Certolizumab pegol

Summary

Certolizumab pegol is a humanized, recombinant Fab' fragment with high affinity for TNFα which has been conjugated to polyethylene glycol (approx. 40kDa) as a means of prolonging elimination half-life. This antibody is reported to target both the soluble and membrane-bound forms of TNFα. Due to absence of the Fc portion of the antibody, studies in-vitro are reported to show no complement fixation, antibody-dependent cell-mediated toxicity, induction of neutrophil degranulation, and no apoptosis induction in human peripheral blood monocytes or lymphocytes.

Certolizumab pegol was approved for treatment of Crohn's disease in the USA in April 2008. Pre-licensing studies included  the 'PRECISE 1' and 'PRECISE 2' studies of certolizumab pegol for treatment of moderate to severe Crohn's disease. In the 'PRECISE 1' study, investigators reported a "...modest improvement in response but no improvement in remission rate, as compared with placebo..." The 'PRECISE 2 study', in which responders in the PRECISE 1 study went on to maintenance treatment with certolizumab pegol, subjects were reported to be "more likely to have a maintained response and a remission at 26 weeks with continued certolizumab pegol treatment than with a switch to placebo".

Brand Name

Cimzia

Other Names

None

Molecular Target

TNFα (soluble and membrane-bound)

Molecular Structure

humanized, recombinant Fab' fragment conjugated to polyethylene glycol

Licensed Indication, Major Target Diseases

Crohn's disease

Manufacturer/Distributor

UCB Pharma
Nektar

References