Encouraging Clinical Data Presented at American College of Rheumatology (ACR) meeting Show Reduced Need for Concomitant Corticosteroid Therapy
SAN FRANCISCO, Oct. 27 /PRNewswire-FirstCall/ -- UCB (Euronext Brussels: 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, UCLA. "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.
Notes to editors:
About SL0003 and SL0004
SL0003 and SL0004 are two randomized controlled trials evaluating the efficacy and safety of epratuzumab for the treatment of severe BILAG A and/or moderate BILAG B in two or more organ systems SLE flare, respectively. Both trials terminated early due to interruptions in medication supply. Among both trials, 90 patients were randomized to receive epratuzumab 360 or 720mg/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. Not all patients received full treatment courses as planned per protocol due to the interruption in drug supply but many patients remained in the study for up to 6 months despite dosing cessation and continued to be followed (number of patients receiving full treatment course was 360mg/m2, n=14, 720mg/m2, n=5, placebo, n=13). Corticosteroids were increased at baseline. Disease activity (BILAG), Patient and MD global assessments (PGA, MDGA), and HRQoL (SF-36) were evaluated at baseline and every 4 weeks. Data from both studies were combined to increase available data at each time point.
The primary endpoint for the proof-of-concept analysis was BILAG response at Week 12, which is a reduction of all BILAG A level disease (severe flares) to B level disease (moderate flares) and B to C (stable disease), no worsening in other systems, and no addition or increase in immunosuppressives and/or anti-malarials or corticosteroids above baseline or tapering levels.
UCB has initiated a new phase IIb clinical study program for epratuzumab. The primary objective of the phase IIb program is to assess the dose response and the dose frequency for epratuzumab. Further information on the study can be found at Clinicaltrials.gov.
Epratuzumab is a humanized anti-CD22 antibody under investigation for the treatment of systemic lupus erythematosus (SLE). CD22 is a B-cell specific surface protein that is involved in B-cell development, function and survival. It is theorized that epratuzumab binds to this surface antigen and inhibits the cell's ability to generate antibodies against self proteins. The product was licensed from Immunomedics, Inc., Morris Plains, NJ, USA.
About systemic lupus erythematosus (SLE)
Systemic lupus erythematosus (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 body's immune system to attack its own cells and tissue 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. It is estimated that between 1.5 - 2 million Americans have a form of lupus, 90 percent of which 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 in Caucasians.
A Lupus Foundation of America survey demonstrated the potential economic impact of the disease, as two of three lupus patients reported a complete or partial loss of their income because they are unable to work due to complications.
*BILAG (British Isles Lupus Assessment Group) is a comprehensive scoring system for assessing both current lupus (SLE) disease activity and changes in that activity since the patient was last seen.
UCB is a global leader in the biopharmaceutical industry dedicated to the research, development and commercialization of innovative medicines with a focus on the fields of central nervous system and immunology disorders. Employing approximately 12,000 people in more than 40 countries, UCB achieved revenue of 3.6 billion euro in 2007. UCB is listed on NYSE Euronext (symbol: UCB). Worldwide headquarters is located in Brussels, Belgium; U.S. headquarters is located in Atlanta, Ga. For more information about UCB, visit http://www.ucb-group.com.
This press release contains forward-looking statements based on current plans, estimates and beliefs of management. Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuations and hiring and retention of its employees.
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