Wang C, et al. Allergy Asthma Immunol Res. 2022 Nov;14(6):604-652. https://doi.org/10.4168/aair.2022.14.6.604

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.

There are limited real-world studies on the differences in leukotriene receptor antagonists (LTRA), H1-antihistamines (H1-AH), and inhaled corticosteroids (ICS) associated neuropsychiatric events. In this study, we aimed to analyze the characteristics of drug associated neuropsychiatric events, and compare the differences among different drug categories. Disproportionality analysis and Bayesian analysis were used in data mining to identify suspected neuropsychiatric events associated with LTRA, H1-AH, and ICS based on the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from January 2004 to September 2020. Demographic information, time interval to onset, and death rates of LTRA, H1-AH, and ICS-associated neuropsychiatric events were also analyzed. A total of 9475 neuropsychiatric events were identified. The number of neuropsychiatric events related to LTRA, H1-AH, and ICS were 5201 (54.89%), 3226 (34.05%), and 1048 (11.06%), respectively. LTRA related neuropsychiatric events were more common in patients aged 4–6 years (18.66%). H1-AH and ICS related neuropsychiatric events were more common in patients aged 18–44 years (29.92%) and older than 65 years (30.60%), respectively. Montelukast was highly associated with neuropsychiatric events, with a high reporting odds ratio (ROR). Most neuropsychiatric symptoms occurred within the first 10 days after drug initiation (78.63% for LTRA, 91.39% for H1-AH, and 84.07% for ICS). The death rate due to neuropsychiatric events of first generation H1-AH was significantly higher than that of LTRA and ICS (p < 0.001). LTRA associated neuropsychiatric events reported in FAERS were most frequent in 4 to 6-year-old children. Most reported cases occurred within the first 10 days after drug initiation. The second generation H1-AH was relatively safe for neuropsychiatric events compared with the first generation. The fatality rate due to first generation H1-AH associated neuropsychiatric events was higher than that of LTRA and ICS. More attention should be paid to specific patients treated with LTRA and H1-AH.

Allergic rhinitis (AR) is a common allergic airway disorder that is often poorly managed. There is an urgent need to enhance medication adherence in order to improve treatment outcomes in patients with AR. The efficacy of wearable smart watches in improving medication adherence is currently unclear. This study aimed to evaluate the efficacy of a novel smart watch in improving medication adherence and symptom control in patients with AR. The reliability of self-reported medication use was also investigated. This randomized, open-label, parallel controlled, pilot study enrolled adult patients with AR caused by cypress pollen. Patients were randomized in a 1:2 ratio to an intervention group and control group. Smart watches were only distributed to patients in the intervention group. During the cypress pollen season, all patients were required to take oral antihistamines daily and use nasal corticosteroids and antihistamine eye drops as needed. Daily AR symptom scores and medication usage were recorded in both groups. The smart watch was able to identify medication-taking behaviors of patients via artificial intelligence (AI) and relay this information to physicians, who sent short message service reminders to patients who forgot to take oral antihistamines for more than 2 days. During the pollen season, the adherence rate to oral antihistamines in the intervention group (n = 17) was significantly higher than that in the control group (n = 38) (63.3% ± 28.5% versus 43.2% ± 30.2%, P = 0.02). The daily symptom score of the intervention group was lower than that of the control group (2.4 ± 1.1 versus 3.9 ± 1.0, P < 0.001). There was no significant difference in the on-demand medication score between the 2 groups (1.3 ± 0.4 versus 1.5 ± 0.5, P = 0.13). The consistency rate between self-reported nasal corticosteroid usage and the gold standard (ie, human observation of medication usage in the videos recorded by the smart watch) was 20.0% (0%, 53.7%), and the consistency rate between self-reported antihistamine eye drop usage and the gold standard was 24.3% (2.1%, 67.1%). This pilot study showed that the application of smart watches in patients with AR was associated with improved medication adherence and symptom control. Furthermore, the reliability of self-reported medication usage was limited.

Background: Data on allergic reactions after the administration of coronavirus disease (COVID-19) vaccines are limited. Our aim is to analyze reports of allergic reactions after COVID-19 vaccine administration.Methods: The Vaccine Adverse Event Reporting System database was searched for reported allergic reactions after the administration of any of the COVID-19 vaccines from December 2020 to June 2021. After data mapping, the demographic and clinical characteristics of the reported cases were analyzed. Potential factors associated with anaphylaxis were evaluated using multivariable logistic regression models.Results: In total, 14,611 cases were reported. Most cases of allergic reactions comprised women (84.6%) and occurred after the first dose of the vaccine (63.6%). Patients who experienced anaphylaxis were younger (mean age 45.11 ± 5.6 vs. 47.01 ± 6.3 years, P < 0.001) and had a higher prevalence of a history of allergies, allergic rhinitis, asthma, and anaphylaxis than those who did not (P < 0.05). A history of allergies (odds ratio (OR) 1.632, 95% confidence interval (CI) 1.467–1.816, P < 0.001), asthma (OR 1.908, 95%CI 1.677–2.172, P < 0.001), and anaphylaxis (OR 7.164, 95%CI 3.504–14.646, P < 0.001) were potential risk factors for anaphylaxis. Among the 8,232 patients with reported outcomes, 16 died.Conclusions: Female predominance in allergic reaction cases after the receipt of COVID-19 vaccines was observed. Previous histories of allergies, asthma, or anaphylaxis were risk factors for anaphylaxis post-vaccination. People with these risk factors should be monitored more strictly after COVID-19 vaccination.