Cimzia Demonstrates Sustained Long-Term Efficacy and Favorable Tolerability in the Treatment of Crohn’s Disease at Stable Doses
New 18-month data presented at American College of Gastroenterology Meeting
ATLANTA, Oct. 15, 2007 — New data presented at the 2007 American College of Gastroenterology (ACG) Annual Scientific Meeting has demonstrated that Crohn’s disease patients treated continuously with CIMZIA® (certolizumab pegol), UCB’s next-generation PEGylated anti-TNF therapy, maintained remission for up to 18 months. In addition, patients who had lost response to CIMZIA in an earlier phase of the study and were subsequently re-induced with only one additional dose, then treated every four weeks with no dose escalation, maintained remission for up to 12 months.
The data covered an interim analysis of two long-term open-label extension studies to the Phase III PRECiSE program (n=215). Results from the first study showed that 40.9 percent of patients who responded to CIMZIA in one of the initial PRECiSE trials at the end of the induction phase were still in remission after 12 months, and 36.3 percent after 18 months. In the second long-term extension study, patients who had deteriorated despite continued CIMZIA maintenance treatment in one of the initial PRECiSE trials (n=49) were re-induced with a single additional dose of CIMZIA. This resulted in a 32.7 percent remission rate at six months, and 34.7 percent at 12 months. For patients who flared after response to open-label induction and were randomized to placebo (n=75), re-induction with CIMZIA recaptured 44.0 percent into remission at six months, and 36.0 percent at twelve months. Safety data from both extension studies suggest that CIMZIA was well-tolerated.
“These results demonstrate that certolizumab pegol, given subcutaneously every four weeks, is able to sustain effectiveness in the treatment of Crohn’s disease, with no dose escalation,” commented study investigator Stephen B. Hanauer, M.D., Professor of Medicine and Clinical Pharmacology , Director of Gastroenterology, Hepatology and Nutrition, The University of Chicago, Department of Medicine, Section of Gastroenterology. “Interestingly, results also suggest that re-inducing previously-relapsed patients with only one additional dose of certolizumab pegol may be a successful and well-tolerated therapeutic strategy.”
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Garry Daniels, UCB
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Antje Witte, UCB
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Notes to Editors
About CIMZIA® (certolizumab pegol)
CIMZIA® is an investigational drug product. CIMZIA is the first and only PEGylated anti-TNF (Tumor Necrosis Factor). CIMZIA has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha. Over the past decade, TNF-alpha has emerged as a major target of basic research and clinical investigation. This cytokine plays a key role in mediating pathological inflammation, and excess TNF-alpha production has been directly implicated in a wide variety of diseases.
UCB filed a BLA with the Food and Drug Administration (FDA) for CIMZIA in the treatment of Crohn’s disease on February 28, 2006 and on April 28, 2006 submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for the same indication. CIMZIA was approved in Switzerland for the treatment of Crohn’s disease on September 27, 2007. UCB plans to file a sBLA and a MAA for the treatment of rheumatoid arthritis by the end of 2007 with regulatory agencies in the U.S. and Europe.
About the PRECiSE Clinical Trial Program
PRECiSE, one of the largest, most comprehensive development programs for an anti-TNF for Crohn’s disease, is composed of two placebo-controlled studies and two open-label safety follow-up studies. The two former studies were recently published in the New England Journal of Medicine (NEJM).1,2 They demonstrated that patients with moderate-to-severe Crohn’s disease achieved and sustained clinical response with CIMZIA for up to six months, compared to placebo. The safety and tolerability of CIMZIA was consistent with that expected of an anti-TNF agent. In the first follow-up study, patients completing both initial studies are to be given CIMZIA every four weeks for up to five years. In the second follow-up study, patients who relapsed in either initial study (defined as an increase in CDAI of >70 or absolute CDAI of >350) were re-introduced to CIMZIA every four weeks to be continued for up to five years, with a single additional dose at week 2.
About Crohn’s Disease
Crohn’s disease is a chronic, progressive, destructive disorder that causes inflammation of the gastrointestinal (GI) tract, most commonly at the end of the small intestine (the ileum) and beginning of the large intestine (the colon). If not effectively treated, it can result in the need for surgery. Crohn’s disease has been estimated to affect as many as half a million Americans.3 Sufferers can be affected all of their lives, experiencing an ongoing cycle of flare-up and remission. Together with ulcerative colitis, Crohn’s disease is an inflammatory bowel disease (IBD).3
Headquartered in Brussels, Belgium, UCB (www.ucb-group.com) is a global leader in the biopharmaceutical industry dedicated to the research, development and commercialization of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diseases, immune and inflammatory disorders and oncology - UCB focuses on securing a leading position in severe disease categories. Employing more than 10,000 people in over 40 countries, UCB achieved revenue of 3.5 billion euro in 2006 on a pro forma basis. UCB is listed on the Euronext Brussels Exchange and owns approximately 88% of the shares of SCHWARZ PHARMA AG. U.S. Headquarters are located in Atlanta, Georgia.
1. Schreiber S et al. Maintenance therapy with certolizumab pegol for Crohn’s disease. NEJM 2007;357:239-50.
2. Sandborn WJ et al. Certolizumab pegol for the treatment of Crohn’s disease. NEJM 2007;357:228-38.
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Posted: October 2007