Post-marketing safety of anti-IL-5 monoclonal antibodies (mAbs): an analysis of the FDA Adverse Event Reporting System (FAERS)

Zou, Shu-Peng; Yang, Hai-Yun; Ouyang, Mengling; Cheng, Qian; Shi, Xuan; Sun, Ming-Hui

doi:10.1080/14740338.2023.2251382

Cited by 5 publications

(7 citation statements)

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“…We noted a recently published FAERS study of post-marketing safety of anti-IL-5 monoclonal antibodies including mepolizumab (Zou et al, 2023). Data mining methods mainly include frequency analysis and Bayesian analysis, and the sensitivity of Bayesian analysis is relatively lower than that of frequency analysis .…”

Section: Discussionmentioning

confidence: 99%

Anti-inflammatory drug development focusing on immune mediated diseases

Monteiro,

Prasad,

Bhatti

et al. 2024

Frontiers Research Topics

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Frontiers is more than just an open access publisher of scholarly articles: it is a pioneering approach to the world of academia, radically improving the way scholarly research is managed. The grand vision of Frontiers is a world where all people have an equal opportunity to seek, share and generate knowledge. Frontiers provides immediate and permanent online open access to all its publications, but this alone is not enough to realize our grand goals. Frontiers journal seriesThe Frontiers journal series is a multi-tier and interdisciplinary set of openaccess, online journals, promising a paradigm shift from the current review, selection and dissemination processes in academic publishing. All Frontiers journals are driven by researchers for researchers; therefore, they constitute a service to the scholarly community. At the same time, the Frontiers journal series operates on a revolutionary invention, the tiered publishing system, initially addressing specific communities of scholars, and gradually climbing up to broader public understanding, thus serving the interests of the lay society, too. Dedication to qualityEach Frontiers article is a landmark of the highest quality, thanks to genuinely collaborative interactions between authors and review editors, who include some of the world's best academicians. Research must be certified by peers before entering a stream of knowledge that may eventually reach the public -and shape society; therefore, Frontiers only applies the most rigorous and unbiased reviews. Frontiers revolutionizes research publishing by freely delivering the most outstanding research, evaluated with no bias from both the academic and social point of view. By applying the most advanced information technologies, Frontiers is catapulting scholarly publishing into a new generation. What are Frontiers Research Topics?Frontiers Research Topics are very popular trademarks of the Frontiers journals series: they are collections of at least ten articles, all centered on a particular subject. With their unique mix of varied contributions from Original Research to Review Articles, Frontiers Research Topics unify the most influential researchers, the latest key findings and historical advances in a hot research area.

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Section: Discussionmentioning

confidence: 99%

Anti-inflammatory drug development focusing on immune mediated diseases

Monteiro,

Prasad,

Bhatti

et al. 2024

Frontiers Research Topics

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“…We noted a recently published FAERS study of post-marketing safety of anti-IL-5 monoclonal antibodies including mepolizumab ( Zou et al, 2023 ). Data mining methods mainly include frequency analysis and Bayesian analysis, and the sensitivity of Bayesian analysis is relatively lower than that of frequency analysis ( Liu et al, 2022 ).…”

Section: Discussionmentioning

confidence: 99%

A real-world disproportionality analysis of mepolizumab based on the FDA adverse event reporting system

Li,

Wang,

Deng

et al. 2023

Front. Pharmacol.

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Background: Mepolizumab has been approved by the FDA for add-on maintenance treatment of severe asthma with an eosinophilic phenotype. Real-world studies on mepolizumab-associated adverse events are limited. The present study aimed to explore mepolizumab-related adverse events based on the US Food and Drug Administration Adverse Event Reporting System (FAERS) database.Methods: A disproportionality analysis was performed to assess the safety profile of mepolizumab based on the reports from the FAERS database between October 2015 and December 2022. Demographic information, the time to onset, the safety of long-term mepolizumab exposure as well as safety in pediatric patients were also investigated.Results: A total of 736 significant preferred terms (PTs) were identified among the 13,497 mepolizumab-associated adverse events (AEs) reports collected from the FAERS database. The frequently reported AEs including dyspnea, fatigue, and headache were in line with drug instruction and previous studies. Unexpected significant AEs such as cough, malaise, and chest discomfort were also identified. Most AEs occurred within the first month after mepolizumab initiation. Pneumonia and wheezing were frequently reported in patients with long-term mepolizumab exposure as well as in the pediatric population.Conclusion: Our results were consistent with the observations in previous clinical and real-world studies. New and unexpected AE signals of mepolizumab were also identified. Close attention should be paid to the long-term safety of mepolizumab as well as safety in the pediatric population. Prospective studies are required for optimal use of mepolizumab.

