Brief Summary

Ibrutinib, an oral inhibitor of Bruton tyrosine kinase (BTK), has recently revolutionized the treatment of various chronic B-cell malignancies and particularly chronic lymphocytic leukemia (CLL). Atrial fibrillation (AF) has early emerged as a cardiovascular adverse effect (CVAE) of ibrutinib but underlying mechanisms of IRAF are not fully understood.

While a dose-reduction or an interruption of ibrutinib is mentioned in the summary of product characteristics of ibrutinib, any beneficial effect on IRAF management of such a management is unclear.

The main aim of this study is to determine if IRAF is a dose-dependent CVAE in chronic B-cell malignancies patients by studying the association between ibrutinib dose and IRAF reporting in Vigibase®, the World Health Organization (WHO) pharmacovigilance database.

Conditions

• Hematological Malignancy
• Atrial Fibrillation

Intervention / Treatment

• Drug: ibrutinib exposure

Primary Outcome Measures

• to determine the influence of ibrutinib dosing on IRAF reporting. Results were expressed as 2-by2 comparisons against the lowest dosing regimen (140mg/day). (Cases reported in the World Health Organization (WHO) of individual safety case reports to 26th July 2023)
  Disproportionality estimates will be perform using both univariate and multivariate analyses and a global p-value will measure the difference between dosing regimen

Countries

France

Locations and Investigators

• Caen University Hospital, Department of Pharmacology, Caen, France

Study Officials

• Joachim Alexandre, MD (Principal Investigator) — University Hospital, Caen