Meta-analysis compares infection rates of teclistamab in clinical trials and real-world evidenceTeclistamab linked to higher infection rates in some patients

Frontiers in Medicine Published April 30, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Note the higher reported incidence of any-grade and grade 3 or greater infections in clinical trials versus real-world evidence.

This meta-analysis synthesized data from 714 patients with relapsed/refractory multiple myeloma to compare infection rates associated with teclistamab between clinical trials and real-world evidence (RWE). The study focused on the incidence of any-grade and grade 3 or greater infections.

The pooled incidence of any-grade infections was 56.5% (95% CI: 43.1% to 69.9%), while the pooled incidence of grade 3 or greater infections was 27.6% (95% CI: 21.0% to 34.3%). A subgroup analysis revealed higher infection rates in clinical trials compared to RWE. Specifically, any-grade infections were reported at 76.4% in clinical trials versus 45.4% in RWE (p < 0.01). Similarly, grade 3 or greater infections were reported at 44.8% in clinical trials versus 22.8% in RWE (p < 0.01).

While the meta-analysis provides a comparison of infection frequencies, the follow-up duration was not reported. The findings highlight a discrepancy in reported infection rates between controlled trial settings and real-world clinical practice, suggesting that clinicians should monitor for infections closely when using teclistamab in relapsed/refractory multiple myeloma.

A large analysis of 714 patients has looked at the risks associated with using teclistamab for relapsed or refractory multiple myeloma. The findings highlight a notable link between the treatment and the occurrence of infections.

According to the pooled data, about 56.5% of patients experienced some type of infection. More serious infections, classified as grade 3 or higher, were reported in 27.6% of the group. The analysis also noted differences in infection rates between those in clinical trials and those in real-world settings.

Specifically, the data showed that patients in clinical trials had a higher rate of any-grade infections (76.4%) compared to those in real-world evidence groups (45.4%). A similar trend was seen for more severe infections, which were more frequent in the clinical trial group.

While these findings provide important information about infection risks, it is important to note that this was a meta-analysis of existing data. Patients should discuss these specific risks and any concerns about infection with their oncology team.

What this means for you:

Teclistamab is linked to higher rates of both mild and serious infections in patients with multiple myeloma.

Study Details

Study typeMeta analysis

EvidenceLevel 1

PublishedApr 2026

View Original Abstract ↓

BackgroundTeclistamab, 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).MethodsWe 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.ResultsFive 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

Meta-analysis compares infection rates of teclistamab in clinical trials and real-world evidenceTeclistamab linked to higher infection rates in some patients

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