Evidence map›Paper›PMID 40095047›Full record

ArticleEuropean journal of clinical pharmacology2025

Unveiling cardiovascular and respiratory toxicities with monoclonal antibodies in multiple myeloma: disproportionality analysis from the FDA Adverse Event Reporting System.

Maria Antonietta Barbieri, Giulia Russo, Giuseppe Cicala, Giuseppe Andò, Tindara Franchina, Nicola Silvestris, Mariacarmela Santarpia, Edoardo Spina

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Article in European journal of clinical pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Perioperative considerations for patients with multiple myeloma.European journal of anaesthesiology and intensive care · 2026
    Review
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Maria Antonietta BarbieriDepartment of Clinical and Experimental Medicine, University of Messina, 98125, Messina, Italy.ORCID http://orcid.org/0000-0002-2019-4696
Giulia RussoDepartment of Clinical and Experimental Medicine, University of Messina, 98125, Messina, Italy.ORCID http://orcid.org/0009-0002-1681-1417
Giuseppe CicalaDepartment of Clinical and Experimental Medicine, University of Messina, 98125, Messina, Italy.ORCID http://orcid.org/0000-0002-8345-8679
Giuseppe AndòDepartment of Clinical and Experimental Medicine, University of Messina, 98125, Messina, Italy.
Tindara FranchinaDepartment of Human Pathology in Adulthood and Childhood Gaetano Barresi, University of Messina, 98125, Messina, Italy.
Nicola SilvestrisDepartment of Human Pathology in Adulthood and Childhood Gaetano Barresi, University of Messina, 98125, Messina, Italy.ORCID http://orcid.org/0000-0001-7814-7318
Mariacarmela SantarpiaDepartment of Human Pathology in Adulthood and Childhood Gaetano Barresi, University of Messina, 98125, Messina, Italy.
Edoardo SpinaDepartment of Clinical and Experimental Medicine, University of Messina, 98125, Messina, Italy. espina@unime.it.ORCID http://orcid.org/0000-0002-2509-7449

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionMonoclonal antibodies (mAbs) have revolutionized the treatment of multiple myeloma (MM), demonstrating remarkable effectiveness, despite potential adverse events (AEs). This study aims to identify unexpected signals of disproportionate reporting (SDRs) for cardiovascular (CV) and respiratory AEs associated with mAbs in MM treatment.

methodsFrom January 2015 to December 2023, reports involving suspected drugs (daratumumab, elotuzumab, elranatamab, isatuximab, belantamab mafodotin, teclistamab, and talquetamab) were analyzed in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. Descriptive analysis was followed by disproportionality analyses first comparing mAbs to all other drugs (reference group, RG1), and subsequently conducting a sensitivity analysis against other MM drugs (RG2).

resultsOut of 13,496,241 reports, 31,052 (0.2%) were associated with MM, with 6574 (0.1%) linked to CV and respiratory adverse events, primarily involving older population (n = 3441; 52.3%) and male (n = 3338; 50.8%) patients. Disproportionality analyses identified unexpected SDRs for daratumumab, including cardiac failure (n = 322; RG1: ROR = 4.74, CI 95% = 4.24-5.29; RG2: ROR = 4.42, 95% CI = 3.91-4.99), embolic and thrombotic event, such as pulmonary embolism (162; RG1: 2.44, 2.09-2.85), deep vein thrombosis (126; RG1: 2.95, 2.47-3.52), and respiratory failure (192; RG1: 4.06, 3.52-4.68; RG2: 4.2, 3.59-4.91). Isatuximab was linked to cardiac arrhythmia, such as atrial fibrillation (46; RG1: 2.54, 1.9-3.4; RG2: 1.35, 1.01-1.81), embolic and thrombotic event, including deep vein thrombosis (26; RG1: 2.93, 1.99-4.3) and pulmonary embolism (89; RG1: 6.56, 5.32-8.1; RG2: 2.93, 2.37-3.63). Elotuzumab showed also SDRs for atrial fibrillation (56; RG1: 3.68, 2.82-4.79; RG2: 1.96, 1.5-2.56) and deep vein thrombosis (41; RG1: 5.49, 4.03-7.47).

conclusionUnexpected CV and respiratory AEs with clinical relevance not previously reported in literature have been identified underlining the importance of pharmacovigilance.

Indexed as

Adverse Drug Reaction Reporting SystemsAntibodies, MonoclonalAntineoplastic Agents, ImmunologicalCardiovascular DiseasesMultiple MyelomaRespiratory Tract DiseasesAdultAgedAged, 80 and overDatabases, FactualFemaleHumansMaleMiddle AgedUnited StatesUnited States Food and Drug AdministrationAntibodies, MonoclonalAntineoplastic Agents, ImmunologicalCardiovascular toxicityDisproportionality analysisFAERSMonoclonal antibodiesMultiple myelomaRespiratory toxicity

Identifiers

PMID40095047

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.