TY - JOUR
T1 - Patient-reported Outcomes and Quality of Life in Anemic and Symptomatic Patients With Myelofibrosis
T2 - Results From the MOMENTUM Study
AU - Mesa, Ruben A.
AU - Harrison, Claire
AU - Palmer, Jeanne M.
AU - Gupta, Vikas
AU - McLornan, Donal P.
AU - McMullin, Mary Frances
AU - Kiladjian, Jean Jacques
AU - Foltz, Lynda
AU - Platzbecker, Uwe
AU - Fox, Maria Laura
AU - Mead, Adam J.
AU - Ross, David M.
AU - Oh, Stephen T.
AU - Perkins, Andrew Charles
AU - Leahy, Michael F.
AU - Kawashima, Jun
AU - Ro, Sunhee
AU - Donahue, Rafe
AU - Gorsh, Boris
AU - Deheshi, Samineh
AU - Verstovsek, Srdan
N1 - Publisher Copyright:
© 2023 Wolters Kluwer Health. All rights reserved.
PY - 2023/11/24
Y1 - 2023/11/24
N2 - Myelofibrosis (MF) is a chronic myeloproliferative neoplasm that typically manifests with debilitating symptoms that progressively worsen, negatively impacting patients' quality of life. Fatigue is a multifactorial and burdensome MF-related symptom due to its severity, persistence, and prevalence, with anemia a contributing factor and major unmet need. Clinical trials of the Janus kinase (JAK)1/JAK2/activin A receptor type 1 inhibitor momelotinib have shown consistent anemia benefits, in addition to improvements in MF-related symptoms. The phase 3 MOMENTUM trial in symptomatic and anemic patients met its primary end point, with a greater proportion having a Myelofibrosis Symptom Assessment Form (MFSAF) Total Symptom Score (TSS) reduction ≥50% at week 24 with momelotinib versus danazol. To support the positive primary end point result, we conducted longitudinal, responder, and time-to-event analyses of patient-reported outcomes from MOMENTUM, as measured by the MFSAF, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), and Patient-Reported Outcomes Measurement Information System (PROMIS) assessments. These analyses demonstrated rapid and durable response benefits with momelotinib, with achievement of first TSS response by day 29 and continued improvement over time. Improvements favored momelotinib versus danazol for each MFSAF individual item, and greater improvements were observed for disease- and cancer-related fatigue and physical functioning at week 24, with significant results for multiple items/domains across the 3 assessments. These findings are consistent in demonstrating that momelotinib provides substantial symptom benefit.
AB - Myelofibrosis (MF) is a chronic myeloproliferative neoplasm that typically manifests with debilitating symptoms that progressively worsen, negatively impacting patients' quality of life. Fatigue is a multifactorial and burdensome MF-related symptom due to its severity, persistence, and prevalence, with anemia a contributing factor and major unmet need. Clinical trials of the Janus kinase (JAK)1/JAK2/activin A receptor type 1 inhibitor momelotinib have shown consistent anemia benefits, in addition to improvements in MF-related symptoms. The phase 3 MOMENTUM trial in symptomatic and anemic patients met its primary end point, with a greater proportion having a Myelofibrosis Symptom Assessment Form (MFSAF) Total Symptom Score (TSS) reduction ≥50% at week 24 with momelotinib versus danazol. To support the positive primary end point result, we conducted longitudinal, responder, and time-to-event analyses of patient-reported outcomes from MOMENTUM, as measured by the MFSAF, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), and Patient-Reported Outcomes Measurement Information System (PROMIS) assessments. These analyses demonstrated rapid and durable response benefits with momelotinib, with achievement of first TSS response by day 29 and continued improvement over time. Improvements favored momelotinib versus danazol for each MFSAF individual item, and greater improvements were observed for disease- and cancer-related fatigue and physical functioning at week 24, with significant results for multiple items/domains across the 3 assessments. These findings are consistent in demonstrating that momelotinib provides substantial symptom benefit.
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U2 - 10.1097/HS9.0000000000000966
DO - 10.1097/HS9.0000000000000966
M3 - Article
AN - SCOPUS:85175553105
SN - 2572-9241
VL - 7
SP - E966
JO - HemaSphere
JF - HemaSphere
IS - 11
ER -