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Diagnostic Utility of Testing for Novel Murine Autoantibodies for Sjögren’s Disease in the Rheumatology Outpatient Setting

Arthritis Care Res (Hoboken). 2025 Nov 28. doi: 10.1002/acr.70005. Online ahead of print.

ABSTRACT

OBJECTIVE: The goal was to assess the diagnostic performance of three novel autoantibodies (NA) for Sjögren’s disease (SjD) by comparing NA prevalence in patients with SjD, other autoimmune rheumatic diseases (ARDs), nonspecific chronic sialadenitis (CS), and controls.

METHODS: We identified rheumatology outpatients with confirmed SjD, systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), systemic sclerosis (SSc), CS, and healthy controls. Subjects underwent serum testing for antibodies to salivary gland protein 1 (SP-1), parotid secretory protein (PSP) and carbonic anhydrase-6 (CA-6). Subjects with SjD, CS and controls also underwent testing of saliva. Receiver operating characteristic (ROC) curve C-statistics along with sensitivity, specificity, positive and negative likelihood ratios were calculated for each serum autoantibody for SjD vs. CS or controls.

RESULTS: Among 468 patients screened, 444 were analyzed including cohorts with: SjD (n=149), SLE (n=70), SSc (n=56), RA (n=73), CS (n=31) and controls (n=65). There was no statistical difference (p=0.80) in the presence of one or more NA in the serum of SjD patients compared to subjects with other ARDs, CS, or controls. ROC curves demonstrated poor discriminative ability for SjD versus CS or controls for any positive NA (0.47) or any individual NA (range 0.44 to 0.53). The positive likelihood ratio for having any positive novel autoantibody was 1.04 and 0.83 for SjD vs. CS or controls, respectively.

CONCLUSION: Testing serum for NA demonstrated poor ability to distinguish patients with SjD from control patients or those with CS or other ARDs. This serum autoantibody panel is not likely to be useful as a diagnostic test for SjD.

PMID:41312674 | DOI:10.1002/acr.70005

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