@article{55402f16c2c64b088df254a4a202fd0d,
title = "Updated results of the placebo-controlled, phase III JAKARTA trial of fedratinib in patients with intermediate-2 or high-risk myelofibrosis",
abstract = "Fedratinib, an oral Janus kinase-2 (JAK2) inhibitor, reduces splenomegaly and improves symptom burden in patients with myelofibrosis. Regulatory approval of fedratinib 400-mg daily was based on results of an updated analysis of the pivotal phase III, placebo-controlled JAKARTA trial in patients with JAK-inhibitor-na{\"i}ve myelofibrosis. At week 24, spleen volume response rate was 47% and symptom response rate was 40% with fedratinib 400 mg, versus 1% and 9% respectively, with placebo. Common adverse events were diarrhoea, nausea, anaemia, and vomiting. No Wernicke encephalopathy occurred in patients receiving fedratinib 400 mg/day. These updated data support use of first-line fedratinib in patients with myelofibrosis.",
keywords = "fedratinib, JAK inhibitor, myelofibrosis",
author = "Animesh Pardanani and Ayalew Tefferi and Tam{\'a}s Masszi and Elena Mishchenko and Mark Drummond and Eric Jourdan and Alessandro Vannucchi and Mindaugas Jurgutis and Vincent Ribrag and Alessandro Rambaldi and Koh, {Liang Piu} and Shelonitda Rose and Jun Zhang and Claire Harrison",
note = "Funding Information: We thank the patients, families, co-investigators, and all study personnel who participated in this trial. The original study was supported by Sanofi S.A.; this re-analysis was funded by Celgene, a Bristol-Myers Squibb company. The authors received editorial assistance on an early draft from Brian Kaiser and Sheila Truten (Medical Communication Company, Inc.), sponsored by Bristol-Myers Squibb. The authors are fully responsible for all content and editorial decisions, and all approved submission of the final manuscript. Publisher Copyright: {\textcopyright} 2021 The Authors. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd.",
year = "2021",
month = oct,
doi = "10.1111/bjh.17727",
language = "English (US)",
volume = "195",
pages = "244--248",
journal = "British Journal of Haematology",
issn = "0007-1048",
publisher = "Wiley-Blackwell",
number = "2",
}