UCB Pharma Canada

UCB Pharma Canada

March 11, 2008 07:30 ET

UCB: Early Data From WELCOME Study Show Cimzia's™ Efficacy in Infliximab-Refractory Crohn's Patients

First Presentation of Six-Week Data from the WELCOME Study at ECCO

BURLINGTON, ONTARIO--(Marketwire - March 11, 2008) - Six-week data from the WELCOME trial presented at the third congress of the European Crohn's and Colitis Organisation (ECCO) show Cimzia (certolizumab pegol), the first and only PEGylated anti-TNFa agent, to be effective in Crohn's patients who are intolerant to, or are no longer responding to, infliximab.

This is the first presentation of the initial six-week induction results from WELCOME, a 539-patient, Phase IIIb multicentre study of the effects of Cimzia on Crohn's patients for whom infliximab treatment was not successful. During this six-week induction stage, all patients received 400mg of Cimzia sub-cutaneous at Weeks 0, 2 and 4. At Week 6, 61 per cent of the patients had achieved the primary endpoint of response, defined as a decrease in Crohn's Disease Activity Index (CDAI)(i) score greater than or equal to 100 points from baseline. In addition, 39 per cent of the patients were in remission, defined as a CDAI score less than or equal to 150 points(1).

"These induction results are extremely promising," commented Dr. Brian Feagan, Professor of Medicine, Epidemiology and Biostatistics, University of Western Ontario, Director, Robarts Clinical Trials, Robarts Research Institute and a WELCOME investigator. "The WELCOME data show that certolizumab pegol is a treatment option for patients with Crohn's disease who are refractory to other biological agents. Consistent results were shown across all patient groups."

In the WELCOME study, Cimzia has demonstrated a low incidence of injection site pain(i) (less than 2 per cent). The most commonly occurring AEs were headache, nasopharyngitis, nausea, vomiting, pyrexia and arthralgia. The incidence of serious adverse events (SAEs) was 7 per cent and the most frequent SAEs involved gastrointestinal disorders (5 per cent) and infections and infestations (2 per cent)(2).

Cimzia is approved and available in Switzerland for the treatment of Crohn's disease.

About Cimzia™ (certolizumab pegol)

Cimzia has been studied in clinical settings for more than 10 years, beginning with rheumatoid arthritis trials in 1998, and a rigorous clinical trial program in Crohn's disease. Cimzia has been studied in more than 2000 Crohn's patients totalling over 2200 patient-years of experience.

Cimzia is the first and only PEGylated anti-TNFa agent (Tumor Necrosis Factor). Cimzia has a high affinity for human TNFa, selectively neutralising the pathophysiological effects of TNFa. Over the past decade, TNFa has emerged as a major target of basic research and clinical investigation. This cytokine plays a key role in mediating pathological inflammation, and excess TNFa production has been directly implicated in a wide variety of diseases.

CIMZIA is currently not approved for any indication in Canada.

About the WELCOME Trial

The WELCOME (26-Week open-label trial Evaluating the clinical benefit and tolerability of certoLizumab pegol induCtiOn and Maintenance in patients suffering from CD with prior loss of response or intolErance to infliximab) study consisted of an initial open-label induction period of six weeks when patients received 400mg of Cimzia at Weeks 0, 2 and 4. After the induction period, 61 per cent of patients had reached the primary endpoint of response (defined as decrease in CDAI score greater than or equal to 100 points from baseline). Responders at Week 6 were then randomized to either Cimzia 400mg maintenance every two or every four weeks(1).

Participants receiving a concomitant medication were: immunosuppressant (46 per cent); corticosteroids (38 per cent) or immunosuppressant and corticosteroids (18 per cent). Cimzia was consistently effective across all patient groups. The most common AEs were headache, nasopharyngitis, nausea, vomiting, pyrexia and arthralgia. The incidence of serious adverse events (SAEs) was 7 per cent and the most frequent SAEs involved gastrointestinal disorders (5 per cent) and infections and infestations (2 per cent)(2).

About Crohn's disease

Crohn's disease is a chronic and debilitating inflammatory disease of the gastrointestinal tract, affecting more than 170,000 people in Canada. The onset of Crohn's disease often occurs between the ages of 18-25. As Crohn's disease is a chronic ailment, people go through unpredictable periods in which the disease flares and causes symptoms. These episodes are followed by times of remission -- periods in which symptoms disappear or decrease and good health returns. Canada has one of the highest incidence and prevalence of Crohn's disease in the world.

About UCB

UCB, Brussels, Belgium (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 over 12,000 people in more than 40 countries, UCB achieved revenue of EURO 3.5 billion in 2006 on a pro forma basis. UCB S.A. is listed on Euronext Brussels. SCHWARZ PHARMA AG (Monheim, Germany) is a member of the UCB Group.

About UCB Pharma Canada

UCB Pharma Canada was officially incorporated in 2006 with the objective of bringing a new-generation, convenient therapy to the Canadian market for auto-immune, inflammatory diseases. As a patient-focused organization, UCB Pharma Canada's is dedicated to bringing new and innovative programs to patients, and to the specialists who treat them, to help improve the lives of people living with severe diseases.

(i) MedDRA Preferred term

For more information or to schedule an interview with a gastroenterologist, please contact: Chrome Communications, 905-567-1406.

(1) Vermeire S et al. Assessment of Certolizumab Pegol in the Treatment of Crohn's Disease in Patients for Whom Infliximab Treatment was not Successful: Open-label Induction Results from the WELCOME Study. Oral presentation at the Congress of European Crohn's and Colitis Organisation, Lyon, France, February 2008.

(2) Data on file

Contact Information

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    Alon Barmapov
    (647) 405-1352 ext. 223
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    Chrome Communications
    Tiana DiMichele
    (416) 666-5331 ext. 225