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. 2023 May;110(5):540-547.
doi: 10.1111/ejh.13928. Epub 2023 Feb 15.

High risk of infection in 'real-world' patients receiving ibrutinib, idelalisib or venetoclax for mature B-cell leukaemia/lymphoma

Amanda Tey  1 , James Schwarer  2 , Robert Raffa  1 , Emily Shi  1 , Eldho Paul  3 , Stephen Opat  4   5 , Claire Dendle  2   4 , Jake Shortt  4   5
Affiliations

High risk of infection in 'real-world' patients receiving ibrutinib, idelalisib or venetoclax for mature B-cell leukaemia/lymphoma

Amanda Tey et al. Eur J Haematol. 2023 May.

Abstract

Objective: The infection risk in patients receiving ibrutinib, idelalisib or venetoclax for chronic lymphocytic leukaemia (CLL) or B-cell lymphoma treated outside of clinical trials is incompletely defined. We sought to identify the severe infection rate and associated risk factors in a 'real-world' cohort.

Methods: We conducted a retrospective cohort study of adult patients with CLL or lymphoma treated with ibrutinib, idelalisib or venetoclax.

Results: Of 67 patients identified (ibrutinib n = 53, idelalisib n = 8 and venetoclax n = 6), 32 (48%) experienced severe infection. Severe infection occurred at a rate of 65 infections per 100 person-years, with a median of 17.8 months of therapy. Median time to first infection (IQR) was 5.4 months (1.4-15.9). Poor baseline Eastern Cooperative Oncology Group (ECOG) performance status and high Charlson Comorbidity Index (CCI) score associated with increased risk of severe infection [hazard ratios (95% CI) 1.57 (1.07-2.31, p = .018) and 1.3 (1.05-1.62, p = .016) respectively].

Conclusion: The severe infection rate for patients receiving ibrutinib, idelalisib or venetoclax for lymphoma and CLL exceeded those reported in clinical trials. Patients with poor ECOG or high CCI should be closely monitored for early signs of infection and prevention strategies actively pursued. Further prospective research is required to define optimal antimicrobial prophylaxis recommendations.

Keywords: ibrutinib; idelalisib; infection; lymphoma; venetoclax.

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Conflict of interest statement

Jake Shortt has received research funding from Astex Pharmaceutical Inc., Amgen and Bristol Myers Squibb/Celgene; Jake Shortt has served on Advisory Boards for Novartis, BMS, Mundipharma and Astellas. Stephen Opat has provided consultancy to AbbVie, Astra Zeneca, Janssen and Roche; Stephen Opat has received research funding from Amgen and Beigene; Stephen Opat has received honoraria from AbbVie, Astra Zeneca, Celgene, CSL Behring, Gilead, Janssen, Merck, Roche and Takeda; Stephen Opat has served on Advisory Boards for AbbVie, Astra Zeneca, Celgene, CSL Behring, Gilead, Janssen, Merck, Roche and Takeda.

Figures

FIGURE 1
FIGURE 1
Consort diagram indicating selection of participants included in final analyses.
FIGURE 2
FIGURE 2
(A) Number of severe infections per subject. (B) Highest CTCAE infection grade per patient with infection. CTCAE, Common Terminology Criteria for Adverse Events; G3, grade 3; G4, grade 4; G5, grade 5.
See this image and copyright information in PMC

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