Meta-analysis compares infection rates of teclistamab in clinical trials and real-world evidence
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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.
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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
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