In order to make a diagnosis of Sjögren’s syndrome, the following criteria must be met:
I. Ocular Symptoms (at least one)
- Symptoms of dry eyes for at least 3 months
- A foreign body sensation in the eyes
- Use of artificial tears 3 or more times per day
II. Oral Symptoms (at least one)
- Symptoms of dry mouth for at least 3 months
- Recurrent or persistently swollen salivary glands
- Need for liquids to swallow dry foods
III. Ocular Signs (at least one)
- Abnormal Schirmer’s test, (without anesthesia; ≤5 mm/5 minutes)
- Positive vital dye staining of the eye surface
IV. Histopathology
- Lip biopsy showing focal lymphocytic sialoadenitis (focus score ≥1 per 4 mm2)
V. Oral Signs (at least one)
- Unstimulated whole salivary flow (≤1.5 mL in 15 minutes)
- Abnormal parotid sialography
- Abnormal salivary scintigraphy
VI. Autoantibodies (at least one)
- Anti-SSA (Ro) or Anti-SSB (La), or both
For a primary Sjögren’s syndrome diagnosis:
- Any 4 of the 6 criteria, must include either item IV (Histopathology) or VI (Autoantibodies)
- Any 3 of the 4 objective criteria (III, IV, V, VI)
For a secondary Sjögren’s syndrome diagnosis:
In patients with another well-defined major connective tissue disease, the presence of one symptom (I or II) plus 2 of the 3 objective criteria (III, IV and V) is indicative of secondary SS.
Exclusion Criteria
- Past head and neck radiation treatment
- Hepatitis C infection
- Acquired immunodeficiency syndrome (AIDS)
- Pre-existing lymphoma
- Sarcoidosis
- Graft versus host disease
- Current use of anticholinergic drugs
Reference:
Vitali C, et al. Classification criteria for Sjogren’s syndrome: a revised version of the European criteria proposed by the American-European Consensus Group. Ann Rheum Dis 2002; 61:554-558.
