GlaxoSmithKline and Genmab Announce Results for Rheumatoid Arthritis Study

GlaxoSmithKline (GSK) and Genmab have announced preliminary results from a Phase III study of ofatumumab administered intravenously for the treatment of Rheumatoid Arthritis (RA) in patients who have an inadequate response to methotrexate.

The study met the primary endpoint, ACR20 at 24 weeks, which indicates a 20 percent 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) with a 50 percent response rate in the patients receiving ofatumumab, compared to 27 percent 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).

There were no unexpected safety findings. The most common adverse events in the ofatumumab treated patients (greater than five percent) were rash, urticaria, nasopharyngitis, pruritus, throat irritation and hypersensitivity.

Other than nasopharyngitis, these events generally occurred within 24 hours of the first infusion. One death, judged by the investigator as unrelated to ofatumumab, was reported in the study during the 24-week study period.