Work

Infection risk associated with teclistamab in relapsed/refractory multiple myeloma: a systematic review and meta-analysis of clinical trial and real-world evidence

Year: 2026

Type: review

Study designs: Systematic Review, Meta-Analysis

Abstract: Background: Teclistamab, a B-cell maturation antigen (BCMA) × CD3 bispecific antibody (BsAb), has shown remarkable efficacy in relapsed/refractory multiple myeloma (RRMM). However, its mechanism leads to profound hypogammaglobulinemia, making infection a critical concern. This systematic review and meta-analysis aimed to quantify the infectious burden and contrast outcomes between clinical trial and real-world evidence (RWE). Methods: We systematically searched PubMed, Embase, Web of Science, and the Cochrane Library for studies reporting infection outcomes in RRMM patients treated with teclistamab. Pooled incidences of any-grade and grade ≥3 infections were calculated using a random-effects model. Subgroup analysis compared the pivotal MajesTEC-1 trial with multi-institutional RWE cohorts. Results: Five studies encompassing 714 patients were included. The overall pooled incidence was 56.5% (95% CI: 43.1%-69.9%) for any-grade infections and 27.6% (95% CI: 21.0%-34.3%) for grade ≥3 infections. Subgroup analysis revealed a significantly higher risk in the clinical trial compared to RWE (Any-grade: 76.4% vs. 45.4%, p< 0.01; Grade ≥3: 44.8% vs. 22.8%, p<0.01). Infection-related mortality was reported in all cohorts, ranging from 0.9% to 7.3%, with COVID-19 and opportunistic pathogens (for example, Pneumocystis jirovecii) being prevalent. Significant heterogeneity was driven by variations in follow-up duration and intravenous immunoglobulin (IVIG) prophylaxis rates (range: 41.8%-81.3%). Conclusions: Teclistamab is associated with a substantial and cumulative infectious burden. The lower infection rates in RWE may reflect shorter follow-up and evolving prophylactic strategies. Standardized infection surveillance, including regular IgG monitoring and consideration of IVIG replacement in patients with low IgG levels, may help optimize the safety of BCMA-directed bispecific therapies. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/, identifier CRD420261297645.

Source: Frontiers in Immunology

DOI: 10.3389/fimmu.2026.1804838

Authors: Zeng-Yi Huang, Jialiang Chen, Boman Zhu, Xiao-Lian Liu

Institution: Gaozhou People's Hospital

Language: English

Topic: Multiple Myeloma Research and Treatments

Subfield: Hematology

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $3,801