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news.UCB and Immunomedics have released the results from the Phase IIB study, Emblem, which showed that certain doses of Epratuzumab were associated with a reduction in disease activity in adult patients with moderate to severe active systemic lupus erythematosus (SLE).
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The Emblem study was designed to evaluate the efficacy and safety of Epratuzumab (in combination with immunosuppressants) in SLE, identify an optimal dose and regimen for further studies, and validate and analyse the performance of a new composite efficacy endpoint.
The Emblem study data demonstrated that all Epratuzumab doses, which ranged from 200mg to 3600mg cumulative dose administered during one 12-week treatment cycle, had numerically superior response rates compared to placebo at week 12.
Additionally, for patients receiving Epratuzumab at a cumulative dose of 2400mg, there were meaningful and significant reductions in SLE disease activity, with responder rates more than double those of placebo.
David Geffen School of Medicine, UCLA, clinical professor of medicine and lead study investigator Daniel Wallace said that given these positive results, they remain excited at the future potential of Epratuzumab.
UCB said that based on analysis of improvement in BILAG 2004 by body system in Emblem, most patients had symptom reduction or absence of active disease within specific body systems after treatment with Epratuzumab.
Reportedly, 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.
UCB chief medical officer Iris Loew-Friedrich said that they were pleased by the repeated consistency of symptom improvement demonstrated by Epratuzumab in all theirr clinical studies to date.