UCB said its six-week 539-patient phase IIIb trial data on Cimzia (certolizumab pegol), a PEGylated anti-TNF-alpha product, found effective in Crohn's patients who are intolerant, or are no longer responding to infliximab.
The phase IIIb multicentre study focussed on 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) score >=100 points from baseline. In addition, 39 per cent of the patients were in remission, defined as a CDAI score <=150 points.
"These induction results are very promising," said 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 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).
In September 2007, Cimzia was approved in Switzerland for the treatment of Crohn's disease and it was launched in January 2008.
Cimzia was approved for the treatment of Crohn's Disease in Switzerland in September 2007. In the European Union, the Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion on the market authorisation 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.
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-TNF-alpha (Tumour Necrosis Factor alpha). Cimzia has a high affinity for human TNF-alpha, selectively neutralising 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, the company informed.
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 percent of patients had reached the primary endpoint of response (defined as decrease in CDAI score >=100 points from baseline). Responders at Week 6 were then randomised to either Cimzia 400mg maintenance every two or every four weeks.