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GlaxoSmithKline and Genmab Present Positive Phase II Results With,ofatumumab in Patients With Rheumatoid Arthritis (RA)

hase III study being planned for later this year," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.

These data will be described in an oral presentation by Professor Mikkel 0stergaard, Department of Rheumatology, Copenhagen University Hospital at the 2007 Annual European Congress of Rheumatology (EULAR) in Barcelona, Spain on June 16.

ACR Response

The ACR response is a standard assessment used to measure patients' responses to anti-rheumatic therapies devised by the of Rheumatology (ACR). It requires a patient to have a defined percentage reduction in a number of symptoms and measures of their disease. For example: At least 20% improvement in the painful joint count and in the swollen joint count; and At least 20% improvement in at least three of the following parameters: ESR or APR, physician's global assessment of disease activity, patient's global assessment of disease activity, patient's assessment of pain, and physical disability. These criteria are known as the ACR20, reflecting the need for a 20% improvement in each parameter, which is considered the clinically relevant cut-off point. A 50% or 70% level of reduction (the percentage of reduction of RA symptoms) is represented as ACR50 and ACR70, respectively.

EULAR Response

The EULAR criteria for rheumatoid arthritis use the disease activity scale (DAS) using the 28-joint tender and swollen joint counts, which includes not only change in disease activity but also current disease activity. To be classified as responders, patients should have a significant change in DAS and also low current disease activity. Patients are classified as good, moderate, or non-responders according to both a significant change in the DAS and the level of residual disease activity.

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