Epratuzumab phase IIb data show pipeline drug had positive effect in patients suffering from systemic lupus erythematosus

11-Nov-2010 - USA

UCB and U.S. based partner Immunomedics Inc.announced that results from the phase IIB study, EMBLEM™, showed that certain doses of epratuzumab were associated with a meaningful and statistically significant reduction in disease activity in adult patients with moderate to severe active SLE.

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 data, which were presented in Atlanta at the 74th Annual Scientific Meeting of the American College of Rheumatology (ACR), demonstrated that, in EMBLEM™, 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. For patients receiving epratuzumab at a cumulative dose of 2400mg, there were meaningful and statistically significant reductions in SLE disease activity, with responder rates more than double those of placebo. Epratuzumab was associated with a similar incidence of serious adverse events (including infections) and infusion reactions compared to placebo.

“While medical advances have improved the lives and survival of people with lupus, effective therapeutic options remain limited. Given these positive results, we remain excited at the future potential of epratuzumab,” commented lead study investigator Daniel J. Wallace, M.D., Clinical Professor of Medicine, David Geffen School of Medicine, UCLA.

Additionally, 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.2 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.

https://www.bionity.com/en/news/125762/epratuzumab-phase-iib-data-show-pipeline-drug-had-positive-effect-in-patients-suffering-from-systemic-lupus-erythematosus.html