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Study Results Show Epratuzumab Provided Clinically Meaningful Reduced Disease Activity in Patients With Lupus



SAN FRANCISCO, October 27, 2008/PRNewswire-FirstCall/ --UCB announced data from two randomized controlled trials showing that treatment with epratuzumab a humanized anti-CD22 antibody, 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 systemic lupus erythematosus (SLE). These findings were presented at the American College of Rheumatology (ACR) annual meeting here today.


"Given the debilitating effect lupus has on a patient's quality of life, these results are encouraging," commented lead study investigator Daniel J. Wallace, M.D., Clinical Professor of Medicine, David Geffen School of Medicine, . "In these trial results, treatment with epratuzumab demonstrated clinically meaningful improvement in patients' flares and significant decrease in steroid use, which is critical given their long-term adverse effects."


"While medical advances have improved the lives and survival of people with lupus, effective therapeutic options remain limited," said Sandra C. Raymond, President and Chief Executive Officer of the Lupus Foundation of America. "It has been nearly five decades since a new treatment was approved for this devastating and life altering disease and current treatments are limited with adverse effects though recent research efforts to find new treatments are encouraging for the millions of people around the world living with lupus."


In the combined studies, beginning at week 4 and continuing through week 48, Total BILAG* scores, a clinical measure of lupus disease activity, in both epratuzumab treatment arms (360 or 720mg/m2) remained lower than placebo. Among study participants who completed all scheduled doses at week 12, 54 percent of epratuzumab 360mg/m2 patients showed a BILAG response compared with 21 percent of placebo patients. Additionally, epratuzumab treated patients achieved a sustained BILAG response sooner than placebo treated patients.


The study also evaluated the ability of epratuzumab to reduce corticosteroid (CS) use, or "steroid sparing" effects, in patients. At weeks 20-24, 75 percent of epratuzumab 360mg/m2 and 100 percent of epratuzumab 720mg/m2 patients achieved tapering of corticosteroids compared to 57 percent of placebo. Epratuzumab patients used cumulatively less corticosteroids than placebo patients over 24 weeks.


In the HRQoL analysis, there were clinically meaningful improvements over 12-48 weeks with epratuzumab 720 and 36-48 weeks with epratuzumab 360 compared to placebo as assessed by the SF-36, a 36-question short-form health survey assessing physical and mental health, including specific questions for physical function, bodily pain, general health, vitality, social and emotional function, and mental health.


Overall, the most commonly reported AE among all patients was upper respiratory tract infection which was experienced by a higher percentage of patients in the placebo group. Additionally, anemia and fatigue were some of the events reported more frequently in the placebo treated group. Of the remainder of the AEs occurring at greater than or equal to 10% incidence in any treatment arm, the following are some of those reported in a higher percentage of patients treated with either dose of epratuzumab compared to placebo treatment: arthralgia, sinusitis, nausea, pyrexia, abdominal pain, oral candidiasis, peripheral edema, chest pain, pharyngolaryngeal pain, rash, abdominal pain upper, and cough. Serious infections (serious adverse events that were infections) occurred in 18% of epratuzumab-treated, and 22% of placebo-treated patients.

Posted: October 2008