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

Bian, Sainan; Zhang, Pingping; Li, Lisha; Wang, Zixi; Cui, Le; Xu, Yingyang; Guan, Kai; Zhao, Bin; Chen, Zhuang‐Gui

doi:10.3389/fphar.2021.767999

Cited by 9 publications

(8 citation statements)

References 25 publications

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“…78 Real-world studies on adverse effects of AIT indicated that AIT had a positive signal for anaphylaxis. 79 Moreover, AIT may destabilize underlying type 2 inflammatory diseases, such as unstable asthma. Due to the need for long-term use, the safety and efficacy of AIT require active surveillance, and personalized dosage, route, and duration of treatment should be suggested by allergists.…”

Section: Aitmentioning

confidence: 99%

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Immunomodulatory properties of mesenchymal stem cells: A potential therapeutic strategy for allergic rhinitis

Wang

Zhao

Zhang

2023

Allergy

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Allergic rhinitis (AR) is a common inflammatory disorder in the nasal mucosa caused by a hyperresponse of the immune system to allergens. The clinical symptoms of AR include sneezing, nasal discharge, itching, and congestion, which have a great impact on health-related quality of life. Since the 1960s, the global prevalence of AR has steadily increased. 1 Currently, the estimated prevalence of AR is 5%-15% in children and 10%-40% in adults. 2,3 The prevalence of allergen-specific immunoglobulin E (IgE) (to any allergen) has been estimated to exceed 50% of the population in Westernised countries. 1 Currently, pharmacotherapy is the cornerstone intervention for AR. However, while this method can control symptoms, it cannot reverse the state of immune imbalance of AR. Moreover, guidelinedirected pharmacotherapy is ineffective for up to 20% of people with AR. 4 Therefore, new and effective treatments are required.

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Section: Aitmentioning

confidence: 99%

“…Although the risk of systemic reactions with AIT is low, anaphylaxis does occur 78 . Real‐world studies on adverse effects of AIT indicated that AIT had a positive signal for anaphylaxis 79 . Moreover, AIT may destabilize underlying type 2 inflammatory diseases, such as unstable asthma.…”

Section: Treatment Strategies For Armentioning

confidence: 99%

Immunomodulatory properties of mesenchymal stem cells: A potential therapeutic strategy for allergic rhinitis

Wang

Zhao

Zhang

2023

Allergy

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“…It is important to keep in mind that biologics themselves can be triggers of anaphylaxis even when they are being used as part of a protocol for allergen immunotherapy. In a study looking at data from the FDA Adverse Event Reporting System (FAERS) from 2004 to 2021, among 9969 drug-associated anaphylaxis events to allergen immunotherapy (AIT), omalizumab, and dupilumab showed that omalizumab accounted for the greatest number of reports (7784 or 78%) [59]. Dupilumab comprised 2121 reports, and AIT alone comprised of only 64 reports.…”

Section: Text Reviewmentioning

confidence: 99%

Biologics to treat anaphylaxis

Yang

2023

Current Opinion in Allergy &Amp; Clinical Immunology

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Purpose of review The purpose of this literature review was to review the latest use of biologics in the management of anaphylaxis. The methodology was to highlight both the nonbiologic management of anaphylaxis and the biologic management and how they can be used in conjunction with each other. Recent findings As the phenotypes and endotypes of anaphylaxis are better portrayed, it furthers our understanding of the mechanisms of anaphylaxis. New applications of existing biologics to the prevention of anaphylaxis are described. Summary Anaphylaxis is a potentially life-threatening acute hypersensitivity reaction affecting up to 16.8% of the U.S. population. Acute management entails swift identification, removal of the causative agent, and the prevention of cardiovascular collapse, firstly with epinephrine. Adjunctive treatments such as antihistamines work to prevent anaphylaxis from recurring. Biologic management of anaphylaxis involves the use of large-molecule drugs such as monoclonal antibodies. Omalizumab, an IgG1 monoclonal antibody targeting unbound IgE, is the most prevalent and widely studied biologic in the prevention of anaphylaxis. Other monoclonal antibodies in development or approved for other indications, such as ligelizumab, quilizumab, MEDI4212, and dupilumab, may also have potential for preventing anaphylaxis through various mechanisms.

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“…Mepolizumab has been linked with musculoskeletal AEs (1.6%) [11], diarrhea (12%), pruritus (7%), and headache (6%) [12]. Lastly, omalizumab has been associated with anaphylaxis [13, 14]. These data suggest specific safety profiles among dupilumab, omalizumab, and mepolizumab, yet comparative studies are lacking.…”

Section: Introductionmentioning

confidence: 99%

“…This analysis includes AEs associated with all biologic indications (asthma, atopic dermatitis, CRSwNP, etc.). Previous FAERS studies [7, 13] have described biologic-associated AEs, but this will be the first AE analysis to compare all three biologics.…”

Section: Introductionmentioning

confidence: 99%

Characterizing Adverse Events of Biologic Treatment of T2 Disease: A Disproportionality Analysis of the FDA Adverse Event Reporting System

Stack,

Kim,

Lamb

et al. 2023

ORL

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Introduction: Over the last 3 years, the FDA has approved dupilumab, omalizumab, and mepolizumab for the treatment of CRSwNP; however, adverse events of these biologics have not been described in post-marketing surveillance trials. By utilizing the FDA Adverse Event Reporting System (FAERS), this study describes and compares biologic-associated adverse events in T2 disease. Methods: This case-non-case study assessed disproportionate reporting rates using reporting odds ratios (RORs). RORs and p values for biologic-associated AEs were categorized and compared among dupilumab, omalizumab, and mepolizumab. This analysis included AEs associated with all treatment indications. Relative AE rates and outcomes were calculated. Results: There were a total of 112,560, 24,428, and 18,741 unique AE reports associated with dupilumab, omalizumab, and mepolizumab, respectively. Omalizumab had the strongest association with anaphylaxis (ROR = 20.80, 95% confidence interval [CI]: 18.58, 23.29). Dupilumab had large relative proportions and positive signals in the ophthalmologic category (7.76%, ROR = 6.20, 95% CI: 6.06, 6.35), such as with blurry vision (ROR = 3.80, CI: 3.52, 4.12) and visual impairment (ROR = 1.98, CI: 1.80, 2.19). Dupilumab was the only biologic associated with injection-site reactions (7.98%, ROR = 8.17, 95% CI: 7.98, 8.37). Discussion/Conclusion: This is the first large-scale comparative analysis of the AE profiles of dupilumab, omalizumab, and mepolizumab. Our data suggest possible relations between dupilumab and ophthalmologic and injection-site AEs. Omalizumab was the only biologic with a positive anaphylaxis signal. This FAERS investigation suggests important AE differences among these biologics.

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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

Cited by 9 publications

References 25 publications

Immunomodulatory properties of mesenchymal stem cells: A potential therapeutic strategy for allergic rhinitis

Immunomodulatory properties of mesenchymal stem cells: A potential therapeutic strategy for allergic rhinitis

Biologics to treat anaphylaxis

Characterizing Adverse Events of Biologic Treatment of T2 Disease: A Disproportionality Analysis of the FDA Adverse Event Reporting System

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