EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
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E W CORNEA 106 March 2014 A new panel test for Sjogren's syndrome puts eyecare professionals on the frontline of diagnosis D ry eye is the hallmark of Sjogren's syndrome and is often the presenting symptom, but eyecare p rofessionals rarely con- sider Sjogren's syndrome in their dif- ferential diagnosis when caring for dry eye patients. Sjogren's syndrome is considered to be rare, and we ex- pect rheumatologists or the patient's internist to have previously made a diagnosis. Contrary to what we be- lieve, it is one of the most common autoimmune diseases; approxi- mately 4 million Sjogren's patients live in the United States, of whom approximately 1 million have been diagnosed. 1 In fact, eyecare profes- sionals have the opportunity to be the first to make a proper diagnosis of Sjogren's syndrome by testing dry eye patients and helping them seek appropriate care and treatment. S ince Sjogren's syndrome is a sys- temic autoimmune disease affecting organs beyond lacrimal and salivary glands, making the diagnosis not only provides patients with an an- swer to their complaints but alerts them to seek further care to evaluate possible diseases in other organ systems, such as the lung and liver. F urthermore, about 5 to 10% of Sjogren's patients develop lym- phoma. 2 About Sjogren's syndrome Sjogren's syndrome is classified into two types, both affecting the tear and saliva glands. Primary Sjogren's syndrome consists of aqueous defi- c ient dry eye syndrome in combina- tion with symptoms of dry mouth caused by reduced salivary secretion and confirmed with a positive focus score on a minor salivary gland biopsy and biomarkers in the blood. Secondary Sjogren's syndrome oc- curs in patients who have another autoimmune disease, such as lupus and rheumatoid arthritis. It consists of the features of primary Sjogren's s yndrome together with an overt autoimmune connective tissues dis- ease, most commonly rheumatoid arthritis. Sjogren's syndrome is a frustrat- ing illness for patients, as the differ- ent symptoms are non-specific. Patients often know they aren't healthy but spend years making the r ounds at different doctors' offices. Patients are thought to be either de- pressed or feigning their symptoms because clinicians are missing the ability to connect their symptoms to a cohesive diagnosis. As a result, the mean time of diagnosis from clinical presentation to diagnosis is currently 4.7 years. 1 Even more d isturbing, more than 90% of these patients have dry eye as one of their initial symptoms and often present to eyecare professionals years before they see a rheumatologist. 3 Adding to the confusion, criteria for diagno- sis have changed 12 times since 1965. A new course for diagnosis We have the opportunity to shorten the course to diagnosis significantly w ith the advent of an evidence- based diagnostic test for Sjogren's syndrome. Nicox (Sophia Antipolis, France) acquired exclusive rights to market to ophthalmologists and op- tometrists a panel test for Sjogren's syndrome, which incorporates pro- prietary biomarkers designed to de- tect Sjogren's syndrome years earlier t han the current standard. The American College of Rheumatology currently suggests using symptoms biomarkers Sjogren-specific antibody A (SS-A), Sjogren-specific antibody B (SS-B), rheumatoid factor (RF), and antinuclear antibody (ANA), along with a lip biopsy and ocular surface staining with vital dyes (fluorescein a nd lissamine) to diagnose Sjogren's syndrome. Testing for these bio- markers alone has been ineffective, as some patients with Sjogren's syn- drome never test positive for SS-A and SS-B, and ANA and RF are help- ful in diagnosing an autoimmune disease but aren't specific to Sjo- gren's syndrome. In many patients, these tests do not become positive until later in the disease process. When all four are performed to- gether, specificity is only 40 to 60%. 4 The new panel test for Sjogren's syndrome identifies these traditional biomarkers as well as three new anti- bodies—salivary gland protein-1 (SP- 1), carbonic anhydrase-6 (CA-6), and parotid secretory protein (PSP)—that have been shown to have a sensitiv- ity and specificity in the 90th per- centile with approximately 50% of early and new cases identified. 5 The panel test is designed with an easy, in-office methodology. It is minimally invasive and consists of the eyecare professional obtaining a small blood sample, similar to glu- cose testing, that is placed on several test strips and then sent to a central laboratory where biomarkers are an- alyzed. Results are returned within one week, providing results and information suggesting a diagnosis confirming or ruling out Sjogren's syndrome. This test allows us to ex- pand our diagnostic armamentarium without the complexity of purchas- ing and implementing a new ma- chine. It does not require a lot of time and effort for the patient or the practice. Patients who have persist- ent chronic signs and symptoms consistent with dry eye are ideal candidates for testing with the Sjogren's syndrome panel test. by Penny A. Asbell, MD Connecting the dots between dry eye and Sjogren's syndrome Systemic effects of Sjogren's syndrome Source: Penny A. Asbell, MD 88-107 Cornea_EW March 2014-DL2_Layout 1 3/6/14 3:47 PM Page 106