Patterns of use and safety of ibrutinib in real‐life practice

Abstract

Aims To provide real‐life data on patterns of use and safety of ibrutinib. Methods A cohort study including all patients initiating ibrutinib between 21 November 2014 and 21 November 2018, and followed for 1 year was conducted. Patient characteristics, ibrutinib use and adverse drug reactions (ADRs) were collected from medical records. Kaplan–Meier analysis estimated the probability of developing ibrutinib‐associated serious ADRs (SADRs) with a 95% confidence interval (CI). A Cox proportional hazards model was used to investigate factors associated with SADR occurrence. Results In total, 102 patients were included in the study. The median age was 70.3 years (interquartile range 64.7–75.6), the male/female gender ratio was 2.9. Almost half the patients (47.1%) were prescribed ibrutinib for chronic lymphocytic leukaemia (CLL). Forty‐three patients (42.1%) permanently discontinued ibrutinib in the first year, mostly for progression (51.2%) or ADRs (32.6%). Forty‐eight patients (47.1%) experienced at least one ibrutinib‐associated SADR. Haematological, infectious and vascular disorders were the most frequent SADRs. The probability of developing ibrutinib‐associated SADR was 35.1% (95% CI 26.3–45.7%) at 3 months, 44.8% (35.2%; 55.8%) at 6 months and 54.3% (44.0%; 65.2%) at 12 months. Age ≥80 years (hazard ratio [HR] 2.03; 95% CI 1.02–4.05) and CLL (HR 1.81; 95% CI 1.01–3.25) were significantly associated with a higher risk of SADR occurrence. Conclusion This study found a high cumulative incidence of ibrutinib‐associated SADRs within the first year of treatment. In view of the risk of SADR, patients aged ≥80 years or treated for CLL deserve special attention.

Efficacy and Safety of Ibrutinib Therapy in Patients with Chronic Lymphocytic Leukemia: Retrospective Analysis of Real-Life Data

“…In a recent French study on patterns of use and safety of ibrutinib in real-life practice in 102 patients, half of whom were CLL patients, the authors reported that 42.1% of patients permanently discontinued ibrutinib in the first year, mostly for progression (51.2%) or adverse drug reactions (ADRs) (32.6%), while 47.1% of patients experienced at least one ibrutinib-associated serious ADR (SADR; hematological, infectious, and vascular disorders in particular) [ 33 ]. These authors also reported the probability of developing an ibrutinib-associated SADR to be 35.1% (95% CI: 26.3-45.7) at 3 months, 44.8% (95% CI: 35.2-55.8) at 6 months, and 54.3% (95% CI: 44.0-65.2) at 12 months, further indicating a significant association of age of ≥80 years (hazard ratio [HR]: 2.03; 95% CI: 1.02-4.05) and being treated for CLL (HR: 1.81; 95% CI: 1.01-3.25) with a higher risk of SADR occurrence [ 33 ].…”

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

“…As a result, comorbidity burden and co-medications could compromise the safety of ibrutinib in real-life practice. In a previously published cohort study (n 102 patients), patients aged ≥80 years were at higher risk of serious adverse drug reaction (SADR) within the first year of ibrutinib treatment (Allouchery et al, 2021).…”

Severe infections in patients with lymphoproliferative diseases treated with new targeted drugs: A multicentric real‐world study

“…Ibrutinib not only inhibits BTK potently and irreversibly, but it also inhibits other related Tec family kinases, and off‐target inhibition appears to contribute to specific ibrutinib toxicities. 4 , 5 It also regulates other cells of the immune system, such as receptor‐mediated phagocytosis of Candida albicans 6 , 7 in macrophages. A “net state of immunosuppression” has been proposed, which includes factors affecting the adaptive and innate immune system, disease‐related factors, aging, comorbidities, immunosuppressive drugs, and possibly a genetic predisposition as contributing to ibrutinib‐associated IFI.…”