Immunomedics has reported that patients with primary Sjogren's syndrome, an autoimmune disease that currently affects between 2 million and 4 million Americans, retained clinical benefits six months after being treated with epratuzumab.
The clinical trial was an open-label, non-randomized, two-center Phase I/II study to assess feasibility, safety, and early evidence of efficacy in fifteen patients with primary Sjogren's syndrome. Epratuzumab, a recombinant humanized antibody against CD22 expressed on B-lymphocytes, was administered intravenously in about one hour, every other week, for four doses of 360mg/m2 each. Patients were then evaluated 24 hours, four weeks, 12 weeks and six months post-therapy. Epratuzumab therapy was associated with a mean decrease in circulating B-cells of 33 percent during the six-month evaluation. No immunogenicity was observed, and one patient experienced a serious drug-related infusion reaction, which resolved completely with no further recurrence of symptoms.