Publications by authors named "Masayuki Takanuma"
Objective: To compare the pharmacokinetics (PK), safety, tolerability, and immunogenicity of single intravenous doses of FKB238, a proposed biosimilar of bevacizumab, with European Union (EU)-approved and United States (US)-licensed bevacizumab in healthy participants.
Materials And Methods: In a randomized, double-blind, parallel-group study, 99 healthy men received 5 mg of FKB238, EU-bevacizumab, or US-bevacizumab in a 1 : 1 : 1 ratio by intravenous infusion. PK, immunogenicity, adverse events, local tolerability, vital signs, electrocardiogram, and safety tests of blood and urine were assessed before and up to 99 days after treatment.
Article Synopsis
- FKB327 is a biosimilar to the adalimumab reference product (RP), and a study was conducted to compare its pharmacokinetics, safety, and immunogenicity in Japanese males after a single subcutaneous injection.
- Two randomized studies with 130 participants each were performed, assessing serum concentration-time profiles and primary pharmacokinetic parameters, finding them comparable between FKB327 and the RP.
- While most results showed biosimilarity, one study had slight AUC discrepancies; overall, the safety profiles and anti-drug antibody occurrences were similar between the two treatments.
Background: In the Phase III CALIMA trial, benralizumab significantly reduced asthma exacerbations, increased lung function, and alleviated symptoms for patients with severe, uncontrolled eosinophilic asthma. The aim of this subgroup analysis was to evaluate the efficacy and safety of benralizumab for Japanese patients in the CALIMA trial.
Methods: CALIMA was a randomised, controlled trial of 1306 patients (aged 12-75 years; registered at ClinicalTrials.