{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T18:33:52Z","timestamp":1790706832666,"version":"4.1.0"},"reference-count":40,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2024,3,19]],"date-time":"2024-03-19T00:00:00Z","timestamp":1710806400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2024,6]]},"abstract":"<jats:sec><jats:title>Aims<\/jats:title><jats:p>To investigate the exposure\u2013response (E\u2010R) relationship, including exposure\u2013efficacy and exposure\u2013safety, of ropeginterferon alfa\u20102b treatment in patients with polycythaemia vera (PV).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Based on the results of the phase II trial A20\u2010202 regarding ropeginterferon alfa\u20102b in patients with PV, E\u2010R analyses were performed to evaluate the efficacy and safety of the given dosing regimen. The E\u2010R analyses were based on logistic and linear regression and the relationship between exposure to ropeginterferon alfa\u20102b and key efficacy and safety variables. The key efficacy variables included complete haematologic response (CHR) and reduction of the driver mutation <jats:italic>JAK2<\/jats:italic>V617F. The safety variable was treatment\u2010related adverse events (TRAEs).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A clear relationship between the exposure to ropeginterferon alfa\u20102b and CHR was observed, with an increase in drug exposure resulting in an increased probability of achieving CHR. Similar CHR probabilities were observed in the third and fourth quantiles of the average concentration at Week 24. The results from the exposure\u2013<jats:italic>JAK2<\/jats:italic>V617F model indicated that the <jats:italic>JAK2<\/jats:italic>V617F allele burden decreased with increasing exposure to ropeginterferon alfa\u20102b and baseline body surface area. Exposure\u2013safety analysis revealed a risk of AEs associated with transaminase abnormalities, which were not associated with clinical significance.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Our analyses have shown that patients with PV treated with ropeginterferon alfa\u20102b had an increased probability of achieving CHR and a molecular response with acceptable safety risks at the 250\u2013350\u2013500\u2009\u03bcg titration dosing regimen. This study has provided the relevant data for the application of a biologics licence of ropeginterferon alfa\u20102b for PV treatment in China.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.16043","type":"journal-article","created":{"date-parts":[[2024,3,19]],"date-time":"2024-03-19T07:53:27Z","timestamp":1710834807000},"page":"1493-1502","source":"Crossref","is-referenced-by-count":21,"title":["Exposure\u2013efficacy and exposure\u2013safety analyses of ropeginterferon alfa\u20102b treatment in patients with polycythaemia vera"],"prefix":"10.1111","volume":"90","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7610-084X","authenticated-orcid":false,"given":"Albert","family":"Qin","sequence":"first","affiliation":[{"name":"Medical Research &amp; Clinical Operations PharmaEssentia Corporation  Taipei Taiwan, ROC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daoxiang","family":"Wu","sequence":"additional","affiliation":[{"name":"PharmaEssentia Biotech (Beijing) Limited  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yaning","family":"Li","sequence":"additional","affiliation":[{"name":"PharmaEssentia Biotech (Beijing) Limited  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jingjing","family":"Zhang","sequence":"additional","affiliation":[{"name":"PharmaEssentia Biotech (Beijing) Limited  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Wang","sequence":"additional","affiliation":[{"name":"PharmaEssentia Biotech (Beijing) Limited  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Weihong","family":"Shen","sequence":"additional","affiliation":[{"name":"PharmaEssentia Biotech (Beijing) Limited  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jason","family":"Liao","sequence":"additional","affiliation":[{"name":"Medical Research &amp; 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