UCB (BRUSSELS, Belgium), a global leader in the biopharmaceutical industry dedicated to the research, development, and commercialization of pharmaceutical and biotechnology products in immune and inflammatory disorders, central nervous system disorders, allergy and respiratory diseases, and oncology, announced that initial 6-week data from the WELCOME trial show that Cimzia^® (certolizumab pegol) is effective in Crohn's patients who are intolerant or who no longer respond to infliximab (INF). WELCOME is short 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 INF.

The data are from a 539-patient, phase IIIb, open-label, multicenter study of the effects of Cimzia, the first and only PEGylated antiTNF-α therapy, in Crohn's patients. All patients received 400 mg of the drug subcutaneous at weeks 0, 2, and 4. At week 6, a total of 61% of the patients had achieved the primary endpoint of response, defined as a decrease in Crohn's Disease Activity Index (CDAI) score ≥100 points from baseline. In addition, 39% of the patients were in remission, defined as a CDAI score ≤150 points. Responders at week 6 were then randomized to Cimzia 400 mg either every 2 or every 4 weeks.

Participants received concomitant medication including immunosuppressant (46%), corticosteroids (38%), or both immunosuppressant and corticosteroids (18%). Cimzia was consistently effective across all patient groups and demonstrated a low incidence of injection site pain. The most common adverse events (AEs) were headache, nasopharyngitis, nausea, vomiting, pyrexia, and arthralgia. The incidence of serious AEs was 7% and included gastrointestinal disorders, infections, and infestations.

In September 2007, the drug was approved in Switzerland for the treatment of Crohn's disease and it was launched in January 2008. In the European Union, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion on the market authorization application for the drug in Crohn's patients. UCB utilized the appeal process to request a CHMP re-examination of the submission. A decision is expected during the first half of 2008. Cimzia has been studied in >2000 Crohn's patients, totaling >2200 patient-years of experience.