Anti-CD20 Antibody Therapy for Sjogren's Syndrome

SS is the second most common autoimmune disease; it is caused by immune cells attacking and destroying the glands that produce tears and saliva, and occurs more often in women than in men. Currently, there are no established disease-modifying treatments for SS. Traditional treatment strategies for SS primarily address dryness symptoms. Rituximab targets the CD20 antigen on the surface of B cells, and was approved in 1997 for the treatment of patients with low-grade or follicular B-cell non-Hodgkin's lymphoma. In a small study, rituximab was also shown to relieve the symptoms of rheumatoid arthritis. Because SS is associated with the development of B cell-related cancers and rituximab has the potential to treat autoimmune disease, rituximab may alleviate the symptoms of SS. This study will evaluate the safety of rituximab in people with SS. This study will last 1 year. At 4 and 2 weeks before the start of the study, patients will undergo medical and medication history assessment, a physical exam, blood and urine collection, rheumatologic evaluation, an eye exam, and salivary gland tests. The screening visit 4 weeks before study start will also include an electrocardiogram (ECG), a chest x-ray, and a tuberculosis exam. Patients will receive IV rituximab at study entry and at Week 2; blood collection will occur prior to infusion and post-infusion for pharmacokinetics studies. There will be 6 follow-up study visits that will occur at Weeks 4, 8, 14, 26, 30, and 52. Blood and urine collection; a physical exam; rheumatologic evaluation; and eye, skin, and salivary gland tests will occur at selected study visits.