UCB’s Cimzia (certolizumab pegol) is an effective treatment for patients with moderate to severe Crohn’s disease, according to Phase III data presented at this week’s United European Gastroenterology Week meeting in Copenhagen.
The anti-tumour necrosis factor-alpha (TNF) antibody, formerly known as CDP-870, was acquired by UCB as part of its £1.5 billion purchase of Celltech last year [[18/05/04a]], and is due to be submitted for approval in Crohn’s in the first quarter of 2006. It is also in Phase III testing as a treatment for rheumatoid arthritis.
The Belgian company is hoping to position Cimzia as an alternative to Johnson & Johnson’s Remicade (infliximab), which remains the only anti-TNF approved to treat Crohn’s. While Cimzia can be given by subcutaneous injection, Remicade requires an intravenous infusion, and UCB hopes that the availability of a second treatment option will expand the take-up of biologic therapy for the disease. At present just 15% of Crohn’s sufferers in the USA – and 8% in Europe – receive anti-TNF treatment.
The results of the new, 668-patient study, called PRECiSE2, showed that 63% of patients given Cimzia maintained an overall clinical response – defined as a 100-point or more improvement in the Crohn’s Disease Activity Index scoring system which measures the severity of symptoms - after 26 weeks’ treatment. A similar improvement was seen in 36% of patients on placebo. Meanwhile 48% of the Cimzia group was in clinical remission at the end of the trial, compared to 29% of the placebo patients. Both these differences were statistically significant.
Cimzia was also well tolerated, although there was one case of tuberculosis among patients receiving the drug, which is a recognised risk associated with anti-TNF therapy. The rate of neutralising antibodies to the drug was also low, according to the investigators, at 8%.
"We now have a potential treatment for Crohn's disease which has shown the efficacy expected of an anti-TNF but was well tolerated and offered the advantage of subcutaneous administration," explained Prof Stefan Schreiber of the Christian-Albrechts University in Germany, who acted as the principal investigator in the study.
The PRECiSE2 results join those of PRECiSE1 [[22/09/04e]] and will form the backbone of UCB’s regulatory submissions in Europe and the USA. The company also has two ongoing open-label trials – PRECiSE 3 and 4 – that will provide data on the drug out to 24 months’ use.