Evidence map›Paper›PMID 37021939›Full record

Trial reportCancer medicine2023

Symptomatic benefit of momelotinib in patients with myelofibrosis: Results from the SIMPLIFY phase III studies.

Ruben A Mesa, Stacie Hudgens, Lysbeth Floden, Claire N Harrison, Jeanne Palmer, Vikas Gupta, Donal P McLornan, Mary F McMullin, Jean-Jaques Kiladjian, Lynda Foltz and 11 more

Open access · goldAbstract readClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
4.0field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 14 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors at 17 institutions in 8 countries.

Ruben A MesaAtrium Health Wake Forest Baptist Comprehensive Cancer Center, Wake Forest University School of Medicine, Winston Salem, North Carolina, USA.ORCID 0000-0001-5880-7972
Stacie HudgensClinical Outcomes Solutions, Tucson, Arizona, USA.
Lysbeth FlodenClinical Outcomes Solutions, Tucson, Arizona, USA.ORCID 0000-0003-0584-6227
Claire N HarrisonGuy's and St. Thomas' NHS Foundation Trust, London, UK.
Jeanne PalmerMayo Clinic, Phoenix, Arizona, USA.
Vikas GuptaUniversity Health Network, University of Toronto, Toronto, Ontario, Canada.
Donal P McLornanGuy's and St. Thomas' NHS Foundation Trust, London, UK.
Mary F McMullinQueens University, Belfast City Hospital Trust, Belfast, UK.
Jean-Jaques KiladjianHôpital Saint-Louis, Université de Paris, Paris, France.
Lynda FoltzSt Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
Uwe PlatzbeckerLeipzig University Hospital, Leipzig, Germany.
M Laura FoxHematology Department, Hospital Universitario Vall d'Hebron, Experimental Hematology, Vall d'Hebron Institute of Oncology (VHIO), Hospital Universitario Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.
Adam J MeadMRC Weatherall Institute of Molecular Medicine, Oxford, UK.
David M RossFlinders Medical Centre and University, Adelaide, South Australia, Australia.
Stephen T OhWashington University School of Medicine, St. Louis, Missouri, USA.
Andrew PerkinsAlfred Hospital, Monash University, Melbourne, Victoria, Australia.
Michael F LeahyUniversity of Western Australia, Perth, Western Australia, Australia.
Samineh DeheshiSierra Oncology, Plymouth, Michigan, USA.
Rafe DonahueSierra Oncology, Plymouth, Michigan, USA.
Barbara J KlenckeSierra Oncology, Plymouth, Michigan, USA.
Srdan VerstovsekMD Anderson Cancer Center, Houston, Texas, USA.
Tissue Regeneration Systems (United States) · USGuy's and St Thomas' NHS Foundation Trust · GBHealth Outcomes Solutions (United States) · USAtrium Health Wake Forest Baptist · USFlinders Medical Centre · AUHebron University · PSMayo Clinic Hospital · USMRC Weatherall Institute of Molecular Medicine · GBQueen's University Belfast · GBThe Alfred Hospital · AUThe University of Texas MD Anderson Cancer Center · USThe University of Western Australia · AUUniversité Paris Cité · FRUniversity Health Network · CAUniversity Hospital Leipzig · DEUniversity of British Columbia · CAWashington University in St. Louis · US

Funding

Cancer Research UK 26988Cancer Research UK 27125Cancer Research UK 27723Medical Research Council G84/6443Medical Research Council MR/L006340/1
6 · The paper itself

Abstract

backgroundMyelofibrosis (MF)-associated constitutional symptoms can severely impact health-related quality of life. Clinical trials in MF traditionally measure symptom response to treatment as a landmark endpoint of total symptom score (TSS) reduction ≥50% from baseline. However, this dichotomous assessment provides a limited view of clinically relevant symptomatic changes. Herein we evaluated longitudinal change from baseline in TSS over the continuous 24-week period and individual symptom scores to obtain a more comprehensive understanding of symptom benefits experienced by patients with MF receiving therapy.

methodsLongitudinal symptom change was evaluated using mixed-effect model repeated measure (MMRM) methodology with individual item-level analyses to complement the interpretation of the landmark symptom results in the completed phase III SIMPLIFY studies of momelotinib in MF. MMRM compared mean change in TSS from baseline with Week 24 using data from all patient visits. Generalized estimating equations were used to estimate item-level odds ratios using multiple predictive imputations for missing data.

resultsMomelotinib and ruxolitinib groups reported similar overall symptom improvements, with a TSS difference of <1.5 points between groups for each post-baseline visit in SIMPLIFY-1. In SIMPLIFY-2, the improvement in TSS observed in momelotinib-treated patients was consistent with that observed in SIMPLIFY-1, whereas progressive TSS deterioration was observed with control. Item-level scores were heterogeneous in both studies. A similar and greater proportion of momelotinib-treated patients were categorized as "improved" or "stable" compared with control in SIMPLIFY-1 and SIMPLIFY-2, respectively. Odds ratios for between-group comparison ranged from 0.75 to 1.21 in SIMPLIFY-1, demonstrating similarity in likelihood of symptom improvement. In SIMPLIFY-2, the likelihood of symptom improvement in each item was higher in the momelotinib arm.

conclusionsThese findings suggest that momelotinib provides clinically relevant symptom benefits in the JAK inhibitor-naïve and JAK inhibitor-exposed settings.

Indexed as

Janus Kinase InhibitorsPrimary MyelofibrosisBenzamidesHumansProtein Kinase InhibitorsPyrimidinesQuality of LifeBenzamidesJanus Kinase InhibitorsN-(cyanomethyl)-4-(2-((4-(4-morpholinyl)phenyl)amino)-4-pyrimidinyl)benzamideProtein Kinase InhibitorsPyrimidinesJAK inhibitormomelotinibmyelofibrosispatient-reported outcomessymptoms

Identifiers

PMID37021939
PMCPMC10225216
OpenAlexW4362657072

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.