Healthcare Industry News: Inflammatory Bowel Disease
News Release - October 23, 2006
New Data Show CIMZIA(TM) (certolizumab pegol) May Improve Productivity in Work and with Daily Activities for People with Crohn's DiseaseData also show improved quality of life and lower levels of disease severity with CIMZIA(TM) (certolizumab pegol)
ATLANTA, Oct. 23 (HSMN NewsFeed) -- UCB announced today that additional data from the PRECiSE 2 clinical trial program demonstrate that CIMZIA(TM) (certolizumab pegol), administered subcutaneously every four weeks with an additional induction dose at week 2, produces sustained significant improvements in work productivity and daily work activities in patients with moderate to severe Crohn's disease. Data to be presented at the 2006 American College of Gastroenterology (ACG) Annual Scientific Meeting in Las Vegas, Nevada, showed that patients receiving CIMZIA(TM) (certolizumab pegol) missed nearly 10% less work and had 15% less work impairment than people taking placebo.
Brian Feagan, M.D., Professor of Medicine and Epidemiology and Biostatistics at the University of Western Ontario, a PRECiSE 2 investigator and co-author on the study, commented on how these results may help to improve work-related and other daily activities for people with Crohn's disease. "Carrying on a normal life at home and at work is a big challenge for people with Crohn's disease. These promising results suggest that treatment with CIMZIA may allow Crohn's patients with moderate to severe symptoms to be more productive at work and carry out their daily work activities more easily. These are important results suggesting CIMZIA may help alleviate absenteeism and contribute to an increase in productivity."
"The comprehensive analyses from PRECiSE 2 continue to provide insights on the positive impact CIMZIA may have on patients' disease activity and overall quality of life. We continue to work toward bringing CIMZIA to market as soon as possible to satisfy unmet needs and help advance treatment of Crohn's disease for patients," said David Robinson, Vice President and General Manager, UCB.
About the Study
In the PRECiSE 2 study, patients responding at Week 6 to open-label induction therapy with CIMZIA(TM) (certolizumab pegol) were randomized to either placebo (n=210) or CIMZIA(TM) (certolizumab pegol) (n=215) and followed for a total of 26 weeks. In this trial, 62.8% of CIMZIA(TM) (certolizumab pegol) patients, compared to 36.2% of placebo patients, maintained clinical response at Week 26 (p<0.001). Clinical response was defined as a greater than or equal to 100 point decrease in CDAI. Similarly, 47.9% of CIMZIA(TM) (certolizumab pegol) patients were in clinical remission at week 26 compared to 28.6% on placebo (p<0.001). Remission was defined as CDAI less than or equal to 150 points.
The new analysis presented at ACG evaluated the impact of treatment on work-related outcomes assessed via the Work Productivity and Activity Impairment(i) (WPAI) questionnaire administered pre-study and at Week 26. In all four dimensions of the WPAI, CIMZIA(TM) (certolizumab pegol) produced significant improvements compared to placebo. Specifically, in addition to 9.9% less work missed and 15.4% less impairment while working (p= 0.03 and p< 0.001, respectively vs. placebo), CIMZIA(TM) (certolizumab pegol) was associated with 14.3% less overall work impairment (p= 0.004) and 9.1% less activity impairment (p= 0.004).
Additional PRECiSE 2 Data Presented at ACG Support These Results
Additional analyses from PRECiSE 2 presented at the 2006 ACG meeting provide insights into the observed improvements in work productivity and daily activities associated with CIMZIA(TM) (certolizumab pegol) treatment. -- Measurements of health-related quality of life, as assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ)(ii) showed that CIMZIA(TM) (certolizumab pegol) produced rapid, overall improvements during treatment induction, and sustained those improvements during the maintenance phase through Week 26 compared to placebo. Furthermore, the proportion of patients considered responders (based on an IBDQ score increase of at least 16 points), was significantly greater with CIMZIA(TM) (certolizumab pegol) compared to placebo (p< 0.001).
