SynthesisScientific reports2024
Comprehensive safety evaluation of isatuximab in multiple myeloma using disproportionality analysis of FAERS and meta-analysis of randomized controlled trials.
Synthesis in Scientific reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pooled it
- Rapid complete remission after one cycle of isatuximab-based quadruplet regimen in 1q21-positive primary plasma cell leukemia: a case report.Frontiers in immunology · 2026Article
- The real-world safety profile and potential mechanism of isatuximab: Integration of pharmacovigilance and transcriptomic analysis.Medicine · 2025Article
- Efficacy and Safety of Isatuximab Combination Therapy in Multiple Myeloma: A Meta-Analysis of Randomized Controlled Trials.Cancers · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Isatuximab, an anti-CD38 monoclonal antibody, has been shown to induce apoptosis in multiple myeloma (MM) cells and is effective in both relapsed/refractory and newly diagnosed MM cases. This study aims to compare the safety profile of isatuximab by examining a broader range of adverse events (AEs) using data from the FDA Adverse Event Reporting System (FAERS) and a meta-analysis of randomized controlled trials (RCTs). The study analyzed FAERS data up to March 2024, identifying suspected AEs using Preferred Terms. Data extraction from FAERS was conducted using OpenVigil-2.1-MedDRA-v24. Disproportionality analysis was performed by calculating the proportional reporting ratio (PRR) with Chi-square value, and the reporting odds ratio (ROR) with a 95% confidence interval (CI). For the meta-analysis, safety outcomes of isatuximab in adult patients were reviewed from RCTs sourced from databases such as PubMed, EMBASE, and ClinicalTrials.gov, employing a random-effects meta-analysis to determine the risk ratio (RR) with 95% CI. The meta-analysis protocol was registered with PROSPERO (CRD42022379632). Based on the FAERS quarterly reports, a total of 2,325 AE reports were identified, with a higher incidence in men (n = 1156, 49.7%) compared to women (n = 960, 41.3%). AEs commonly observed with isatuximab therapy included neutropenia, pneumonia, infusion-related reactions, thrombocytopenia, acute kidney injury, and anemia. In our meta-analysis of three RCTs involving 1,258 patients, 659 (52.4%) in the isatuximab treatment group experienced 1,135 AEs, with 58% classified as grade three or higher. In comparison, 599 (47.6%) patients in the control group reported 906 AEs, with 59% categorized as grade three or higher. Notably, the isatuximab group showed a statistically significant increased risk of grade three or higher neutropenia (RR = 2.13, 95% CI: 1.12-4.03, p = 0.0207) and a 30% increased risk of grade 3 or higher thrombocytopenia (RR = 1.30, 95% CI: 1.03-1.64, p = 0.0244). Isatuximab therapy was generally well-tolerated and exhibited a manageable safety profile. Considering these findings, future research might benefit from longer follow-up periods to capture delayed and less frequent AEs.
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