In patients who received two doses of HuMax-CD20, 77% achieved a 20% improvement in the number of swollen and tender joints.
There were three dose levels tested in the study. In the lowest dose group of 300mg, 75% of patients who received both doses obtained the 20% improvement in the number of swollen and tender joints. In both the 700mg and 1000mg dose groups, 78% of patients who received both doses obtained the desired 20% improvement.
The study included 39 patients with rheumatoid arthritis (RA) and 33 received either two infusions of HuMax-CD20 or placebo, given two weeks apart.
In August 2005, the study was expanded into a phase II trial which will include 200 additional patients.
“The initial results of this phase I/II study in RA are very encouraging,” said Dr Lisa Drakeman, CEO of Genmab. “We are looking forward to the ongoing development of HuMax-CD20 in RA.”