Randomised, phase I pharmacokinetic study of adalimumab biosimilar CT‐P17 (40 mg/0.4 mL) by autoinjector and prefilled syringe in healthy subjects

Abstract

area under the concentration-time curve from time zero to infinity (AUC 0-inf ); area under the concentration-time curve from time zero to the last quantifiable concentration (AUC 0-last ); maximum serum concentration (C max ). Equivalence was determined if the 90% confidence interval for the geometric least-squares mean ratio was within the 80-125% equivalence margin. Additional pharmacokinetic endpoints, safety and immunogenicity were evaluated.Results: Of 193 subjects who were randomised (98 CT-P17 AI; 95 CT-P17 PFS), 180 received study drug. Pharmacokinetic equivalence was demonstrated: 90% confidence intervals were within the 80-125% equivalence margin (AUC 0-inf : 93.98-114.29; AUC 0-last : 91.09-121.86; C max : 94.08-111.90). Mean serum CT-P17 concentrations, secondary pharmacokinetic parameters and numbers of subjects with antidrug antibodies (ADAs) or neutralising ADAs were comparable between groups. AUC 0-inf , AUC 0-last and C max were numerically lower for ADA-positive than for ADAnegative subjects (both groups); pharmacokinetic equivalence was also demonstrated among ADA-positive subjects. CT-P17 AI and CT-P17 PFS were well tolerated, with comparable overall safety profiles.Conclusions: CT-P17 AI and CT-P17 PFS were pharmacokinetically equivalent.Overall safety and immunogenicity were comparable between the 2 delivery devices.

Efficacy and safety of switching from reference adalimumab to CT-P17 (100 mg/ml): 52-week randomized, double-blind study in rheumatoid arthritis

“…To date, two randomized phase I studies have evaluated the pharmacokinetics (PK) and safety of CT-P17 in healthy adults. These studies compared CT-P17 with reference adalimumab sourced from the European Union (EU) and USA [ 2 ], and evaluated CT-P17 administration by autoinjector or prefilled syringe [ 3 ].…”