Title The Anti-TNF Agents Entanercept and Infliximab Not Efficacious For Sjogren’s Syndrome
Clinical Question In patients with primary Sjogrens Syndrome, do anti-TNF agents treat oral symptoms more effectively than a placebo?
Clinical Bottom Line Anti-TNF agents such as infliximab and entanercept do not effectively treat symptoms in patients with primary Sjogren’s Syndrome.
Best Evidence  
PubMed ID Author / Year Patient Group Study type
(level of evidence)
15077311Mariette/2004103 patients with primary Sjogren’s SyndromeRandomized Controlled Trial
Key resultsInfliximab does not relieve primary Sjogren’s Syndrome symptoms more than placebo. Active disease was measured by the visual analog scales (VAS) which evaluate joint pain, fatigue, and buccal, ocular, skin, vaginal, or bronchial dryness. Ten weeks into treatment, 27.8% of the infliximab patient group and 26.5% of the placebo group had a favorable response (P = 0.89). At 22 weeks, 16.7% of the infliximab group and 20.4% of the placebo group had a favorable response (P = 0.62). Secondary end points were values on each of three visual analog scales (VAS), the number of tender and swollen joints, the basal salivary flow rate, the Schirmer test for lacrimal gland function, the focus score on labial salivary gland biopsy, the level of C-reactive protein, and the erythrocyte sedimentation rate. Also quality of life was assessed by use of the generic Short Form 36 questionnaire. Throughout the 22 week study, the treatment and placebo groups did not differ in any of the secondary end points.
18198195Moutsopoulos/200828 patients with Sjogren’s Syndrome Randomized Controlled Trial
Key resultsEntanercept is not effective in treating primary Sjogren’s Syndrome, most likely because TNF-alpha is not a major cytokine in the pathogenesis of the disease. Expression of TNF-alpha was evaluated by flow cytometry of peripheral blood mononuclear cells. Cytokine levels were measured by multiplex ELISA assay in plasma and in lipopolysaccharide-stimulated whole blood. Baseline cytokine levels did not correlate with salivary gland inflammatory focus scores. Entanercept treatment did not restore normal levels of enhanced markers of immune activation, frequency of cell sub-populations, or aberrant cytokine profiles. In fact, Etanercept treatment significantly increased circulating TNF-alpha levels.
Evidence Search ("Sjogren's Syndrome"[Mesh]) AND (("TNFR-Fc fusion protein" [Supplementary Concept]) OR "infliximab" [Supplementary Concept])
Comments on
The Evidence
In the Moutsopoulos study, 6 of the patients had secondary Sjogren’s Syndrome.
Applicability There is no clinical benefit to prescribing anti-TNF agents to patients for treatment of primary Sjogren’s syndrome.
Specialty (Oral Medicine/Pathology/Radiology) (General Dentistry)
Keywords Sjogren’s Syndrome, Infliximab, Entanercept, TNFalpha, anti-TNF, TNF blockers, Xerostomia
ID# 2238
Date of submission 04/25/2012
E-mail alsalman@livemail.uthscsa.edu
Author Zeena Alsalman
Co-author(s) e-mail
Faculty mentor Vidya Sankar, DMD, MHS
Faculty mentor e-mail SankarV@uthscsa.edu
Basic Science Rationale
(Mechanisms that may account for and/or explain the clinical question, i.e. is the answer to the clinical question consistent with basic biological, physical and/or behavioral science principles, laws and research?)
None available
Comments and Evidence-Based Updates on the CAT
None available