GSK and Genmab Announce Positive Arthritis Drug Trial Results

30 July 2009 (Last Updated July 30th, 2009 18:30)

GlaxoSmithKline (GSK) and Genmab have announced positive resuts from a Phase III study of ofatumumab, an intravenous treatment for patients with rheumatoid arthritis (RA) who had an inadequate response to methotrexate. The study met the primary endpoint at 24 weeks, which required a 20% o

GlaxoSmithKline (GSK) and Genmab have announced positive resuts from a Phase III study of ofatumumab, an intravenous treatment for patients with rheumatoid arthritis (RA) who had an inadequate response to methotrexate.

The study met the primary endpoint at 24 weeks, which required a 20% or greater improvement in the number of swollen and tender joints, as well as improvements in other disease-activity measures.

Of the 260 patients who were included in the trial, at week 24 the ACR20 response rate was significantly greater for RA patients on ofatumumab than those on placebo with a 50% response rate in the patients receiving ofatumumab, compared to 27% for patients on placebo.

GSK Biopharm Development senior vice-president Carlo Russo said that RA can be a highly debilitating disease.

"It is encouraging to see the reduction in disease symptoms achieved with intravenous ofatumumab, and we look forward to presenting the full study results," Russo said.

There were no unexpected safety findings. However, 5% of patients experienced rash, urticaria, nasopharyngitis, pruritus, throat irritation and hypersensitivity, with these symptoms generally occurring within 24 hours of the first infusion.