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

ell as improvements in other disease-activity measures.

In the subgroup of patients receiving concomitant stable doses of methotrexate, comprising 178 patients, results across the three dose levels of ofatumumab studied showed that an ACR20 response was obtained by 42% (p=0.006), 56% (p<0.001) and 50% (p=0.001) of patients in the 300 mg, 700 mg and 1000 mg dose groups, respectively compared to 16% in the placebo group. An ACR50 response was obtained by 21%, 26% and 26% of patients receiving the varying doses of ofatumumab, with 8%, 2% and 5% obtaining an ACR70 response. The corresponding responses for the placebo group were 7% and 0%.

At 24 weeks, the patients' immune responses to study medication (ofatumumab or placebo) were also evaluated by testing for the presence of human anti-human antibodies (HAHAs). All patients tested negative at 24 weeks.

Overall, 72% (300 mg p<0.001; 700 mg p=0.001; 1000 mg p=0.001) of patients treated with each of the ofatumumab doses experienced at least a moderate (moderate or good) EULAR response compared to 40% of patients receiving placebo at week 24.

The data also showed that ofatumumab appeared well tolerated, with no increased frequency of serious infections. Approximately half of the adverse events occurred on infusion days (51%) with the most frequently reported being mild or moderate (CTC grade 1-2 events), including throat irritation, dyspnoea and rash.

"These results represent another positive milestone in the development of ofatumumab. They will enable us to progress development in the rheumatoid arthritis (RA) indication and help bring this potentially important treatment to patients suffering from this often painful and debilitating condition," commented Dr. Kathy Rouan, Vice President, Research and Development, GlaxoSmithKline.

"The level of response of patients in the study illustrates the potential of ofatumumab in the treatment of RA and we hope to see similar results in the P
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