GlaxoSmithKline and Genmab announce top-line results for ofatumumab in rheumatoid arthritis
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 5 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.
"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," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.
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