PMID- 37792065
OWN - NLM
STAT- MEDLINE
DCOM- 20231113
LR  - 20231122
IS  - 1432-0584 (Electronic)
IS  - 0939-5555 (Print)
IS  - 0939-5555 (Linking)
VI  - 102
IP  - 12
DP  - 2023 Dec
TI  - Real-world analysis of ruxolitinib in myelofibrosis: interim results focusing on 
      patients who were naive to JAK inhibitor therapy treated within the JAKoMo 
      non-interventional, phase IV trial.
PG  - 3383-3399
LID - 10.1007/s00277-023-05458-1 [doi]
AB  - Ruxolitinib (RUX) is a Janus kinase 1/2 inhibitor (JAKi) approved in the EU for 
      treating disease‑related splenomegaly or symptoms in adults patients with 
      myelofibrosis (MF). This is an interim analysis of JAKoMo, a prospective, 
      non‑interventional, phase IV study in MF. Between 2012-2019 (cutoff March 2021), 
      928 patients (JAKi-naive and -pretreated) enrolled from 122 German centers. This 
      analysis focuses on JAKi-naive patients. RUX was administered according to the 
      Summary of Product Characteristics. Compared to the COMFORT-I, -II, and JUMP 
      trials, patients in JAKoMo were older (median 73 years), had poorer Eastern 
      Cooperative Oncology Group (ECOG) performance statuses (16.5% had ECOG >/= 2), and 
      were more transfusion dependent (48.5%). JAKoMo represents the more challenging 
      patients with MF encountered outside of interventional studies. However, patients 
      with low-risk International Prognostic Scoring System (IPSS) scores or without 
      palpable splenomegaly were also included. Following RUX treatment, 82.5% of 
      patients experienced rapid (</= 1 month), significant decreases in palpable spleen 
      size, which remained durable for 24 months (60% patients). Symptom assessment 
      scores improved significantly in Month 1 (median -5.2) up to Month 12 (-6.2). 
      Common adverse events (AEs) were anemia (31.2%) and thrombocytopenia (28.6%). At 
      cutoff, 54.3% of patients had terminated the study due to, death, AEs, or 
      deterioration of health. No new safety signals were observed. Interim analysis of 
      the JAKoMo study confirms RUX safety and efficacy in a representative cohort of 
      real-world, elderly, JAKi-naive patients with MF. Risk scores were used in less 
      than half of the patients to initiate RUX treatment.Trial registration: 
      NCT05044026; September 14, 2021.
CI  - (c) 2023. The Author(s).
FAU - Koschmieder, Steffen
AU  - Koschmieder S
AUID- ORCID: 0000-0002-1011-8171
AD  - Department of Hematology, Oncology, Hemostaseology, and Stem Cell 
      Transplantation, Faculty of Medicine, RWTH Aachen University, Aachen, Germany. 
      skoschmieder@ukaachen.de.
AD  - Center for Integrated Oncology, Aachen Bonn Cologne Dusseldorf (CIO ABCD), 
      Aachen, Germany. skoschmieder@ukaachen.de.
FAU - Isfort, Susanne
AU  - Isfort S
AUID- ORCID: 0000-0002-2855-561X
AD  - Department of Hematology, Oncology, Hemostaseology, and Stem Cell 
      Transplantation, Faculty of Medicine, RWTH Aachen University, Aachen, Germany.
AD  - Center for Integrated Oncology, Aachen Bonn Cologne Dusseldorf (CIO ABCD), 
      Aachen, Germany.
FAU - Schulte, Clemens
AU  - Schulte C
AD  - Gemeinschaftspraxis Fur Hamatologie Und Onkologie, Dortmund, Germany.
FAU - Jacobasch, Lutz
AU  - Jacobasch L
AUID- ORCID: 0000-0001-7519-8830
AD  - Gemeinschaftspraxis Hamatologie - Onkologie, Dresden, Germany.
FAU - Geer, Thomas
AU  - Geer T
AD  - Medizinische Klinik III, Diakonie-Klinikum Schwabisch Hall, Schwabisch Hall, 
      Germany.
FAU - Reiser, Marcel
AU  - Reiser M
AUID- ORCID: 0000-0002-0457-7793
AD  - Praxis Internistischer Onkologie Und Hamatologie, Cologne, Germany.
FAU - Koenigsmann, Michael
AU  - Koenigsmann M
AD  - Onkologisches Ambulanzzentrum (OAZ) Hannover, Hannover, Germany.
FAU - Heinrich, Bernhard
AU  - Heinrich B
AD  - Hamatologisch-Onkologische Praxis Heinrich/Bangerter, Augsburg, Germany.
