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Open-Label Study of Epratuzumab Shows Promise for Lupus

Monday, September 11, 2006

Open-Label Study of Epratuzumab Shows Promise for Lupus

Epratuzumab, under development by Immunomedics, Inc., is a treatment that interferes with B cells, a type of white blood cell that is important in lupus. This small, preliminary study tested epratuzumab in 14 patients with moderately active lupus. This study, like many preliminary studies, was an “open label” study. This means that the patient, physician and study team all know for sure that the patient is receiving the treatment and what the dose is.

The results are considered preliminary because they are not as scientific as “double-blind” studies in which patients are randomly selected to get the real treatment or a “dummy” treatment (placebo), and the patients and study team do not know which one they are getting. Double-blind studies make it a lot less likely that improvements in symptoms are from wishful thinking.

Patients were given epratuzumab every 2 weeks for 18 weeks. The activity of their lupus was measured using a special index measure called the BILAG (which stands for British Isles Lupus Assessment Group). High BILAG scores reflect that a person has a lot of active inflammation or significant symptoms from lupus in one or more organ.

In this study the BILAG scores decreased by 50 percent or more in all 14 patients at some point during the study. Almost all patients experienced improvements in disease activity after 6, 10 and 18 weeks of treatment, and 3 patients had no disease activity at all by 18 weeks. Also, it did look as if the drug managed to affect its intended target, since B cell levels decreased by an average of 35 percent at 18 weeks and remained low when measured 6 months after treatment.

In this study, patients with mild to moderate active lupus tolerated epratuzumab well and showed some preliminary evidence of clinical improvement after the first dose. Further studies of epratuzumab are now underway. These studies will be larger and more scientific and will help to determine whether this drug is safe and effective.

Click here to read the abstract.

Thomas Dörner, Joerg Kaufmann, William A. Wegener, Nick Teoh, David M. Goldenberg, and Gerd R. Burmester, Arthritis Research & Therapy 2006;8:R74

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Blogged on 9:44 PM

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