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“…Meta-analyses and post-marketing US Food and Drug Administration (FDA) analyses did not show alarming adverse events. The most frequently reported adverse events include headache, nasopharyngitis, upper respiratory tract infection, bronchitis, and asthma exacerbation [ 7 , 8 ]. According to FDA data, the proportion of serious adverse events with mepolizumab seems to be greater than benralizumab in each age group (≤20, 20–65, and ≥65 years); however, such data also include self-reports from patients and other confounding factors [ 8 ].…”

Section: Introductionmentioning

confidence: 99%

“…The most frequently reported adverse events include headache, nasopharyngitis, upper respiratory tract infection, bronchitis, and asthma exacerbation [ 7 , 8 ]. According to FDA data, the proportion of serious adverse events with mepolizumab seems to be greater than benralizumab in each age group (≤20, 20–65, and ≥65 years); however, such data also include self-reports from patients and other confounding factors [ 8 ]. Immunogenicity was tested for these drugs in phase III randomized controlled trials (RCTs), testing positive for anti-drug antibodies in 4% of patients for mepolizumab (in most cases non-neutralizing) [ 9 ], in 4.8–5.4% for reslizumab (with no impact on exposure, blood eosinophils, clinical efficacy and safety) [ 10 ], and in 11–13% for benralizumab (with no associated adverse clinical outcomes) [ 11 , 12 ].…”

Section: Introductionmentioning

confidence: 99%

“…EOE eosinophilic esophagitis. Part of the figure was created with BioRender.com asthma exacerbation [7,8]. According to FDA data, the proportion of serious adverse events with mepolizumab seems to be greater than benralizumab in each age group (≤20, 20-65, and ≥65 years); however, such data also include self-reports from patients and other confounding factors [8].…”

Section: Introductionmentioning

confidence: 99%

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Anti-IL-5 Pathway Agents in Eosinophilic-Associated Disorders Across the Lifespan

Lombardi,

Comberiati,

Ridolo

et al. 2024

Drugs

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Monoclonal antibodies targeting interleukin (IL)-5 pathways have revolutionized the treatment expectations for eosinophilic-associated conditions, particularly in patients with respiratory involvement. Mepolizumab (IL-5 antagonist monoclonal antibody), benralizumab (IL-5 receptor blocker monoclonal antibody), and reslizumab (IL-5 antagonist monoclonal antibody) have collectively contributed to the overall improvement of the disease burden in various conditions. Eosinophilic asthma currently boasts the most robust evidence across all age groups: all three biologics are approved for adults (aged ≥18 years); mepolizumab is approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) also in children (aged ≥ 6 years), while bernalizumab was recently approved by the FDA for patients aged ≥6 years in the USA. In chronic rhinosinusitis with nasal polyps, subcutaneous mepolizumab is the only anti-IL-5 therapy approved so far and can be used in adult patients (aged ≥18 years). For eosinophilic esophagitis, conflicting evidence surrounds both mepolizumab, reslizumab, and benralizumab, leading to non-approval of these agents by the FDA/EMA. Recently, mepolizumab was approved for eosinophilic granulomatosis with polyangiitis patients aged ≥6 years or older and for hypereosinophilic syndrome adult patients. A phase III trial proving noninferiority of benralizumab versus mepolizumab in eosinophilic granulomatosis with polyangiitis has been recently published, while evidence on reslizumab is scant. Overall, current evidence on anti-IL-5 biologics for eosinophilic-associated disorders is mostly focused on adults, whereas data for individuals aged under 18 years and over 65 years are scarce, resulting in a lack of evidence, particularly regarding efficacy, for the use of anti-IL-5 agents in these specific patient populations. This review addresses high-quality evidence from randomized controlled trials and real-world post-marketing studies regarding the use of anti-IL-5 therapies for eosinophilic-associated disorders across all age groups, spanning childhood, adulthood, and older age.

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Post-marketing safety of anti-IL-5 monoclonal antibodies (mAbs): an analysis of the FDA Adverse Event Reporting System (FAERS)

Cited by 5 publications

References 44 publications

Anti-inflammatory drug development focusing on immune mediated diseases

Anti-inflammatory drug development focusing on immune mediated diseases

A real-world disproportionality analysis of mepolizumab based on the FDA adverse event reporting system

Anti-IL-5 Pathway Agents in Eosinophilic-Associated Disorders Across the Lifespan

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