Etanercept Therapy for Sjogren's Syndrome

Overview

This study will test the effectiveness of etanercept (Enbrel) for treating Sjogren's syndrome-an autoimmune disease that affects the secreting glands. (In autoimmune diseases, the immune system attacks the body's own tissues.) Reduced lacrimal (tear) gland function causes dry eyes with a scratchy sensation, and, in severe cases, vision be may impaired. Reduced salivary gland function causes dry mouth, resulting in greatly increased tooth decay. Dry mouth also makes chewing and swallowing difficult, which may lead to nutrition deficiencies. Sjogren's syndrome can also cause dryness of the skin and of mucous membranes in the nose, throat, airways, and vagina. Patients with Sjogren's syndrome who have had oral and eye examinations under NIDCR's protocol 84-D-0056 may participate in this study. Participants will be randomly assigned to receive either etanercept or placebo (an inactive look-alike substance) by injection under the skin twice a week for 3 months. Patients will be seen for evaluation before treatment begins (baseline) and again at 1, 3, and 4 months. The baseline and 3-month visits include a physical examination, eye examination, saliva collection from salivary glands, blood tests, and evaluation for changes in symptoms and treatment side effects. The 1- and 4-month visits include saliva collection, blood tests, and review of symptoms and treatment side effects. In addition, blood will be drawn every 2 weeks for safety monitoring. Patients will also be surveyed weekly (by telephone or during the clinic visit) about symptoms and treatment side effects. The Food and Drug Administration has approved Enbrel for treating certain forms of arthritis, which, like Sjogren's syndrome, are autoimmune disorders of the connective tissue. Laboratory studies also indicate that etanercept may be an effective treatment for Sjogren's syndrome.

Sjogren's syndrome (SS) is an autoimmune disease chiefly affecting the exocrine glands. Manifestations of SS include salivary and lacrimal gland dysfunction. There is no generally accepted treatment for the underlying autoimmune reactivity or the exocrine gland dysfunction in SS. We propose to test the effects of etanercept therapy. In a randomized, double-masked, outpatient protocol, patients will receive etanercept for 2 times/week for 3 months. Therapy will be given by subcutaneous injection. Efficacy of treatment will be assessed by monitoring salivary and lacrimal function, serological markers of autoimmune activity, and subjective reports of local and systemic symptoms. The present trial will serve as a screening protocol to identify if etanercept should be further analyzed in a larger clinical trial for efficacy.