Biopsy Accuracy in Sjögren’s Syndrome: Analysis of 803 Patients Presenting with Sicca Syndrome Referred to Labial Salivary Gland Biopsy

Diego Baenas¹, Soledad Retamozo², Juan Pablo Pirola³, Nadia Benzaquén⁴, María Flavia Ceballos⁵, Soledad Fiorentino³, Maria Jezabel Haye Salinas⁴, Nadia Riscanevo⁶, Janet Flores⁷, Ana C. Alvarez⁴, Verónica Saurit⁸, Alejandro Alvarellos⁸ and Francisco Caeiro⁹, ¹Reumatologia, Hospital Privado Universitario de Córdoba, Córdoba, Argentina, ²Rheumatology Unit, Hospital Privado Universitario de Córdoba, Institute University of Biomedical Sciences University of Córdoba (IUCBC), Cordoba, Argentina, ³Rheumatology, Rheumatology Unit, Hospital Privado Universitario de Córdoba., Cordoba, Argentina, ⁴Rheumatology, Rheumatology Unit, Hospital Privado Universitario de Córdoba, Córdoba, Argentina, ⁵Rheumatology, Rheumatology Unit, Hospital privado Universitario de Córdoba., Cordoba, Argentina, ⁶Rheumatology, Rheumatology Unit, Hospital privado Universitario de Córdoba, Cordoba, Argentina, ⁷Rheumatology Unit, Hospital privado Universitario de Córdoba, Cordoba, Argentina, ⁸Rheumatology, Rheumatology Unit, Hospital Privado Universitario de Córdoba, Cordoba, Argentina, ⁹Rheumatology, Hospital Privado Centro Médico de Córdoba, Córdoba, Argentina

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: biopsies and salivary gland, Sjogren's syndrome

Session Information

Date: Sunday, November 5, 2017

Title: Sjögren's Syndrome Poster I: Translational Research

Session Type: ACR Poster Session A

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

Background/Purpose:

Labial salivary gland biopsy (LSGB) is a minimally invasive procedure used in the diagnostic of Sjögren’s Syndrome (SS). Objectives: to describe demographic, clinical and histological features of patients submitted to LSGB; to analyze the usefulness of LSGB in diagnosis of primmary SS (pSS) and secondary SS (sSS); to assess the association between histological findings and autoantibodies; to compare the sensitivity (Sn) and specificity (Sp) of the American-European 2002 (AE02) and ACR 2012 criteria.

Methods:

An observational, analytical, cross-sectional study was performed. A total of 803 patients were included between June 1996 and May 2016. A sub analysis of 674 patients was performed, excluding those with SSs and others without antibodies.

Grades III and IV biopsy of the Chisholm and Mason´s (CM) classification were considered positive. Data was analyzed using STATA 17 software.

Results:

803 patients were included, 90% females. The mean age was 53 years (range 14-86). PSS was diagnosed in 238 (29.6%), and SS in 45 (5.6%), with female predominance in both groups (30.1% and 5.8%, respectively). Table 1 shows the clinical characteristics and complementary studies in patients with nonspecific dryness syndrome (NoSS) and SSP and SS.

Table 1.

Parameters n (%)	NoSS n(%)	PSS n(%)	SSS n(%)	P value
*Xerostomía*	399 (76.6)	200 (84)	39 (88.6)	0.019
*Xerophthalmia*	447 (85.8)	220 (92.4)	36 (81.8)	0.018
*Abnormal ophtalmic test*	209 (67.4)	175 (96.2)	28 (96.6)	<0.01
*Abnormal parotid sialography*	31 (52.5)	24 (75)	–	0.036
*Ro/SS-A* *La/SS-B* *ANA* RF	11 (2.4) – 61 (12.4) 81 (16.4)	73 (32.7) 31 (14) 116 (49.6) 96 (41.6)	13 (32.5) 3 (7.5) 20 (48.8) 31 (73.8)	<0.01 <0.01 <0.01 <0.01
*LSGB G III-IV*	8 (1.5)	217 (91.2)	26 (59.1)	<0.01
*Pilocarpine* *Hydroxychloroquine* *Prednisone <20mg* *Prednisone >20 mg* *Rituximab* *Other immunosuppressive drug*	21 (4.04) 43 (8.3) 68 (65) 6 (1.5) 2 (0.4) 64 (15.7)	57 (24.1) 206 (86.9) 68 (29.5) 3 (1.5) 2 (0.9) 171 (72.8)	2 (4.6) 26 (59) 30 (5.5) 6 (13.6) 1 (2.3) 38 (86.4)	<0.01 <0.01 <0.01 <0.01 0.27 <0.01

In the subanalysis of 674 patients, 33.1% were pSS, of which 204 (91.5%) were female. The mean age was 54 years (range 14-86). LSGB was 0, I or II grades in 8.5% patients with PSS, versus 91.5% patients with III-IV grades (p <0.01); Sn 91.5%, Sp 98.5%, positive predictive value (PPV) 96.7, negative predictive value (NPV) 95.9. Table 2 compares the serological characteristics of patients using LSGB as a “gold standard”.

Table 2.

Parameters	LSGB (+)	LSGB (-)	p	Sensitivity	Specificity	PPV	NPV	LR
Ro/SS-A	58 (27.5)	26 (31)	<0.01	27.5	94.4	69.1	74.1	4.9
La/SS-B	24 (11.4)	7 (1.5)	<0.01	11.4	98.5	77.4	70.9	7.5
ANA	97 (46.4)	71 (15.4)	<0.01	46.4	84.6	57.7	77.6	3
RF	84 (40.8)	78 (48.2)	<0.01	40.8	83	51.9	75.7	2.4

In multivariate analysis the significance for anti-Ro (OR: 2.0), ANA (OR: 2.9) and RF (OR: 2.5) was maintained.

The AE02 criteria had a Sn of 32.3%, Sp 97.3%, PPV 85.7% and NPV 74.4%.

The ACR 2012 had a Sn of 83.4%, Sp 98.5%, PPV 96.4% and NPV 92.3%.

Conclusion:

LSGB is a simple, safe, and useful tool for the diagnosis of Sjögren’s syndrome. It exhibits an adequate balance between Sn, Sp, PPV and NPV..

Antibodies showed a significant association with a positive LSGB with low Sn for pSS screening but high Sp.The LSGB had a great value in “seronegatives patients”.

Disclosure: D. Baenas, None; S. Retamozo, None; J. P. Pirola, None; N. Benzaquén, None; M. F. Ceballos, None; S. Fiorentino, None; M. J. Haye Salinas, None; N. Riscanevo, None; J. Flores, None; A. C. Alvarez, None; V. Saurit, None; A. Alvarellos, None; F. Caeiro, None.

To cite this abstract in AMA style:

Baenas D, Retamozo S, Pirola JP, Benzaquén N, Ceballos MF, Fiorentino S, Haye Salinas MJ, Riscanevo N, Flores J, Alvarez AC, Saurit V, Alvarellos A, Caeiro F. Biopsy Accuracy in Sjögren’s Syndrome: Analysis of 803 Patients Presenting with Sicca Syndrome Referred to Labial Salivary Gland Biopsy [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/biopsy-accuracy-in-sjogrens-syndrome-analysis-of-803-patients-presenting-with-sicca-syndrome-referred-to-labial-salivary-gland-biopsy/. Accessed .

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