-- Overall health status, as reported by patients using the Short-Form Health Survey 36-Item (SF-36)(iii) and the EuroQoL-5 Dimensions (EQ- 5D)(iv) questionnaires, improved during induction to levels approximating scores found in the general population. These improvements were sustained to a significantly greater extent with CIMZIA(TM) (certolizumab pegol) compared to placebo during the maintenance phase. Specifically, the overall mental and physical component summaries of the SF-36 were significantly higher compared to placebo at Week 26 (p= 0.001, and p= 0.014 respectively). The Visual Analog Score (VAS) of the EQ-5D was also maintained at a significantly higher level with CIMZIA(TM) (certolizumab pegol) than with placebo (p= 0.002).
-- Finally, significant correlations (p< 0.0001) were reported between the improved WPAI scores and CDAI scores demonstrating less disease severity, decreased abdominal pain, and general well being. Strong correlations (p< 0.0001) also existed between WPAI scores and improved quality of life as reflected by the IBDQ.
UCB filed a BLA with the Food and Drug Administration (FDA) for CIMZIA(TM) (certolizumab pegol) in the treatment of Crohn's disease on February 28th, 2006 and on April 28, 2006 submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for the same indication. CIMZIA(TM) (certolizumab pegol) is the first and only PEGylated Fab' fragment of a humanized anti-TNF-alpha antibody (TNF-alpha; Tumour Necrosis Factor), evaluated as once-monthly dosing administered subcutaneously. The engineered Fab' fragment retains the biologic potency of the original antibody without the cytotoxicity mediated by the Fc portion present in the original monoclonal antibodies. CIMZIA(TM) (certolizumab pegol) 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.
About Crohn's Disease
Crohn's disease is a chronic and debilitating inflammatory disease of the gastrointestinal tract, most commonly affecting the end of the small intestine (the ileum) and beginning of the large intestine (the colon). Together with ulcerative colitis, Crohn's disease belongs to the group of illnesses known as Inflammatory Bowel Disease. Crohn's disease affects nearly one million people worldwide including an estimated 500,000 people in the United States. People with Crohn's disease may suffer an ongoing cycle of "flare-up" and remission. Symptoms of the disease include persistent diarrhea, abdominal pain, and loss of appetite/weight, fever or rectal bleeding. In an effort to provide Crohn's disease patients with disease management information and resources designed expressly with their needs in mind, UCB has launched CrohnsandMe.com, a dynamic, cutting-edge web site focused on helping patients thoroughly understand Crohn's disease and live with it every day.
UCB (www.ucb-group.com) is a leading global biopharmaceutical company 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 8,300 people in 40 countries, UCB achieved revenues of euro 2.3 billion in 2005. With worldwide headquarters located in Brussels, Belgium, UCB is listed on the Euronext Brussels Exchange.
This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the safety, efficacy and potential benefits of certolizumab pegol, the development and commercialization of certolizumab pegol. Among the factors that could cause actual results to differ materially from those indicated by such forward- looking statements are: the results of research, development and clinical trials; the timing and success of submission, acceptance, and approval of regulatory filings; the time and resources UCB devotes to the development and commercialization of certolizumab pegol and the scope of UCB's patents and the patents of others. In addition, the statements in this press release represent UCB's expectations and beliefs as of the date of this press release. UCB anticipates that subsequent events and developments may cause these expectations and beliefs to change. However, while UCB may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing UCB's expectations or beliefs as of any date subsequent to the date of this press release.
(i)The Work Productivity and Activity Impairment (WPAI) was developed to assess validity and accuracy of the Work Productivity and Activity Impairment questionnaire in irritable bowel syndrome as a tool for quantifying the effects of irritable bowel syndrome on productivity and daily activities. Discriminative validity of the Work Productivity and Activity Impairment questionnaire in irritable bowel syndrome was established, making it the only validated tool for measuring the relative differences between disease severity groups and quantifying work productivity loss and activity impairment in irritable bowel syndrome patients.
(ii) Inflammatory Bowel Disease Questionnaire (IBDQ) assesses quality of life of patients with Inflammatory Bowel Diseases.
(iii) A 36-item short-form (SF-36) was constructed to survey health status in the Medical Outcomes Study. The SF-36 was designed for use in clinical practice and research, health policy evaluations, and general population surveys. The SF-36 includes one multi-item scale that assesses eight health concepts
(iv) EuroQoL 5 Dimensions (EQ-5D) questionnaire is a generic utility measure used to characterize current health states. Consists of 5- domains and a visual analog scale.
(v) http://www.ccfa.org/info/about/crohns & http://www.ccfa.org/info/about/?LMI=3.0
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