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Introduction Material and Methods Results Conclusions Asthma is the most common chronic disease during pregnancy. Maternal asthma has been associated with a multitude of unwanted pregnancy outcomes, in some studies also with neurodevelopmental disorders. Here we investigated associations between maternal asthma and neurodevelopmental disorders.We studied a retrospective population‐based cohort of 1 271 439 mother–child pairs from singleton live births in Finland between the years 1996–2018. We used multiple high‐cover registers for data collection. Adjusted unconditional Cox regression models were used to investigate associations between maternal asthma, asthma medication used during pregnancy, and offspring's neurodevelopmental disorder diagnoses.We identified 106 163 mother–child pairs affected by maternal asthma. We found that maternal asthma was associated with offspring neurodevelopmental disorders, but the differences in absolute prevalence between the control and exposure groups were small. Attention‐deficit hyperactivity disorder (ADHD) was found in 4114 (3.9%) offspring with maternal asthma and in 32 122 (3.0%) controls (adjusted hazard ratio (HR): 1.49; 95% CI 1.44–1.54); autism in 1617 (1.5%) offspring versus 13 701 (1.3%) controls (HR: 1.33; 95% CI 1.26–1.40); motor‐developmental disorder in 1569 (1.5%) offspring versus 12 147 (1.1%) controls (HR: 1.37; 95% CI 1.30–1.45); language disorder in 3057 (2.9%) offspring versus 28 421 (2.7%) controls (HR: 1.13; 95% CI 1.08–1.17), learning disabilities in 849 (0.8%) offspring versus 6534 (0.6%) controls (HR: 1.51; 95% CI 1.41–1.62); mixed developmental disorder in 1633 (1.5%) offspring versus 14 434 (1.3%) controls (HR 1.20; 95% CI, 1.14–1.26); and intellectual disability in 908 (0.9%) versus 9155 (0.9%) controls (HR: 1.12; 95% CI 1.04–1.20). No substantial differences were found between allergic and non‐allergic asthma phenotypes, and neither allergic tendency nor respiratory infection was associated with a similar likelihood of neurodevelopmental disorders.Maternal asthma and allergic and non‐allergic phenotypes showed weak associations with the offspring's neurodevelopmental disorders. The association is concerned especially with learning disabilities, ADHD, motor development, and autism. [ABSTRACT FROM AUTHOR]

BackgroundThe upper-airway microbiome is involved in asthma exacerbations despite inhaled corticosteroid (ICS) treatment. Although human genetics regulates microbiome composition, its influence on asthma-related airway bacteria remains unknown.ObjectiveWe sought to identify genes and biological pathways regulating airway-microbiome traits involved in asthma exacerbations and ICS response.MethodsSaliva, nasal, and pharyngeal samples from 257 European patients with asthma were analyzed. The association of 6,296,951 genetic variants with exacerbation-related microbiome traits despite ICS treatment was tested through microbiome genome-wide association studies. Variants with 1 × 10-4 -6 were examined in gene-set enrichment analyses. Significant results were sought for replication in 114 African American and 158 Latino children with and without asthma. ICS-response-associated single nucleotide polymorphisms reported in the literature were evaluated as microbiome quantitative trait loci. Multiple comparisons were adjusted by the false discovery rate.ResultsGenes associated with exacerbation-related airway-microbiome traits were enriched in asthma comorbidities development (ie, reflux esophagitis, obesity, and smoking), and were likely regulated by trichostatin A and the nuclear factor-κB, the glucocorticosteroid receptor, and CCAAT/enhancer-binding protein transcription factors (7.8 × 10-13 ≤ false discovery rate ≤ 0.022). Enrichment in smoking, trichostatin A, nuclear factor-κB, and glucocorticosteroid receptor were replicated in the saliva samples from diverse populations (4.42 × 10-9 ≤ P ≤ .008). The ICS-response-associated single nucleotide polymorphisms rs5995653 (APOBEC3B-APOBEC3C), rs6467778 (TRIM24), and rs5752429 (TPST2) were identified as microbiome quantitative trait loci of Streptococcus, Tannerella, and Campylobacter in the upper airway (0.027 ≤ false discovery rate ≤ 0.050).ConclusionsGenes associated with asthma exacerbation-related microbiome traits might influence asthma comorbidities. We reinforced the therapeutic interest of trichostatin A, nuclear factor-κB, the glucocorticosteroid receptor, and CCAAT/enhancer-binding protein in asthma exacerbations.

AbstractIntroductionObjectiveMethodsResultsConclusionAllergic bronchopulmonary aspergillosis (ABPA) is a lung disease caused by a hypersensitivity reaction to antigens of Aspergillus fumigatus.The aim of this study was to evaluate the long-term clinical outcomes of omalizumab use in patients with ABPA.In this retrospective study, 12 patients diagnosed with ABPA and receiving omalizumab for at least 2 years, and 32 patients diagnosed with severe allergic asthma and receiving omalizumab for at least 2 years (control group) were evaluated.Evaluation was made of a total of 44 participants, comprising 11 (25%) males and 33 (75%) females, who received omalizumab for at least 2 years with the diagnosis of the control group (n = 32) and ABPA (n = 12). The increase in asthma control test (ACT) score after omalizumab was significant at 12 months and at 24 months in patients with ABPA. After omalizumab, the use of oral corticosteroid (OCS), the annual number of asthma attacks and hospitalizations were significantly decreased at 12 months and at 24 months in patients with ABPA. The increase in forced expiratory volume in 1 s (FEV1) (%) and ACT score after omalizumab were significant at 12 months and at 24 months in the control group. After omalizumab, the use of OCS, annual number of asthma attacks and hospitalizations were significantly decreased at 12 months and at 24 months in the control group.Long-term omalizumab use in patients with ABPA seems to be an effective treatment for improving pulmonary function and reducing asthma exacerbations and hospitalizations. [ABSTRACT FROM AUTHOR]

Background/Aims Despite short-acting β2-agonist (SABA) overuse being associated with poor asthma outcomes, data on SABA use in South Korea is scarce. Herein, we describe prescription patterns of SABA and other asthma medications in patients from the South Korean cohort of the SABA use IN Asthma (SABINA) III study. Methods This study included patients with asthma aged ≥ 12 years, who had ≥ 3 consultations with the same healthcare provider, and medical records containing data for ≥ 12 months prior to the study visit. Patients were classified by investigator-defined asthma severity (per 2017 Global Initiative for Asthma recommendations) and practice type (primary or specialist care). Data on disease characteristics, asthma treatments, and clinical outcomes in the 12 months before the study visit were collected using electronic case report forms. Results Data from 476 patients (mean age, 55.4 years; female, 63.0%) were analyzed. Most patients were treated by specialists (83.7%) and had moderate-to-severe asthma (91.0%). Overall, 7.6% of patients were prescribed ≥ 3 SABA canisters (defined as over-prescription). In patients prescribed SABA in addition to maintenance therapy, 47.4% were over-prescribed SABA. Most patients (95.4%) were prescribed a fixed-dose combination of an inhaled corticosteroid and a long-acting β2-agonist as maintenance therapy. Although asthma was well-controlled/partly-controlled in 91.6% of patients, 29.6% experienced ≥ 1 severe asthma exacerbation. Conclusions SABA over-prescription was reported in nearly 50% of patients prescribed SABA in addition to maintenance therapy, underscoring the need to align clinical practices with the latest evidence-based recommendations and educate physicians and patients on appropriate SABA use.

