Updated results of the placebo-controlled, phase III JAKARTA trial of fedratinib in patients with intermediate-2 or high-risk myelofibrosis

Animesh Pardanani; Ayalew Tefferi; Tamás Masszi; Elena Mishchenko; Mark Drummond; Eric Jourdan; Alessandro Vannucchi; Mindaugas Jurgutis; Vincent Ribrag; Alessandro Rambaldi; Liang Piu Koh; Shelonitda Rose; Jun Zhang; Claire Harrison

doi:10.1111/bjh.17727

Updated results of the placebo-controlled, phase III JAKARTA trial of fedratinib in patients with intermediate-2 or high-risk myelofibrosis

Animesh Pardanani, Ayalew Tefferi, Tamás Masszi, Elena Mishchenko, Mark Drummond, Eric Jourdan, Alessandro Vannucchi, Mindaugas Jurgutis, Vincent Ribrag, Alessandro Rambaldi, Liang Piu Koh, Shelonitda Rose, Jun Zhang, Claire Harrison

Hematology

Research output: Contribution to journal › Article › peer-review

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-naïve 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.

Original language	English (US)
Pages (from-to)	244-248
Number of pages	5
Journal	British journal of haematology
Volume	195
Issue number	2
DOIs	https://doi.org/10.1111/bjh.17727
State	Published - Oct 2021

Keywords

JAK inhibitor
fedratinib
myelofibrosis

ASJC Scopus subject areas

Hematology

Access to Document

10.1111/bjh.17727

Cite this

Pardanani, A., Tefferi, A., Masszi, T., Mishchenko, E., Drummond, M., Jourdan, E., Vannucchi, A., Jurgutis, M., Ribrag, V., Rambaldi, A., Koh, L. P., Rose, S., Zhang, J., & Harrison, C. (2021). Updated results of the placebo-controlled, phase III JAKARTA trial of fedratinib in patients with intermediate-2 or high-risk myelofibrosis. British journal of haematology, 195(2), 244-248. https://doi.org/10.1111/bjh.17727

Pardanani, A , Tefferi, A, Masszi, T, Mishchenko, E, Drummond, M, Jourdan, E, Vannucchi, A, Jurgutis, M, Ribrag, V, Rambaldi, A, Koh, LP, Rose, S, Zhang, J & Harrison, C 2021, 'Updated results of the placebo-controlled, phase III JAKARTA trial of fedratinib in patients with intermediate-2 or high-risk myelofibrosis', British journal of haematology, vol. 195, no. 2, pp. 244-248. https://doi.org/10.1111/bjh.17727

@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 = "JAK inhibitor, fedratinib, 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 = "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",

}

TY - JOUR

T1 - Updated results of the placebo-controlled, phase III JAKARTA trial of fedratinib in patients with intermediate-2 or high-risk myelofibrosis

AU - Pardanani, Animesh

AU - Tefferi, Ayalew

AU - Masszi, Tamás

AU - Mishchenko, Elena

AU - Drummond, Mark

AU - Jourdan, Eric

AU - Vannucchi, Alessandro

AU - Jurgutis, Mindaugas

AU - Ribrag, Vincent

AU - Rambaldi, Alessandro

AU - Koh, Liang Piu

AU - Rose, Shelonitda

AU - Zhang, Jun

AU - Harrison, Claire

PY - 2021/10

Y1 - 2021/10

N2 - 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-naïve 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.

AB - 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-naïve 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.

KW - JAK inhibitor

KW - fedratinib

KW - myelofibrosis

UR - http://www.scopus.com/inward/record.url?scp=85111490063&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85111490063&partnerID=8YFLogxK

U2 - 10.1111/bjh.17727

DO - 10.1111/bjh.17727

M3 - Article

C2 - 34331348

AN - SCOPUS:85111490063

SN - 0007-1048

VL - 195

SP - 244

EP - 248

JO - British journal of haematology

JF - British journal of haematology

IS - 2

ER -

Updated results of the placebo-controlled, phase III JAKARTA trial of fedratinib in patients with intermediate-2 or high-risk myelofibrosis

Abstract

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this