Premium
Patterns of use and safety of ibrutinib in real‐life practice
Author(s) -
Allouchery Marion,
Tomowiak Cécile,
Guidez Stéphanie,
Delwail Vincent,
Delaunay Paul,
LafayChebassier Claire,
Salvo Francesco,
PéraultPochat MarieChristine
Publication year - 2021
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1111/bcp.14440
Subject(s) - ibrutinib , medicine , hazard ratio , interquartile range , cumulative incidence , proportional hazards model , adverse effect , confidence interval , incidence (geometry) , cohort , chronic lymphocytic leukemia , leukemia , physics , optics
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.