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Solomon Forouzesh MD, FACP, FACR
Associate Clinical Professor of Rheumatology and Internal Medicine at UCLA and Cedars Sinai Medical Center
UCB Announces Start Of Phase III Clinical Trial With Epratuzumab For Patients With Moderate To Severe SLE
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today
Article Date: 16 Dec 2010
UCB and U.S. based partner Immunomedics Inc. announced the enrollment of
the first patient into EMBODY™1, one of two pivotal phase III studies
of epratuzumab in patients with moderate to severe systemic lupus
erythematosus (SLE). Patient enrollment for EMBODY™ 2 has also begun.
"We are pleased to announce the launch of our phase III
programme with epratuzumab which marks UCB's intent to develop this
compound for such a severe disease," said Prof. Dr. Iris Loew-Friedrich,
Chief Medical Officer of UCB. She added, "The consistency of
improvements demonstrated by epratuzumab in the clinical studies to date
is an encouraging platform to start the next phase of trials, and is a
hopeful sign of the drug's potential to become an effective new
treatment option for lupus."
Both studies (EMBODY™ 1 and EMBODY™ 2) are multicenter,
placebo-controlled, randomized, double-blind studies designed to
evaluate the efficacy, safety, tolerability, and immunogenicity of
epratuzumab in patients with moderate to severe SLE. Each study will
last a maximum of 54 weeks and will randomize 780 patients in the study,
with approximately 130 planned investigational sites per study. The
phase III programme has undergone the relevant regulatory advice
The primary objective of the studies is to confirm the clinical
efficacy of epratuzumab in the treatment of patients with moderate to
severe general SLE, in addition to continuing standard of care
The results from the phase IIb study, EMBLEM™, showed that all
epratuzumab doses, which ranged from 200mg to 3,600mg 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 2,400mg there were meaningful and
statistically significant* reductions in SLE disease activity, with
responder rates more than double those of placebo.
The EMBLEM™ results showed that in a patient population with
predominantly high disease activity, epratuzumab improved patients'
health at week 12, with the emergence of improvements as early as week
8. Epratuzumab was associated with a similar incidence of serious
adverse events (including infections) and infusion reactions compared to
* This study was not powered to detect statistical differences
between treatment arms (p values were not adjusted for multiple
comparisons and are based on an exploratory post-hoc analysis)
1. Arthritis and Rheumatism 2010; 62(10): S605. ACR 2010 American College of Rheumatology
(ACR) Annual Scientific Meeting, November 7-11, 2010, Atlanta, GA, USA.
Epratuzumab is a humanized anti-CD22 monoclonal antibody under
investigation for the treatment of SLE. CD22 is a B cell specific
surface protein that is considered to be involved in B cell function.
The product was licensed from Immunomedics, Inc., Morris Plains, NJ,
USA. Under the license agreement, UCB owns the rights and is responsible
for the clinical development, and commercialization of epratuzumab in
all autoimmune disorders including SLE.
In EMBLEM™ (n= 227), patients were randomized to 1 of 6
intravenous regimens: placebo (PBO), epratuzumab cumulative dose (cd)
200, 800, 2400, or 3600 mg in equal divided doses using 2 every other
week (EOW) infusions or epratuzumab cd 2400 mg delivered as 4 equal
infusions 1 week apart. Concomitant oral corticosteroids (CS) and
immunosuppressives (IS) were stable for at least 5 and 28 days,
respectively, prior to first study drug infusion. Primary endpoint was
responder rate on a combined index of clinical disease activity at week
12 (defined as reduction of all baseline (BL) BILAG 2004 A to B/C/D and
BL BILAG B to C/D, no BILAG worsening in other organ systems, and no
deterioration in SLEDAI or physician global assessment [VAS]), with no
CS, IS and antimalarials increase over BL dose. The study was not
powered to detect statistical differences between treatment arms.
About systemic lupus erythematosus (SLE)
SLE, commonly referred to as lupus, is a chronic and potentially
fatal autoimmune disease with a variable and unpredictable course.
Antibodies are generated against the body's own nuclear proteins causing
the immune system to attack its own cells and tissues resulting in
inflammation and tissue damage. This can occur in any part of the body,
but most often targets the heart, joints, skin, lungs, blood vessels,
liver, kidneys and nervous system.
Lupus is characterized by periods of flares, or exacerbations,
interspersed with periods of improvement or remission. The Lupus
Foundation of America estimated that 1.5 million Americans have a form
of lupus, 90 percent of whom are women. Symptoms and diagnosis occur
most often between the ages of 15 and 45. In the U.S., lupus is more
common in African Americans, Latinos, Asians, and Native Americans than
Lupus Foundation of America, Inc.
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Copyright © 2010 Dr. Solomon Forouzesh in Los Angeles, CA.