Anaphylaxis to three humanized antibodies for severe asthma: a case study

Jingo, Koichi; Harada, Norihiro; Nishioki, Toshihiko; Torasawa, Masahiro; Yamada, Tomoko; Asao, Tetsuji; Takagi, Haruhi; Takeshige, Tomohito; Ito, Jun; Takahashi, Kazuhisa

doi:10.1186/s13223-020-00446-w

Cited by 10 publications

(6 citation statements)

References 50 publications

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“…A previous study reported that omalizumab associated with an estimated 0.1-0.2% of the anaphylaxis incidence [17]. Mepolizumab and benralizumab also demonstrated a risk of anaphylactic reactions in previous studies [18,19], which is consistent with our ndings. Regarding reslizumab, the incidence of anaphylaxis in clinical trials was approximately 0.3% bur there were only 315 cases of total AEs; therefore, more reports were required to determine the association with anaphylactic reactions [14].…”

Section: Discussionsupporting

confidence: 93%

Biologics for asthma have risk of anaphylactic reactions and serious? : A pharmacovigilance study based on a global real-world database

Park

Kim

Lee

et al. 2023

Preprint

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Asthma is a chronic inflammatory condition that affects the lung airways. Chronic use of oral glucocorticoids in patients with severe asthma is associated with several adverse events (AEs). Biologics (omalizumab, benralizumab, mepolizumab, reslizumab, and dupilumab) have been developed as alternative therapies for the treatment of asthma. The aim of this study was to evaluate the risk of anaphylactic reactions associated with these five biologics based on a large global database. We utilized individual case reports from the Uppsala Monitoring Center from 1968 to December 29, 2019. A disproportionality analysis of all drugs and monoclonal antibodies. Anaphylactic reactions were defined according to the "anaphylactic reaction” of the standardized MedDRA queries. Contrary to dupilumab, omalizumab, benralizumab, and mepolizumab demonstrated positive signals related to anaphylactic reactions among all drugs and monoclonal antibodies. Reslizumab, which represented only 315 cases of all AEs, required more reports to determine its association with anaphylactic reactions. This was an important study since the majority (96.2%) of the cases of anaphylactic reactions were reported serious. In conclusion, the results indicate that omalizumab, benralizumab, and mepolizumab are associated with a high risk of anaphylactic reactions, and careful monitoring in the post-injection period is recommended.

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Section: Discussionsupporting

confidence: 93%

Biologics for asthma have risk of anaphylactic reactions and serious? : A pharmacovigilance study based on a global real-world database

Park

Kim

Lee

et al. 2023

Preprint

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“…As to mepolizumab, clinical trials of mepolizumab showed no cases of drug‐related anaphylaxis; 18 however, our results found that mepolizumab had a low but positive anaphylaxis signal. In addition, a case of anaphylaxis following the administration of mepolizumab was recently reported by Jingo et al., 19 and more cases might be observed with the extension of the monitoring period. Thus, we also need to be aware of the risk of anaphylaxis with mepolizumab during its clinical application.…”

Section: Discussionmentioning

confidence: 89%

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

Wang

Cui

et al. 2021

Clinical & Translational All

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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.

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“…A patient in the present study experienced anaphylaxis with three biologics, improved markedly after BT, and now participates in amateur swimming. 31 In addition, the success of some of our patients in discontinuing systemic steroids and benralizumab one year after BT indicates the potential of BT to alleviate the side effects associated with systemic steroids, as well as the financial and overall burden of the disease burden experienced by individuals with severe asthma.…”

Section: Discussionmentioning

confidence: 88%

Usefulness of Computed Tomography for Evaluating the Effects of Bronchial Thermoplasty in Japanese Patients with Severe Asthma

Abe,

Yasuda,

Tobino

et al. 2024

JAA

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Background Bronchial thermoplasty (BT) improves clinical outcomes and quality of life for patients with severe asthma and has shown sustained reductions in airway narrowing and air trapping in previous CT studies. However, there is a lack of a comprehensive analysis, including CT evaluation, of clinical outcomes in Japanese patients who have undergone BT for severe asthma. This study aimed to evaluate the impact of BT in Japanese asthma patients, with a focus on the CT metric “WA at Pi10” to assess airway disease. Methods Twelve patients with severe persistent asthma who underwent BT were assessed using ACQ6, AQLQ, pulmonary function tests, FeNO measurement, blood sampling, and chest CT before BT and one year after the third procedure for the upper lobes. Results The median age of the patient was 62.0 years, 7/12 (58.3%) were male, 4/12 (33.3%) used regular oral corticosteroids, and 8/12 (66.7%) received biologics. Median FEV 1 % was 73.6%, and median peripheral eosinophil count was 163.8/μL. After one year of BT, ACQ6 scores improved from 2.4 to 0.8 points ( p = 0.007), and AQLQ scores improved from 4.3 to 5.8 points ( p < 0.001). Significant improvements were also observed in asthma exacerbations, unscheduled visits due to exacerbations, FeNO, and √WA at Pi10 ( p < 0.05). The baseline mucus score on the CT findings was negatively correlated with FEV 1 (r = −0.688, p = 0.013) and with the maximum mid-expiratory flow rate (r = −0.631, p = 0.028), and positively correlated with the peripheral blood eosinophil count (r = −0.719, p = 0.008). Changes in √WA at Pi10 after one year were positively correlated with changes in the mucus score (r = 0.742, p = 0.007). Conclusion This study has limitations, including its single-arm observational design and the small sample size. However, BT led to a symptomatic improvement in patients with severe asthma. The validated “√WA at Pi10” metric on CT effectively evaluated the therapeutic response in Japanese asthma patients after BT.

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Anaphylaxis to three humanized antibodies for severe asthma: a case study

Cited by 10 publications

References 50 publications

Biologics for asthma have risk of anaphylactic reactions and serious? : A pharmacovigilance study based on a global real-world database

Biologics for asthma have risk of anaphylactic reactions and serious? : A pharmacovigilance study based on a global real-world database

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

Usefulness of Computed Tomography for Evaluating the Effects of Bronchial Thermoplasty in Japanese Patients with Severe Asthma

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