Objectives To investigate whether ultrasound findings of major salivary glands are correlated with serological markers, autoantibodies, patient- or doctor-reported disease activity in a Danish cohort of patients with primary Sjögren’s Syndrome (pSS). Methods In all, 49 patients at Odense University Hospital with pSS diagnosed according to the 2002 American-European Consensus Group (AECG) classification criteria were included. Patients were characterized using the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI, score of systemic complications) and EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI), serologic markers, Schirmer’s test and salivary test. Salivary gland ultrasound (SGUS) was performed of the submandibular and parotid glands and scored according to the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) semi-quantitative scoring system. Results More patients with abnormal SGUS had antinuclear antibodies (ANA) (p = 0.002), anti-Ro52 (p = 0.001), anti-Ro60 (p<0.001), anti-La (p<0.001) and IgM-RF (p<0.001). Titers for ANA (p = 0.02) and anti-Ro52 (p = 0.03) were higher in patients with abnormal SGUS. Twenty-three of the pSS patients had no pathological findings on SGUS. There was no correlation between SGUS severity and ESSDAI- or ESSPRI-scores. Conclusions Abnormal SGUS findings are associated with autoantibodies of high specificity for pSS but not with ESSDAI, ESSPRI or inflammatory markers.

Background:Salivary gland ultrasound (SGUS) may have the potential of facilitating diagnosis and therapy monitoring of salivary gland disease in patients with primary Sjögren’s syndrome (pSS). A novel consensus based OMERACT SGUS scoring system for the parotid and submandibular glands has recently been developed.(1)Objectives:To assess the reliability of 3 readers using the written definition of the scoring system provided by the OMERACT group and subsequent the impact of a SGUS-atlas based on the OMERACT SGUS scoring system.Methods:3 sonographers with 6 months to 10 years US experience performed a US exercise of 30 SGUS images of patients with SS. 16 images were of the submandibular gland (SMG) and 14 images of the parotid gland (PG) ranging from normal to varying degrees of abnormalities. The images were scored using the US scoring system provided by the OMERACT-group and subsequently using a SGUS atlas made for the study consisting of 4 images of every grade 0-3 of both the SMG and the PG. The readings were performed over 4 rounds: the first reading without using the atlas and second reading using the atlas 1 week later. The 30 images were scrambled by a physician not included in the readings and a third and fourth reading were performed without and with the atlas respectively – with 1 week in between. Inter- and intra-reader reliability were calculated by kappa-tests.Results:Light weighted Kappa for intra- and inter-reliability was determined for each reading. The results of the intra-reader reliability was ranging from moderate to almost perfect with improvement in the 2ndround of readings and with use of the atlas. The inter-reader reliability was moderate and better in the 2ndround of readings. Readings improved with the atlas. Details are shown in table 1.Table 1Intrareader reliability Weighted Kappa:Weighted Kappa, reader 1-3Reading 1 without atlas vs. reading 1 with atlas0.93, 0.85, 0.80Reading 2 without atlas vs. reading 2 with atlas0.78, 0.93, 0.78Reading 1 without atlas vs. reading 2 without atlas0.78, 1.00, 0.58Reading 1 with atlas vs. reading 2 with atlas0.93, 0.93, 0.86Interreader reliability Weighted Kappa:Weighted Kappa: mean (min – max)Reading 1 without atlas0.50 (0.33 – 0.72)Reading 1 with atlas0.55 (0.39 – 0.86)Reading 2 without atlas0.55 (0.33 – 0.93)Reading 2 with atlas0.60 (0.40 – 0.93)Conclusion:The results of the inter- and intra-reliability showed a moderate to almost perfect agreement respectively, of scoring SGUS in patients with pSS and especially in the 2ndround of readings indicating that training and the SGUS atlas increased the reliability.References:[1]Jousse-Joulin S, D'Agostino MA, Nicolas C, Naredo E, Ohrndorf S, Backhaus M, et al. Video clip assessment of a salivary gland ultrasound scoring system in Sjogren's syndrome using consensual definitions: an OMERACT ultrasound working group reliability exercise. Annals of the rheumatic diseases. 2019;78(7):967-73.Disclosure of Interests:Nanna Surlemont Schmidt: None declared, Viktoria Fana: None declared, Hanne Merete Lindegaard: None declared, Lene Terslev Speakers bureau: LT declares speakers fees from Roche, MSD, BMS, Pfizer, AbbVie, Novartis, and Janssen.

