Ibrutinib discontinuation and associated factors in a real-world national sample of elderly Medicare beneficiaries with chronic lymphocytic leukemia

Abstract

Prior studies evaluating ibrutinib discontinuation are limited to clinical trials and selected medical centers and hence may not reflect real-world practice. This study used Medicare claims (2013–2019) to examine ibrutinib discontinuation and associated factors among elderly patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Over a median follow-up of 2.1 years, two-thirds (65.2%) of the 11,870 new ibrutinib initiators were discontinued, with half (45.1%) of patients discontinuing within 12 months of initiation. Factors such as advanced age, lack of Part D low-income subsidy, evidence of prior CLL/SLL treatment, and cardiovascular comorbidities (e.g. atrial fibrillation) were associated with higher risk of discontinuation. Over a median of 1.2 years from discontinuation, 40% of discontinuers initiated another CLL/SLL treatment after ibrutinib discontinuation; 25% of patients restarted ibrutinib treatment at some point over follow-up. Our findings point to a large unmet need with the widely used BTKi ibrutinib and underscore the importance of ongoing development of efficacious and well-tolerated CLL/SLL therapies.

Keywords:

• Chronic lymphocytic leukemia
• ibrutinib
• Medicare
• elderly
• discontinuation

Disclosure statement

SFH: consultancy for Janssen, Pharmacyclics, AbbVie, AstraZeneca, Flatiron Health Inc., Novartis, SeaGen, Genentech, 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 & Co., Inc. JP and SKB are employees of COVIA Health Solutions, a consulting firm with clients in the biotech/pharmaceutical industry. JAD: consultancy for AbbVie, Acadia, Allergan, Boehringer Ingelheim, Catabasis, Ironwood Pharmaceuticals, Janssen, Kite Pharma, MeiraGTx, Merck, Otsuka, Regeneron, Sarepta, Sage Therapeutics, Sanofi, Takeda, The Medicines Company, and Vertex; research funding from AbbVie, Biogen, Humana, Janssen, Merck, Novartis, Pfizer, PhRMA, Regeneron, Sanofi, and Valeant.

Additional information

Funding

This study was funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, New Jersey, USA. The sponsor was involved in the interpretation of the results and drafting of the manuscript.