Antibody Treatment Promising for Arthritis

An extension of a phase I/II study has shown that a fully human antibody used to treat rheumatoid arthritis was well tolerated in patients and significantly reduced swollen and painful joints.

In the study, 10 patients with active rheumatoid arthritis recived a single dose of HuMax-CD4 in combination with low-dose methotrexate. The number of swollen joints, painful joints, and physician assessment of disease activity were reduced, by medians of 57%, 46%, and 54%, respectively. Furthermore, two of the 10 patients achieved ACR 20, objective criteria defined by the American College of Rheumatology that is used by regulatory authorities to evaluate whether a product is approvable. In the initial phase I/II study, 50% of the treated patients in the four highest dose cohorts achieved ACR 20.

HuMax-CD4 was developed by Genmab A/S (Copenhagen, Denmark), a biotechnology company that creates and develops human antibodies for the treatment of diseases. Phase II trials are now in progress. "The magnitude of response to only a single dose of HuMax-CD4 is very encouraging,” said Joergen Petersen, M.D., head of rheumatology, Rigshospitalet, Copenhagen. "We look forward to the results of the ongoing multi-dose study.”



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