Updated results of the placebo-controlled, phase III JAKARTA trial of fedratinib in patients with intermediate-2 or high-risk myelofibrosis.
Administration, Oral
Adult
Aged
Aged, 80 and over
Case-Control Studies
Follow-Up Studies
Humans
Janus Kinase 2
/ antagonists & inhibitors
Janus Kinase Inhibitors
/ administration & dosage
Middle Aged
Placebos
/ administration & dosage
Primary Myelofibrosis
/ complications
Pyrrolidines
/ administration & dosage
Safety
Spleen
/ drug effects
Splenomegaly
/ drug therapy
Sulfonamides
/ administration & dosage
JAK inhibitor
fedratinib
myelofibrosis
Journal
British journal of haematology
ISSN: 1365-2141
Titre abrégé: Br J Haematol
Pays: England
ID NLM: 0372544
Informations de publication
Date de publication:
10 2021
10 2021
Historique:
revised:
06
07
2021
received:
16
05
2021
accepted:
12
07
2021
pubmed:
1
8
2021
medline:
17
12
2021
entrez:
31
7
2021
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 34331348
doi: 10.1111/bjh.17727
pmc: PMC9292894
doi:
Substances chimiques
Janus Kinase Inhibitors
0
Placebos
0
Pyrrolidines
0
Sulfonamides
0
fedratinib
6L1XP550I6
JAK2 protein, human
EC 2.7.10.2
Janus Kinase 2
EC 2.7.10.2
Types de publication
Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
244-248Informations de copyright
© 2021 The Authors. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd.
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