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Abstract Number: 1581

Lack of Specificity in Testing for Murine Tissue Specific Autoantibodies for the Diagnosis of Sjogren’s Syndrome

Frederick B Vivino1, Michael D. George2, Chadwick Johr3, Nora Sandorfi4, Vatinee Bunya5, Giacomina Massaro-Giordano5, Andrew Diederich6, Brandon Eilberg6, Lakshmanan Suresh7 and Long Shen7, 1Rheumatolgy Division, Department of Medicine, University of Pennsylvania, Philadelphia, PA, 2Division of Rheumatology, University of Pennsylvania, Philadelphia, PA, 3University of Pennsylvania, Philadelphia, PA, 4Rheumatology, University of Pennsylvania, Philadelphia, PA, 5Ophthalmology, University of Pennsylvania, Philadelphia, PA, 6Orthopedic Surgery, University of Pennsylvania, Philadelphia, PA, 7Trinity Biotech, Inc., Buffalo, NY

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: autoantibodies, diagnosis and mouse model, Sjogren's syndrome

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Session Information

Date: Monday, October 22, 2018

Title: Sjögren's Syndrome – Basic and Clinical Science Poster

Session Type: ACR Poster Session B

Session Time: 9:00AM-11:00AM

Background/Purpose:

A group of murine parotid tissue specific autoantibodies (TSAs) which includes anti-SP1 (salivary protein 1), anti-PSP (parotid secretory protein) and anti-CA6 (carbonic anhydrase) are markers for early disease in the IL-14α transgenic mouse model of Sjogren’s (SS). These TSAs are also found in NOD mice, patients (pts) classified with SSA+ or – Sjogren’s according to the American European Consensus Group criteria and in pts with idiopathic dry eyes.

Methods:

We tested serum for TSAs from 6 patient groups followed in a rheumatology clinic for > 1 year at a university medical center including: 1) SS who met published classification criteria (n=152), 2) non-autoimmune controls (n=36), 3) SLE (n=22), 4) RA (n=17), 5) scleroderma (n=7) and 6) chronic nonspecific sialadenitis (n=16). Saliva samples were also obtained from groups 1,2 & 6. Electronic medical records were reviewed to verify diagnoses & all pts were questioned re: the presence & duration of dry eyes/mouth & medical history. Volunteers with history of dry eyes/mouth, any autoimmune diseases or family history of autoimmune disease were excluded as controls. Serum samples were anonymously coded & assayed by a modified ELISA (Trinity Biotech, Inc., Buffalo, NY). All laboratory personnel were blinded to pts diagnoses. Analyses was performed to determine the sensitivity, specificity & discriminative ability of the presence of > 1 TSAs to differentiate SS from other groups.

Results:

Of the 152 SS pts, 9% had disease duration ≤ 3 years. TSAs were detected in both the serum and saliva of pts with SS. The most frequently detected TSA in SS was anti-PSP IgG (13%) (Table 1). The presence of > 1 TSA was similar in SS (40%), controls (44%), chronic sialadenitis (50%), and patients with other CTD (35%).No particular TSA or isotype was specific for SS. Results suggested a sensitivity and specificity of 40% and 56% respectively for the presence of ≥ 1 TSAs in SS. Prevalence of + ANAs/ RF IgM in each group were as follows: SS (57%/ 44%), controls (14%/ 39%), chronic sialoadenitis (31%/ 31%) and other connective tissue diseases (65%/ 47%) (Table 2). Prevalence of ≥ 1 TSAs did not significantly vary between ANA+ vs. ANA- or between SSA+ vs. SSA- individuals.

Conclusion:

The presence of ≥ 1 TSAs in the serum does not distinguish between established SS and other patient groups. The value of the serum assay, as presently performed, for confirmation of early or undiagnosed SS (≤ 3 years) in humans is doubtful given the lack of assay specificity. Assay of TSAs in saliva or calculation of a saliva/serum TSA ratio may prove to be a more valuable diagnostic test.

Table 1: Frequency of Positive Murine Parotid Tissue Specific

Autoantibodies in Different Patient Groups

Primary Sjogren’s

(N = 152)

Controls

(N = 36)

Chronic Sialadenitis
(N = 16)

CTD

(N = 46)

CA6 IgG ≥20

7 (4.6%)

0 (0.0%)

1 (6.3%)

0 (0.0%)

CA6 IgM ≥20

5 (3.3%)

4 (11.1%)

0 (0.0%)

3 (6.5%)

CA6 IgA ≥20

8 (5.3%)

0 (0.0%)

2 (12.5%)

1 (2.2%)

CA6 any ≥20

19 (12.5%)

4 (11.1%)

2 (12.5%)

4 (8.7%)

PSP IgG ≥20

20 (13.2%)

5 (13.9%)

3 (18.8%)

8 (17.4%)

PSP IgM ≥20

13 (8.6%)

5 (13.9%)

3 (18.8%)

5 (10.9%)

PSP IgA ≥20

7 (4.6%)

1 (2.8%)

3 (18.8%)

3 (6.5%)

PSP any ≥20

38 (25.0%)

9 (25.0%)

7 (43.8%)

11 (23.9%)

SP1 IgG ≥20

6 (3.9%)

3 (8.3%)

1 (6.3%)

4 (8.7%)

SP1 IgM ≥20

16 (10.5%)

6 (16.7%)

0 (0.0%)

7 (15.2%)

SP1 IgA ≥20

12 (7.9%)

3 (8.3%)

0 (0.0%)

2 (4.3%)

SP1 any ≥20

31 (20.4%)

11 (30.6%)

1 (6.3%)

10 (21.7%)

Any novel Ab ≥20

61 (40.1%)

16 (44.4%)

8 (50.0%)

16 (34.8%)

All p > 0.05 in pairwise comparision with primary Sjogren’s with Fisher’s exact test

Table 2: Patient Characteristics

Primary Sjogren’s

Controls

Chronic Sialoadenitis

CTD*

N

152

36

16

46

Female

145 (95.4%)

22 (61.1%)

14 (87.5%)

38 (82.6%)

Age, years

±13.8

±22.3

±18.7

±12.4

ANA ≥ 1:160

86 (56.6%)

5 (13.9%)

5 (31.2%)

30 (65.2%)

RF IgM ≥ 10)

67 (44.1%)

14 (38.9%)

5 (31.2%)

21 (46.7%)

SSA ≥ 20

92 (60.5%)

2 (5.6%)

0 (0%)

14 (31.1%)

SSB ≥ 20

50 (32.9%)

1 (2.8%)

2 (12.5%)

13 (28.9%)

± standard deviation. * 22 lupus, 17 rheumatoid arthritis, 7 scleroderma


Disclosure: F. B. Vivino, Biogen Idec, 2,Novartis, 5,Trinity Biotech, 2; M. D. George, Bristol Myers Squibb, 2; C. Johr, None; N. Sandorfi, None; V. Bunya, None; G. Massaro-Giordano, None; A. Diederich, None; B. Eilberg, None; L. Suresh, Trinity Biotech, Inc., 3; L. Shen, Trinity Biotech, Inc., 3.

To cite this abstract in AMA style:

Vivino FB, George MD, Johr C, Sandorfi N, Bunya V, Massaro-Giordano G, Diederich A, Eilberg B, Suresh L, Shen L. Lack of Specificity in Testing for Murine Tissue Specific Autoantibodies for the Diagnosis of Sjogren’s Syndrome [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/lack-of-specificity-in-testing-for-murine-tissue-specific-autoantibodies-for-the-diagnosis-of-sjogrens-syndrome/. Accessed .
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