PMID- 37610085 OWN - NLM STAT- MEDLINE DCOM- 20240308 LR - 20240308 IS - 1744-764X (Electronic) IS - 1474-0338 (Linking) VI - 23 IP - 3 DP - 2024 Mar TI - Post-marketing safety of anti-IL-5 monoclonal antibodies (mAbs): an analysis of the FDA Adverse Event Reporting System (FAERS). PG - 353-362 LID - 10.1080/14740338.2023.2251382 [doi] AB - BACKGROUND: Anti-IL-5 monoclonal antibodies (mAbs) targeting IL-5 or IL-5 R alpha (including mepolizumab, benralizumab, and reslizumab) are widely used for inflammatory diseases such as asthma, eosinophilia, and polyangiitis. However, real-world data regarding its safety in a large sample population are incomplete. So, we evaluated the safety of anti-IL-5 mAbs by pharmacovigilance analyzes based on related adverse events (AEs) from the FDA Adverse Event Reporting System (FAERS). METHODS: In disproportionality analysis, four algorithms were employed to detect the signals of anti-IL-5 mAbs from the FAERS between 2016 and 2022. In addition, we also used MYSQL 8.0, Navicat Premium 15, and Microsoft EXCEL 2019 to analyze the signals of anti-IL-5 mAbs systematically. RESULTS: There are 9,476,351 reports collected from the FAERS database, of which 22,174 reports listed anti-IL-5 mAbs as the 'primary suspected (PS)' drug. A total of 59 (20 new signals, mepolizumab) and 62 (19 new signals, benralizumab) significant disproportionality preferred terms (PTs) conforming to the four algorithms were retained synchronously. Finally, we detected that the anti-IL-5 mAbs-induced AEs occurred in 31 organ systems (mepolizumab) and 30 organ systems (benralizumab). For mepolizumab and reslizumab, unexpected and new significant PTs of AEs were found, such as asthmatic crisis, chronic obstructive pulmonary disease (COPD), pneumonia, COVID-19, pneumothorax, adrenal insufficiency and so on. Notably, the risk signal of asthmatic crisis for mepolizumab was stronger than benralizumab (ROR 108.04 [95%CI, 96.09-121.47] vs 26.83 [95%CI, 18.91-38.06]). Comparing with mepolizumab and benralizumab, we found the proportion of serious adverse events in mepolizumab was both greater than benralizumab in each age group (/= 65). The median onset time of mepolizumab was 280 days (interquartile range [IQR] 1-367 days). CONCLUSION: Analysis of FAERS data identified anti-IL-5 mAbs-associated AEs, and our findings supported continuous clinical monitoring, pharmacovigilance, and further studies of anti-IL-5 mAbs. In addition, clinicians may be more aware of the limitations of use in package inserts of anti-IL-5 mAbs: Not for relief of acute bronchospasm or status asthmaticus. Because of some limitations in the FAERS such as self-reports from patients and other confounding factors, the safety of anti-IL-5 mAbs needed more studies in different dimensions, especially the risk of cancer. FAU - Zou, Shu-Peng AU - Zou SP AD - Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei Province, China. FAU - Yang, Hai-Yun AU - Yang HY AD - School of Pharmacy, Lanzhou University, Lanzhou, Gansu Province, China. FAU - Ouyang, Mengling AU - Ouyang M AD - Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei Province, China. FAU - Cheng, Qian AU - Cheng Q AD - Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei Province, China. FAU - Shi, Xuan AU - Shi X AD - Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei Province, China. FAU - Sun, Ming-Hui AU - Sun MH AD - Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei Province, China. LA - eng PT - Journal Article DEP - 20230829 PL - England TA - Expert Opin Drug Saf JT - Expert opinion on drug safety JID - 101163027 RN - 0 (Interleukin-5) RN - 0 (Antibodies, Monoclonal) SB - IM MH - Humans MH - United States MH - *Drug-Related Side Effects and Adverse Reactions/epidemiology/etiology MH - Interleukin-5 MH - *Status Asthmaticus MH - Antibodies, Monoclonal/adverse effects MH - *Asthma/drug therapy MH - Pharmacovigilance MH - United States Food and Drug Administration MH - Adverse Drug Reaction Reporting Systems OTO - NOTNLM OT - COVID-19 OT - FAERS OT - IL-5 OT - adverse events OT - mepolizumab OT - pharmacovigilance EDAT- 2023/08/23 12:42 MHDA- 2024/03/08 06:42 CRDT- 2023/08/23 07:44 PHST- 2024/03/08 06:42 [medline] PHST- 2023/08/23 12:42 [pubmed] PHST- 2023/08/23 07:44 [entrez] AID - 10.1080/14740338.2023.2251382 [doi] PST - ppublish SO - Expert Opin Drug Saf. 2024 Mar;23(3):353-362. doi: 10.1080/14740338.2023.2251382. Epub 2023 Aug 29.