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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
Authors
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Authors Affiliations
  1. 1. School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  2. 2. I.M. Sechenov First Moscow State Medical University, Moscow, Russian Federation
  3. 3. Student Research Committee, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
  4. 4. School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran
  5. 5. Faculty of Medicine, Islamic Azad University, Yazd Branch, Yazd, Iran
  6. 6. Student Research Committee, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran
  7. 7. Students Research Committee, School of Pharmacy, Zanjan University of Medical Sciences, Zanjan, Iran
  8. 8. Students Research Committee, School of Medicine, Iran University of Medical Sciences, Tehran, Iran
  9. 9. Student Research Committee, Tehran University of Medical Sciences, Tehran, Iran

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.
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