Objective:

To quantify the infection rates and outcomes associated with teclistamab in RRMM patients and compare findings between clinical trials and real-world evidence.

Key Findings:

• Overall pooled incidence of any-grade infections was 56.5% (95% CI: 43.1%–69.9%) and grade ≥3 infections was 27.6% (95% CI: 21.0%–34.3%).
• Infection rates were significantly higher in clinical trials compared to real-world evidence (76.4% vs. 45.4% for any-grade, and 44.8% vs. 22.8% for grade ≥3).
• Infection-related mortality ranged from 0.9% to 7.3%, with COVID-19 and opportunistic pathogens being common.

Interpretation:

Teclistamab is associated with a significant infectious burden, with clinical trials showing higher infection rates than real-world settings, potentially due to differences in follow-up and prophylactic strategies, which may impact patient safety.

Limitations:

• Variability in follow-up duration and IVIG prophylaxis rates among studies may limit the generalizability of findings.
• The limited number of studies included in the analysis restricts the robustness of the conclusions drawn.

Conclusion:

Implementing standardized infection surveillance and regular IgG monitoring, along with considering IVIG replacement for patients with low IgG levels, may enhance the safety of teclistamab therapy in RRMM patients.