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2016 ACR/EULAR Classification Criteria for Primary Sjögren’s Syndrome

Classification criteria for primary Sjögren’s disease by ACR/EULAR.

Inclusion Criteria

Inclusion criteria are met if at least one of the following ocular or oral dryness symptoms is present:

Daily, persistent, troublesome dry eyes for more than 3 months

Recurrent sensation of sand or gravel in the eyes

Use of tear substitutes more than 3 times a day

Daily feeling of dry mouth for more than 3 months

Frequent drinking of liquids to aid in swallowing dry food

Result:

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Advice

  • A score ≥4 indicates that a patient who meets inclusion criteria (and has no exclusion criteria) can be classified as having primary Sjögren’s disease.

  • Results are not diagnostic; interpret alongside clinical findings and consider specialist input and additional testing as needed.

Management
  • For patients with Sjögren’s disease, initiate treatment tailored to their manifestations and disease severity, such as:
    • Symptomatic care for dry eyes and/or mouth (e.g., artificial tears, salivary stimulation, oral and eye hygiene). 
    • Management of other sicca symptoms (e.g., saline spray for nasal dryness, moisturizers for dry skin).
    • Immunosuppressive therapy (e.g., corticosteroids, steroid-sparing agents, biologics) may be appropriate for moderate to severe disease and/or systemic involvement.
  • Care often requires a multidisciplinary team (e.g., rheumatology, ophthalmology, dentistry/oral medicine).
Critical Actions

A patient may have Sjögren’s disease without meeting classification criteria; persistent clinical suspicion should prompt comprehensive evaluation and management based on clinical judgment and specialist expertise, regardless of the score.

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