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Adverse events of mepolizumab in the treatment of nasal polyps: A FDA database evaluation
Brooke Stephanian1, Kalena Liu2, Aida Martinez Salazar3
1Indiana University School of Medicine, 340 W 10th St., Indianapolis, IN 46202, USA; Kaiser Permanente Oakland Medical Center, 3600 Broadway, Oakland, CA 94611, USA.
Background:
Mepolizumab has shown significant efficacy in managing eosinophil-associated disorders such as eosinophilic asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). Despite the advancements in treatment options for CRSwNP, traditional therapies often fail to prevent polyp recurrence and come with substantial side effects, emphasizing the need for ongoing evaluation of new therapeutic approaches and their safety profiles.
Objectives:
Utilize the FDA Adverse Event Reporting System to identify and evaluate adverse effects related to the use of mepolizumab in treating CRSwNP.
Methods:
From Q12021 until Q12023, the FDA Adverse Event Reporting System database was queried to identify mepolizumab adverse reactions (MARs), which were compared between the two treatment groups of interest, CRSwNP and asthma. Individual MARs (iMARs) were modeled using zero-truncated Poisson regression, while serious MARs and outcomes were modeled using logistic regression.
Results:
For the CRSwNP-tx group, there were 80 MARs (16 serious MARs, 19 serious outcomes, 0 deaths). For the asthma-tx group, there were 4779 MARs (4308 serious MARs, 2334 serious outcomes, 124 deaths). 68,479 iMARs were observed, with 1198 iMARS in the CRSwNP-tx group. Common CRSwNP-tx iMARs were pulmonary (27.1 %), generalized (10.9 %), neurologic (9.9 %), and hematologic (9.0 %). Age < 50, RR 1.63 [1.41, 1.90], and asthma, RR 5.73 [4.29, 7.66], were significant predictive factors for total iMAR, while sex, RR 1.00 [0.86, 1.16], was not. Within the CRSwNP-tx group, concurrent asthma treatment increased the odds of having a serious MAR by 11.77 [3.02, 53.74] and serious outcome by 26.58 [3.23, 605.81].
Conclusion:
Mepolizumab treatment of CRSwNP is associated with fewer individual adverse reactions. Pulmonary reactions were, by far, the most common type of adverse reaction. Concurrent asthma treatment in CRSwNP-only-tx increases the number of reactions, and the seriousness of reactions and outcomes.
Insights
Mepolizumab for chronic rhinosinusitis with nasal polyps (CRSwNP) shows fewer adverse reactions compared to asthma treatment. Pulmonary reactions are most common, and concurrent asthma treatment increases reaction severity in CRSwNP patients.
Area of Science:
- Pharmacovigilance
- Respiratory Medicine
- Immunology
Background:
- Mepolizumab is effective for eosinophil-associated disorders like asthma and CRSwNP.
- CRSwNP treatments face challenges with polyp recurrence and side effects, necessitating new therapeutic evaluations.
- Assessing mepolizumab's safety profile in CRSwNP is crucial.
Purpose of the Study:
- To identify and evaluate adverse effects of mepolizumab in CRSwNP patients using the FDA Adverse Event Reporting System.
- To compare mepolizumab adverse reactions (MARs) between CRSwNP and asthma treatment groups.
- To analyze factors influencing MARs and serious outcomes.
Main Methods:
- Utilized FDA Adverse Event Reporting System data from Q1 2021 to Q1 2023.
- Compared MARs between CRSwNP and asthma treatment cohorts.
- Employed zero-truncated Poisson and logistic regression for MARs and serious outcomes.
Main Results:
- Mepolizumab treatment for CRSwNP yielded 80 MARs (16 serious), versus 4779 for asthma (4308 serious).
- Pulmonary reactions were most frequent in CRSwNP patients (27.1%).
- Concurrent asthma treatment in CRSwNP patients significantly increased odds of serious MARs and outcomes.
Conclusions:
- Mepolizumab treatment for CRSwNP is associated with a lower incidence of adverse reactions.
- Pulmonary reactions represent the most common adverse event type.
- Concurrent asthma treatment in CRSwNP patients elevates the frequency and severity of adverse reactions and outcomes.
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