GSK, Genmab Report Topline Results For Phase III Ofatumumab Trial

Published: 29-Jul-2009

The study met the primary endpoint, ACR20 at 24 weeks

GlaxoSmithKline (GSK) and Genmab have announced preliminary top-line results from a phase III study of ofatumumab, administered intravenously. The drug is for the treatment of rheumatoid arthritis (RA) in patients who had an inadequate response to methotrexate. The study met the primary endpoint, ACR20 at 24 weeks, which indicates a 20% or greater improvement in the number of swollen and tender joints, as well as improvements in other disease-activity measures.

In the study, 260 patients were treated and included in the analysis. At week 24, the ACR20 response rate was significantly greater for RA patients on ofatumumab (n=129) than on placebo (n=131). It was a 50% response rate in the patients receiving ofatumumab, compared to 27% for patients on placebo (p-value less than 0.001). All key secondary endpoints were significant (p-value less than or equal to 0.001), said the company.

Lisa Drakeman, chief executive officer of Genmab, said: We have always believed in ofatumumab's potential to make a difference in patients' lives. We are pleased with the results of this study, supporting the further investigation of this antibody's promise in the treatment of RA.

Tell your friend about this article