New Criteria for Diagnosis of Sjögren Syndrome

Implications for the Oral Healthcare Provider

Eric T. Stoopler, DMD


June 28, 2012

American College of Rheumatology Classification Criteria for Sjögren's Syndrome: A Data-Driven, Expert Consensus Approach in the Sjögren's International Collaborative Clinical Alliance Cohort

Shiboski SC, Shiboski CH, Criswell L, et al
Arthritis Care Res. 2012;64:475-487

New Criteria for Sjögren Syndrome

Sjögren syndrome is a multisystem autoimmune disease characterized by hypofunction of the lacrimal and salivary glands, resulting in dry eyes (keratoconjunctivitis sicca) and dry mouth (xerostomia).[1] Historically, Sjögren syndrome was considered "primary" when present alone and "secondary" when associated with other autoimmune rheumatic conditions.[1]

Currently, classification criteria for the diagnosis of Sjögren syndrome have been based on both objective and subjective criteria recommended by the American-European Consensus group.[1] This consensus report, published by investigators on behalf of the Sjögren's International Collaborative Clinical Alliance [SICCA] Research Groups, updates the classification criteria for diagnosis of Sjögren syndrome. These criteria were developed from international registry data (1618 participants) collected using standardized instruments and diagnostic tests, which were based entirely on objective measures.

The new criteria for the diagnosis of Sjögren syndrome, which apply to individuals with signs and symptoms that may be suggestive of Sjögren syndrome, will be met in patients who have at least 2 of the following objective features:

  • Positive serum anti-SSA/Ro and/or anti-SSB/La or (positive rheumatoid factor and antinuclear antibody titer ≥ 1:320);

  • Labial salivary gland biopsy exhibiting focal lymphocytic sialadenitis with a focus score ≥ 1 focus/4 mm2; and

  • 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).

In addition, the consensus statement recommends discarding the terms "primary Sjögren syndrome " and "secondary Sjögren syndrome" because they are obsolete and represent a source of potential confusion.


The newly proposed criteria for Sjögren syndrome represent the most current evidence-based, objective recommendations for diagnosing this chronic disorder. Moreover, they aim to eliminate confusion about primary and secondary forms of the disease. Patients with xerostomia and/or other signs and symptoms of Sjögren syndrome may present initially to their oral healthcare provider for consultation. It is important for oral healthcare providers to recognize manifestations of Sjögren syndrome to refer patients to appropriate medical providers, such as rheumatologists and ophthalmologists, for further evaluation and management of this condition.

The potentially devastating local effects of xerostomia are managed by oral healthcare practitioners. Maintenance of oral health is imperative for patients with Sjögren syndrome. In addition, oral healthcare providers may be called upon more frequently to perform oral biopsies to confirm presence of focal lymphocytic sialadenitis with a focus score ≥ 1 focus/4 mm2 in labial minor salivary glands, 1 of the 3 major criteria for diagnosis of Sjögren syndrome, according to the newly proposed classification system. The American College of Rheumatology (ACR) has voted to accept the SICCA criteria, marking the first time that this organization has approved classification criteria for Sjögren syndrome.[3] In addition, the ACR recognizes the need for rheumatologists, ophthalmologists, and oral medicine practitioners to collaborate in research studies about diagnosing this condition.[2]



Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as: