Risk‐adjusted safety analysis of the oral JAK2/IRAK1 inhibitor pacritinib in patients with myelofibrosis

Naveen Pemmaraju; Claire Harrison; Vikas Gupta; Srdan Verstovsek; Bart Scott; Stephen T. Oh; Francesca Palandri; Haifa Kathrin Al‐Ali; Marta Sobas; Mary Frances McMullin; Ruben Mesa; Sarah Buckley; Karisse Roman‐Torres; Alessandro Vannucchi; Abdulraheem Yacoub

doi:10.1002/jha2.591

Risk‐adjusted safety analysis of the oral JAK2/IRAK1 inhibitor pacritinib in patients with myelofibrosis

Naveen Pemmaraju^*, Claire Harrison, Vikas Gupta, Srdan Verstovsek, Bart Scott, Stephen T. Oh, Francesca Palandri, Haifa Kathrin Al‐Ali, Marta Sobas, Mary Frances McMullin, Ruben Mesa, Sarah Buckley, Karisse Roman‐Torres, Alessandro Vannucchi, Abdulraheem Yacoub

^*Corresponding author for this work

School of Medicine, Dentistry and Biomedical Sciences

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

89 Downloads (Pure)

Abstract

The safety profile of the novel oral JAK2/IRAK1 inhibitor pacritinib in patients with cytopenic myelofibrosis was described in the Phase 2 PAC203 and Phase 3 PERSIST‐2 studies. To account for longer treatment durations on the pacritinib arms compared to best available therapy (BAT), we present a risk‐adjusted safety analysis of event rates accounting for different time on treatment. While the rate of overall events was higher on pacritinib compared to BAT, the rate of fatal events was lower, and there was no excess in bleeding, cardiac events, secondary malignancy, or thrombosis on pacritinib, including in patients with severe thrombocytopenia.

Original language	English
Pages (from-to)	1346-1351
Number of pages	6
Journal	eJHaem
Volume	3
Issue number	4
Early online date	20 Oct 2022
DOIs	https://doi.org/10.1002/jha2.591
Publication status	Published - Nov 2022

Keywords

SHORT REPORT
myelofibrosis
myeloproliferative neoplasms
pacritinib
safety

Access to Document

10.1002/jha2.591Licence: CC BY

Risk‐adjusted safety analysis of the oral JAK2/IRAK1 inhibitor pacritinib in patients with myelofibrosis
Copyright 2022 the authors. This is an open access article published under a Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium, provided the author and source are cited.
Final published version, 162 KBLicence: CC BY

Cite this

Pemmaraju, N., Harrison, C., Gupta, V., Verstovsek, S., Scott, B., Oh, S. T., Palandri, F., Al‐Ali, H. K., Sobas, M., McMullin, M. F., Mesa, R., Buckley, S., Roman‐Torres, K., Vannucchi, A., & Yacoub, A. (2022). Risk‐adjusted safety analysis of the oral JAK2/IRAK1 inhibitor pacritinib in patients with myelofibrosis. eJHaem, 3(4), 1346-1351. https://doi.org/10.1002/jha2.591

@article{6f2715f81fb147de87e0a262213776e1,

title = "Risk‐adjusted safety analysis of the oral JAK2/IRAK1 inhibitor pacritinib in patients with myelofibrosis",

abstract = "The safety profile of the novel oral JAK2/IRAK1 inhibitor pacritinib in patients with cytopenic myelofibrosis was described in the Phase 2 PAC203 and Phase 3 PERSIST‐2 studies. To account for longer treatment durations on the pacritinib arms compared to best available therapy (BAT), we present a risk‐adjusted safety analysis of event rates accounting for different time on treatment. While the rate of overall events was higher on pacritinib compared to BAT, the rate of fatal events was lower, and there was no excess in bleeding, cardiac events, secondary malignancy, or thrombosis on pacritinib, including in patients with severe thrombocytopenia.",

