Rituximab therapy for primary Sjogren's syndrome: an open-label clinical trial and mechanistic analysis.

ABSTRACT:

Objective

To study the safety and clinical efficacy of rituximab therapy for primary Sjögren's syndrome, as well as to investigate its mechanisms.

Methods

Patients with primary Sjögren's syndrome were enrolled in an open-label trial, were given rituximab (1 gm) infusions on days 1 and 15, and were monitored through week 52. The primary end point was safety, with secondary end points evaluating clinical and biologic efficacy. Blood was obtained for enumeration of lymphocyte subsets, measurement of serum autoantibody and BAFF levels, and analysis of gene expression.

Results

Twelve female patients with primary Sjögren's syndrome were administered rituximab. They had a median age of 51 years (range 34-69 years) and a median disease duration of 8.0 years (range 2-18 years)

SUBMITTER: St Clair EW 

PROVIDER: S-EPMC3618621 | biostudies-literature | 2013 Apr

REPOSITORIES: biostudies-literature