Anaphylactic risk related to omalizumab, benralizumab, reslizumab, mepolizumab, and dupilumab

Abstract

Background Monoclonal antibodies (mAbs) are novel, effective therapeutics for the treatment of inadequately controlled severe asthma. Knowledge of the anaphylaxis risks related to different mAbs is essential for their appropriate and safe administration. This study aimed to evaluate the associations between different mAbs and anaphylactic reactions by applying statistical approaches to pharmacovigilance data. Methods This was a retrospective study using data from the US Food and Drug Administration Adverse Event Reporting System database from January 2004 to September 2020. A total of 2006 reports of anaphylaxis related to benralizumab, dupilumab, mepolizumab, omalizumab, and reslizumab were obtained through data mining. The clinical characteristics of the cases were analyzed, and the risk signals of anaphylactic reactions and corresponding outcomes were investigated in the five mAbs. Results The patients were mainly young and middle‐aged adults, with markedly more women than men. Omalizumab, benralizumab, reslizumab, and mepolizumab showed positive signals for anaphylaxis, while only dupilumab showed a negative signal. The risk of initial or prolonged hospitalization due to anaphylaxis was significantly higher in the benralizumab group than in the omalizumab group (42.86% vs. 28.92%, p = 0.024). Further, when anaphylaxis to omalizumab occurred, patients with asthma were more likely to have life‐threatening outcomes than those with chronic urticaria (18.0% vs. 12.9%, p = 0.022). Conclusion In the current real‐world study, the positive anaphylaxis signals related to omalizumab, benralizumab, reslizumab, and mepolizumab suggested the need for the close monitoring of patients after drug use, and dupilumab showed a negative signal for anaphylaxis.

Anaphylaxis Associated With Allergen Specific Immunotherapy, Omalizumab, and Dupilumab: A Real World Study Based on the US Food and Drug Administration Adverse Event Reporting System

“…Other studies also showed that the fatal reactions to AIT were low (Epstein et al, 2021). Death rate of omalizumab associated anaphylaxis was a little lower than that of dupilumab associated anaphylaxis, which was consistent with another real-world study about anaphylaxis related to biologis (Li et al, 2021). In a systematic review for the EAACI guidelines of recommendations on the use of biologics in severe asthma, omalizumab might increase serious adverse events in adolescent/adults (Risk ratio 1.62, 95%CI 0.76-3.45) with low certainty of evidence.…”

“…The anaphylactic symptoms of omalizumab and dupilumab were more common in female than in male. In another study of biologics related anaphylaxis based on FAERS, females made up a large part of reported cases (Li et al, 2021). A report of anaphylaxis associated with omalizumab also revealed a preponderance of female subjects (84%) (Lieberman et al, 2017).…”

Dupilumab Adverse Events in Nasal Polyp Treatment: Analysis of FDA Adverse Event Reporting System

“…Men had significantly lower risk for iDAR in all treatment groups, and older adults were at higher risk for iDAR in all treatment groups. In a study using FAERS to evaluate anaphylactic risk related to dupilumab use for AD and asthma, men were less likely to experience anaphylaxis, as was the trend observed across the other four monoclonal antibodies studied 33 . Real‐world data for CRSwNP‐tx using dupilumab is lacking 34 .…”

Isoorientin ameliorates OVA-induced asthma in a murine model of asthma

“…This response may be mild, transient, subclinical, or it may be a serious and potentially fatal reaction when the immune system overreacts (hypersensitivity). 9,10 In addition, mAbs treatment is used primarily for patients with severe asthma. 11 No single cytokine is responsible for the entire pathogenesis of asthma.…”