ArticlePharmacology research & perspectives2025
Population Pharmacokinetics-Pharmacodynamics and Exposure-Response of Ropeginterferon Alfa-2b in Chinese and Japanese Patients With Polycythemia Vera.
Article in Pharmacology research & perspectives, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 1 Bridging Study to Investigate and Compare the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Four Single Ascending Doses of Ropeginterferon Alfa-2b (P1101) in Healthy Japanese and Healthy Caucasian Subjects
Phase 2 Single Arm Study of Efficacy and Safety of P1101 for Polycythemia Vera (PV) Patients for Whom the Current Standard of Treatment is Difficult to Apply
A Phase II Single-Arm Multicenter Study to Access Efficacy and Safety of P1101 in Chinese Polycythemia Vera Patients Who Are Intolerant or Resistance to Hydroxyurea
Who cites it
6 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Exposure-Response Analyses of Ropeginterferon Alfa-2b in Essential Thrombocythemia.Journal of clinical pharmacology · 2026Pooled it
- Efficacy and safety of a three-step dose escalation regimen of ropeginterferon alfa-2b in Japanese patients with polycythemia vera: a phase 3b, single-arm, multicenter study.International journal of hematology · 2026Trial
- Beyond Oncogenes: Selectively Targeting Whole-Tumor Cell Growth Regulation.Drug design, development and therapy · 2026Review
- Real-World Retrospective Report on the Efficacy, Tolerability, and Molecular Responses to Ropeginterferon-α2b in Patients with Myeloproliferative Neoplasms.Journal of clinical medicine · 2025Article
- From Genetic Engineering to Preclinical Safety: A Study on Recombinant Human Interferons.International journal of molecular sciences · 2025Article
- Emerging Significance and Implications of a Durable Complete Molecular Remission in the Treatment of Polycythemia Vera.Current hematologic malignancy reports · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors.
Funding
Abstract
Ropeginterferon alfa-2b (ropeg) represents a new-generation interferon-based therapy approved for polycythaemia vera (PV) treatment. This study aimed to elucidate its population pharmacokinetics-pharmacodynamics (PopPK-PD) and exposure-response (E-R) relationships. A PopPK model was developed using pooled data from four clinical studies, including two Phase I studies in healthy volunteers (n = 48) and two Phase II studies in Chinese or Japanese patients with PV (n = 78). Sequential modeling was used to analyze pharmacokinetics-pharmacodynamics (PK-PD) regarding hematological parameters, including hematocrit, platelet, and white blood cell counts. Hematological changes were simulated using fast- and slow-dose titration regimens. Individual exposure values were used to analyze the E-R relationships regarding complete hematologic response (CHR), driver mutation, JAK2V617F allele burden, and safety. In this study, we developed a target-mediated drug disposition model. Sigmoid indirect effects elucidated the PK-PD in terms of hematological changes. Simulations showed that the fast-titration regimen significantly accelerated hematocrit reduction. Logistic regression models showed that the probability of achieving CHR increased with exposure at Week 24 but not at Week 52. In contrast, JAK2V617F allele reductions correlated with exposure at both Weeks 24 and 52. Exposure-safety analysis revealed a manageable risk of adverse events associated with transaminase increases. This study established a robust framework for ropeg PK-PD, providing insights into its E-R relationships and disease-modifying action. Trial Registration: A17-102, A19-201, and A20-202 are registered at ClinicalTrials.gov. The registration numbers are as follows: A17-102, NCT03546465; A19-201, NCT04182100; and A20-202, NCT05485948. A17-101 is registered at www.chinadrugtrials.org.cn. The registration number is CTR20190451.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.