The most widespread chronic condition observed amid children globally is asthma. Only half of children with asthma adhere to their prescribed inhaled corticosteroids (ICS) therapy. Parents' emotions and perspectives regarding asthma have an impact on inhalation corticosteroid adherence. The participants in this study were 148 parents of children with asthma, with the aim to redintegrate their beliefs about medicines in general and specifically of ICS and the impact on ICS adherence in children with asthma. Children were mostly male (66.9%), older than five years (58.8%), parents were female, mean age 38, employed, and with a history of consumption of some form of corticosteroids. Parents' answers show that 50% of them disagreed with the statement that medicines are addictive, and 90% agree that medicine helps many to live better. A percentage of 77.7% of parents acknowledge that their child's health relies on inhaled corticosteroids (ICS), and 86.5% of parents agree that these medications safeguard their child from worsening health. Most of the parents (93.2%) adhere to the guidelines and instructions of the doctor. In summary, parents who hold the belief that medicines are neither overused nor harmful tend to exhibit a higher adherence. Furthermore, those with elevated adherence levels express lower levels of concern regarding the use of inhaled corticosteroids (ICS) in their children's asthma therapy. [ABSTRACT FROM AUTHOR]

Background: The fractional exhaled nitric oxide (FENO) test is a point-of-care test that is used in the assessment of asthma. Objective: To provide evidence-based clinical guidance on whether FENO testing is indicated to optimize asthma treatment in patients with asthma in whom treatment is being considered. Methods: An international, multidisciplinary panel of experts was convened to form a consensus document regarding a single question relevant to the use of FENO. The question was selected from three potential questions based on the greatest perceived impact on clinical practice and the unmet need for evidence-based answers related to this question. The panel performed systematic reviews of published randomized controlled trials between 2004 and 2019 and followed the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) evidence-to-decision framework to develop recommendations. All panel members evaluated and approved the recommendations. Main Results: After considering the overall low quality of the evidence, the panel made a conditional recommendation for FENO-based care. In patients with asthma in whom treatment is being considered, we suggest that FENO is beneficial and should be used in addition to usual care. This judgment is based on a balance of effects that probably favors the intervention; the moderate costs and availability of resources, which probably favors the intervention; and the perceived acceptability and feasibility of the intervention in daily practice. Conclusions: Clinicians should consider this recommendation to measure FENO in patients with asthma in whom treatment is being considered based on current best available evidence.

BackgroundAsthma is a heterogeneous disease. Clinical blood parameters differ by race/ethnicity and are used to distinguish asthma subtypes and inform therapies. Differences in subtypes may explain population-specific trends in asthma outcomes. However, these differences in racial/ethnic minority pediatric populations are unclear.ObjectiveWe investigated the association of blood parameters and asthma subtypes with asthma outcomes and examined population-specific eligibility for biologic therapies in minority pediatric populations.MethodsUsing data from 2 asthma case-control studies of pediatric minority populations, we performed case-control (N = 3738) and case-only (N = 2743) logistic regressions to quantify the association of blood parameters and asthma subtypes with asthma outcomes. Heterogeneity of these associations was tested using an interaction term between race/ethnicity and each exposure. Differences in therapeutic eligibility were investigated using chi-square tests.ResultsRace/ethnicity modified the association between total IgE and asthma exacerbations. Elevated IgE level was associated with worse asthma outcomes in Puerto Ricans. Allergic asthma was associated with worse outcomes in Mexican Americans, whereas eosinophilic asthma was associated with worse outcomes in Puerto Ricans. A lower proportion of Puerto Ricans met dosing criteria for allergic asthma-directed biologic therapy than other groups. A higher proportion of Puerto Ricans qualified for eosinophilic asthma-directed biologic therapy than African Americans.ConclusionsWe found population-specific associations between blood parameters and asthma subtypes with asthma outcomes. Our findings suggest that eligibility for asthma biologic therapies differs across pediatric racial/ethnic populations. These findings call for more studies in diverse populations for equitable treatment of minority patients with asthma.

Omalizumab is used for the treatment of severe allergic asthma. The aim of this study was to evaluate the clinical features and laboratory data of patients with severe allergic asthma classified as super-responder or non super-responder to omalizumab. Comparisons were made of the laboratory data and clinical features of patients with severe allergic asthma. Patients who had no asthma exacerbation, no oral corticosteroid (OCS) use, asthma control test (ACT) score >20 and forced expiratory volume in 1 s (FEV1) >80% were considered super-responder after omalizumab. A total of 90 patients were included in the study, comprising 19 (21.1%) males. The age at onset of asthma, allergic rhinitis rate, number of endoscopic sinus surgeries (ESS), intranasal corticosteroid (INS) use, baseline FEV 1 (%) and ACT score were significantly higher in the omalizumab super-responder group (p = 0.013, p = 0.015, p = 0.002, p = 0.001, p = 0.001 and p < 0.001, respectively). The duration of asthma, rate of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP), regular use of OCS, baseline eosinophil count and eosinophil-to-lymphocyte ratio were significantly higher in the omalizumab non super-responder group (p = 0.015, p < 0.001, p = 0.004, p < 0.001 and p < 0.001, respectively). Blood eosinophil count (AUC: 0.187, p < 0.001), eosinophil-to-lymphocyte ratio (AUC: 0.150, p < 0.001) and FEV1 (%) (AUC:0.779, p = 0.001) were determined to have diagnostic value in predicting the treatment response to omalizumab of patients with severe allergic asthma. High-blood eosinophil levels, CRSwNP and low pretreatment lung capacity may affect omalizumab treatment response in patients with severe allergic asthma. These results should be supported by further multicenter real-life studies. [ABSTRACT FROM AUTHOR]

