TABLE 4

2016 American College of Rheumatology (ACR) and European Alliance of Associations for Rheumatology (EULAR) classification for primary Sjögren syndrome

Inclusion criteriaExclusion criteria
At least 1 symptom of ocular or oral dryness, defined as a positive response to at least 1 of the following questions:

  • Have you had daily, persistent, troublesome dry eyes for more than 3 months?

  • Do you have a recurrent sensation of sand or gravel in the eyes?

  • Do you use tear substitutes more than 3 times a day?

  • Have you had a daily feeling of dry mouth for more than 3 months?

  • Do you frequently drink liquids to aid in swallowing dry food?


Or suspicion of Sjögren syndrome based on glandular enlargement or the presence of characteristic extraglandular involvement		Prior diagnosis of any of the following conditions:

  • History of head and neck radiation treatment

  • Active hepatitis C infection (with positive polymerase chain reaction)

  • Acquired immunodeficiency syndrome

  • Sarcoidosis

  • Amyloidosis

  • Graft-vs-host disease

  • Immunoglobulin G4-related disease

ACR/EULAR classification criteria for primary Sjögren syndromea
CriteriaScore
ACR/EULAR classification criteria for primary Sjögren syndrome3
Anti-Ro/SS-A positive3
Ocular staining score ≥ 5 (or van Bijsterveld score ≥ 4) in at least 1 eye1
Schirmer test ≤ 5 mm at 5 minutes in at least 1 eye1
Unstimulated whole saliva flow rate ≤ 0.1 mL/minute1

  • ↵a The classification of primary Sjögren syndrome applies to any patient who meets the inclusion criteria, does not have any of the conditions listed as exclusion criteria, and has a score ≥ 4.

  • Adapted from reference 7.