Objective. To study the efficacy and safety of B cell depletion with rituximab, a chimeric murine/human anti-CD20 monoclonal antibody, in patients with primary Sjögren's syndrome (SS) in a double-blind, randomized, placebo-controlled trial.Methods. Patients with active primary SS, as determined by the revised American-European Consensus Group criteria, and a rate of stimulated whole saliva secretion of >0.15 ml/minute were treated with either rituximab (1,000 mg) or placebo infusions on days 1 and 15. Patients were assigned randomly to a treatment group in a ratio of 2:1 (rituximab:placebo). Followup was conducted at 5, 12, 24, 36, and 48 weeks. The primary end point was the stimulated whole saliva flow rate, while secondary end points included functional, laboratory, and subjective variables.Results. Thirty patients with primary SS (29 female) were randomly allocated to a treatment group. The mean ؎ SD age of the patients receiving rituximab was 43 ؎ 11 years and the disease duration was 63 ؎ 50 months, while patients in the placebo group were age 43 ؎ 17 years and had a disease duration of 67 ؎ 63 months. In the rituximab group, significant improvements, in terms of the mean change from baseline compared with that in the placebo group, were found for the primary end point of the stimulated whole saliva flow rate (P ‫؍‬ 0.038 versus placebo) and also for various laboratory parameters (B cell and rheumatoid factor Conclusion. These results indicate that rituximab is an effective and safe treatment strategy for patients with primary SS.Sjögren's syndrome (SS) is a systemic autoimmune disease that is characterized by chronic inflammation of the salivary and lacrimal glands, resulting in xerostomia and keratoconjunctivitis sicca in ϳ95% of patients (1). These symptoms are frequently accompanied by extraglandular manifestations such as Raynaud's phenomenon, arthritis, arthralgia, and myalgia, and 85% of patients experience severe fatigue. Moreover, B cell hyperactivity, reflected by increased serum levels of IgG and IgM rheumatoid factor (RF) and the presence of anti-SSA and anti-SSB autoantibodies, is a common finding in SS. Furthermore, SS has a large impact on health-related quality of life, employment, and disability, as reflected by lower Short Form 36 (SF-36) health survey scores, reduced employment rates, and higher rates of disability in patients with SS compared with the general population (1).ClinicalTrials.gov identifier: NCT00363350.

Objective. Accumulating data support the role of regulatory T cells, a subset of CD4؉ T cells that expresses CD25high and the transcription factor forkhead box P3 (FoxP3), in controlling and preventing autoimmunity. In Wegener's granulomatosis (WG), an autoimmune vasculitis, up-regulation of CD25 on circulating CD4؉ T cells has been observed, even in patients in remission. The objective of this study was to test whether the frequency and/or function of Treg cells from WG patients in remission are disturbed.Methods. Peripheral blood mononuclear cells were freshly isolated from 52 WG patients in remission and from 27 age-and sex-matched healthy control subjects. The proportion of circulating Treg cells was assessed by flow cytometry using CD4, CD25, FoxP3, and CD45RO markers. Anergy and suppressive function of CD25 high ,CD4؉ T cells were determined using polyclonal stimulants and coculture assay in 10 WG patients in remission and in 10 age-and sex-matched healthy controls.Results. In WG patients, a significant increase was observed in the percentage of circulating

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2009-015558-40.