Trial Results Show a New Drug's Promise for Relieving RA Symptoms

August 5, 2009

Patients with rheumatoid arthritis who do not respond well to methotrexate may benefit from ofatumumab, preliminary results from a Phase III trial show.

Patients with rheumatoid arthritis (RA) who do not respond well to methotrexate may benefit from ofatumumab, preliminary results from a Phase III trial show.

By the primary endpoint of the study, ACR20 at week 24, RA patients receiving ofatumumab had achieved an ACR20 response that was “significantly greater” than patients on the placebo, according to the release from GlaxoSmithKline. Patients receiving the drug achieved an ACR20 response of 129, while patients on the placebo were at 131. Those being treated with ofatumumab showed a 50% response rate, while patients on placebo had a 27% response rate. Also, according to the release, “all key secondary endpoints were significant (p-value less than or equal to 0.001).”

For the study, patients with active RA were randomly divided to receive either “two 700 mg doses of intravenous ofatumumab or placebo two weeks apart in addition to background methotrexate.” Patients’ disease status was measured every four weeks throughout the course of the study. The primary objective of the study was to “determine the efficacy of intravenous ofatumumab in reducing the clinical signs and symptoms in RA patients after two 700 mg doses of ofatumumab compared to placebo.” Key secondary objectives included safety, patient reported outcomes, biomarkers, and ACR 50 and ACR 70.

In addition to the primary endpoint findings, GlaxoSmithKline reports “no unexpected safety findings.” Common adverse events seen in the patients treated with ofatumumab included rash, urticaria, nasopharyngitis, pruritus, throat irritation, and hypersensitivity at a rate of more than 5%. Aside from nasopharyngitis, all problems presented within 24 hours of the drug’s injection. One death did occur during the course of the 24 weeks, though the investigator determined that the death was unrelated to the trial drug.

The investigators report that the trial results show ofatumumab’s “promise” for treating RA.

“RA can be a highly debilitating disease,” Carlo Russo, MD, Senior Vice President, Biopharm Development, GlaxoSmithKline. “It is encouraging to see the reduction in disease symptoms achieved with intravenous ofatumumab, and we look forward to presenting the full study results.”