Data from the WELCOME trial presented at the third congress of the European Crohn’s and Colitis Organisation (ECCO) show that, at the six week mark, Cimzia® (certolizumab pegol) is effective in Crohn’s patients showing intolerance or no response to infliximab.

Crohn’s Disease (CD) is a gastrointestinal disorder which is indicated by chronic inflammation of the wall of the digestive tract, usually in the ileum or large intestines. It usually affects young people, between the ages of 15 and 35, and approximately half a million people have the disease in Europe alone. The disease involves constant cycles of flare-ups and remission throughout the life of the patient, and without proper treatment, must be addressed surgically. It is considered an inflammatory bowel disease (IBD), similar to ulcerative colitis.

Cimzia® is the first and only PEGylated anti-TNF-alpha (anti-tumor necrosis factor-alpha). The drug itself shows affinity for the human tumor necrosis factor-alpha (TNF-alpha), a cytokine that helps trigger many physiological responses including the immune reaction. This attraction allows the drug to neutralize TNF-alpha’s potential pathophysiological effects.

Excess TNF-alpha production has been associated with a wide variety of diseases, and in recent research, TNF-alpha has become a central target for basic research and clinical investigation regarding pathological inflammation. In particular, Cimzia® has been studied for more than a decade in several clinical settings, including treatments for rheumatoid arthritis and Crohn’s disease.

This is the first presentation from WELCOME, a Phase IIIb multicenter study of 539 Crohn’s patients in which infliximab treatment was not successful. (WELCOME stands for 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.) In the study, the effects of Cimzia® were studied during a six-week induction period in which all patients received 400mg of Cimzia® subcutaneously at zero, two, and four weeks. At week six, subjects were randomized to continued administration of Cimzia® every two or four weeks. Concomitant medications included: immunosuppressants (46%); corticosteroids (38%) or both (18%).

Patients were analyzed according to the Crohn’s Disease Activity Index (CDAI) score. which measures the severity of Crohn’s by integrating factors including intensity of symptoms, medication levels, and general well-being. A higher score indicates a more active case of Crohn’s while a lower score indicates a milder presentation. By week six, 61% of the patients had achieved the primary endpoint response, with a decrease in score of 100 points or more from baseline. Additionally, 39% of patients showed disease remission, defined as a total CDAI score less than 150 points. 

Investigator Professor Severine Vermeire of Katholieke Universiteit Leuven, Belgium commented on the data. “These induction results are very promising,” she said. “The WELCOME data show that certolizumab pegol could be a treatment option for patients with Crohn’s disease who are refractory to other biological agents, showing consistent results across all patient groups.”

The drug Cimzia® has demonstrated a low incidence of injection site pain in the WELCOME study, in less than 2% of cases. Common adverse events (AEs) included: headache; nasopharyngitis, or the common cold; nausea; vomiting; pyrexia, or fever; and arthralgia, or joint pain. Serious adverse events (SAEs) were present in 7% of cases, and were most commonly gastrointestinal (5%) or infections and infestations (2%).

Cimzia® was approved in Switzerland for the treatment of Crohn’s Disease in September 2007. In the European Union, the Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion on the market authorization application (MAA) for Cimzia® in the treatment of patients with Crohn’s disease. UCB utilised the appeal process to request a CHMP re-examination of the submission. A decision is expected during the first half of 2008.
 
About UCB:
UCB, Brussels, Belgium (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 around 12,000 people in over 40 countries, UCB achieved revenue of 3.6 billion euro in 2007. UCB S.A. is listed on the Euronext Brussels Exchange and, through its affiliate, owns approx. 89% of the shares of SCHWARZ PHARMA AG. SCHWARZ PHARMA AG (Monheim, Germany) is a member of the UCB Group.

Source: UCB /BXS: UCB /ISIN: BE0003739530

Written by Anna Sophia McKenney