HGS Presents Results For Lupus Trial

Human Genome Sciences (HGS) has reported the publication of the results of primary endpoint of two pivotal phase 3 clinical trials of Benlysta (belimumab) in serologically active patients with SLE. The article was pubished by the journal Arthritis Care & Research.

The primary endpoint of the study was to evaluate the development and the use of a novel evidence-based systemic lupus erythematosus (SLE) Responder Index. The primary endpoint was accepted by the FDA under a Special Protocol Assessment agreement for the phase 3 trials.

The primary efficacy endpoint of both phase 3 trials of belimumab is the SLE Responder Index at week 52, as defined by a reduction from baseline of at least 4 points on the SELENA SLEDAI disease activity scale, no worsening of disease as measured by the Physician’s Global Assessment, and no new BILAG A organ domain score and no more than one new BILAG B organ domain score.

In July 2009, HGS and GSK has announced that belimumab met this primary endpoint in BLISS-52, the first of the two phase 3 trials. Results from BLISS-76, the second phase 3 trial, are expected in November 2009.

William Freimuth, vice president of clinical research for immunology, rheumatology and infectious diseases at HGS, said: “The SLE Responder Index selected as the primary efficacy endpoint of the BLISS studies of belimumab emerged directly from exploratory analysis of the results of our phase 2 clinical trial.

“This novel and robust index now allows clinical investigators to measure improvement in overall SLE disease activity while at the same time ensuring that the improvement is not accompanied by worsening in other disease manifestations such as organ flares. I am delighted that the validity of the endpoint has now been established with its successful prospective use in the recently completed BLISS-52 study.”