A retrospective observational study of ibrutinib in chronic lymphocytic leukaemia in a real-life setting in France using the national claims database (OSIRIS)

• DOI: 10.1007/s00277-024-05859-w
• Publication Date: 2024-07-05T03:33:53Z
• Authors: Sylvain Choquet; Clarisse Marchal; Floriane Deygas; Marine Deslandes; Nahid Macher; Gérard de Pouvour...; Vincent Levy
• Keywords: Hematology

Abstract Background Ibrutinib is a Bruton’s tyrosine kinase inhibitor indicated for the first-line treatment and relapse of chronic lymphocytic leukaemia (CLL), Waldenström’s macroglobulinemia (WM) mantle cell lymphoma (MCL). This study aimed to describe characteristics CLL patients treated with ibrutinib its effectiveness, safety, pattern in real life. Methods All covered by general health scheme (approximately 80% French population) first dispensation from August 1, 2017 (date reimbursement France) December 31, 2020, were identified National Health Insurance database (SNDS). An algorithm was developed identify disease (CLL, MCL or WM) which prescribed. article focused on patients. The time next (TTNT) plotted using Kaplan‒Meier curves. Results During this period, 6,083 initiated ibrutinib, among whom 2,771 (45.6%) had (mean age 74 years; 61% men). At initiation, 46.6% cardiovascular comorbidity. Most (91.7%) not hospitalized during exposure period one bleeding events studied. Hospitalizations more frequent comorbidity (5.9% versus 11.0%, p-value < 0.0001) aged over 70 9.4%, 0.0001). median TTNT reached. Conclusion largest cohorts ibrutinib-treated world. profile accordance marketing authorization reimbursement. confirmed effectiveness safety data.