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http://www.medicalnewstoday.com/articles/111627.php

The data were from the first placebo-controlled studies using epratuzumab in SLE patients and were presented at the 2008 European Congress of Rheumatology (EULAR).

"These initial clinical results for epratuzumab are very encouraging," commented lead study author Dr Michelle Petri, Director, Lupus Center and Professor of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA. "Developing new compounds for SLE patients is critical because currently available treatments, such as immunosuppressants and corticosteroids, often have serious and debilitating side-effects. We look forward to seeing results from other clinical trials involving epratuzumab."

Epratuzumab is a fully-humanised anti-CD22 compound with the potential to modulate B-cell activity. Although the exact function of CD22 is not fully understood, it is known to be involved in B-cell development, function and survival. B-cells are known to contribute to SLE by producing antibodies against the body's own tissues, causing the body's immune system to turn on itself, attacking cells and tissue and resulting in inflammation and tissue damage. SLE is a chronic and potentially fatal autoimmune disease with a variable and unpredictable course. It can affect any part of the body, but most often harms the heart, joints, skin, lungs, blood vessels, liver, kidneys and nervous system and is characterised by periods of flares, or exacerbations, interspersed with periods of improvement or remission.

In the clinical studies, 90 patients were randomised to receive epratuzumab 360 or 720 mg/m2 infusions at weeks 0, 1, 2 and 3, with subsequent treatment cycles of two infusions one week apart, every 12 weeks, for up to four treatment cycles over a 48-week period. The efficacy endpoints included a reduction in disease activity, as measured by the BILAG* Activity Index, steroid sparing and improvements in both physician and patient global disease activity assessments. Both doses of epratuzumab resulted in clinically meaningful reductions in total BILAG scores versus placebo from week 4 through to week 48 and reduced steroid use. Also, according to physician and patient global assessment scores, more epratuzumab patients showed improvement compared with the placebo group, with a high degree of correlation between the patient and physician global assessments. Additionally, epratuzumab was shown to be well-tolerated in these studies, with a similar safety profile as placebo. The incidence of serious adverse events, adverse events in particular reflecting infections and infusion-related reactions, were similar across active and placebo treatments.

UCB has initiated a new Phase IIb clincal study programme for epratuzumab, which consists of two studies. The primary objective of the phase IIb programme is to assess the dose response and the dose frequency for epratuzumab. Further information on the study can be found at http://www.Clinicaltrials.gov
Clare
 

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Hi Clare,

Thank you for posting this article. It will be interesting to see if after Phase 3 it passes as significant improvement in all areas. Hopefully it does and can be moved on for FDA approval.

Take care,
Lazylegs
 

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the big thing for me with this drug is that it is FULLY HUMANIZED, as I am very allergic to the mouse component of rituxan. So fingers crossed this one is released soon, it will definitely save me some heartache (or lung ache, I get severe bronchospasm from rituxan)

cheers

raglet
 
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