Efficacy and Safety of Belimumab in Primary Sjögren's Syndrome
Status:
Completed
Trial end date:
2012-08-01
Target enrollment:
Participant gender:
Summary
Background and rationale Sjögren's syndrome (SS) is a systemic autoimmune disease
characterized by chronic inflammation of salivary and lachrymal glands, frequently
accompanied by systemic symptoms. The presence of various autoantibodies such as rheumatoid
factor (RF) and anti-SSA/SSB antibodies, as well as hypergammaglobulinemia, reflect B cell
hyperactivity. About five percent of patients with SS develop malignant B cell lymphoma,
usually of the mucosa-associated lymphoid tissue (MALT) type and most frequently located in
the major salivary glands. Currently, there is a lack of evidence-based intervention therapy
which may influence SS-related chronic inflammation and lymphoproliferation. B cells are
involved in the pathogenesis of SS, and B cell downregulation may lead to a decrease of
disease activity. Patients with more residual exocrine gland function, e.g., those with SS of
shorter duration, might better benefit from systemic therapy, as reported in a preliminary
study on the efficacy of B-cell depletion in SS.This study will examine the effect of the
drug Belimumab in patients with SS. Patients aged more than 18 years with SS may be eligible
for this study. Candidates will be screened with complete history and physical examination,
chest x-rays, and oral and eye examinations.