Unusual, spontaneous aneurysm formation in a patient being treated with ibrutinib for chronic lymphocytic leukemia

Wiedower, Eric; Hare, Felicia; Arthur, Adam S; Chandler, Jason C.; Martin, Michael

doi:10.1177/2040620716648563

Cited by 4 publications

(3 citation statements)

References 9 publications

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“…Although the majority events are mucocutaneous, cases of hemorrhagic stroke such as ours have also been observed, albeit rarely, likely from platelet dysfunction, VWF-mediated platelet activation, and disruption of the vascular system by acting on collagen and endothelial cells. 7 Besides CVA, occurrence of peripheral neuropathy in our patient was particularly unique, which we cannot explain with any known mechanisms.…”

Section: Discussionmentioning

confidence: 61%

“…Therefore, although its off-target activity is helpful to disease regulation as well, there is evidence that it can result in long-term side effects such as slow turnover of bone due to osteoclast inhibition, 6 bleeding by interference in platelet and vascular collagen function, etc. 7 Most of our reported cases will associate with the off-target effects of ibrutinib.…”

Section: Introductionmentioning

confidence: 95%

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Case series of unique adverse events related to the use of ibrutinib in patients with B-cell malignancies—A single institution experience and a review of literature

Shaikh

Khattab

Faisal

et al. 2018

J Oncol Pharm Pract

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Background Ibrutinib, a Bruton's tyrosine kinase inhibitor has reformed the treatment of various B-cell malignancies including chronic lymphocytic leukemia, mantle cell lymphoma, and Waldenstrom's macroglobulinemia. Although generally well tolerated, here we describe our institutional experience of unique adverse effects encountered with the use of ibrutinib in patients with B-cell lymphomas. Methods This is a retrospective observational study done at a tertiary care facility, to evaluate adverse events in patients with B-cell malignancies on treatment with ibrutinib between 2014 and 2018. Further details including type of malignancy, cytogenetics, interventions for treatment of the side effect, and outcomes were obtained through electronic health record. Case series We found 10 patients with unique adverse events related to ibrutinib. Among those, six had chronic lymphocytic leukemia, two had Waldenstrom's macroglobulinemia, and two had mantle cell lymphoma. The events included palindromic rheumatoid arthritis, diffuse spongiotic dermatitis, bullous pemphigoid, recurrent hemorrhagic stroke, peripheral neuropathy, recurrent paronychia, intramedullary fibrosis, recurrent joint pains, pulmonary aspergillosis, dyspnea with exacerbation of atrial fibrillation, and resolution of autoimmune hemolytic anemia. Conclusion Our case series illustrates the wide variety of unique events recognized in patients treated with ibrutinib, some of which required cessation and most had dose reduction of the treatment. Thus, stressing the importance of early identification and intervention for the events to avoid worsening of toxicity and inability to continue treatment in such patients.

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Section: Discussionmentioning

confidence: 61%

Section: Introductionmentioning

confidence: 95%

Case series of unique adverse events related to the use of ibrutinib in patients with B-cell malignancies—A single institution experience and a review of literature

Shaikh

Khattab

Faisal

et al. 2018

J Oncol Pharm Pract

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“…Interestingly, ibrutinib was shown to interrupt collagen fibrosis in a murine model of chronic graft-versus-host disease (Dubovsky et al, 2014). Furthermore, Wiedower et al (2016) reported a cerebral aneurysm in a 46-year-old man treated for CLL, with spontaneous resolution after ibrutinib discontinuation, suggesting the possible direct role of ibrutinib on vascular remodeling. In addition to ibrutinib-induced hypertension, VEGF blockade may also explain the SDR of aortic aneurysm with ibrutinib in patients aged <75 years.…”

Section: Potential Safety Signalsmentioning

confidence: 99%

Safety Profile of Ibrutinib: An Analysis of the WHO Pharmacovigilance Database

et al. 2021

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As ibrutinib has become a standard of care in B-cell malignancies in monotherapy or in combination with other agents, definition of its safety profile appears essential. The aim of this study was to further characterize the safety profile of ibrutinib through the identification of potential safety signals in a large-scale pharmacovigilance database. All serious individual case safety reports (ICSRs) in patients aged ≥18 years involving ibrutinib suspected in the occurrence of serious adverse drug reactions or drug interacting from November 13th, 2013 to December 31st, 2020 were extracted from VigiBase, the World Health Organization global safety database. Disproportionality reporting was assessed using the information component (IC) and the proportional reporting ratio (PRR), with all other anticancer drugs used as the reference group. To mitigate the confounding of age, two subgroups were considered: patients aged<75 years and ≥75 years. A signal of disproportionate reporting (SDR) was defined if both IC and PRR were significant. A total of 16,196 ICSRs were included. The median age of patients was 72.9 years, 42.6% of ICSRs concerned patients aged ≥75 years, and 64.2% male patients. More than half (56.2%) of ICSRs resulted in hospitalization or prolonged hospitalization. Among 713 SDRs, 36 potential safety signals emerged in ibrutinib-treated patients, mainly ischemic heart diseases, pericarditis, uveitis, retinal disorders and fractures. All potential safety signals having arisen in this analysis may support patient care and monitoring of ongoing clinical trials. However, owing to the mandatory limitations of this study, our results need further confirmation using population-based studies.

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2016

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Unusual, spontaneous aneurysm formation in a patient being treated with ibrutinib for chronic lymphocytic leukemia

Cited by 4 publications

References 9 publications

Case series of unique adverse events related to the use of ibrutinib in patients with B-cell malignancies—A single institution experience and a review of literature

Case series of unique adverse events related to the use of ibrutinib in patients with B-cell malignancies—A single institution experience and a review of literature

Safety Profile of Ibrutinib: An Analysis of the WHO Pharmacovigilance Database

Ibrutinib

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