A multicentre randomised controlled trial to compare the pharmacokinetics, efficacy and safety of CT-P10 and innovator rituximab in patients with rheumatoid arthritis

Abstract

Objective To demonstrate pharmacokinetic equivalenceof CT-P10 and innovator rituximab (RTX) in patientswith rheumatoid arthritis (RA) with inadequate responsesor intolerances to antitumour necrosis factor agents.Methods In this randomised phase I trial, patients withactive RA were randomly assigned (2:1) to receive1000 mg CT-P10 or RTX at weeks 0 and 2 (alongsidecontinued methotrexate therapy). Primary endpoints werearea under the serum concentration–time curve fromtime zero to last quantifiable concentration (AUC0–last)and maximum serum concentration after second infusion(Cmax). Additional pharmacokinetic parameters, efficacy,pharmacodynamics, immunogenicity and safety were alsoassessed. Data are reported up to week 24.Results 103 patients were assigned to CT-P10 and 51to RTX. The 90% CIs for the ratio of geometric means(CT-P10/RTX) for both primary endpoints were within thebioequivalence range of 80%–125% (AUC0–last: 97.7%(90% CI 89.2% to 107.0%); Cmax: 97.6% (90% CI92.0% to 103.5%)). Pharmacodynamics and efficacywere comparable between groups. Antidrug antibodieswere detected in 17.6% of patients in each group atweek 24. CT-P10 and RTX displayed similar safetyprofiles.Conclusions CT-P10 and RTX demonstrated equivalentpharmacokinetics and comparable efficacy,pharmacodynamics, immunogenicity and safety.