Cimzia: animal efficacy model or human cells?

“Certolizumab pegol was studied in two in vivo models where normal mice or rabbits were challenged with hTNFα. In these models, certolizumab pegol inhibited hTNFα induced effects. Effective doses ranged from 3-3000 µg/kg. certolizumab pegol also protected against development of arthritis in one transgenic mouse, serving as a disease model for polyarthritis, at 10 and 30 mg/kg”

“Certolizumab pegol cross-reacts poorly with TNF from rodents and rabbits, therefore in vivo efficacy was evaluated using animal models in which human TNFα was the physiologically active molecule.”

“These facts may question the relevance of this model to fully identify effects related to inhibition of TNFα. Nevertheless, it is acknowledged that plasma levels in monkeys were above the IC90 for monkey TNFα and the plasma concentrations obtained resulted in saturation of membrane TNFα binding as well as binding of soluble TNFα.”