FAERS Analysis Finds Lower Infection Burden With Ide-Cel Compared With Other BCMA Therapies

Data presented at the 2025 International Myeloma Society Annual Meeting show that idecabtagene vicleucel (ide-cel, Abecma; Celgene Corporation/Bristol Myers Squibb) is associated with a lower risk of infection compared with other BCMA-directed therapies, supported by data from a retrospective analysis of the FDA Adverse Event Reporting System (FAERS).

The findings emphasize the importance of integrating safety profiles of BCMA-directed therapies to guide treatment decisions and reduce risk, particularly infection-related burden and mortality in patients with MM who are immunocompromised or have comorbidities.

“This retrospective analysis showed a favorable [real-world] safety profile for ide-cel vs other BCMA-directed therapies in terms of infections and infection-related NRMs and hospitalizations,” the authors wrote.

FAERS is a real-world (RW), post-marketing safety surveillance database that reports instances of adverse events (AEs) for all marketed drugs approved by the FDA in the United States. The FAERS database offers long-term drug safety follow-up, capturing data from a broader patient population than clinical trials and providing increased statistical power to detect and characterize toxicities.

The authors assessed RW infection-related AEs in patients with multiple myeloma (MM) receiving BCMA-directed chimeric antigen receptor (CAR) T-cell and bispecific antibodies therapies using FAERS to capture cases of infections and infection-related non-relapse mortality (NRM) and hospitalizations. The assessment included patients treated with ide-cel, ciltacabtagene autoleucel (cilta-cel; Carvykti, Janssen Biotech, Inc/Legend Biotech), teclistamab (Teclavy; Janssen), and elranatamab (Elrexfio; Pfizer).

The authors defined Infection-related non-relapse mortality and hospitalization as deaths excluding those from progressive MM with further filtering for infections. They analyzed all case report forms (CRFs) from Q1 of 2021 to Q4 of 2024, which is the latest FAERS release.

To account for differences in follow-up duration between treatments after market approval, the authors performed sensitivity analyses that restricted the CRF analysis period to 2 years post-approval for each drug. Reporting odds ratios (RORs) were then calculated to compare treatments, with an ROR greater than 1 indicating that the event was reported more frequently for the comparator than for ide-cel.

The data revealed that of the 4809 AE reports in MM, 689 were associated with ide-cel, 1732 with teclistamab, 363 with elranatamab (n = 363), and 2025 with cilta-cel (n = 2025). Disproportionality analyses (ROR [95% CI]) showed a significantly higher frequency of infection reports in patients treated with teclistamab (3.81 [2.51–5.77]), elranatamab (5.67 [3.53–9.10]), and cilta-cel (1.78 [1.16–2.73]) vs ide-cel. Sensitivity analyses had similar results.

Teclistamab (ROR, 4.02 [95% CI, 1.43–11.32]) and elranatamab (ROR, 5.57 [95% CI, 1.76–17.65]) led to a statistically higher frequency of infection-related NRM reports compared with ide-cel. These results were comparable in ide-cel and cilta-cel (ROR, 1.01 [95% CI, 0.33–3.12]). For infection-related hospitalizations, the authors reported similar findings (teclistamab: ROR, 3.44 [95% CI, 2.03–5.83]; elranatamab: ROR, 5.65 [95% CI 3.14–10.19]; and (cilta-cel: ROR, 1.53 [95% CI, 0.88–2.65]).

“This highlights the importance of integrating safety profiles into treatment decisions to optimize outcomes and reduce risks,” the authors concluded in their abstract, “especially infection-related burden and mortality in pts with MM who are immunocompromised or have other comorbidities.”

By leveraging FAERS data, the analysis demonstrates that ide-cel may offer a more favorable infection-related safety profile compared with other BCMA therapies, particularly bispecific antibodies. For patients with multiple myeloma who are immunocompromised or managing comorbidities, this distinction is clinically meaningful, underscoring the value of integrating safety profiles—such as those seen with ide-cel—into treatment planning to optimize outcomes and reduce risk.

REFERENCES

Sidana S, Patel K, Dhandra D, et al. Infections in patients (pts) with multiple myeloma (Mm) Tteated with BCMA-directed CAR T cell therapies and bispecific antibodies: Analysis of the FDA Adverse Event Reporting System (FAERS). 2025 International Myeloma Society Annual Meeting. September 17, 2025, to September 20, 2025. Toronto, Canada. Abstract PA-067