Qin Albert, Wu Daoxiang, Liao Jason, Xie Shuping, Chen Haoqi, Gao Yucheng, Cui Jie, Su Xia, Miyachi Narihisa, Sato Toshiaki, Li Yaning, Zhang Jingjing, Shen Weihong, Wang Wei
PharmaEssentia Corporation, Taipei, Taiwan.
PharmaEssentia Biotech (Beijing) Limited, Beijing, China.
Front Pharmacol. 2024 Sep 24;15:1455979. doi: 10.3389/fphar.2024.1455979. eCollection 2024.
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. 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.
聚乙二醇干扰素α-2b（Ropeg）已被批准用于治疗成人真性红细胞增多症（PV）。本报告旨在分析Ropeg治疗PV的种族敏感性，比较不同种族群体的药代动力学（PK）、疗效和安全性。我们对PV进行了相关综述，并分析了从涉及Ropeg的临床研究中获得的数据。Ropeg的PK行为在中国人群和海外人群之间没有显著差异。不同种族群体的疗效和安全性相似。分析表明，无论种族差异如何，Ropeg的剂量-暴露-反应曲线都是一致的。结果表明，Ropeg在不同种族群体中表现出一致的PK和药效学特征以及相似的治疗效果，证实了其在全球治疗PV中的疗效和安全性。更广泛地说，这些发现支持Ropeg在不同患者群体中的更广泛应用，并强调了包容性临床实践的必要性。
