EULAR/ACR Criteria for the Classification of Primary Sjögren Syndrome

Inclusion Criteria

Score*

Labial salivary gland with focal lymphocytic sialadenitis and a focus score† of ≥ 1

3

Anti-SSA antibodies (anti-Ro)

3

Ocular staining score‡ ≥ 5 (or van Bijsterveld score ≥ 4) in at least 1 eye

1

Schirmer test ≤ 5 mm/5 min in at least 1 eye

1

Unstimulated whole saliva flow rate ≤ 0.1 mL/min§

1

* To fulfill the inclusion criteria, patients must have a score of ≥ 4, at least 1 symptom of eye or oral dryness, and no exclusion criteria.

Patients who fulfill the following exclusion criteria do not have primary Sjögren syndrome:

  • History of radiation treatment to the head and neck

  • Active hepatitis C infection (confirmed by polymerase chain reaction)

  • Advanced HIV infection

  • Sarcoidosis

  • Amyloidosis

  • Graft-vs-host disease

  • IgG4-related disease

† A focus score is the number of inflammatory infiltrates of at least 50 cells present in 4 mm2 of gland surface unit.

‡ As described in Whitcher JP, Shiboski CH, Shiboski SC, et al: A simplified quantitative method for assessing keratoconjunctivitis sicca from the Sjögren's syndrome international registry. Am J Ophthalmol149(3):405–415, 2010. doi: 10.1016/j.ajo.2009.09.013

§ As described in Navazesh M: Methods for collecting saliva. Ann N Y Acad Sci 694:72–77, 1993. doi: 10.1111/j.1749-6632.1993.tb18343.x

EULAR/ACR = European League Against Rheumatism/American College of Rheumatology.

Modified from Shiboski CH, Shiboski SC, Seror R, et al: 2016 American College of Rheumatology/European League Against Rheumatism classification criteria for primary Sjögren's syndrome: A consensus and data-driven methodology involving three international patient cohorts. Arthritis Rheumatol 69(1):35–45, 2017. doi: 10.1002/art.39859

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