevalent autoimmune disorders, according to the Sjögren’s Syndrome Foundation, with approximately 4 million, or one in 70, Americans suffering from the disease.
As noted by Nicox as well as the Sjögren’s Syndrome Foundation, the trademark symptoms of the disease are dry eyes and dry mouth. A 2012 study conducted by Liew and colleagues found that about one in 10 dry eye patients also had Sjögren’s syndrome.
Indications, patient feedback
“The Sjö test has given us additional insights into the underlying etiology for the dry eye that we see clinically,” Brujic explained. “When a patient has moderate or severe dry eye, in particular with patch staining on the cornea, I consider running the test. Additionally, if they have dry eye associated with any of the other signs or symptoms that often are seen in a Sjögren’s patient, such as dry mouth, diffuse rheumatological conditions or Raynaud’s phenomenon, the blood test would be warranted.”
Both Brujic and Han have received encouraging feedback from their patients regarding Sjö.
“The initial response from patients has been positive,” Brujic said. “They have been very appreciative that we are investigating the cause of their dry eye as something that is more systemic in nature and truly trying to uncover the etiology of the condition.”
“I would definitely recommend it to other doctors for better patient care,” Han said. “Oftentimes we concentrate so much on the eyes that we overlook the rest of the body. We want to improve eye health and comfort, but we also have an opportunity to improve overall systemic health. With Sjö, we are able to diagnose these conditions earlier than before. Earlier diagnosis of autoimmune conditions allows for timely referral to the proper specialist to begin coordinating the care these patients will likely need for the rest of their life.
“It also means improving their quality of life and potentially saving their life,” he added. “Patients like to know if they have other reasons for their dry eyes. Some of my most loyal patients are my dry eye patients because we are making meaningful differences in their lives.”
Han noted that not all rheumatologists are familiar with the novel markers.
“I use this as an opportunity to share our perspective and expectations,” he said. “Not all positive patients will need treatment for rheumatoid arthritis, but we want them under the care of someone in case they progress in the future. When rhematologists see how knowledgeable you are about dry eye disease, they are likely to refer their patients to you.” – by Chelsea Frajerman