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-TNF-alpha, to be effective in Crohn’s patients who are intolerant, 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 subcutaneous at Weeks 0, 2 and 4. At Week 6, 61 percent 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 percent of the patients were in remission, defined as a CDAI score <=150 points.
“These induction results are very promising,” commented study investigator Professor Severine Vermeire of Katholieke Universiteit Leuven, Belgium. “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.”
In the WELCOME study, Cimzia has demonstrated a low incidence of injection site pain (less than 2%). The most commonly occurring AEs were headache, nasopharyngitis, nausea, vomiting, pyrexia and arthralgia. The incidence of serious adverse events (SAEs) was 7% and the most frequent SAEs involved gastrointestinal disorders (5%) and infections and infestations (2%).
In September 2007, Cimzia, manufactured by Belgium-based biopharma firm UCB, was approved in Switzerland for the treatment of Crohn’s disease and it was launched in January 2008.