The most prevalent children's chronic disease worldwide is asthma which has notable negative impacts on patients' and parent's quality of life. Daily inhaled corticosteroids (ICS) therapy is a preferred controller choice. This study was conducted on 148 parents of asthmatic children to establish parents' perception of illness and fear of inhaled corticosteroids using B-IPQ and TOPICOP questionnaires. Children were in the majority male (66.9%), older than five years (58.8%), with comorbidities, and family history of atopy. Parents were female, with a mean age of 38, employed, and with a history of some form of corticosteroid use. Most parents were not afraid of ICS usage (71.6%). Unemployed parents and parents who had no medical education had a statistically significantly higher fear of using ICS (p = 0.002, p = 0.03). A child's illness affects the parents' lives and parents who are afraid of using ICS react more emotionally to the child's illness. Better understanding and less concerned about child's disease are parents of children with controlled asthma. The parents' perspective of children's asthma will affect the duration and dose of ICS treatment they will give to their children and directly influence the level of asthma control. [ABSTRACT FROM AUTHOR]

The most widespread chronic condition observed amid children globally is asthma. Only half of children with asthma adhere to their prescribed inhaled corticosteroids (ICS) therapy. Parents’ emotions and perspectives regarding asthma have an impact on inhalation corticosteroid adherence. The participants in this study were 148 parents of children with asthma, with the aim to redintegrate their beliefs about medicines in general and specifically of ICS and the impact on ICS adherence in children with asthma. Children were mostly male (66.9%), older than five years (58.8%), parents were female, mean age 38, employed, and with a history of consumption of some form of corticosteroids. Parents’ answers show that 50% of them disagreed with the statement that medicines are addictive, and 90% agree that medicine helps many to live better. A percentage of 77.7% of parents acknowledge that their child’s health relies on inhaled corticosteroids (ICS), and 86.5% of parents agree that these medications safeguard their child from worsening health. Most of the parents (93.2%) adhere to the guidelines and instructions of the doctor. In summary, parents who hold the belief that medicines are neither overused nor harmful tend to exhibit a higher adherence. Furthermore, those with elevated adherence levels express lower levels of concern regarding the use of inhaled corticosteroids (ICS) in their children’s asthma therapy.

Neuropsychiatric events (NEs) reported with montelukast during post-marketing surveillance by the US Food & Drug Administration resulted in a 2008 safety alert and a black box warning in 2020. Our objective was to evaluate montelukast exposure and NEs risk using sequence symmetry analysis. National Veterans Health Administration (VHA) administrative data were used to identify 11 840 patients prescribed incident montelukast during fiscal year 2014. Incident prescribing of neuropsychiatric medication was used as a proxy marker for incident NEs and included antidepressants, benzodiazepines, hypnotics, antipsychotics, mood stabilizers, and buspirone. Symmetry ratios were calculated as the ratio of patients with an incident neuropsychiatric event in the year following montelukast initiation to the year preceding initiation. Exposure counterfactual analyses were used to examine the relationship between potential therapeutic alternatives to montelukast and risk for NEs. Incident NEs were observed in 2305 patients following montelukast initiation and 2734 patients preceding montelukast initiation (SR 0.84, 95% CI 0.80–0.89). Sensitivity analyses examining each of the 6 sub-types of psychiatric medications also failed to show increased risk of NEs following montelukast initiation. Therapeutic alternatives to montelukast, such as inhaled corticosteroids, were also not associated increased NE risk. Initiation of montelukast was not associated with increased risk of a variety of NEs in this sequence symmetry analysis involving adult patients in the VHA. Our findings do not support the hypothesis that NEs are associated with montelukast initiation. [ABSTRACT FROM AUTHOR]

The most prevalent children’s chronic disease worldwide is asthma which has notable negative impacts on patients’ and parent’s quality of life. Daily inhaled corticosteroids (ICS) therapy is a preferred controller choice. This study was conducted on 148 parents of asthmatic children to establish parents’ perception of illness and fear of inhaled corticosteroids using B-IPQ and TOPICOP questionnaires. Children were in the majority male (66.9%), older than five years (58.8%), with comorbidities, and family history of atopy. Parents were female, with a mean age of 38, employed, and with a history of some form of corticosteroid use. Most parents were not afraid of ICS usage (71.6%). Unemployed parents and parents who had no medical education had a statistically significantly higher fear of using ICS (p = 0.002, p = 0.03). A child’s illness affects the parents’ lives and parents who are afraid of using ICS react more emotionally to the child’s illness. Better understanding and less concerned about child’s disease are parents of children with controlled asthma. The parents’ perspective of children’s asthma will affect the duration and dose of ICS treatment they will give to their children and directly influence the level of asthma control.

Abstract Background Adherence to inhaler medication is an important contributor to optimum asthma control along with adequate pharmacotherapy. The objective of the present study was to assess self-reported adherence levels and to identify the potential factors associated with non-adherence to the inhalers among asthma patients. Methods This facility-based cross-sectional study was conducted in the medicine outpatient department of Rajshahi Medical College Hospital from November 2020 to January 2021. A total of 357 clinically confirmed adult asthma patients were interviewed. Inhaler adherence was measured using the 10-item Test of Adherence scale (TAI).. Both descriptive and inferential statistics were used to express the socio-demographic of the patients and predictors of poor adherence to inhaler. Results A substantial number of participants were non-adherent (86%) to inhaler medication. Patients non-adherent to inhaler medication are often younger (23.15, 95% CI 3.67–146.08), lived in the rural area (23.28, 95% CI 2.43–222.66), less year of schooling (5.69, 95% CI 1.27–25.44), and belonged to the middle income (aOR 9.74, 95% CI 2.11–44.9) than those adherent with the inhaler. The presence of comorbidities (12.91, 95% CI 1.41–117.61), prolonged duration of inhaler intake (5.69, 95% CI 1.22–26.49), consulting non-qualified practitioners (13.09, 95% CI 3.10–55.26) were the significant contributor of non-adherence. Conclusion Despite ongoing motivation and treatment, non-adherence to inhalation anti-asthmatic is high and several factors have been found to contribute. Regular monitoring and a guided patient-centered self-management approach might be helpful to address them in long run.

