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Its use is limited by inflammation\u2010mediated toxicity, leading to treatment discontinuation in 10\u201030% of patients. Ruxolitinib, a potent anti\u2010inflammatory agent, has demonstrated benefit in myelofibrosis (<jats:styled-content style=\"fixed-case\">MF<\/jats:styled-content>) and polycythemia vera (<jats:styled-content style=\"fixed-case\">PV<\/jats:styled-content>) patients. Combination therapy (<jats:styled-content style=\"fixed-case\">CT<\/jats:styled-content>) with these two agents may be more efficacious than monotherapy with either, potentially improving tolerability of interferon\u2010\u03b12 as well. We report the preliminary results from a phase <jats:styled-content style=\"fixed-case\">II<\/jats:styled-content> study of <jats:styled-content style=\"fixed-case\">CT<\/jats:styled-content> with pegylated interferon\u2010\u03b12 and ruxolitinib in 50 <jats:styled-content style=\"fixed-case\">MPN<\/jats:styled-content> patients (<jats:styled-content style=\"fixed-case\">PV<\/jats:styled-content>, n\u00a0=\u00a032; low\u2010\/intermediate\u20101\u2010risk <jats:styled-content style=\"fixed-case\">MF<\/jats:styled-content>, n\u00a0=\u00a018), the majority (n\u00a0=\u00a047) being resistant and\/or intolerant to interferon\u2010\u03b12 monotherapy. Objectives included remission (2013 revised criteria encompassing histologic, hematologic, and clinical responses), complete hematologic response (<jats:styled-content style=\"fixed-case\">CHR<\/jats:styled-content>), molecular response, and toxicity. Follow\u2010up was 12\u00a0months. Partial remission (<jats:styled-content style=\"fixed-case\">PR<\/jats:styled-content>) and sustained <jats:styled-content style=\"fixed-case\">CHR<\/jats:styled-content> were achieved in 9% and 44% of <jats:styled-content style=\"fixed-case\">PV<\/jats:styled-content> patients, respectively. In <jats:styled-content style=\"fixed-case\">MF<\/jats:styled-content> patients, complete or partial remission was achieved in 39%, and sustained <jats:styled-content style=\"fixed-case\">CHR<\/jats:styled-content> in 58%. The median <jats:italic><jats:styled-content style=\"fixed-case\">JAK<\/jats:styled-content>2<\/jats:italic>V617F allele burden declined significantly in both groups. Hematologic toxicity was the most common adverse event and was managed by dose reduction. Thirty\u2010seven serious adverse events were recorded in 23 patients; the discontinuation rate was 20%. We conclude that <jats:styled-content style=\"fixed-case\">CT<\/jats:styled-content> with interferon\u2010\u03b12 and ruxolitinib is efficacious in patients with low\u2010\/intermediate\u20101\u2010risk <jats:styled-content style=\"fixed-case\">MF<\/jats:styled-content> and, to a lesser extent, in patients with <jats:styled-content style=\"fixed-case\">PV<\/jats:styled-content>. These preliminary results encourage phase <jats:styled-content style=\"fixed-case\">III<\/jats:styled-content> studies as well as a study with <jats:styled-content style=\"fixed-case\">CT<\/jats:styled-content> in newly diagnosed <jats:styled-content style=\"fixed-case\">MPN<\/jats:styled-content> patients.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cam4.1619","type":"journal-article","created":{"date-parts":[[2018,6,22]],"date-time":"2018-06-22T11:29:12Z","timestamp":1529666952000},"page":"3571-3581","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":47,"title":["Safety and efficacy of combination therapy of interferon\u2010\u03b12 and ruxolitinib in polycythemia vera and myelofibrosis"],"prefix":"10.1002","volume":"7","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2104-9201","authenticated-orcid":false,"given":"Stine Ulrik","family":"Mikkelsen","sequence":"first","affiliation":[{"name":"Department of Hematology Zealand 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