Factors Associated with Asthma Clinical Remission After Monoclonal Antibody Therapy Initiation in Adults

Authors: L Gomez, et al.

This retrospective cohort study evaluated patient factors associated with achieving clinical remission in adults with asthma treated with monoclonal antibody therapy at Penn Medicine between January 2017 and May 2025. Among 1,465 patients who initiated monoclonal antibody therapy, 465 patients (31.7%) had at least 9 months of follow-up and were included in the analysis. Clinical remission at 12 months was defined as no asthma exacerbations, no oral corticosteroid use, and no more than two short-acting beta-agonist prescriptions. At 12 months, 157 of 465 patients (33.8%; 95% confidence interval [CI]: 29.5–38.3%) achieved clinical remission. Remission rates were higher among patients with lower baseline exacerbation burden, including 44.9% in patients with no baseline exacerbations, 29.0% in those with 1–2 exacerbations, and 17.9% in those with ≥3 exacerbations. Remission rates also increased with age, occurring in 23.8% of patients aged <40 years, 32.7% of those aged 40–59 years, and 44.1% of those aged ≥60 years.

In univariable analyses, older age, public or other insurance coverage, and lower baseline disease burden were associated with remission. In the multivariable analysis of 310 patients with baseline severity data, older age (adjusted odds ratio [aOR] 1.03 per year; 95% CI: 1.01–1.05; p=0.005) and fewer baseline exacerbations (aOR 0.91 per event; 95% CI: 0.83–0.98; p=0.02) remained independently associated with remission after adjustment for sex, race, insurance, and body mass index (BMI).

Overall, older patients and those with lower baseline exacerbation burden were more likely to achieve clinical remission following monoclonal antibody therapy for asthma.

Inflammatory and Lung Function Changes at the Onset of Asthma Symptoms by Anti Inflammatory Reliever Therapy: The Civetta Study

Authors: F Baraldi, et al.

This randomized, single-centre, cross-over phase II study evaluated the anti-inflammatory effects of anti-inflammatory reliever (AIR) therapy using inhaled corticosteroids (ICS) plus salbutamol compared with salbutamol alone during symptomatic asthma episodes Twenty-one adults with mild to moderate asthma (GINA steps 1–3) were included. Patients received either ICS plus salbutamol or salbutamol alone as rescue therapy for up to three symptomatic episodes or 4 weeks, followed by crossover after a ≥1-week washout period. Airway inflammation and lung function were assessed using fractional exhaled nitric oxide (FeNO), peak expiratory flow (PEF), forced expiratory volume in 1 second (FEV1), and symptom scores using a visual analog scale. Measurements were repeated up to 36 hours post-dose. A total of 49 symptomatic episodes were recorded. Episodes were associated with a significant reduction in FEV1 compared with stable conditions (-0.70 L; p=0.003). Following rescue medication use, FeNO levels progressively increased in the salbutamol-alone group compared with the ICS plus salbutamol group, with a difference of + 4.43 ppb at 8-15 min (p=0.052). Significant differences were observed at 30–60 minutes (+6.30 parts per billion [ppb]; 95% confidence interval [CI]: 1.91–10.68; p=0.005), 11–25 hours (+8.93 ppb; 95% CI: 2.35–15.51; p=0.008), and 26–36 hours (+10.63 ppb; 95% CI: 0.42–20.85; p=0.041).

After peak bronchodilation at 30–60 minutes, the total decline in FEV1 was greater in the salbutamol-alone group compared with the ICS plus salbutamol group (0.47 L vs 0.28 L; p=0.003).

Overall, AIR therapy with ICS plus salbutamol reduced airway inflammation and attenuated post-bronchodilation decline in lung function compared with salbutamol alone during symptomatic asthma episodes.

As-Needed Inhaled Corticosteroid-Short-Acting Beta Agonist Combination versus Short-Acting Beta Agonist Alone in Asthma: A Systematic Review and Meta-Analysis

Authors: S Razzaq, et al.

This meta-analysis evaluated the effectiveness and safety of as-needed inhaled corticosteroid (ICS) plus short-acting beta-2 agonist (SABA) therapy compared with SABA alone in patients with asthma. A systematic search of PubMed, Embase, ClinicalTrials.gov, and the Cochrane Library identified 5 randomized controlled trials (RCTs) involving 5,268 participants. Outcomes were analyzed using a random-effects model. Patients receiving ICS-SABA combination therapy had a 35% reduction in the odds of time to first severe asthma exacerbation compared with SABA alone, with a pooled odds ratio (OR) of 0.65 (95% confidence interval [CI]: 0.52–0.81; p=0.0001) and heterogeneity was also low to moderate (I²=43%). Three trials also evaluated the risk of experiencing at least one severe exacerbation. Pooled analysis showed a 68% relative reduction in the odds of severe exacerbation with ICS-SABA therapy compared with SABA alone (OR 0.32; 95% CI: 0.14–0.74; p=0.007), with moderate heterogeneity (I²=48%). No significant differences were observed between groups in overall adverse events (OR 0.98; 95% CI: 0.88–1.10; p=0.73) or serious adverse events (OR 0.99; 95% CI: 0.74–1.31; p=0.92).

Overall, as-needed ICS-SABA therapy significantly reduced asthma exacerbation-related outcomes compared with SABA alone, without significant adverse event rate.

Assessing Inflammatory and Clinical Markers in Predicting Asthma Exacerbations in Real-world and Genomic Data-based Asthma Insights Through Network Analysis (REGAIN) Cohort

Authors: M Duong, et al.