Background/Aim. Asthma is a chronic inflammatory lung disorder. The effect of asthma drugs on oral health is still the subject of debate among researchers in dentistry. The aim of this study was t o e valuate dental status in asthmatic children and evaluate the possible effect of drugs treating asthma on dental health. Methods. Study participants were divided into two groups: the asthma (AG) and the non-asthma (NAG) group. Based on the symptoms of asthma and the possibility for effective control of the disease, the AG group was divided into two subgroups. The oral examination of the teeth was per-formed using a probe and mouth mirror under artificial light in accordance with the recommendations of the World Health Organization. Saliva analysis was carried out by the GC Saliva-Check Buffer, according to the manufacturer's instructions. Results. The study included 136 children aged 6 to 16 years (10.5 ± 3.3). The mean of decayed, missing, and filled teeth (dmft/DMFT) of the children in the AG group (6.0 ± 4.0/3.3 ± 4.4) was higher than in the NAG group (4.8 ± 4.4/2.5 ± 3.4), but significant differences were not observed between the groups. Salivary pH values were found to be similar in both groups, but the quantity and buffering capacity of the stimulated saliva were found to be significantly lower in the AG group (p < 0.001 and p < 0.05, respectively). Conclusion. Although the prevalence of dental caries in the AG group was similar to that of the NAG group in this study, decreased quantity and buffering capacity of the stimulated saliva in the A G group may contribute to higher values of dental caries in asthmatic children in the future.

Single maintenance and reliever therapy (SMART) is an asthma treatment approach that utilizes combined inhaled corticosteroids and long-acting β-agonists for maintenance and quick relief therapy. Despite the evidence for its benefits in asthma treatment and its adoption into American and international asthma guidelines and recommendations, SMART remains a practice of some debate. This article reviews the available evidence for SMART and offers guidance for its integration into comprehensive asthma management. Overall, short-acting β-agonist-only asthma therapy regimens should be avoided, regardless of condition severity (SOR A Recommendation). Family medicine clinicians should start SMART for patients requiring either GINA Step 3 or 4 therapy, especially if they have signs of poor adherence (SOR B Recommendation). Finally, use budesonide-formoterol over other inhaled corticosteroid/long-acting β-agonist combinations when implementing SMART (SOR B Recommendation)., Competing Interests: Conflict of interest: The authors report no potential conflict of interest relevant to this article., (© Copyright by the American Board of Family Medicine.)

Twelve undescribed compounds, including five flavonoids and seven phenols, were isolated from the stems of Ephedra equisetina Bunge. Their structures were elucidated by spectroscopic methods, including NMR spectroscopy and HRESIMS analysis. Their absolute configurations were elucidated by comparing their experimental and calculated ECD spectra. In the in vitro bioactive assay, all compounds were tested for their anti-asthmatic activities by releasing β-Hex in C48/80-induced RBL-2H3 cells. The β-Hex release rates of compounds 3, 8, 10, and 11 were 0.8502 ± 0.0231, 0.8802 ± 0.0805, 0.7850 ± 0.0593, and 0.8361 ± 0.0728, respectively, suggesting that compounds 3, 8, 10, and 11 have potential anti-asthmatic activities., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Objectives: Simple clinical parameters that could be helpful in choice of monoclonal antibodies and prediction of their effectiveness are being sought. The aim was to assess if neutrophil-to-lymphocyte, eosinophil-to-lymphocyte and platelet-to-lymphocyte ratios may predict outcomes of biologic therapy for severe asthma., Methods: Retrospective, single-center study including severe asthma patients treated with three different biologics. The blood ratios were assessed at initiation of treatment (point 0) and after six months (point 1). The chi-square test was used to analyze differences in nominal variables. Quantitative variables were compared by Student's t -test, Mann-Whitney U or Wilcoxon signed-rank tests., Results: 53 patients with severe asthma were included, among them 21 patients (40%) treated with omalizumab and 32 patients (60%) with mepolizumab or benralizumab. Neutrophil-to-lymphocyte and platelet-to-lymphocyte ratios did not change during six-month-course of biological treatment. Eosinophil-to-lymphocyte ratio was higher at the point 0 ( p  = 0.016) in the group treated with anti-eosinophils than in the omalizumab group and lower at the point 1 ( p  = 0.006). In the anti-eosinophil group this ratio decreased between points 0 and 1 ( p  < 0.001). In the omalizumab group there was an inverse correlation between the initial ratio and oral corticosteroid dose reduction (r s = -0,67). In the a/eos group there were significant correlations between initial ratio and age (r s = 0.36), and ACQ (r s = -0.4) and ACQ (r s = 0.41) measured at the point 1., Conclusions: Pretreatment eosinophil-to-lymphocyte ratio may predict oral corticosteroid dose reduction resulting from omalizumab treatment and change in quality of life and asthma control resulting from anti-IL-5 and IL-5R treatment.

