Pf387 French Ibrutinib Observational Study (Fire): Real‐world Study of Ibrutinib Treatment for Chronic Lymphocytic Leukemia (Cll) in France

Dartigeas, Caroline; Feugier, Pierre; Ysebaert, Loïc; Dilhuydy, Marie Sarah; Delmer, Alain; Tardy, Stéphanie; Annibale, Bruno; Voillat, Laurent; Dû, Katell Le; Slama, Borhane; Albrecht, Claire; Jenayah, L.; Beauclair, S.; Wapenaar, Robert; Kavanagh, Caitlin; Leblond, Véronique

doi:10.1097/01.hs9.0000559760.20946.1f

Cited by 3 publications

(1 citation statement)

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“…Despite increasing use in B-cell malignancies, the postmarketing safety profile of ibrutinib remains unclear. While several studies have assessed the safety of ibrutinib in real life settings, but they have been focused on specific ADRs, such as infectious, bleeding or cardiovascular ADRs (Lipsky et al, 2015;Varughese et al, 2018;Dartigeas et al, 2019;Dickerson et al, 2019;Salem et al, 2019;Frei et al, 2020). Unlike chemotherapy, which is given for a finite number of cycles, ibrutinib is continued until the occurrence of disease progression or unacceptable toxicity.…”

Section: Introductionmentioning

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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Section: Introductionmentioning

confidence: 99%

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

et al. 2021

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Effectiveness and Safety of Ibrutinib for Chronic Lymphocytic Leukemia in Routine Clinical Practice: 3-Year Follow-up of the Belgian Ibrutinib Real-World Data (BiRD) Study

et al. 2022

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The multicenter observational BiRD study investigated the real-world effectiveness and safety of ibrutinib in patients with chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL) and Waldenström’s macroglobulinemia (WM) in Belgium. This interim analysis reports results for patients with CLL, with a median follow-up of 34 months. Overall, patients had predominantly relapsed/refractory disease (73%) and were elderly (median age 72 years) with high-risk features such as del17p and/or TP53 mutations (59%). Patients were included either prospectively or retrospectively, and the total patient population effectiveness results were adjusted with left truncation. In the effectiveness population (N = 221: prospective, n = 71; retrospective, n = 150), the overall response rate was 90.0%. Median progression-free survival was 38.3 months (prospective, not estimable; retrospective, 51.5 months) and median overall survival was not yet estimable in the total, prospective and retrospective groups. Treatment-emergent adverse events (TEAEs) for the prospective and retrospective groups are reported separately. Any-grade TEAEs of interest in the prospective/retrospective groups included infections (67.1%/60.1%), diarrhea (20.5%/10.5%), hypertension (16.4%/9.8%) and atrial fibrillation (12.3%/7.2%). Major bleeding was reported in 5.5%/3.3% of prospective/retrospective patients, with little difference observed between those receiving versus not receiving antithrombotic treatment. Discontinuations due to toxicity were reported in 10.5% of patients. Results from this interim analysis show treatment with ibrutinib to be effective and tolerable, with no new safety signals observed. Future analyses will report on longer-term follow-up.

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The safety of Bruton's tyrosine kinase inhibitors in B‐cell malignancies: A systematic review

Arustamyan

Kibrik

Hatipoglu

et al. 2022

European J of Haematology

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B‐cell malignancies, most notably lymphomas, make up most of the non‐Hodgkin lymphomas in the United States. There are limited randomized data comparing first‐ and second‐generation Bruton tyrosine kinase (BTK) inhibitors. Our aim was to compare the safety profiles of first versus second‐generation BTK inhibitors. A systematic search was performed from database inception to January 13, 2020. Studies with BTK inhibitor monotherapy for the treatment of B‐cell malignancies in the adult population (>18 years old) were utilized and the adverse events (AEs) were extracted. Fifty‐five studies that met the inclusion criteria were included in the systematic review with 41 studies with first generation and 14 studies with second generation. The review included both clinical trials and retrospective studies with average time of follow‐up of 2 years for the first‐generation group and 18 months for the second‐generation group. We found that the incidence of cardiovascular AEs was significantly higher in the first‐generation group (20.8%) as compared to the second‐generation group (6.3%). However, there was a higher incidence of hematologic/oncologic and gastrointestinal side effects in the second‐generation group compared to the first (62.3% compared to 39.2% and 36.9% compared to 28.9%). The number of Grade 5 cardiovascular events (death) was same in the first‐generation group compared to the second generation. Further research is needed to develop highly selective BTK inhibitors to avoid unwanted AEs by minimizing off‐targets.

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Pf387 French Ibrutinib Observational Study (Fire): Real‐world Study of Ibrutinib Treatment for Chronic Lymphocytic Leukemia (Cll) in France

Cited by 3 publications

References 0 publications

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

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

Effectiveness and Safety of Ibrutinib for Chronic Lymphocytic Leukemia in Routine Clinical Practice: 3-Year Follow-up of the Belgian Ibrutinib Real-World Data (BiRD) Study

The safety of Bruton's tyrosine kinase inhibitors in B‐cell malignancies: A systematic review

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