OH, Stephen T, Srdan VERSTOVSEK, Vikas GUPTA, Uwe PLATZBECKER, Timothy DEVOS, Jean-Jacques KILADJIAN, Donal P MCLORNAN, Andrew PERKINS, Maria Laura FOX, Mary Frances MCMULLIN, Adam J MEAD, Miklos EGYED, Jiří MAYER, Tomasz SACHA, Jun KAWASHIMA, Mei HUANG, Bryan STROUSE and Ruben MESA. Changes in bone marrow fibrosis during momelotinib or ruxolitinib therapy do not correlate with efficacy outcomes in patients with myelofibrosis. eJHaem. Hoboken: Wiley, 2024, vol. 5, No 1, p. 105-116. ISSN 2688-6146. Available from: https://dx.doi.org/10.1002/jha2.854.
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Basic information
Original name Changes in bone marrow fibrosis during momelotinib or ruxolitinib therapy do not correlate with efficacy outcomes in patients with myelofibrosis
Authors OH, Stephen T, Srdan VERSTOVSEK, Vikas GUPTA, Uwe PLATZBECKER, Timothy DEVOS, Jean-Jacques KILADJIAN, Donal P MCLORNAN, Andrew PERKINS, Maria Laura FOX, Mary Frances MCMULLIN, Adam J MEAD, Miklos EGYED, Jiří MAYER (203 Czech Republic, belonging to the institution), Tomasz SACHA, Jun KAWASHIMA, Mei HUANG, Bryan STROUSE and Ruben MESA.
Edition eJHaem, Hoboken, Wiley, 2024, 2688-6146.
Other information
Original language English
Type of outcome Article in a journal
Field of Study 30205 Hematology
Country of publisher United States of America
Confidentiality degree is not subject to a state or trade secret
WWW URL
Organization unit Faculty of Medicine
Doi http://dx.doi.org/10.1002/jha2.854
UT WoS 001216592400041
Keywords in English bone marrow fibrosis; JAK inhibitor; momelotinib; myelofibrosis; ruxolitinib
Tags 14110212, rivok
Tags International impact, Reviewed
Changed by Changed by: Mgr. Tereza Miškechová, učo 341652. Changed: 19/8/2024 10:16.
Abstract
Bone marrow fibrosis (BMF) is a pathological feature of myelofibrosis, with higher grades associated with poor prognosis. Limited data exist on the association between outcomes and BMF changes. We present BMF data from Janus kinase (JAK) inhibitor-naive patients from SIMPLIFY-1 (NCT01969838), a double-blind, randomized, phase 3 study of momelotinib vs ruxolitinib. Baseline and week 24 bone marrow biopsies were graded from 0 to 3 as per World Health Organization criteria. Other assessments included Total Symptom Score, spleen volume, transfusion independence status, and hemoglobin levels. Paired samples were available from 144 and 160 patients randomized to momelotinib and ruxolitinib. With momelotinib and ruxolitinib, transfusion independence was achieved by 87% and 44% of patients with BMF improvement of >= 1 grade and 76% and 56% of those with stable/worsening BMF; there was no association between BMF changes and transfusion independence for either arm (momelotinib, p = .350; ruxolitinib, p = .096). Regardless of BMF changes, hemoglobin levels also generally increased on momelotinib but decreased on ruxolitinib. In addition, no associations between BMF changes and spleen (momelotinib, p = .126; ruxolitinib, p = .407)/symptom (momelotinib, p = .617; ruxolitinib, p = .833) outcomes were noted, and no improvement in overall survival was observed with >= 1-grade BMF improvement (momelotinib, p = .395; ruxolitinib, p = .407). These data suggest that the anemia benefit of momelotinib is not linked to BMF changes, and question the use of BMF assessment as a surrogate marker for clinical benefit with JAK inhibitors.
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