Background: Uncontrolled asthma in growing children can impair lung growth that may lead to adverse complications in later life. Dupilumab, a human monoclonal antibody, blocks the shared receptor for IL-4 and IL-13, key drivers of type 2 inflammation., Objective: To extensively evaluate the effect of dupilumab on lung function in children (6-11 years) with moderate-to-severe asthma enrolled in phase 3 LIBERTY ASTHMA VOYAGE (NCT02948959)., Methods: Children with asthma were randomized 2:1 to add-on dupilumab 100/200 mg by bodyweight or placebo every 2 weeks, for 52 weeks. We analyzed spirometry parameters in children with type 2 asthma (blood eosinophils ≥150 cells/μL or fractional exhaled nitric oxide [FeNO] ≥20 parts per billion [ppb] at baseline) and within subgroups defined by baseline blood eosinophils or FeNO values., Results: A total of 116 (49%) dupilumab-treated children and 59 (52%) on placebo had impaired lung function (prebronchodilator percent-predicted forced expiratory volume in 1 second [ppFEV 1 ] <80%) at baseline. Dupilumab improved pre- and postbronchodilator ppFEV 1 as early as week 2, sustained for up to 52 weeks (least-squares mean difference vs placebo at week 52: 7.79 percentage points; 95% confidence interval [CI]: 4.36-11.22; P < .001 and 4.37 points; 95% CI: 0.95-7.78; P = .01, respectively). Sustained improvements were also observed in other lung function parameters, including pre- and postbronchodilator forced vital capacity (FVC), prebronchodilator forced expiratory flow, and FEV 1 /FVC ratio across all populations., Conclusions: Dupilumab led to significant, sustained lung function improvements across a range of lung function measures in children (6-11 years) with uncontrolled, moderate-to-severe type 2 asthma., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Seasonal variability could influence asthma exacerbations. Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin (IL)-4/IL-13, key and central drivers of type 2 inflammation. In the 52-week QUEST study (NCT02414854), add-on dupilumab every 2 weeks vs placebo significantly reduced exacerbations and improved prebronchodilator forced expiratory volume in 1 second in patients with uncontrolled, moderate-to-severe asthma. TRAVERSE (NCT02134028), the open-label QUEST extension study, enrolled patients with moderate-to-severe asthma to investigate long-term safety and efficacy of dupilumab, including patients who previously received placebo that initiated dupilumab therapy., Objective: To investigate long-term dupilumab efficacy in reducing exacerbations across yearly seasons in patients with type 2 inflammatory asthma with and without clinical evidence of allergic asthma., Methods: Unadjusted annualized exacerbation rate and proportions of patients experiencing severe asthma exacerbations are reported by month and season and for both hemispheres., Results: The proportion of patients with type 2 asthma experiencing 1 or more severe asthma exacerbations during QUEST was 20.8% vs 10.0% in spring, 18.2% vs 7.3% in summer, 22.2% vs 12.6% in autumn, and 26.4% vs 12.0% in winter, for placebo- vs dupilumab-treated patients, respectively; P was less than .001 for placebo vs dupilumab in all seasons. Reductions in the proportion of patients experiencing severe exacerbations across seasons in subgroups with and without evidence of allergic asthma were similar to the overall type 2 population. Reductions in severe exacerbations observed during QUEST were sustained during TRAVERSE, up to 96 weeks across both hemispheres., Conclusion: Dupilumab reduced asthma exacerbations, with no difference in the reduction between seasons, in patients with type 2 inflammation, with and without evidence of allergic asthma., Trial Registration: ClinicalTrials.gov Identifiers: NCT02414854, NCT02134028., Competing Interests: Disclosures Dr Peters has served as a consultant for and received research support from Regeneron Pharmaceuticals Inc. and Sanofi, received research support from AstraZeneca, and provided consultancy for Optinose. Dr Sagara has received speaker fees from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis, and Sanofi. Dr Corren reports receiving research grants from and providing consultancy for AstraZeneca, Genentech, Novartis, Regeneron Pharmaceuticals Inc., and Sanofi and has received speaker fees from AstraZeneca, Genentech, and Novartis. Dr Domingo reports receiving travel and speaker fees from ALK, Allergy Therapeutics, Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, HAL Allergy, ImmunoTek, Menarini, Novartis, Pfizer, Sanofi-Aventis, Stallergenes Greer, and Teva. Mr Altincatal, Dr Pandit-Abid, Dr Rowe, and Dr Jacob-Nara are Sanofi employees and may hold stock and/or stock options in the company. Dr Soler, Ms Crikelair, and Dr Deniz are employees and shareholders of Regeneron Pharmaceuticals Inc., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Prevention of asthma exacerbations and reduction of systemic corticosteroid burden remain unmet needs in asthma. US asthma guidelines recommend concomitant short-acting β 2 -agonist (SABA) and inhaled corticosteroid (ICS) as an alternative reliever at step 2. The Food and Drug Administration approved a pressurized metered-dose inhaler containing albuterol and budesonide for as-needed treatment or prevention of bronchoconstriction and for reducing exacerbation risk in patients with asthma aged ≥18 years. This combination is approved for use as a reliever with or without maintenance therapy, but it is not indicated for maintenance therapy (or for single maintenance and reliever therapy). Intervening with as-needed SABA-ICS during the window of opportunity to reduce inflammation during loss of asthma control can reduce exacerbation risk, by exerting both genomic and nongenomic anti-inflammatory effects. We propose that the use of albuterol-budesonide rather than albuterol as a reliever to manage episodic symptoms driven by acute bronchoconstriction and airway inflammation can improve outcomes. This combination approach, shown to decrease asthma exacerbations and oral corticosteroid burden in patients with moderate-to-severe asthma, represents a paradigm shift for asthma treatment in the United States. Further safety and efficacy studies should provide evidence that this type of reliever should be standard of care., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Cost-effectiveness studies evaluate health technologies and help choose treatments. The current study compared dupilumab to omalizumab, mepolizumab, and benralizumab in Colombian adults with severe uncontrolled type 2 asthma., Methods: Over a 5-year period, a Markov model was utilized to assess the costs of biological treatments and management of exacerbations, comparing various doses of exacerbations, comparing various doses of dupilumab, omalizumab, mepolizumab, and benralizumab as add-on treatments. It included a 5% annual discount rate per local HTA, and set willingness-to-pay at three times GDP per capita per quality-adjusted life year (QALY) in Colombia., Results: Dupilumab (200 mg) exhibited greater QALYs and reduced overall costs compared to mepolizumab (100 mg), benralizumab (30 mg), and omalizumab (450 mg and 600 mg), with the incremental cost-effectiveness ratio (ICER) per QALYgained being -$5.429, -$6.269, -$196.567 and -$991.007, respectively. Dupilumab had greater QALYs and costs versus omalizumab 300 mg (ICERof $200.653 per QALY, above the willingness-to-pay threshold of 3 × GDP per capita). Sensitivity analyses were consistent with base case results., Conclusions: Dupilumab 200 mg was strongly dominant versus omalizumab 450 mg and 600 mg, mepolizumab 100 mg, and benralizumab 30 mg; however, cost-effectiveness was not demonstrated versus omalizumab 300 mg. These results could assist healthcare professionals in choosing an appropriate biologic for treating severe type 2 asthma.

