Human Genome's LymphoStat-B shown to improve rheumatoid arthritis symptoms

By Angela McDaniels

Seattle, Nov. 17 - Human Genome Sciences Inc. said results from a phase 2 clinical trial of LymphoStat-B (belimumab) in patients with rheumatoid arthritis show that LymphoStat-B is safe and well tolerated, biologically active and reduces rheumatoid arthritis disease activity at a level of statistical significance.

The double-blind, placebo-controlled, multicenter clinical trial was designed to evaluate the safety, optimal dosing and efficacy of LymphoStat-B in patients with active moderate-to-severe rheumatoid arthritis who had failed prior treatment.

The study was conducted in the United States and Poland with 283 patients, who were randomized to receive one of three different doses of LymphoStat-B or placebo administered intravenously over a 24-week treatment period, in addition to standard-of-care therapy.

Efficacy was evaluated according to the American College of Rheumatology criteria for defining clinical improvement in rheumatoid arthritis patients.

The primary efficacy endpoint for the LymphoStat-B phase 2 study was the rate of ACR 20 response at week 24 - the percentage of patients who achieved at least 20% improvement on the ACR-specified measures of disease activity.

The rate of improvement in ACR 20 response at week 24 was 29% in all groups treated with the drug combined - significantly higher than the 16% rate of improvement observed for the placebo group, the company said.

Human Genome Sciences said it will continue to collect data from the current phase 2 trial of LymphoStat-B in patients with rheumatoid arthritis through an ongoing optional extension protocol.

LymphoStat-B was also found to produce statistically significant reductions of 20% or more in B-cell subpopulations in patients, the company said.

Plasma B cells produce antibodies. Studies have shown elevated levels of B-lymphocyte stimulator protein, or BlyS, in the blood and joint fluid of patients with rheumatoid arthritis, the company said.

LymphoStat-B is a human monoclonal antibody that specifically recognizes and inhibits the biological activity of BlyS, which is required for the development of B-lymphocyte cells into mature plasma B cells.

The results were reported at the 69th Annual Meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals in San Diego.

LymphoStat-B was created through collaboration with Cambridge Antibody Technology. GlaxoSmithKline has exercised its option under a June 1996 agreement to develop and commercialize LymphoStat-B jointly with Human Genome Sciences.

Rheumatoid arthritis is a systemic, chronic autoimmune disease characterized by inflammation of the membrane lining the joint, the company said. Symptoms typically appear during middle age and may include swelling of the joints, difficulty moving and daily joint pain that frequently interferes with a person's ability to conduct normal activities.

Rockville, Md.-based Human Genome Sciences develops drugs that serve patients with unmet medical needs, with a primary focus on protein and antibody drugs.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.