A real-world disproportionality analysis of mepolizumab based on the FDA adverse event reporting system
Huqun Li1, Chongshu Wang2, Aiping Deng1
1Department of Pharmacy, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Abstract:
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.
Insights
This study analyzed real-world data on mepolizumab adverse events (AEs). While common AEs were noted, unexpected signals like cough and pneumonia in long-term pediatric use require further investigation.
Area of Science:
- Pharmacovigilance
- Pulmonology
- Clinical Pharmacology
Background:
- Mepolizumab is FDA-approved for severe eosinophilic asthma.
- Real-world safety data on mepolizumab remains limited.
- This study investigates mepolizumab-associated adverse events using FAERS data.
Purpose of the Study:
- To assess the real-world safety profile of mepolizumab.
- To identify potential adverse event signals not previously reported.
- To evaluate long-term and pediatric safety of mepolizumab.
Main Methods:
- Disproportionality analysis of FAERS database reports (October 2015 - December 2022).
- Investigation of demographic factors, time to onset, and specific populations (long-term use, pediatric).
- Analysis of 13,497 mepolizumab-associated adverse event reports.
Main Results:
- 13,497 adverse event reports identified, with 736 significant preferred terms.
- Common AEs (dyspnea, fatigue, headache) align with existing data.
- Unexpected AEs (cough, malaise, chest discomfort) and frequent pneumonia/wheezing in long-term/pediatric use were observed.
Conclusions:
- Findings align with previous studies, confirming known safety profiles.
- New adverse event signals for mepolizumab were identified.
- Further research is needed on long-term and pediatric mepolizumab safety.
