46% of ofatumumab patients reach ACR 20

UK drug major GlaxoSmithKline and Denmark's Genmab AS reported positive primary efficacy data at the 2007 meeting of the European League Against Rheumatism, on their co-developed drug ofatumumab (HuMax-CD20) in patients with rheumatoid arthritis. A total of 225 patients with active RA who have previously failed one or more disease-modifying anti-rheumatic drugs (DMARDs) were enrolled into this Phase II double-blind, placebo-controlled study to evaluate the safety and efficacy of ofatumumab. Patients were assessed on their American College of Rheumatology (ACR) and EULAR responses at 24 weeks.

In the intention-to-treat study population, comprising 224 patients, ACR20 was achieved by 46% of all those receiving ofatumumab, ACR50 achieved by 24% and ACR70 by 6% of ofatumumab subjects compared to 15%, 5% and 0% in the placebo group, respectively. Evaluated by dose groups, an ACR20 response was obtained by 41% (p=0.002), 49% (p<0.001) and 46% (p<0.001) of patients on 300mg, 700mg and 1000mg of ofatumumab. An ACR50 response was achieved by 19%, 26% and 26% of patients receiving the varying doses of ofatumumab, with 9%, 4% and 6% getting an ACR70 response. These scores indicate a 20%, 50% or 70% improvement, respectively, in the number of swollen and tender joints, as well as improvements in other disease-activity measures, the firms noted.