Introduction: Extrafine formulation of beclomethasone/formoterol fixed combination (BDP/F pMDI HFA) is approved for both fixed maintenance and maintenance and reliever therapy (MART) of asthma, and recent data has proven that BDP/F pMDI HFA maintenance and reliever therapy is an effective alternative to other regimens., Objective: This study aimed to assess the level of asthma control in a real-life setting in adult patients using extrafine BDP/F pMDI HFA fixed combination in a pressurized metered-dose inhaler (pMDI) as fixed maintenance dosing as well as maintenance and maintenance and reliever therapy. Additionally, we examined patients' satisfaction with the inhaler device and compliance with therapy as essential factors determining asthma control., Methods: This multicenter prospective non-interventional observational study lasted 4 months with 3 patient visits. We used the Asthma Control Questionnaire 7 (ACQ-7) to evaluate the degree of asthma control and Morisky Medication Adherence Scale (MMAS-4) to assess compliance. A self-developed questionnaire was used to assess satisfaction with the inhaler device., Results: 2179 patients using BDP/F pMDI HFA fixed combination as maintenance and reliever therapy or BDP/F pMDI HFA as maintenance therapy and SABA (short-acting beta 2 -agonist) as a reliever for at least 2 months were included. During the prospective follow-up, we observed an upward trend in the FEV1% (forced expiratory volume in 1 s) predicted values, improvement in the control of symptoms as indicated by a decline in the mean ACQ-7 score was noted (1.62 at Visit 1 vs. 1.21 at Visit 2 vs. 0.94 at Visit 3, p < 0.001) and increase in patients' compliance (the number of patients that reported forgetting at times to take their medication was reduced from 49.7 % to 27.1 %, p < 0.001). At the same time, we noted a reduction in the number of as-needed doses used for symptom relief (p < 0.001). Most patients were satisfied with the pMDI, considered it easy and convenient to use, and preferred it to a dry powder inhaler (p < 0.001)., Conclusions: The use of extrafine BDP/F pMDI HFA as maintenance as well as reliever therapy seems to be associated with increased asthma control and better compliance to therapy., Competing Interests: Declaration of competing interest Tomasz Dębowski is an employee of Chiesi Poland sp. z o.o. Monika Marko declared no competing interest. Barbara Rogala declared no competing interest. Paweł Majak declared no competing interest. Rafał Pawliczak received travel grants and lecture honoraria from Chiesi Poland sp. z o.o. This work was supported by a grant from Chiesi Polska sp. z o.o., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)

For patients with moderate-to-severe persistent allergic asthma, omalizumab is approved for subcutaneous administration according to a recommended dosing table based on weight and total immunoglobulin E (IgE) level. The aim of this analysis was to assess asthma outcomes including quality of life in patients with allergic asthma initiated on omalizumab in the PROSPERO trial; patients were stratified by where their IgE and body weight fell on the approved dosing table. Patient groups were defined as Inside Dosing Table: patients whose IgE and weight fell within the approved dosing table (n = 506); Insufficient Data to Recommend a Dose: patients who fell into the section of the approved dosing table where not enough clinical data were available to make dosing recommendations (n = 72); and Outside Dosing Table: patients who fell outside the approved dosing table due to baseline IgE and/or weight (n = 209). Overall, asthma and quality of life outcomes were improved after omalizumab initiation for both patients who fall within the recommended dosing table or those who fall outside the recommended dosing table. Our results suggest that omalizumab treatment may be effective in a wide range of patients with moderate-to-severe allergic asthma. ClinicalTrials.gov identifier NCT01922037., Competing Interests: Declaration of competing interest NMC: consultant and/or speaker bureau member for Amgen, ARS Pharmaceuticals Inc., AstraZeneca, Blueprint Medicines, Bryn Pharma, Genentech Inc., GlaxoSmithKline, Hikma Pharmaceuticals, Incyte, Novartis, Regeneron, and Sanofi; speaker bureau member for Incyte; consultant for ARS Pharmaceuticals Inc., Bryn Pharma, Genentech, Inc., Hikma Pharmaceuticals, and Novartis Pharmaceuticals Corporation. ML: institution received research grant support on her behalf from Sanofi; received honoraria for serving as a consultant for AstraZeneca. CTJH: former employee of Genentech, Inc. LAM, AS, JWS, BLT: employees of Genentech, Inc.; stockholders of Roche. NAH: received honoraria for serving as advisor or consultant for Amgen, AstraZeneca, Genentech, Inc., GlaxoSmithKline, Novartis Pharmaceuticals Corporation, Regeneron, Sanofi, and Teva. Institution received research grant support on his behalf from AstraZeneca, Genentech, Inc., GlaxoSmithKline, Novartis, Sanofi, and Teva. TBC: consultant and speaker bureau member for Genentech, Inc.; consultant for Novartis Pharmaceuticals Corporation; chief medical advisor for Food Allergy Research & Education., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Introduction: Asthma is one of the most common diseases in children, with a variable range of severity. In recent years, treatment for severe asthma has been largely improved by the availability of targeted biologic therapies. Nevertheless, studies reporting real-world data and cost-effectiveness analyses are lacking. The aim of this study was to evaluate, on a population-based cohort of children with asthma, the impact of the treatment with biologics on healthcare service utilization and associated costs., Methods: Data were retrieved from Healthcare Utilization database of Lombardy region (Italy). A cohort of 46 asthmatic children aged 6-11 in treatment with dupilumab, mepolizumab or omalizumab was identified during 2017-2021. We compared healthcare resources use between the year before ("baseline period") and the year after the treatment initiation ("follow-up period"). Average 1-year healthcare costs were also calculated., Results: Comparing the baseline with the follow-up period, the number of patients with at least one exacerbation-related hospitalization and ER access decreased by 75.0% and 85.7%, respectively. The use of biologic agents, namely omalizumab, mepolizumab and dupilumab, significantly reduced oral corticosteroids (OCS), short-acting β2-agonists and the association inhaled corticosteroids/long-acting β2-agonists use. ER admissions for non-respiratory causes were also significantly reduced, while discontinuation rate was low (6.5%). The overall costs increased, due to the costs of the biologic agents, but the hospital admission-related costs due to respiratory causes reduced significantly., Conclusions: Our real-world investigation suggests that biologic agents reduced hospital admissions for respiratory causes and use of anti-asthmatic drugs, including OCS. However, long-term healthcare sustainability still needs more in-depth assessments., (© 2023 The Authors. Pediatric Pulmonology published by Wiley Periodicals LLC.)

Objective: Results of biological therapies are often encouraging for severe asthma who are phenotyped as Type 2 inflammation. Unfortunately, some patients do not achieve the desired responses. In this group of patients, there are often switches between anti Ig E and anti-IL-5s and partial improvements are often is deemed sufficient., Method: We planned to start combination therapy with mepolizumab and omalizumab in a 52-year-old patient with uncontrolled allergic asthma whose asthma could not be controlled with omalizumab and mepolizumab treatment, respectively. After complete asthma control was achieved, we aimed to discontinue mepolizumab and continue with omalizumab because it was allergic asthma., Result: The combination of omalizumab 300 mg/month and mepolizumab 100 mg/month was tried and emergency admissions and oral corticosteroids were stopped. At the same time, significant improvement was observed in asthma control test, pulmonary function test and comfort of life., Conclusion: Combined use of Anti-Ig E (omalizumab) and Anti IL 5 (mepolizumab) with a synergistic effect by acting through both pathways, especially in patients with allergic asthma and high levels of both total Ig E and eosinophilia, was found to be effective and no side effects were observed in long-term follow-up. Combination therapy with omalizumab and mepolizumab may become a safe option in patients with severe allergic asthma with a Type 2 inflammatory phenotype who cannot be controlled with each biologic agent.

