Clinically Meaningful Reduction in Disease Activity Reported with Epratuzumab
Thursday, October 30, 2008
San Francisco, October 27, 2008 – Encouraging initial findings from the combined results of two early clinical trials of the drug epratuzumab for lupus were announced by UCB Pharma at the annual meeting of the American College of Rheumatology in San Francisco this week.
Results from the randomized, 48-week trials in people with moderate to high lupus disease activity suggest that UCB’s epratuzumab, a humanized anti-CD22 monoclonal antibody that targets B cells:
- Improved health quality of life measures such as bodily pain, vitality, and emotional function
- Improved indices of clinical disease activity (BILAG)
- Decreased use of powerful but ultimately damaging corticosteroid drugs.
“These results are very encouraging and promising for lupus patients and we look forward to the results of additional clinical trials,” said Margaret Dowd, president of the Lupus Research Institute.
Data from trials were pooled to allow for more robust analysis; unfortunately the trials had to be discontinued early due to interruption of drug supply. In all, 90 participants were randomized to receive either a placebo or epratuzumab at a dose of 360 mg/m2 or 760 mg/m2.
The effects of epratuzumab were rapid—with initial changes in quality of life measures and disease activity scores seen within 8 to 12 weeks, and decrease in corticosteroid use seen by 24 weeks—and had a similar safety profile to placebo.
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