FAU - Wehmeyer, Jurgen
AU  - Wehmeyer J
AD  - Gemeinschaftspraxis Fur Hamatologie Und Onkologie, Munster, Germany.
FAU - von der Heyde, Eyck
AU  - von der Heyde E
AD  - Onkologische Schwerpunktpraxis Dres. Ingo Zander und Eyck von der Heyde, 
      Hannover, Germany.
FAU - Tesch, Hans
AU  - Tesch H
AD  - Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus, Frankfurt/Main, 
      Germany.
FAU - Groschl, Benedikt
AU  - Groschl B
AD  - Providing services for Novartis Pharma GmbH, Nurnberg, Germany.
FAU - Bachhuber, Petra
AU  - Bachhuber P
AD  - Novartis Pharma GmbH, Nurnberg, Germany.
FAU - Grosser, Susanne
AU  - Grosser S
AD  - Novartis Pharma GmbH, Nurnberg, Germany.
FAU - Pahl, Heike L
AU  - Pahl HL
AUID- ORCID: 0000-0003-2857-2396
AD  - Department of Medicine I, Medical Center - University of Freiburg, Faculty of 
      Medicine, University of Freiburg, Freiburg, Germany. 
      heike.pahl@klinikum.unifreiburg.de.
LA  - eng
SI  - ClinicalTrials.gov/NCT05044026
PT  - Clinical Trial, Phase IV
PT  - Journal Article
DEP - 20231004
PL  - Germany
TA  - Ann Hematol
JT  - Annals of hematology
JID - 9107334
RN  - 0 (Janus Kinase Inhibitors)
RN  - 82S8X8XX8H (ruxolitinib)
RN  - 0 (Nitriles)
SB  - IM
MH  - Adult
MH  - Humans
MH  - Aged
MH  - *Janus Kinase Inhibitors
MH  - Splenomegaly/drug therapy
MH  - *Primary Myelofibrosis/diagnosis/drug therapy
MH  - Prospective Studies
MH  - Nitriles
MH  - Treatment Outcome
PMC - PMC10640411
OTO - NOTNLM
OT  - JAK1/2 inhibitors
OT  - JAKoMo clinical trial
OT  - Myelofibrosis
OT  - Patient-reported outcome measures (PROMs)
OT  - Real-world evidence
OT  - Ruxolitinib
COIS- Steffen Koschmieder reports funding from Novartis, Bristol-Myers Squibb, AOP 
      Pharma, Janssen, Geron; advisory board honoraria from Pfizer, Incyte, Ariad, 
      Novartis, AOP Pharma, BMS, Celgene, Geron, Janssen, CTI, Roche, Baxalta, Sanofi, 
      Sierra Oncology, GSK, Abbvie; patent fur BET inhibitor at RWTH Aachen University; 
      honoraria from Novartis, BMS, Celgene, Geron, Janssen, Pfizer, Incyte, Ariad, 
      Shire, Roche, AOP Pharma, GSK, Abbvie; and other financial support (e.g. travel 
      support) from Alexion, Novartis, BMS, Incyte, Ariad, AOP Pharma, Baxalta, CTI, 
      Pfizer, Sanofi, Celgene, Shire, Janssen, Geron, Abbvie, Karthos, Sierra Oncology, 
      Imago Bioscience, GSK, Abbvie. Susanne Isfort reports advisory board honoraria 
      from Pfizer, Incyte, and Novartis, honoraria from Novartis, BMS, Pfizer, Incyte, 
      Abbvie, AOP Orphan and other financial support (e.g. travel support) from 
      Alexion, Novartis, Pfizer, Mundipharma, Roche, Hexal and AOP Orphan. Heike Pahl 
      reports advisory board honoraria from Novartis and AOP Pharma.
EDAT- 2023/10/04 12:42
MHDA- 2023/11/13 06:42
PMCR- 2023/10/04
CRDT- 2023/10/04 11:05
PHST- 2023/07/28 00:00 [received]
PHST- 2023/09/16 00:00 [accepted]
PHST- 2023/11/13 06:42 [medline]
PHST- 2023/10/04 12:42 [pubmed]
PHST- 2023/10/04 11:05 [entrez]
PHST- 2023/10/04 00:00 [pmc-release]
AID - 10.1007/s00277-023-05458-1 [pii]
AID - 5458 [pii]
AID - 10.1007/s00277-023-05458-1 [doi]
PST - ppublish
SO  - Ann Hematol. 2023 Dec;102(12):3383-3399. doi: 10.1007/s00277-023-05458-1. Epub 
      2023 Oct 4.