Background: Stepwise intensification of inhaled corticosteroids (ICS) is routine for severe eosinophilic asthma, despite some poor responses to high-dose ICS. Dose reductions are recommended in patients responding to biologics, but little supporting safety evidence exists., Methods: SHAMAL was a phase 4, randomised, open-label, active-controlled study done at 22 study sites in four countries. Eligible participants were adults (aged ≥18 years) with severe eosinophilic asthma and a five-item Asthma Control Questionnaire score below 1·5 and who received at least three consecutive doses of benralizumab before screening. We randomly assigned patients (3:1) to taper their high-dose ICS to a medium-dose, low-dose, and as-needed dose (reduction group) or continue (reference group) their ICS-formoterol therapy for 32 weeks, followed by a 16-week maintenance period. The primary endpoint was the proportion of patients reducing their ICS-formoterol dose by week 32. The primary outcome was assessed in the reduction group, and safety analyses included all randomly assigned patients receiving study treatment. This study is registered at ClinicalTrials.gov, NCT04159519., Findings: Between Nov 12, 2019, and Feb 16, 2023, we screened and enrolled in the run-in period 208 patients. We randomly assigned 168 (81%) to the reduction (n=125 [74%]) and reference arms (n=43 [26%]). Overall, 110 (92%) patients reduced their ICS-formoterol dose: 18 (15%) to medium-dose, 20 (17%) to low-dose, and 72 (61%) to as-needed only. In 113 (96%) patients, reductions were maintained to week 48; 114 (91%) of patients in the reduction group had zero exacerbations during tapering. Rates of adverse events were similar between groups. 91 (73%) patients had adverse events in the reduction group and 35 (83%) in the reference group. 17 patients had serious adverse events in the study: 12 (10%) in the reduction group and five (12%) in the reference group. No deaths occurred during the study., Interpretation: These findings show that patients controlled on benralizumab can have meaningful reductions in ICS therapy while maintaining asthma control., Funding: AstraZeneca., Competing Interests: Declaration of interests DJJ has received advisory board and speaker fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Novartis, and Sanofi. LGH has received grant funding, participated in advisory boards, and given lectures at meetings supported by Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Evelo Biosciences, GSK, Hoffmann-La Roche, Novartis, Sanofi, Teva, and Theravance; he has received grants from Aerocrine, Amgen, AstraZeneca, Genentech/Hoffman-La Roche, GSK, MedImmune, Novartis UK, Roche/Genentech, and Vitalograph; he has received sponsorship for attending international scientific meetings from AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, and Napp Pharmaceuticals; he has also taken part in asthma clinical trials sponsored by AstraZeneca, Boehringer Ingelheim, GSK, and Hoffmann-La Roche, for which his institution received remuneration; he is the academic lead for the Medical Research Council Stratified Medicine UK Consortium in Severe Asthma, which involves industrial partnerships with a number of pharmaceutical companies, including Amgen, AstraZeneca, Boehringer Ingelheim, GSK, Hoffmann-La Roche, and Janssen. MH has received consulting fees from AstraZeneca, Chiesi, GSK, Novartis, and Sanofi. BDK has participated in advisory boards or received speaker fees from AstraZeneca, Chiesi, GSK, Novartis, and Teva; has received educational travel bursaries from Boehringer Ingelheim, Chiesi, and Napp Pharmaceuticals; and has received research funding from Itamar Medical. AS was an employee of AstraZeneca at the time of this study and may own stock. LH was an employee of AstraZeneca at the time of this study and may own stock. LO is an employee of Cytel and was on contract to AstraZeneca at the time of this study. DC was an employee of AstraZeneca at the time of this study and may own stock. AM-G was an employee of AstraZeneca at the time of this study and may own stock; has attended advisory boards for AstraZeneca, GSK, Novartis, Regeneron, Sanofi, and Teva; has received speaker fees from AstraZeneca, Novartis, Sanofi, and Teva; has participated in research with AstraZeneca, for which his institution was remunerated; and has had consultancy agreements with AstraZeneca and Sanofi. SK has received grants and personal fees for lectures and advisory boards from AstraZeneca, GSK, Novartis, Sanofi-Genzyme, and Teva., (Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Background: Evaluation of biologic therapy response is vital to monitor its effectiveness. Authors have proposed various response criteria including good responder, super-responder, non-responder, and clinical remission., Objectives: To ascertain the prevalence of response and clinical remission after long-term treatment (>6 months) of anti-IgE and anti-IL-5/IL-5Rα biologics, compare these results with existing criteria, and identify predictors for non-responders and clinical remission., Methods: A multicenter, real-life study involving severe asthma patients in Spain. Various outcomes were assessed to gauge response and clinical remission against established criteria., Results: The study included 429 patients, 209 (48.7%) omalizumab, 112 (26.1%) mepolizumab, 19 (4.4%) reslizumab and 89 (20.7%) benralizumab, with a mean treatment duration of 55.3±38.8 months. In the final year of treatment, 218 (50.8%) were super-responders, 173 (40.3%) responders, 38 (8.9%) non-responders, and clinical remission in 116 (27%), without differences among biologics. The short-term non-responders (<6 months) were 25/545 (4.6%). Substantial variations in response and clinical remission were observed when applying different published criteria. Predictors of non-response included higher BMI (OR:1.14; 95% CI:1.06-1.23; p<0.001), admissions at ICU (2.69; 1.30-5.56; p=0.01), high count of SAE (1.21; 1.03-1.42; p=0.02) before biologic treatment. High FEV 1 % (0.96; 0.95-0.98; p<0.001), a high ACT score (0.93; 0.88-0.99; p=0.01) before biologic treatment or NSAID-ERD (0.52; 0.29-0.91; p=0.02) showed strong associations with achieving clinical remission., Conclusion: A substantial proportion of severe asthma patients treated long-term with omalizumab or anti-IL5/IL-5Rα achieved a good response. Differences in response criteria highlight the need for harmonization in defining response and clinical remission in biologic therapy to enable meaningful cross-study comparisons., (Copyright © 2023 SEPAR. Published by Elsevier España, S.L.U. All rights reserved.)

