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-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.

• Authors: 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
• Journal: British journal of haematology (Br J Haematol) Vol. 195 Issue 2 Pg. 244-248 (10 2021) ISSN: 1365-2141 [Electronic] England
• PMID: 34331348 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)
• Copyright: © 2021 The Authors. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd.

Chemical References

• Janus Kinase Inhibitors
• Placebos
• Pyrrolidines
• Sulfonamides
• fedratinib
• JAK2 protein, human
• Janus Kinase 2

Topics

• 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, adverse effects, pharmacology, therapeutic use)
• Middle Aged
• Placebos (administration & dosage)
• Primary Myelofibrosis (complications, diagnosis, drug therapy)
• Pyrrolidines (administration & dosage, adverse effects, pharmacology, therapeutic use)
• Safety
• Spleen (drug effects)
• Splenomegaly (drug therapy)
• Sulfonamides (administration & dosage, adverse effects, pharmacology, therapeutic use)