{"doi":"10.1056/evidoa2200335","title":"Ropeginterferon versus Standard Therapy for Low-Risk Patients with Polycythemia Vera","abstract":null,"journal":"NEJM Evidence","year":2023,"id":613542,"datarank":0.6010999777848708,"base_score":4.007333185232471,"endowment":4.007333185232471,"self_citation_contribution":0.6010999777848708,"citation_network_contribution":0.0,"self_endowment_contribution":0.6010999777848708,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":54,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":null,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":null,"fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1580688,"name":"Alessandro Maria Vannucchi","orcid":null,"position":1,"is_corresponding":false},{"id":846488,"name":"Valerio De Stefano","orcid":"0000-0002-5178-5827","position":2,"is_corresponding":false},{"id":851193,"name":"Alessandra Carobbio","orcid":"0000-0001-9664-7084","position":3,"is_corresponding":false},{"id":1580691,"name":"Arianna Ghirardi","orcid":null,"position":4,"is_corresponding":false},{"id":722183,"name":"Greta Carioli","orcid":"0000-0002-7012-707X","position":5,"is_corresponding":false},{"id":852093,"name":"Arianna Masciulli","orcid":null,"position":6,"is_corresponding":false},{"id":852094,"name":"Elena Rossi","orcid":null,"position":7,"is_corresponding":false},{"id":104174,"name":"Fabio Ciceri","orcid":"0000-0003-0873-0123","position":8,"is_corresponding":false},{"id":1052913,"name":"Massimiliano Bonifacio","orcid":"0000-0003-0716-1686","position":9,"is_corresponding":false},{"id":1052918,"name":"Alessandra Iurlo","orcid":"0000-0002-4401-0812","position":10,"is_corresponding":false},{"id":1363126,"name":"Francesca Palandri","orcid":"0000-0001-8367-5668","position":11,"is_corresponding":false},{"id":1529148,"name":"Giulia Benevolo","orcid":null,"position":12,"is_corresponding":false},{"id":1580692,"name":"Fabrizio Pane","orcid":null,"position":13,"is_corresponding":false},{"id":362844,"name":"Alessandra Ricco","orcid":null,"position":14,"is_corresponding":false},{"id":1580693,"name":"Giuseppe Carli","orcid":null,"position":15,"is_corresponding":false},{"id":130153,"name":"Marianna Caramella","orcid":null,"position":16,"is_corresponding":false},{"id":1565932,"name":"Davide Rapezzi","orcid":null,"position":17,"is_corresponding":false},{"id":1580694,"name":"Caterina Musolino","orcid":null,"position":18,"is_corresponding":false},{"id":1580695,"name":"Sergio Siragusa","orcid":null,"position":19,"is_corresponding":false},{"id":884602,"name":"Elisa Rumi","orcid":"0000-0002-7572-9504","position":20,"is_corresponding":false},{"id":361392,"name":"Andrea Patriarca","orcid":"0000-0003-4415-2906","position":21,"is_corresponding":false},{"id":1580696,"name":"Nicola Cascavilla","orcid":null,"position":22,"is_corresponding":false},{"id":1218063,"name":"Barbara Mora","orcid":"0000-0002-6325-3916","position":23,"is_corresponding":false},{"id":1580697,"name":"Emma Cacciola","orcid":null,"position":24,"is_corresponding":false},{"id":1580698,"name":"Carmela Mannarelli","orcid":null,"position":25,"is_corresponding":false},{"id":851195,"name":"Giuseppe Gaetano Loscocco","orcid":"0000-0002-6241-1206","position":26,"is_corresponding":false},{"id":851194,"name":"Paola Guglielmelli","orcid":"0000-0003-1809-284X","position":27,"is_corresponding":false},{"id":1580699,"name":"Francesca Gesullo","orcid":null,"position":28,"is_corresponding":false},{"id":1580700,"name":"Silvia Betti","orcid":null,"position":29,"is_corresponding":false},{"id":1580701,"name":"Francesca Lunghi","orcid":null,"position":30,"is_corresponding":false},{"id":1580702,"name":"Luigi Scaffidi","orcid":null,"position":31,"is_corresponding":false},{"id":1580703,"name":"Cristina Bucelli","orcid":null,"position":32,"is_corresponding":false},{"id":1529159,"name":"Nicola Vianelli","orcid":null,"position":33,"is_corresponding":false},{"id":1519372,"name":"Marta Bellini","orcid":null,"position":34,"is_corresponding":false},{"id":1580704,"name":"Maria Chiara Finazzi","orcid":null,"position":35,"is_corresponding":false},{"id":847367,"name":"Gianni