{"entity":{"id":"proud-pv","kind":"trial","name":"PROUD-PV and CONTINUATION-PV","aka":[],"tldr":"PROUD-PV and its extension showed that ropeginterferon matches hydroxyurea in the first year and then pulls ahead, with more complete responses and far more molecular responses by three years.","summary":"PROUD-PV randomised 257 patients with PV to ropeginterferon alfa-2b every two weeks or hydroxyurea; CONTINUATION-PV followed 171 of them. Non-inferiority for complete haematological response at 12 months was not formally shown, but from 24 months onward the interferon arm had more complete haematological responses with improved disease burden and a much higher rate of molecular response, with the JAK2 V617F allele burden falling steadily over years (Gisslinger and colleagues, Lancet Haematology 2020). The trials underpinned the EU approval in 2019 and the FDA approval in 2021.","status":"positive","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT01949805","url":"https://clinicaltrials.gov/study/NCT01949805"},{"label":"ClinicalTrials.gov NCT02218047","url":"https://clinicaltrials.gov/study/NCT02218047"},{"label":"Lancet Haematology 2020","url":"https://doi.org/10.1016/S2352-3026(19)30236-4"}],"tags":["polycythaemia-vera","mpn"],"related":[],"cancers":["polycythaemia-vera","myeloproliferative-neoplasms"],"sections":[],"technologies":["cytokine-therapy"],"targets":[],"drugs":["ropeginterferon-alfa-2b","hydroxyurea"],"companies":["pharmaessentia"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-gisslinger-lancet-haematol"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01949805","phase":"3","setting":"Polycythaemia vera needing cytoreduction: ropeginterferon alfa-2b versus hydroxyurea, with long-term follow-up","sponsor":"AOP Orphan Pharmaceuticals","result":"By 36 months, complete haematological response with improved disease burden and molecular response were both more frequent with ropeginterferon than hydroxyurea.","started":"2013-09","yearReported":2020,"enrolled":257,"enrolledBasis":"registry","outcomes":[{"endpoint":"Complete haematological response with normal spleen size at 12 months (PROUD-PV)","primary":true,"unit":"%","arms":[{"name":"Ropeginterferon alfa-2b","n":122,"value":21,"note":"Non-inferiority to hydroxyurea not shown at 12 months"},{"name":"Hydroxyurea","n":123,"value":28}],"source":"https://doi.org/10.1016/S2352-3026(19)30236-4"},{"endpoint":"Complete haematological response with improved disease burden at 36 months (CONTINUATION-PV)","primary":true,"unit":"%","arms":[{"name":"Ropeginterferon alfa-2b","n":95,"value":53},{"name":"Hydroxyurea","n":74,"value":38}],"p":"0.044","source":"https://doi.org/10.1016/S2352-3026(19)30236-4"},{"endpoint":"Complete haematological response at 36 months (without the spleen criterion)","unit":"%","arms":[{"name":"Ropeginterferon alfa-2b","n":95,"value":71},{"name":"Hydroxyurea","n":74,"value":51}],"p":"0.012","source":"https://doi.org/10.1016/S2352-3026(19)30236-4"}]},"route":"/trials/proud-pv/","neighbours":{"cancer":[{"id":"myeloproliferative-neoplasms","kind":"cancer","name":"Myeloproliferative neoplasms (PV, ET, myelofibrosis)","route":"/cancers/myeloproliferative-neoplasms/"},{"id":"polycythaemia-vera","kind":"cancer","name":"Polycythaemia vera (PV)","route":"/cancers/polycythaemia-vera/"}],"technology":[{"id":"cytokine-therapy","kind":"technology","name":"Cytokines & engineered cytokines","route":"/technologies/cytokine-therapy/"}],"drug":[{"id":"hydroxyurea","kind":"drug","name":"Hydroxyurea (hydroxycarbamide)","route":"/drugs/hydroxyurea/"},{"id":"ropeginterferon-alfa-2b","kind":"drug","name":"Ropeginterferon alfa-2b","route":"/drugs/ropeginterferon-alfa-2b/"}],"company":[{"id":"pharmaessentia","kind":"company","name":"PharmaEssentia","route":"/companies/pharmaessentia/"}],"paper":[{"id":"paper-gisslinger-lancet-haematol","kind":"paper","name":"Ropeginterferon alfa-2b versus standard therapy for polycythaemia vera (PROUD-PV and CONTINUATION-PV): a randomised, non-inferiority, phase 3 trial and its extension study","route":"/key-papers/paper-gisslinger-lancet-haematol/"}],"idea":[{"id":"idea-pv-clone-directed-therapy","kind":"idea","name":"Clearing the JAK2 clone in polycythaemia vera: interferon plus mutant-selective inhibitors as a route to treatment-free remission","route":"/ideas/idea-pv-clone-directed-therapy/"}]}}