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Abstract Number: 2540

Sjö™, an Advanced Diagnostic Panel for Detection of Sjögren’s Syndrome Autoantibodies

Mark Jasek1, Kishore Malyavantham2, Lakshmanan Suresh3, Julian Ambrus4 and Dennis Pardo5, 1Medical and Scientific Affairs, Nicox Inc, Fort Worth, TX, 2Office of Science & Technology, IMMCO Diagnostics Inc., Amherst, NY, 360 Pineview Drive, State University of New York/Buffalo, Buffalo, NY, 4Division of Allergy, Immunology and Rheumatology, Department of Medicine, State University of New York at Buffalo, Buffalo, NY, 5Professional Affairs, Nicox Inc, Fort Worth, TX

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: Biomarkers, clinical practice and serologic tests, Diagnostic Tests, Sjogren's syndrome

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Session Information

Title: Sjogren's Syndrome: Clinical Science

Session Type: Abstract Submissions (ACR)

Background/Purpose

Sjögren’s syndrome (SS) is a complex autoimmune disease involving the salivary and lacrimal glands along with various systemic manifestations. It is a difficult disease to identify especially in its early stages. Average time from disease onset to diagnosis is 4.7 years.   The serological markers suggested by the American College of Rheumatology for diagnosis of SS are antinuclear antibodies (ANA), rheumatoid factor (RF), anti-Ro, and anti-La.  Novel SS autoantibodies, anti-salivary gland protein 1 (SP1), anti-carbonic anhydrase 6 (CA6) and anti-parotid secretory protein (PSP), often expressed earlier compared to traditional SS biomarkers, have been identified in animal studies and clinical trials.  An approved diagnostic blood panel (Sjö™) incorporating classic and novel biomarkers was integrated as standard procedure in ophthalmic/optometric practices across 12 geographic markets.

Methods

Serum samples from patients with idiopathic dry eyes were analyzed with the Sjö™ panel through the end of May 2014.  These patients had not previously been diagnosed with SS. Antibodies to RF, anti-Ro, anti-La, anti-SP1, anti-CA6 and anti-PSP were tested using enzyme linked immunosorbent assay. ANA was analyzed by indirect immunofluorescence using Hep-2 substrate.

Results

By the end of May 2014, 2306 samples had been analyzed. Of the dry eye patients analyzed, 608 (27%) turned out to be positive for SS markers.  Of the positive patients, 62.6% were identified solely by the novel markers SP-1, CA6, and PSP. Only 13.2% of the patients were identified with solely the classic markers.  Majority of samples were from women (88%), of whom 24% were positive for SS markers.  In the subset of male dry eye patients tested (n=273), 64 were identified as positive for SS (23%).

Conclusion

The current data illustrates many patients with “idiopathic” dry eyes have autoantibodies consistent with early SS, at a frequency higher than currently reported in the literature. The majority of patients express the novel autoantibodies associated with an early stage of SS, anti-SP1, anti-CA6 and anti-PSP, without anti-Ro or anti-La. Earlier diagnosis of SS in these patients may lead to better management of their dry eye and other systemic manifestations via referral/co-management with rheumatologists and other health care providers.


Disclosure:

M. Jasek,

NiCox, S.A.,

1,

Nicox Inc,

3;

K. Malyavantham,

Immco Diagnostics,

3;

L. Suresh,
None;

J. Ambrus,

NiCox, S.A.,

2,

NiCox, S.A.,

5;

D. Pardo,

NiCox, S.A.,

1,

Nicox Inc,

3.

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