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Epratuzumab Phase IIb Data Presented at ACR Show Pipeline Drug had Positive Effect in Patients Suffering From Moderate to Severe Systemic Lupus Erythematosus
Date:11/9/2010

ific body systems after treatment with epratuzumab.  Improvements were particularly prominent in cardiorespiratory and neuropsychiatric systems in which symptom improvements are often difficult to achieve.

These results demonstrated that in a patient population with predominantly high or severe disease activity, differences in responder rates between the epratuzumab 600mg weekly and 1200mg every other week groups, and the placebo group was observed as early as week 12, with the emergence of improvements apparent in week 8.

In two previous phase II randomized controlled trials, epratuzumab treatment resulted in clinically meaningful reduced disease activity, improved health-related quality of life (HRQoL) measurements and reduced reliance on corticosteroids compared to placebo treatment in patients with active moderate and severe SLE.

"We are pleased by the repeated consistency of symptom improvement demonstrated by epratuzumab in all our clinical studies to date and we look forward to confirming these results in our phase 3 studies due to start later this year," said Prof. Dr. Iris Loew-Friedrich, Chief Medical Officer of UCB. She added, "Achieving a BILAG improvement, especially at an early timepoint seen in EMBLEM™, is a hopeful sign of the drug's future potential."

Epratuzumab is a humanized monoclonal antibody targeting CD22 and modulating B cell activity.  Although the exact role of CD22 is not fully understood, it is considered to be a regulator of B cell function. B cells are known to contribute to SLE by producing antibodies against the body's own cells and tissues, causing the immune system to turn on itself, resulting in inflammation and tissue damage. Epratuzumab is an anti-B-cell therapeutic, because of its ability to modulate B cell function without depleting a large portion of these lymphocytes.

* This study was not powered to detect statistical differences between treatment arms (p values were no
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