BACKGROUND: To demonstrate pharmacokinetic (PK) similarity of PF-06438179/GP1111, a potential biosimilar to Remicade®, to Remicade® sourced from European Union (infliximab-EU) and United States (infliximab-US), and of infliximab-EU to infliximab-US. METHODS: In this phase I, parallel-group, three-arm trial, healthy adult subjects were randomized to receive a single 10-mg/kg intravenous infusion of PF-06438179/GP1111, infliximab-EU, or infliximab-US. PK, and safety and immunogenicity evaluations were performed over 8 and 12 weeks, respectively. PK similarity was established if the 90% confidence intervals (CIs) of the test-to-reference ratios for PK parameters, Cmax, AUCT, and AUCinf, were within the 80.00-125.00% pre-specified equivalence window. RESULTS: Of 151 subjects randomized, 146 received study treatment; 130 were eligible for PK similarity assessment. Serum concentration-time profiles were similar across the three treatments. The 90% CIs for test-to-reference ratios for Cmax, AUCT, and AUCinf were within 80.00-125.00% for comparison of PF-06438179/GP1111 to infliximab-EU and infliximab-US, and of infliximab-EU to infliximab-US. Similar numbers of subjects across treatment groups experienced adverse events. Anti-drug and neutralizing antibody profiles were largely similar among groups. CONCLUSIONS: This study demonstrated PK similarity of PF-06438179/GP1111 to infliximab-EU and infliximab-US, and of infliximab-EU to infliximab-US. All three products displayed comparable safety and immunogenicity profiles. TRIAL REGISTRATION: CT.gov identifier NCT01844804.
RCT Entities:
BACKGROUND: To demonstrate pharmacokinetic (PK) similarity of PF-06438179/GP1111, a potential biosimilar to Remicade®, to Remicade® sourced from European Union (infliximab-EU) and United States (infliximab-US), and of infliximab-EU to infliximab-US. METHODS: In this phase I, parallel-group, three-arm trial, healthy adult subjects were randomized to receive a single 10-mg/kg intravenous infusion of PF-06438179/GP1111, infliximab-EU, or infliximab-US. PK, and safety and immunogenicity evaluations were performed over 8 and 12 weeks, respectively. PK similarity was established if the 90% confidence intervals (CIs) of the test-to-reference ratios for PK parameters, Cmax, AUCT, and AUCinf, were within the 80.00-125.00% pre-specified equivalence window. RESULTS: Of 151 subjects randomized, 146 received study treatment; 130 were eligible for PK similarity assessment. Serum concentration-time profiles were similar across the three treatments. The 90% CIs for test-to-reference ratios for Cmax, AUCT, and AUCinf were within 80.00-125.00% for comparison of PF-06438179/GP1111 to infliximab-EU and infliximab-US, and of infliximab-EU to infliximab-US. Similar numbers of subjects across treatment groups experienced adverse events. Anti-drug and neutralizing antibody profiles were largely similar among groups. CONCLUSIONS: This study demonstrated PK similarity of PF-06438179/GP1111 to infliximab-EU and infliximab-US, and of infliximab-EU to infliximab-US. All three products displayed comparable safety and immunogenicity profiles. TRIAL REGISTRATION: CT.gov identifier NCT01844804.
Authors: Stanley B Cohen; Rieke Alten; Hideto Kameda; Tomas Hala; Sebastiao C Radominski; Muhammad I Rehman; Ramesh Palaparthy; Karl Schumacher; Susanne Schmitt; Steven Y Hua; Claudia Ianos; K Lea Sewell Journal: Arthritis Res Ther Date: 2018-07-27 Impact factor: 5.156
Authors: Hideto Kameda; Eishi Uechi; Tatsuya Atsumi; Carlos Abud-Mendoza; Kazumasa Kamei; Tsugumi Matsumoto; Dario Ponce de Leon; Muhammad I Rehman; Min Zhang; Sebastiao C Radominski Journal: Int J Rheum Dis Date: 2020-05-31 Impact factor: 2.454
Authors: Rieke Alten; Bogdan Batko; Tomas Hala; Hideto Kameda; Sebastiao C Radominski; Vira Tseluyko; Goran Babic; Carol Cronenberger; Sarah Hackley; Muhammad Rehman; Oliver von Richter; Min Zhang; Stanley Cohen Journal: RMD Open Date: 2019-03-28
Authors: Stanley B Cohen; Sebastiao C Radominski; Hideto Kameda; Alan J Kivitz; Michael Tee; Carol Cronenberger; Min Zhang; Sarah Hackley; Muhammad I Rehman; Oliver von Richter; Rieke Alten Journal: BioDrugs Date: 2020-04 Impact factor: 5.807