keywords = "SHORT REPORT, myelofibrosis, myeloproliferative neoplasms, pacritinib, safety",

author = "Naveen Pemmaraju and Claire Harrison and Vikas Gupta and Srdan Verstovsek and Bart Scott and Oh, {Stephen T.} and Francesca Palandri and Al‐Ali, {Haifa Kathrin} and Marta Sobas and McMullin, {Mary Frances} and Ruben Mesa and Sarah Buckley and Karisse Roman‐Torres and Alessandro Vannucchi and Abdulraheem Yacoub",

year = "2022",

month = nov,

doi = "10.1002/jha2.591",

language = "English",

volume = "3",

pages = "1346--1351",

journal = "eJHaem",

issn = "2688-6146",

publisher = "Wiley-ISTE",

number = "4",

}

Pemmaraju, N, Harrison, C, Gupta, V, Verstovsek, S, Scott, B, Oh, ST, Palandri, F, Al‐Ali, HK, Sobas, M, McMullin, MF, Mesa, R, Buckley, S, Roman‐Torres, K, Vannucchi, A & Yacoub, A 2022, 'Risk‐adjusted safety analysis of the oral JAK2/IRAK1 inhibitor pacritinib in patients with myelofibrosis', eJHaem, vol. 3, no. 4, pp. 1346-1351. https://doi.org/10.1002/jha2.591

TY - JOUR

T1 - Risk‐adjusted safety analysis of the oral JAK2/IRAK1 inhibitor pacritinib in patients with myelofibrosis

AU - Pemmaraju, Naveen

AU - Harrison, Claire

AU - Gupta, Vikas

AU - Verstovsek, Srdan

AU - Scott, Bart

AU - Oh, Stephen T.

AU - Palandri, Francesca

AU - Al‐Ali, Haifa Kathrin

AU - Sobas, Marta

AU - McMullin, Mary Frances

AU - Mesa, Ruben

AU - Buckley, Sarah

AU - Roman‐Torres, Karisse

AU - Vannucchi, Alessandro

AU - Yacoub, Abdulraheem

PY - 2022/11

Y1 - 2022/11

N2 - The safety profile of the novel oral JAK2/IRAK1 inhibitor pacritinib in patients with cytopenic myelofibrosis was described in the Phase 2 PAC203 and Phase 3 PERSIST‐2 studies. To account for longer treatment durations on the pacritinib arms compared to best available therapy (BAT), we present a risk‐adjusted safety analysis of event rates accounting for different time on treatment. While the rate of overall events was higher on pacritinib compared to BAT, the rate of fatal events was lower, and there was no excess in bleeding, cardiac events, secondary malignancy, or thrombosis on pacritinib, including in patients with severe thrombocytopenia.

AB - The safety profile of the novel oral JAK2/IRAK1 inhibitor pacritinib in patients with cytopenic myelofibrosis was described in the Phase 2 PAC203 and Phase 3 PERSIST‐2 studies. To account for longer treatment durations on the pacritinib arms compared to best available therapy (BAT), we present a risk‐adjusted safety analysis of event rates accounting for different time on treatment. While the rate of overall events was higher on pacritinib compared to BAT, the rate of fatal events was lower, and there was no excess in bleeding, cardiac events, secondary malignancy, or thrombosis on pacritinib, including in patients with severe thrombocytopenia.

KW - SHORT REPORT

KW - myelofibrosis

KW - myeloproliferative neoplasms

KW - pacritinib

KW - safety

U2 - 10.1002/jha2.591

DO - 10.1002/jha2.591

M3 - Article

SN - 2688-6146

VL - 3

SP - 1346

EP - 1351

JO - eJHaem

JF - eJHaem

IS - 4

ER -

Risk‐adjusted safety analysis of the oral JAK2/IRAK1 inhibitor pacritinib in patients with myelofibrosis

Abstract

Keywords

Access to Document

Fingerprint

Cite this