New CIMZIA(R) Data Demonstrates Efficacy For Up To 18 Months In Patients With Crohn's Disease, With No Dose Escalation

Main Category: Crohn's
Also Included In: GastroIntestinal / Gastroenterology
Article Date: 30 Oct 2007 - 1:00 PDT

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CIMZIA(R) (certolizumab pegol), the first and only PEGylated anti-TNF therapy, has been shown to maintain remission for up to 18 months in patients with Crohn's disease, according to new data presented at the 15th United European Gastroenterology Week (UEGW). The data also showed that some patients who were re-introduced to CIMZIA after losing clinical response were re-captured with only one additional induction dose and maintained remission with no dose escalation.

The findings are from analyses of two ongoing open-label, long-term extension studies of the Phase III PRECiSE programme. Of the patients who were randomised to CIMZIA (n=215) after response to open-label induction with CIMZIA in PRECiSE 2, 42 percent were still in remission after 12 months (n=90), and 37 percent were in remission up to 18 months (n=80). Over one third of the patients who had lost clinical response in the active arm of the same Phase III study were successfully recaptured with CIMZIA, achieving and maintaining remission for up to 12 months thereafter (n=17). Data from both extension studies suggest that CIMZIA continues to demonstrate an acceptable safety profile. The percentages of patients in the PRECiSE programme experiencing injection-site reactions and injection-site pain were low (<2%, <1% respectively). The most common reported adverse events in the PRECiSE studies were headache, nasopharyngitis, cough and abdominal pain.1,2

"These results demonstrated the long-term effectiveness of certolizumab pegol in patients with active Crohn's disease when treated subcutaneously every four weeks," commented study investigator Professor Stefan Schreiber, Hospital for General Internal Medicine, University-Hospital Schleswig-Holstein, Christian Albrechts University, Kiel, Germany. "The results demonstrated that re-inducing previously-relapsed patients with a single dose of certolizumab pegol may be beneficial for some patients, with a high percentage of those patients regaining long-term remission for up to a year."

Quality of Life and Work Productivity

An additional new analysis of PRECiSE data presented at UEGW reinforced the benefits of CIMZIA on patient quality of life. Patients enrolled in the PRECiSE 2 study were asked to complete a health status questionnaire which included self-assessment of mobility, self-care, discomfort and anxiety/depression. Results were then converted into quality of life scores. During the maintenance phase of the study, the mean utility scores were consistently higher in the CIMZIA group: 9% (p=0.007); 4% (p=0.064); and 7% (p=0.002), compared with the placebo group at weeks 16, 26 and at the withdrawal visit, respectively.3

Another new analysis of the PRECiSE data highlighted the benefits of CIMZIA on work productivity and daily activity levels. Patients enrolled in the PRECiSE 1 study completed a Work Productivity and Activity Impairment (WPAI) questionnaire, and overall scores were assessed. Results showed a significant improvement in work productivity at week 6, 16 and 26 (all p<0.05) in patients taking CIMZIA compared with the placebo group. Additionally, there was a significant reduction in activity impairment at weeks 16 and 26 (both p<0.05) in patients taking CIMZIA compared with placebo. These data represent a gain of approximately half a fully productive workday a week in the CIMZIA group, from an average of 2.4 days lost or impaired every week at the start of the study. These results demonstrate the potential benefit of CIMZIA in decreasing the economic burden of Crohn's disease.4

About CIMZIA® (certolizumab pegol)

CIMZIA is the first and only PEGylated anti-TNF (Tumour 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.

CIMZIA was approved in Switzerland for the treatment of Crohn's disease in September 2007. 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 Authorisation Application (MAA) to the European Medicines Agency (EMEA) for the same indication. Preparation for a regulatory submission for CIMZIA in the treatment of rheumatoid arthritis in the U.S. is ongoing.

About the PRECiSE Clinical Trial Programme

PRECiSE, one of the largest, most comprehensive development programmes 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. 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 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). It is a severe and debilitating condition that affects approximately half a million people in Europe alone.5 People with Crohn's disease are likely to experience flare-ups in between intervals of remission or reduced symptoms and symptoms fluctuate unpredictably over time. Together with ulcerative colitis, Crohn's disease is an inflammatory bowel disease (IBD).6

About UCB

Headquartered in Brussels, Belgium, UCB (http://www.ucb-group.com) is a global leader in the biopharmaceutical industry dedicated to the research, development and commercialisation 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.

References

1. Sandborn WJ et al. Certolizumab pegol for the treatment of Crohn's disease. NEJM 2007;357:228-38.

2. Schreiber S et al. Maintenance therapy with certolizumab pegol for Crohn's disease. NEJM 2007;357:239-50.

3. Feagan B et al. Utility scores of patients with active Crohn's disease: changes following induction and maintenance regimen with certolizumab pegol 400 mg (PRECiSE 2). Presented at UEGW 2007.

4. Feagan B et al. Confirmed benefits on work productivity and daily activities of certolizumab pegol in Crohn's disease patients: data from PRECiSE 1. Presented at UEGW 2007.

5. European Federation of Crohn's & Ulcerative Colitis Associations Newsletter number 24, May 2006, page 19.

6. National Association for Colitis and Crohn's Disease (NACC) Disease Information page http://www.nacc.org.uk/content/ibd.asp accessed on 4 October 2007).

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