Background:Studies have shown that salivary gland ultrasonography (SGUS) may have a potential value in the diagnosis of Sjogren’s Syndrome (SS).Knowledge of the association between ultrasonography findings, disease activity and damage, serologic markers and patient report outcome is limited.Objectives:To investigate whether the results of SGUS are associated with disease manifestations and damage measured by doctor-reported activity score index (ESSDAI) and serologic markers. Furthermore to investigate the contribution of patient reported outcome measure (ESSPRI) in disease monitoring.Methods:Patients registered at Odense University Hospital with the diagnosis primary SS were included in a Danish cohort. The patients were characterized using the ESSDAI, ESSPRI, serologic markers and SGUS-findings in submandibular and parotid glands. Schirmer’s test and salivary test were performed for measurement of tear and salivary production.SGUS was performed using a linear transducer, Siemens (ACUSON Sequoia Ultrasound System) on the two parotid and two submandibular glands. SGUS images was scored according to the OMERACT SS severity scoring system from 0 to 3, where 2 is moderate and 3 severe(1). A reliability study was performed in advance of the present study.Spearman´s r correlation coefficient was used to assess correlation between scores.Results:The cohort consisted of 48 Caucasian patients diagnosed with primary SS. Details on patient characteristics are shown in table 1.Table 1.Sex, n (%)Women46 (95.8)Age, mean (95%CI)60 (57-62)Smoking, n (%)Smoker1 (2.1)BMI, n (%)< 18.55 (10.4)18.5 – 24.920 (41.7)25.0 – 29.912 (25.0)30.0 – 34.910 (20.8)> 35.01 (2.1)Serologic markers, n (%)SSa positive33 (68.8)SSb positive22 (45.8)ANA positive38 (79.2)Cryoglobulin positive9 (18.8)ESSPRI 0-10, mean (95%CI)Dryness7.3 (6.7-7.9)Fatigue7.1 (6.4-7.7)Pain5.9 (5.1-6.7)SGUS, n (%)Score 06 (12.5)Score 115 (31.3)Score 213 (27.1)Score 314 (29.2)ESSDAI, n (%)ESSDAI < 5 (low-activity)22 (45.8)≤ 5 ESSDAI ≤ 13 (moderate-activity) ESSDAI ≥17 (35.4)14 (high-activity)9 (18.8)The correlation between ESSDAI-scores and SGUS-scores was r = 0.153 (p = 0.299). The correlation between ESSDAI-scores and ESSPRI-scores (dryness, fatique, pain) was r = 0.071 (p = 0.632), r = 0.254 (p = 0.082) and r = -0.002 (p = 0.987). The correlation between SGUS-scores and ESSPRI-scores (dryness, fatique, pain) was r = 0.124 (p = 0.400), r = -0.292 (p = 0.044) and r = -0.459 (p = 0.001).Conclusion:In a Danish cohort of SS most patients had SSa and ANA autoantibodies. SGUS demonstrated high damage (score 2-3) in approximately half of the patients. ESSDAI activity score did not correlate with SGUS damage scores or the ESSPRI. SGUS damage scores correlated with ESSPRI-scores of fatique and pain, but not dryness.Associations between other factors of importance for damage and SGUS scores are to be analyzed. SGUS and the ESSPRI describe different SS-related dimensions and will probably contribute in disease monitoring in the future.References:[1]Jousse-Joulin S, D’Agostino MA, Nicolas C, Naredo E, Ohrndorf S, Backhaus M, et al. Video clip assessment of a salivary gland ultrasound scoring system in Sjogren’s syndrome using consensual definitions: an OMERACT ultrasound working group reliability exercise. Annals of the rheumatic diseases. 2019;78(7):967-73.Disclosure of Interests:None declared

The objective of this pilot study was to assess the impact of a salivary gland ultrasound (SGUS) atlas for scoring parenchymal changes in Sjögren’s syndrome by assessing the reliability of the scoring system (0–3), without and with the use of the SGUS atlas. Ten participants with varying experience in SGUS contributed to the reliability exercise. Thirty SGUS images of the submandibular and parotid gland with abnormalities ranging from 0 to 3 were scored using the written definitions of the OMERACT SGUS scoring system and using the SGUS atlas based on the OMERACT scoring system. For intra-reader reliability, two rounds were performed without and with the atlas—in the 2nd round the 30 images were rearranged in random order by a physician not included in the scoring. Inter-reader reliability was also determined in both rounds. Without using the atlas, the SGUS OMERACT scoring system showed fair inter-reader reliability in round 1 (mean kappa 0.36; range 0.06–0.69) and moderate intra-reader reliability (mean kappa 0.55; range 0.28–0.81). With the atlas, inter-reader reliability improved in round 1 to moderate (mean kappa 0.52; range 0.31–0.77) and intra-reader reliability to good (mean kappa 0.69; range 0.46–0.86). Higher intra-reader reliability was noted in participants with previous SGUS experience. The SGUS atlas increased both intra- and inter-reader reliability for scoring gland pathology in participants with varying SGUS experience suggesting a possible future role in clinical practice and trials. Key Points• Ultrasonography can detect parenchymal changes in salivary glands in patients with Sjögren’s disease.• An ultrasound atlas may improve reliability of scoring parenchymal changes in salivary glands.