PMID- 38348963
OWN - NLM
STAT- MEDLINE
DCOM- 20240214
LR  - 20240312
IS  - 2045-7634 (Electronic)
IS  - 2045-7634 (Linking)
VI  - 13
IP  - 2
DP  - 2024 Jan
TI  - Real-world analysis of adverse event rates after initiation of ibrutinib among 
      Medicare beneficiaries with chronic lymphocytic leukemia.
PG  - e6953
LID - 10.1002/cam4.6953 [doi]
LID - e6953
AB  - BACKGROUND: The first-generation BTK inhibitor ibrutinib is a standard-of-care 
      therapy in the treatment of chronic lymphocytic leukemia (CLL) despite potential 
      side effects that often lead to discontinuation. METHODS: This study used 
      2013-2019 claims data to describe the incidence rate of adverse events (AEs) 
      among elderly Medicare beneficiaries newly initiating ibrutinib for CLL. RESULTS: 
      The final sample contained 11,870 Medicare beneficiaries with CLL (mean age 77.2) 
      newly initiating ibrutinib, of whom 65.2% discontinued over mean follow-up of 
      2.3 years. The overall incidence rate of AEs was 62.5 per 1000 patient-months for 
      all discontinuers and 32.9 per 1000 patient-months for non-discontinuers. 
      Discontinuers had a higher incidence rate of AEs per 1000 patient-months compared 
      with non-discontinuers for all AEs examined, including infection (22.8 vs. 14.5), 
      atrial fibrillation (15.1 vs. 7.0), anemia (21.9 vs. 14.5), and 
      arthralgia/myalgia (19.5 vs. 13.6). CONCLUSION: In this first real-world study of 
      a national sample of elderly US patients treated with ibrutinib, we found a clear 
      unmet need for improved management of ibrutinib-related AEs and/or new treatments 
      to improve real-world outcomes in patients with CLL.
CI  - (c) 2024 Merck Sharp & Dohme LLC. Cancer Medicine published by John Wiley & Sons 
      Ltd.
FAU - Huntington, Scott F
AU  - Huntington SF
AUID- ORCID: 0000-0001-7071-6475
AD  - Department of Internal Medicine, Section of Hematology, Yale University School of 
      Medicine, New Haven, Connecticut, USA.
FAU - de Nigris, Enrico
AU  - de Nigris E
AD  - MSD (UK) Limited, London, UK.
FAU - Puckett, Justin T
AU  - Puckett JT
AUID- ORCID: 0000-0002-5135-7216
AD  - COVIA Health Solutions, Ambler, Pennsylvania, USA.
FAU - Kamal-Bahl, Sachin
AU  - Kamal-Bahl S
AD  - COVIA Health Solutions, Ambler, Pennsylvania, USA.
FAU - Farooqui, Mohammed
AU  - Farooqui M
AD  - Merck & Co., Inc, Rahway, New Jersey, USA.
FAU - Ryland, Katherine
AU  - Ryland K
AD  - Merck & Co., Inc, Rahway, New Jersey, USA.
FAU - Sarpong, Eric M
AU  - Sarpong EM
AD  - Merck & Co., Inc, Rahway, New Jersey, USA.
FAU - Leng, Siyang
AU  - Leng S
AD  - Merck & Co., Inc, Rahway, New Jersey, USA.
FAU - Yang, Xiaoqin
AU  - Yang X
AD  - Merck & Co., Inc, Rahway, New Jersey, USA.
FAU - Doshi, Jalpa A
AU  - Doshi JA
AD  - Division of General Internal Medicine, Perelman School of Medicine, University of 
      Pennsylvania, Philadelphia, Pennsylvania, USA.
LA  - eng
GR  - UL1 TR001863/TR/NCATS NIH HHS/United States
PT  - Journal Article
PL  - United States
TA  - Cancer Med
JT  - Cancer medicine
JID - 101595310
RN  - 1X70OSD4VX (ibrutinib)
RN  - JAC85A2161 (Adenine)
RN  - 0 (Piperidines)
RN  - 0 (Protein Kinase Inhibitors)
SB  - IM
MH  - Humans
MH  - Aged
MH  - United States/epidemiology
MH  - *Leukemia, Lymphocytic, Chronic, B-Cell/drug therapy/epidemiology
MH  - Medicare
MH  - Adenine/adverse effects/*analogs & derivatives
MH  - Piperidines/adverse effects
MH  - Protein Kinase Inhibitors/adverse effects
PMC - PMC10832339
OTO - NOTNLM
OT  - Medicare
OT  - adverse event
OT  - chronic lymphocytic leukemia
OT  - discontinuation
OT  - elderly
OT  - ibrutinib
COIS- SFH: consultancy for Janssen, Pharmacyclics, AbbVie, AstraZeneca, Flatiron Health 
      Inc., Novartis, SeaGen, Genetech, Merck, TG Therapeutics, ADC Therapeutics, 
      Epizyme, Servier, Arvinas, and Thyme Inc.; research funding from Celgene, DTRM 
      Biopharm, and TG Therapeutics; honoraria form Pharmacyclics and AstraZeneca, 
      Bayer; EDN, MF, KR, ES, SL, and XY are employees of Merck Sharp & Dohme LLC, a 
      subsidiary of Merck & Co., Inc., Rahway, New Jersey, USA; JP and SKB are 
      employees of COVIA Health Solutions, a consulting form with clients in the 
      biotech/pharmaceutical industry; JAD: consultancy for AbbVie, Acadia, Janssen, 
      Merck, Otsuka, and Takeda; research funding from Janssen, Merck, and Spark 
      Therapeutics.
EDAT- 2024/02/13 12:48
MHDA- 2024/02/14 12:50
PMCR- 2024/02/01
CRDT- 2024/02/13 08:26
PHST- 2023/12/11 00:00 [revised]
PHST- 2023/10/11 00:00 [received]
PHST- 2024/01/10 00:00 [accepted]
PHST- 2024/02/14 12:50 [medline]
PHST- 2024/02/13 12:48 [pubmed]
PHST- 2024/02/13 08:26 [entrez]
PHST- 2024/02/01 00:00 [pmc-release]
AID - CAM46953 [pii]
AID - 10.1002/cam4.6953 [doi]
PST - ppublish
SO  - Cancer Med. 2024 Jan;13(2):e6953. doi: 10.1002/cam4.6953.