2016 ACR/EULAR Primary Sjogren Syndrome Classification Criteria

Applies the 2016 ACR/EULAR classification criteria for primary Sjogren syndrome — weighing biopsy, anti-SSA/Ro, and ocular/salivary findings after entry and exclusion gates — to classify patients for research/cohort enrollment, not to diagnose or measure disease activity.

Entry criterion met: ≥1 symptom of ocular/oral dryness (daily dry eyes >3 mo, sand/gravel sensation, tear substitutes >3x/day, daily dry mouth >3 mo, or frequently drinking liquids to swallow dry food) OR systemic-feature suspicion (≥1 positive ESSDAI domain item)

Any exclusion condition present (head/neck radiation, active hepatitis C by PCR, AIDS, sarcoidosis, amyloidosis, graft-versus-host disease, or IgG4-related disease)

Labial salivary gland biopsy: focal lymphocytic sialadenitis with focus score ≥1 focus/4 mm²

Anti-SSA/Ro antibody positive

Ocular staining score ≥5 (OR van Bijsterveld ≥4) in at least one eye (patient not on daily glaucoma drops and without corneal/cosmetic eyelid surgery in last 5 years)

Schirmer test ≤5 mm/5 min in at least one eye (same ocular medication/surgery caveat)

Unstimulated whole salivary flow rate ≤0.1 mL/min (patient not on daily anticholinergic medication, or after adequate washout)