KEY TAKEAWAYS
- The study aimed to investigate the real-world effectiveness, safety, and treatment patterns of ibrutinib in patients with CLL.
- Researchers confirmed ibrutinib’s effectiveness and safety in patients with CLL, consistent with marketing authorization.
Ibrutinib is a Bruton’s tyrosine kinase inhibitor approved for the first-line (1L) treatment and relapse of chronic lymphocytic leukaemia (CLL), Waldenström’s macroglobulinemia (WM), and mantle cell lymphoma (MCL).
Sylvain Choquet and the team aimed to analyze the characteristics of patients with CLL receiving ibrutinib, evaluating its effectiveness, safety, and real-world treatment patterns.
They performed an inclusive analysis of one of the largest cohorts of ibrutinib-treated patients globally. Data were extracted from a national claims database to describe the characteristics of patients with CLL undergoing ibrutinib therapy. The study evaluated treatment patterns, effectiveness, and safety outcomes, comparing these findings with marketing authorization and reimbursement criteria.
About 6,083 patients initiated ibrutinib during this period, of whom 2,771 (45.6%) had CLL, with a mean age of 74 years; 61% were men. At the time of ibrutinib initiation, 46.6% of patients had a cardiovascular comorbidity. The majority of patients (91.7%) were not hospitalized during the exposure period for any of the cardiovascular or bleeding events studied.
However, hospitalizations were more frequent in patients with a cardiovascular comorbidity (11.0% compared to 5.9%, P-value < 0.0001) and those aged over 70 (9.4% compared to 5.9%, P-value < 0.0001). The median time to the next treatment (TTNT) was not reached.
The study concluded that ibrutinib treatment in patients with CLL aligns with marketing authorization and reimbursement guidelines. The findings confirmed the drug’s effectiveness and safety, supporting its continued use in real-world clinical settings.
The study was funded by Janssen-Cilag France.
Source: https://pubmed.ncbi.nlm.nih.gov/38965145/
Choquet S, Marchal C, Deygas F, et al. (2024). “A retrospective observational study of ibrutinib in chronic lymphocytic leukaemia in a real-life setting in France using the national claims database (OSIRIS).” Ann Hematol. 2024 Aug;103(8):2969-2981. doi: 10.1007/s00277-024-05859-w. Epub 2024 Jul 5. PMID: 38965145; PMCID: PMC11283383.
