Rituximab appears to offer no long term benefit to patients with primary Sjögren syndrome (pSS), according to an article published in Annals of Internal Medicine.
pSS is a chronic autoimmune disorder characterized by dryness of the eyes and mouth. Up to half of patients have systemic involvement, with fatigue being a symptom associated with significant disability. No systemic treatment has been proved to significantly improve symptoms.
Mounting evidence on B cell involvement in pSS suggests that B-cell depletion could be an effective treatment for pSS. The CD20 antigen, a transmembrane protein found on pre-B and mature B cells, is the most widely studied target for achieving B-cell depletion. Rituximab is an anti-CD20 antibody.
Researchers conducted a multicenter, double-blind, placebo-controlled, randomized trial to evaluate the efficacy and harms of rituximab in adults with recent-onset or systemic pSS. They found that rituximab given in two infusions over two weeks alleviated some symptoms, particularly fatigue, early in the trial but did not alleviate symptoms or disease activity at 24 months. More infusion reactions occurred with rituximab than placebo. The data do not support use of rituximab for treating pSS.