A randomized study comparing the pharmacokinetics of the potential biosimilar PF-06438179/GP1111 with Remicade® (infliximab) in healthy subjects (REFLECTIONS B537-01)
| Autor: | Ramesh Palaparthy, D. Yin, Muhammad I. Rehman, Joseph E. McClellan, Steven Y. Hua, Chandrasekhar Udata, Chun-Hua Cai, S. Salts, Xu Meng |
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| Rok vydání: | 2018 |
| Předmět: |
0301 basic medicine
Adult Male musculoskeletal diseases Adolescent Immunology Pharmacology law.invention 03 medical and health sciences 0302 clinical medicine Pharmacokinetics Similarity (network science) Randomized controlled trial law medicine Immunology and Allergy media_common.cataloged_instance Humans European union skin and connective tissue diseases Biosimilar Pharmaceuticals media_common 030203 arthritis & rheumatology business.industry Healthy subjects Biosimilar Middle Aged Infliximab stomatognathic diseases 030104 developmental biology Female business medicine.drug |
| DOI: | 10.6084/m9.figshare.5972515 |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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