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ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Pharmacology of Anti-Cancer Drugs
Volume 15 - 2024 |
doi: 10.3389/fphar.2024.1455979
Ethnic Sensitivity Analyses of Pharmacokinetics, Efficacy and Safety in Polycythemia Vera Treatment with Ropeginterferon alfa-2b
Provisionally accepted- 1 PharmaEssentia, Burlington, United States
- 2 Medical Research & Clinical Operations, PharmaEssentia Corporation, Taipei, Taiwan
- 3 PharmaEssentia Biotech (Beijing) Limited, Beijing, China
- 4 PharmaEssentia Corporation, Taipei, Taiwan
- 5 Independent researcher, Chengdu, China
- 6 Pharma Essentia, Tokyo, Japan
Ropeginterferon alfa-2b (Ropeg) is approved for the treatment of adults with polycythemia vera (PV). This report aims to analyze the ethnic sensitivity of Ropeg for the treatment of PV, comparing the pharmacokinetics (PK), efficacy, and safety profiles across diverse ethnic groups. We conducted a relevant review of PV and analysis of data obtained from clinical studies involving Ropeg. The PK behavior of ropeg showed no significant differences between Chinese and overseas populations. Their efficacy and safety profiles were similar across the ethnic groups studied. The analyses indicated that the dose-exposure-response profile of Ropeg was consistent irrespective of ethnic variations. The results suggest that Ropeg exhibits a consistent PK and pharmacodynamics profile and a similar therapeutic effect across different ethnic groups, confirming its efficacy and safety in the global treatment of PV. More generally, these findings support the broader application of Ropeg in diverse patient populations and emphasize the need for an inclusive clinical practice.
Keywords: rRopeginterferon alfa-2b,, ethnic sensitivity analyses,, polycythemia vera,, Pharmacokinetics,, Safety,
Received: 27 Jun 2024; Accepted: 27 Aug 2024.
Copyright: © 2024 Qin, Wu, Liao, Xie, Chen, Gao, Cui, Su, Miyachi, Sato, Li, Zhang, Shen and Wang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Albert Qin, PharmaEssentia, Burlington, United States
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