Real World Results of Ibrutinib in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia: A Meta-Analysis of Clinical Studies Publisher Pubmed



Karimi MA¹ ; Norooziseyedhosseini H² ; Khademi R³ ; Ghajary A⁴ ; Kargar H⁵ ; Abdollahi SS⁶ ; Belbasi M⁷ ; Naziri M⁸ ; Deravi N¹ ; Hajihosseini S⁹ ; Mofidi S⁹
Source: BMC Pharmacology and Toxicology Published:2025

Abstract

Background: Chronic lymphocytic leukemia (CLL) is a B-cell malignancy primarily diagnosed in older adults. For younger patients, treatment options often include regimens based on fludarabine, cyclophosphamide, and rituximab; however, at least 20% of patients exhibit resistance to these therapies. Ibrutinib, a covalent Bruton’s tyrosine kinase (BTK) inhibitor, has demonstrated enhanced safety compared to conventional treatments. This meta-analysis examines the efficacy and safety of ibrutinib in managing relapsed/refractory CLL. Method: Relevant keywords were used to conduct a comprehensive search across online databases, including PubMed, Scopus, and Google Scholar. Data related to complete response (CR), overall response rate (ORR), and adverse events were extracted to evaluate the efficacy and safety of ibrutinib treatment. The results were presented in forest plots illustrating event rates and risk ratios with 95% confidence intervals (CI), while heterogeneity was assessed using I² statistics. Funnel plots were employed to examine potential publication bias visually. Result: Twenty-one studies were included in this meta-analysis. Ibrutinib as a single-agent treatment was associated with a 9% complete response (CR) rate (95% CI: 5–14%) and a 77% overall response rate (ORR) (95% CI: 70–83%). When combined with other agents, ibrutinib achieved a CR rate of 21% (95% CI: 9–41%) and an ORR of 84% (95% CI: 80–88%). Adverse events were not significantly correlated with treatment outcomes. Funnel plots indicated no significant publication bias. Conclusion: Single-agent ibrutinib has proven to be an effective therapy for patients with relapsed/refractory CLL. However, combining ibrutinib with other agents has demonstrated enhanced treatment efficacy. Further studies are needed to evaluate the safety profile of this therapeutic regimen thoroughly. © The Author(s) 2025.