UCB Presents Positive Cimzia(TM) Results From Pivotal Phase III Crohn's Disease Trial At Major U.S. Medical Meeting
HONOLULU, Oct. 31 /PRNewswire/ -- A single 400 mg injection of Cimzia(TM) (certolizumab pegol, CDP 870) every four weeks was effective in maintaining control of the signs and symptoms of Crohn's disease following induction therapy, according to pivotal phase III research presented this week at the annual meeting of the American College of Gastroenterology.
The study, entitled PRECiSE 2, found that a significantly higher proportion of patients who responded to an induction regimen of 400 mg Cimzia(TM) at weeks zero, two and six, were able to maintain clinical response and achieve remission by week 26 when given a single injection every four weeks, compared to those treated with placebo. A regulatory submission for the treatment of Crohn's disease is planned in the US during the first quarter of 2006.
"As there is considerable unmet need in the treatment of Crohn's disease, it is important that the research community continue to explore new therapies," said William J. Sandborn, MD, professor of medicine, Mayo Clinic College of Medicine, Rochester, MN, PRECiSE study investigator. "These data are exciting because it shows that Cimzia(TM) holds significant promise in meeting many of these needs."
Crohn's disease is a chronic inflammatory bowel disorder that affects approximately one million people in the US and Europe alone.(1,2) Because there is no cure, treatment is focused on suppressing the inflammatory response that is at the root of its cause. Cimzia(TM) is a biologic agent that has been designed to inhibit the production of tumor necrosis factor alpha (TNF-alpha), a protein involved in the inflammation process.
Study Highlights -- 64 percent of the 668 patients enrolled in the trial responded to induction therapy by week 6. Those who responded were randomized to receive maintenance treatment with either Cimzia(TM) (n=216) or placebo (n=212). -- 62.8 percent of patients receiving Cimzia(TM) maintenance therapy sustained an overall clinical response throughout the 26-week study period, compared to 36.2 percent with placebo. -- The primary endpoints of PRECiSE 2 trial were met with statistical significance, irrespective of C-reactive protein (CRP, a marker of inflammation) status or prior exposure to anti-TNF therapy. -- 47.9 percent of patients receiving Cimzia(TM) maintenance therapy were in clinical remission at week 26, compared to 28.8 percent with placebo. -- Adverse events were mostly mild to moderate with the most common being headache (maintenance: certolizumab 6.9 percent; placebo 6.6 percent). Serious non-CD-related infections were observed in both the Cimzia(TM) (certolizumab pegol, CDP 870) (3 events) and placebo (2 events) treatment groups.
The PRECiSE clinical trial program is composed of four studies (PRECiSE 1, 2, 3 and 4). In addition to PRECiSE 2, the detailed results of which were presented at ACG, PRECiSE 1 is a 26-week double-blind, placebo-controlled trial, and represents the first long-term fully placebo-controlled clinical trial of a biologic in Crohn's disease. PRECiSE 1 successfully met its primary endpoints with statistical significance. As expected from a study with such a challenging trial design, top-line results were of lower magnitude than observed in the PRECiSE 2 trial. The detailed analysis of the PRECiSE 1 data is still ongoing, with results planned for presentation at a forthcoming gastroenterology congress. PRECiSE 3 and 4 are both 24-month, open-label trials for patients who participated in either PRECiSE 1 or 2, assessing the longer-term safety and tolerability of Cimzia(TM), and are currently ongoing.
Methods
The 26-week PRECiSE 2 study was designed to assess the safety and efficacy of Cimzia 400 mg for the maintenance of clinical response after open-label induction therapy in patients with mild to moderate Crohn's disease. Those who responded by week six were randomized to receive either a once-monthly maintenance dose of certolizumab 400 mg or placebo. Clinical response was defined as a 100 point drop in the Crohn's Disease Activity Index (CDAI), which measures the disease severity by taking into account a number of factors such as intensity of symptoms, medication and general well-being. The primary endpoint was the percentage of patients at week 26 with a C-reactive protein (CRP, a marker of inflammation) level greater than or equal to 10 mg who maintained a clinical response after successful induction. Major secondary endpoints included remission (CDAI less than or equal to 150) in those with a CRP level greater than or equal to 10mg, and response and remission in the overall treatment population.
About Crohn's Disease
Crohn's disease is a chronic disorder that causes inflammation of the gastrointestinal tract, most commonly at the end of the small intestine (the ileum) and beginning of the large intestine (the colon). Common symptoms include diarrhea, fever, abdominal pain and weight loss. Although it can occur at any age, it primarily impacts young adults between the ages of 15 and 35. Because it is a chronic illness, patients experience an ongoing cycle of symptom "flare-ups" and periods of remission, when symptoms disappear or are controlled.(1) This cycle can impact all aspects of a patient's life, including their pursuit of higher education and relationships with employers, friends and family members.(3)
About Cimzia(TM)
Cimzia(TM) is unique anti-TNF therapy in that it is a humanized antibody Fab' fragment chemically attached to polyethylene glycol (PEG, i.e. PEGylated). PEGylation increases the plasma half-life of certolizumab to approximately two weeks.
About UCB
UCB (www.ucb-group.com) is a global biopharmaceutical leader dedicated to the research, development and commercialization of innovative products in the fields of central nervous system disorders, allergy and respiratory diseases, immune and inflammatory disorders and oncology. UCB employs over 8,500 people operating in over 40 countries, and achieved revenues of 2.1 billion euros (including net turnover, royalties, and fees) in 2004. UCB is listed on the Euronext Brussels with a market capitalization of approximately 5.5 billion euros. Worldwide headquarters are located in Brussels, Belgium.
UCB Pharma, Inc. is the North American subsidiary of UCB, with U.S. headquarters located in Smyrna, Georgia. UCB's key products in the U.S. are Keppra(R) (levetiracetam), Zyrtec(R)+ (cetirizine HCl), Tussionex(R) CIII
(hydrocodone polistirex/chlorpheniramine polistirex), and Metadate CD(TM) CII (methylphenidate HCl, USP).
+ Zyrtec is licensed to and co-promoted with Pfizer, Inc. in the United States. (1) Crohn's and Colitis Foundation of America. Disease Information page: www.ccfa.org/info/about/crohns. Accessed October 3, 2005. (2) European Federation of Crohn's & Ulcerative Colitis Associations. Newsletter, pg. 30, May 2005 (www.efcca.org/efcca_nl22.pdf). (3) Crohn's and Colitis Foundation of America and the Digestive Disease National Coalition. Voices of Crohn's Survey: www.crohnsresource.com/voices/key_findings.html. Accessed September 22, 2005.
UCB Pharmaceuticals Inc.CONTACT: Lisa B. Garman, Head, U.S. Communications & Public Relations,Mobile, +1-404-291-4772, or Susan Thiele, Ketchum Public Relations,+1-646-935-4133, susan.thiele@ketchum.com; or Investor Relations -Jean-Christophe Donck, Vice President, Corporate Communication & InvestorRelations, +32-2-559-9588, Fax +32-2-559-9571, JC.Donck@UCB-Group.com