Tognoni","orcid":null,"position":36,"is_corresponding":false},{"id":847358,"name":"Alessandro Rambaldi","orcid":null,"position":37,"is_corresponding":false},{"id":846490,"name":"Tiziano Barbui","orcid":"0000-0003-2747-6327","position":0,"is_corresponding":false}],"reference_count":0,"raw_metadata":{"has_enrichment":true,"resolved":true,"title":"Ropeginterferon versus Standard Therapy for Low-Risk Patients with Polycythemia Vera","abstract":"BACKGROUND: Whether phlebotomy alone can adequately maintain target hematocrit in patients with low-risk polycythemia vera (PV) remains elusive. METHODS: In a phase 2 open-label randomized trial, we compared ropeginterferon alfa-2b (ropeg; 100 μg every 2 weeks) with phlebotomy only regarding maintenance of a median hematocrit level (≤45%) over 12 months in the absence of progressive disease (primary end point). In follow-up, crossover to the alternative treatment group was allowed if the primary end point was not met. RESULTS: In total, 127 patients were enrolled (ropeg: n=64; standard group: n=63). The primary end point was met in 81% and 51% in the ropeg and standard groups, respectively. Responders continued the assigned treatment until month 24 and maintained response in 83% and 59%, respectively (P=0.02). Ropeg responders less frequently experienced moderate/severe symptoms (33% vs. 67% in the standard group) and palpable splenomegaly (14% vs. 37%) and showed normalization of ferritin levels and blood counts. Nonresponders at 12 months crossed over to the standard (n=9) or ropeg (n=23) group; in patients switched to ropeg only, 7 of 23 met the response criteria in 12 months, and phlebotomy need was high (4.7 per patient per year). Discontinuation because of adverse events occurred in seven patients treated with ropeg. CONCLUSIONS: In this 24-month trial, ropeg was superior to phlebotomy alone in maintaining hematocrit on target. No dose-limiting side effects or toxicities were noted; 9.2% of patients on ropeg and no patients on standard treatment developed neutropenia. (Funded by AOP Health and others; ClinicalTrials.gov number, NCT03003325.)","is_dataset_classified":null,"base_score":3.970291913552122,"endowment":3.970291913552122,"datacite_reuse_total":0,"file_count":0,"downloads":0,"views":0,"has_version_chain":false,"is_dataset":false,"is_oa":false,"pmid":"38320126","pmcid":null,"openalex_id":"https://openalex.org/W4376611057","authors":[],"funders":[],"total_grants":0,"fwci":8.7606,"citation_percentile":0.98619903,"influential_citations":0,"citation_trend":[{"year":2023,"count":6},{"year":2024,"count":21},{"year":2025,"count":18},{"year":2026,"count":7}],"oa_status":"bronze","license":"cc-by","oa_locations":[{"url":"https://evidence.nejm.org/doi/pdf/10.1056/EVIDoa2200335","host_type":"journal"},{"url":"https://evidence.nejm.org/doi/pdf/10.1056/EVIDoa2200335","host_type":"publisher"},{"url":"https://doi.org/10.1056/evidoa2200335","host_type":"journal"},{"url":"https://pubmed.ncbi.nlm.nih.gov/38320126","host_type":"repository"},{"url":"https://hdl.handle.net/2434/995408","host_type":"repository"},{"url":"https://hdl.handle.net/2158/1313513","host_type":"repository"},{"url":"https://hdl.handle.net/11380/1332059","host_type":"repository"},{"url":"https://air.unimi.it/bitstream/2434/995408/2/NEJM%20evidence%20Barbui.pdf","host_type":"repository"}],"fields_of_study":["Myeloproliferative Neoplasms: Diagnosis and Treatment","Hemoglobinopathies and Related Disorders","Acute Myeloid Leukemia Research"],"mesh_terms":["Humans","Leukocytosis","Polycythemia","Polycythemia Vera","Thrombocytosis","Thrombosis"],"keywords":["Medicine","Phlebotomy","Discontinuation","Hematocrit","Clinical endpoint","Adverse effect","Neutropenia","Surgery","Polycythemia vera","Randomization","Internal medicine","Randomized controlled trial","Gastroenterology","Chemotherapy"],"sdg_mappings":[{"sdg_number":0,"sdg_label":"Good health and well-being"}],"linked_datasets":[],"clinical_trials":[],"software_tools":[],"database_accessions":[{"name":"nct"}],"source":"live","citation_network_status":"fetched"},"created_at":"2026-08-02T08:28:39.382323Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}