Background/aims: Despite short-acting β2-agonist (SABA) overuse being associated with poor asthma outcomes, data on SABA use in South Korea is scarce. Herein, we describe prescription patterns of SABA and other asthma medications in patients from the South Korean cohort of the SABA use IN Asthma (SABINA) III study., Methods: This study included patients with asthma aged ≥ 12 years, who had ≥ 3 consultations with the same healthcare provider, and medical records containing data for ≥ 12 months prior to the study visit. Patients were classified by investigator-defined asthma severity (per 2017 Global Initiative for Asthma recommendations) and practice type (primary or specialist care). Data on disease characteristics, asthma treatments, and clinical outcomes in the 12 months before the study visit were collected using electronic case report forms., Results: Data from 476 patients (mean age, 55.4 years; female, 63.0%) were analyzed. Most patients were treated by specialists (83.7%) and had moderate-to-severe asthma (91.0%). Overall, 7.6% of patients were prescribed ≥ 3 SABA canisters (defined as over-prescription). In patients prescribed SABA in addition to maintenance therapy, 47.4% were over-prescribed SABA. Most patients (95.4%) were prescribed a fixed-dose combination of an inhaled corticosteroid and a long-acting β2-agonist as maintenance therapy. Although asthma was well-controlled/partly-controlled in 91.6% of patients, 29.6% experienced ≥ 1 severe asthma exacerbation., Conclusion: SABA over-prescription was reported in nearly 50% of patients prescribed SABA in addition to maintenance therapy, underscoring the need to align clinical practices with the latest evidence-based recommendations and educate physicians and patients on appropriate SABA use.

Introduction: Biomarkers are needed to inform the choice of biologic therapy in patients with asthma given the increasing number of biologics. We aimed to identify proteins associated with response to omalizumab and mepolizumab., Methods: Aptamer-based proteomic profiling (SomaScan) was used to assess 1437 proteins from 51 patients with moderate to severe asthma who received omalizumab (n = 29) or mepolizumab (n = 22). Response was defined as the change in asthma-related exacerbations in the 12 months following therapy initiation. All models were adjusted for age, sex, and pre-treatment exacerbation rate. Additionally, body mass index was included in the omalizumab model and eosinophil count in the mepolizumab model. We evaluated the association between molecular signatures and response using negative binomial regression correcting for the false discovery rate (FDR) and gene set enrichment analyses (GSEA) to identify associated pathways., Results: Over two-thirds of patients were female. The average age for omalizumab patients was 42 years and 57 years for mepolizumab. At baseline, the average exacerbation rate was 1.5/year for omalizumab and 2.4/year for mepolizumab. Lower levels of LOXL2 (unadjusted p: 1.93 × 10E-05, FDR-corrected: 0.028) and myostatin (unadjusted: 3.87 × 10E-05, FDR-corrected: 0.028) were associated with better response to mepolizumab. Higher levels of CD9 antigen (unadjusted: 5.30 × 10E-07, FDR-corrected: 0.0006) and MUC1 (unadjusted: 1.15 × 10E-06, FDR-corrected: 0.0006) were associated with better response to omalizumab, and LTB4R (unadjusted: 1.12 × 10E-06, FDR-corrected: 0.0006) with worse response. Protein-protein interaction network modeling showed an enrichment of the TNF- and NF-kB signaling pathways for patients treated with mepolizumab and multiple pathways involving MAPK, including the FcER1 pathway, for patients treated with omalizumab., Conclusions: This study provides novel fundamental data on proteins associated with response to mepolizumab or omalizumab in severe asthma and warrants further validation as potential biomarkers for therapy selection., (© 2023. The Author(s).)

Background: Asthma has a high healthcare burden globally, with up to 10% of the asthma population suffering from severe disease. Biologic agents are a newer class of asthma treatments for severe asthma, with good evidence for efficacy in clinical trials. Nevertheless, real-world studies of its impact on clinical outcomes are limited. Methods: This is an observational cohort study using administrative claims data. The study population consisted of patients aged ≥18 years who had a diagnosis of asthma and initiated mepolizumab after November 4, 2015 and had continuous medical and drug coverage in both the 365 days prior to and following mepolizumab initiation. In patients treated with mepolizumab, we described clinically significant asthma exacerbations by minimum continuous treatment thresholds following initiation of mepolizumab, medication switching patterns and chronic oral corticosteroid (≥28 days) use. Results: We identified 2,536 adults with asthma who initiated mepolizumab. There was an association toward reduction in severe asthma-related events over the first one year of exposure. We observed associations with reduced dispensings of oral corticosteroids over the first year after mepolizumab initiation. Very few patients switched to other biologics during the study period. Conclusions: Treatment with mepolizumab may be associated with fewer asthma-related events in the first year. Over the first one year after initiating mepolizumab, we found associations with decreased concomitant dispensings of oral corticosteroids and medium to high dose ICS/LABA. Additionally, most patients who initiated mepolizumab did not switch to other biologics.

Background: The major problem at the Cleveland Allergy and Asthma Center was the need for additional therapy for severe eosinophilic asthma patients who were steroid-dependent or required frequent bursts of prednisone., Objectives: The objectives of this study were to determine the efficacy of monthly mepolizumab (MP) injections up to 6½ years using Asthma Control Quesitonnaire-7 (ACQ-7), forced expiratory volume in 1 second (FEV 1 ), forced expiratory flow at 25% to 75% (FEF 25%-75% ) overall and among super-responders, and to understand whether FEF 25%-75% is an effective parameter to evaluate MP efficacy., Methods: We reviewed the charts of 67 patients with severe eosinophilic asthma and compared the results between 47 super-responders and the rest of the cohort regarding ACQ-6, ACQ-7, eosinophils, FEV 1 , and FEF 25%-75% . The groups of super-responders and all other patients were described with respect to initial and current values of the study end points using medians and 25th and 75th percentiles. Changes from the initial to the current values in the study end points were measured using percent changes. The Wilcoxon signed rank test was used within each group to test the null hypothesis of 0 median percent change., Results: After 6½ years, there were no significant changes in FEV 1 . The FEF 25%-75% , had a significant median percent increase of 40% among the super-responders (P < .001), which was substantially higher (P = .026) than the median percent increase of 13.8% observed among all other patients., Conclusions: The use of MP up to 6½ years was safe and effective, with significant changes to ACQ-7 and FEF 25%-75% associated with MP treatment, but not the FEV 1 . A higher magnitude of changes was observed among super-responders than the rest of the cohort. Changes in FEF 25%-75% were more meaningful than changes in FEV 1 in evaluating pulmonary function responsiveness of severe eosinophilic asthma to MP., (Copyright © 2023 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)