The classification of SS, which applies to individuals with signs/symptoms that may be suggestive of SS, will be met in patients who have at least 2 of the following 3 objective features:
(1) positive serum anti-SSA/Ro and/or anti-SSB/La or (positive rheumatoid factor and ANA titer ≥1 : 320)
(2) labial salivary gland biopsy exhibiting focal lymphocytic sialadenitis with a focus score ≥ 1 focus/4 mm2 (using histopathologic definitions and focus score assessment methods as previously described)
(3) keratoconjunctivitis sicca with ocular staining score ≥ 3 (assuming that the individual is not currently using daily eye drops for glaucoma and has not had corneal surgery or cosmetic eyelid surgery in the last 5 years) (using ocular staining score as previously described)
Prior diagnosis of any of the following conditions would exclude participation in SS studies or therapeutic trials because of overlapping clinical features or interference with criteria tests:
(i) history of head and neck radiation treatment
(ii) hepatitis C infection
(iii) acquired immunodeficiency syndrome
(iv) sarcoidosis
(v) amyloidosis
(vi) graft versus host disease
(vii) IgG4-related disease
Exclusion criteria: rheumatoid arthritis, systemic lupus erythematosus, scleroderma, or other connective tissue diseases. ANA = antinuclear antibody.
