Mayo Clinic proceedings. Innovations, quality & outcomes · 2026
Safety Profile of Chimeric Antigen Receptor T-cell Therapies in Diffuse Large B-cell Lymphoma: An Analysis of Real-World Adverse Event Reporting From the FDA Adverse Event Reporting System.
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Elsallab Magdi, Lunning Matthew, Ellithi Moataz, Toron Farah, Braun Robert, Wang Lin, Wang Pearl, Jones Maxwell, Maus Marcela V
Аннотация
OBJECTIVE: To compare the real-world safety profiles of lisocabtagene maraleucel (liso-cel) and axicabtagene ciloleucel (axi-cel) in patients with diffuse large B-cell lymphoma, leveraging data from the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database.
PATIENTS AND METHODS: Case reports submitted to FAERS (Q4 2017 to Q3 2024) were evaluated if liso-cel or axi-cel was identified as the primary suspect therapy for adverse events of interest such as cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), cytopenia, and infections. Disproportionality analyses compared AE frequencies using reporting odds ratios (ROR). Concomitant treatment use rates were captured to assess the need for supportive medications.
RESULTS: Among 3251 diffuse large B-cell lymphoma-related reports, liso-cel was the primary therapy in 232 cases compared with 3019 attributed to axi-cel. Liso-cel had significantly lower RORs (95% CI) for CRS (0.68; 0.52-0.89), ICANS (0.62; 0.47-0.82), and cytopenia (0.41; 0.24-0.71) vs axi-cel; infection rates were similar (0.73; 0.40-1.33). Fewer patients used concomitant treatments with liso-cel than axi-cel (49 [21.1%] vs 1019 [33.8%]; P<.001), particularly corticosteroids, azoles, and levetiracetam. Tocilizumab use was similar (8 [3.5%] liso-cel vs 97 [3.2%] axi-cel), and intravenous immunoglobulin use was rare (<1%).
CONCLUSION: Liso-cel reported a more favorable safety profile than axi-cel, with fewer reports of CRS, ICANS, cytopenia, and the need for supportive medications. Although efficacy outcomes were not analyzed, safety outcomes are consistent with previously published indirect treatment comparisons and can inform evidenced-based decision-making of clinicians.
PATIENTS AND METHODS: Case reports submitted to FAERS (Q4 2017 to Q3 2024) were evaluated if liso-cel or axi-cel was identified as the primary suspect therapy for adverse events of interest such as cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), cytopenia, and infections. Disproportionality analyses compared AE frequencies using reporting odds ratios (ROR). Concomitant treatment use rates were captured to assess the need for supportive medications.
RESULTS: Among 3251 diffuse large B-cell lymphoma-related reports, liso-cel was the primary therapy in 232 cases compared with 3019 attributed to axi-cel. Liso-cel had significantly lower RORs (95% CI) for CRS (0.68; 0.52-0.89), ICANS (0.62; 0.47-0.82), and cytopenia (0.41; 0.24-0.71) vs axi-cel; infection rates were similar (0.73; 0.40-1.33). Fewer patients used concomitant treatments with liso-cel than axi-cel (49 [21.1%] vs 1019 [33.8%]; P<.001), particularly corticosteroids, azoles, and levetiracetam. Tocilizumab use was similar (8 [3.5%] liso-cel vs 97 [3.2%] axi-cel), and intravenous immunoglobulin use was rare (<1%).
CONCLUSION: Liso-cel reported a more favorable safety profile than axi-cel, with fewer reports of CRS, ICANS, cytopenia, and the need for supportive medications. Although efficacy outcomes were not analyzed, safety outcomes are consistent with previously published indirect treatment comparisons and can inform evidenced-based decision-making of clinicians.