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. 2024 Feb;24(2):122-132.
doi: 10.1016/j.clml.2023.09.008. Epub 2023 Sep 29.

Real-World Use of Fedratinib for Myelofibrosis Following Prior Ruxolitinib Failure: Patient Characteristics, Treatment Patterns, and Clinical Outcomes

John Mascarenhas  1 , Claire Harrison  2 , Tammy A Schuler  3 , Djibril Liassou  3 , Marné Garretson  3 , Taavy A Miller  3 , Sankar Mahadevan  4 , Ali McBride  4 , Derek Tang  4 , Irene S DeGutis  4 , Pranav Abraham  4 , Jonathan Kish  3 , Bruce A Feinberg  3 , Aaron T Gerds  5
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Free article

Real-World Use of Fedratinib for Myelofibrosis Following Prior Ruxolitinib Failure: Patient Characteristics, Treatment Patterns, and Clinical Outcomes

John Mascarenhas et al. Clin Lymphoma Myeloma Leuk. 2024 Feb.
Free article

Abstract

Background: There is a lack of established clinical outcomes for patients with myelofibrosis (MF) receiving fedratinib following ruxolitinib failure. This study examined real-world patient characteristics, treatment patterns, and clinical outcomes of patients with MF treated with fedratinib following ruxolitinib failure in US clinical practice.

Patients and methods: This retrospective patient chart review included adults with a physician-reported diagnosis of MF, who initiated fedratinib after discontinuing ruxolitinib. Descriptive analyses characterized patient characteristics, clinical outcomes, and treatment patterns from MF diagnosis through ruxolitinib and fedratinib treatment.

Results: Twenty-four physicians abstracted data for 150 eligible patients. Approximately 55.3% of the patients were male, 68.0% were White, and median age at MF diagnosis was 68 (range, 35-84) years. Median duration of ruxolitinib therapy was 7.6 (range, 0.7-65.5) months. At initiation of fedratinib, 88.0% of patients had palpable spleen and a mean spleen size of 16.0 (standard deviation [SD], 5.9) cm. Spleen size decreased by 19.4% to 13.2 (SD, 7.9) cm at month 3 (P = .0001) and by 53.4% to 7.2 (SD, 7.4) cm at month 6 (P = .01) of fedratinib treatment, respectively. Almost one-third (26.8%) of patients had achieved ≥ 50% spleen reduction by month 6. Mean number of symptoms also decreased significantly at month 3 (P < .0001) and month 6 (P = .01).

Conclusion: Fedratinib appears to deliver spleen and symptom benefits in real-world patients with MF previously treated with ruxolitinib.

Keywords: Janus kinase 2 inhibitor; Myeloproliferative neoplasms; Real-world data.

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Conflict of interest statement

Disclosure J.M. reports research funding paid to institution from AbbVie, BMS, CTI BioPharm, Geron, Incyte, Kartos, Novartis, PharmaEssentia, and Roche; consulting fees from AbbVie, BMS, CTI BioPharm, Galecto, Geron, GSK, Incyte, Kartos, Karyopharm, MorphoSys, Novartis, PharmaEssentia, Roche, and Sierra Oncology. C.H. reports research funding from BMS/Celgene, Constellation Pharmaceuticals, a MorphoSys Company, and Novartis; and advisory role and speaker funding from Abbvie, AOP Orphan Pharmaceuticals, BMS/Celgene, CTI BioPharma, Galacteo, Geron, Gilead, Janssen, Keros, Novartis, Promedior, Roche, and Shire. T.A.S., D.L., M.G., and T.A.M. report employment with Cardinal Health. S.M. and A.M. report employment with BMS. D.T. and I.S.D. report employment with and stock ownership in BMS. P.A. reports no conflicts of interest. J.K. reports employment with and stock ownership in Cardinal Health at the time this study was conducted. B.A.F. reports research funding from BMS; and stock ownership in and employment with Cardinal Health. A.T.G. reports consulting for AbbVie, BMS/Celgene, CTI BioPharma, Constellation Pharmaceuticals, a MorphoSys Company, GSK/Sierra Oncology, Incyte, Kartos, Novartis, and PharmaEssentia.

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