This analysis from the REal-world and Genomic data-based Asthma Insights through Network analysis (REGAIN) study evaluated the ability of type 2 (T2) inflammatory biomarkers and clinical factors to predict future asthma exacerbations in routine subspecialty care. The 18-month prospective observational study included asthma patients receiving stable therapy in specialty care settings, most of whom had well-controlled asthma at enrollment. A total of 426 patients with available follow-up data were included in the analysis. Predictors assessed included baseline blood eosinophil count (BEC), fractional exhaled nitric oxide (FeNO), Asthma Control Test (ACT) score, forced expiratory volume in 1 second (FEV1), prior exacerbation history, and Global Initiative for Asthma (GINA) step therapy level on asthma exacerbation risk. During follow-up, patients who experienced exacerbations had significantly higher GINA step therapy levels (p<0.001), lower ACT scores (p<0.001), and lower FEV1 values (p=0.003) compared with those without exacerbations. However, no differences were observed in baseline or maximum BEC or FeNO levels between groups.

Multivariate regression analysis showed that prior exacerbations within the previous 12 months were moderately associated with future exacerbation risk (risk ratio [RR] 3.19; 95% confidence interval [CI]: 1.74–5.87; p<0.001). Lower baseline ACT score was also associated with exacerbation risk (RR 0.87; 95% CI: 0.83–0.92; p<0.001). No significant association was identified for baseline or maximum BEC, baseline or maximum FeNO, baseline FEV1, or GINA step therapy.

Overall, current asthma control test (ACT) and prior exacerbation history were stronger predictors of future exacerbations than blood eosinophil count or FeNO levels in this real-world specialty care cohort.

Bridging the Gap: A Quality Improvement Study on Hospitalist and Resident Adherence to Asthma SMART Therapy After Educational Intervention

Authors: A Chapa-Rodriguez, et al.

This retrospective study evaluated adherence to single maintenance and reliever therapy (SMART) discharge recommendations for hospitalized asthma patients before and after an asthma lecture series for residents and hospitalists. The study included adults hospitalized with asthma exacerbations and assessed compliance with SMART therapy discharge prescriptions during the 6 months before and after educational lectures on updated asthma management guidelines. SMART therapy refers to the use of inhaled corticosteroid (ICS) and formoterol as both maintenance and reliever treatment, as recommended by the Global Initiative for Asthma (GINA) guidelines since 2019. Following the lecture series, hospital-wide discharge compliance with SMART therapy increased from 11.8% to 48.1%, representing an absolute increase of 36.3% (95% confidence interval [CI]: 13.3%–59.3%). This improvement was statistically significant (p=0.012), with physicians being seven times more likely to prescribe guideline-concordant inhaler therapy after the educational intervention (odds ratio [OR]=7). The hospitalist service accounted for 93.3% of SMART-adherent prescriptions after the intervention.

Overall, the asthma lecture series significantly improved adherence to SMART therapy discharge guidelines in hospitalized asthma patients.

Toward Precision Biologic Selection: Metabolite Ratios Predict Omalizumab Response in Severe Asthma

Authors: A Akenroye, et al.

This study evaluated whether circulating metabolites could predict response to omalizumab therapy in patients with severe asthma. Longitudinal plasma samples from 168 participants in the Study of Mechanisms of Action of Omalizumab in Severe Asthma (SoMOSA) underwent global and targeted metabolomic profiling. Treatment response at 52 weeks was defined by at least 50% reduction in oral corticosteroid (OCS) use, reduction in exacerbations, and improvement in Asthma Control Test (ACT) scores. Individual metabolites were not significantly associated with treatment response after multiple-testing correction. However, several metabolite ratios, particularly sphingolipid-to-steroid and ceramide-to-steroid ratios measured at week 52, were significantly associated with reduced OCS use (p=0.041–0.05) and improved ACT scores (false discovery rate-adjusted p=0.043–0.05). Prediction models using selected metabolite ratios showed high accuracy in identifying treatment responders, with a median area under the curve (AUC) of 0.86. Baseline metabolite-based surrogate measures also predicted response with similar accuracy (median AUC=0.85). These findings were validated in an independent cohort from the Mass General Brigham Biobank.

Overall, sphingolipid-to-steroid and ceramide-to-steroid metabolite ratios were strongly associated with omalizumab response and may help support metabolomics-guided precision medicine approaches in severe asthma. This study evaluated whether circulating metabolites could predict response to omalizumab therapy in patients with severe asthma. Longitudinal plasma samples from 168 participants in the Study of Mechanisms of Action of Omalizumab in Severe Asthma (SoMOSA) underwent global and targeted metabolomic profiling. Treatment response at 52 weeks was defined by at least 50% reduction in oral corticosteroid (OCS) use, reduction in exacerbations, and improvement in Asthma Control Test (ACT) scores. Individual metabolites were not significantly associated with treatment response after multiple-testing correction. However, several metabolite ratios, particularly sphingolipid-to-steroid and ceramide-to-steroid ratios measured at week 52, were significantly associated with reduced OCS use (p=0.041–0.05) and improved ACT scores (false discovery rate-adjusted p=0.043–0.05). Prediction models using selected metabolite ratios showed high accuracy in identifying treatment responders, with a median area under the curve (AUC) of 0.86. Baseline metabolite-based surrogate measures also predicted response with similar accuracy (median AUC=0.85). These findings were validated in an independent cohort from the Mass General Brigham Biobank.

Overall, sphingolipid-to-steroid and ceramide-to-steroid metabolite ratios were strongly associated with omalizumab response after one year of therapy and may help support metabolomics-guided precision medicine approaches in severe asthma.

Budesonide/Glycopyrrolate/Formoterol Fumarate Effects on Time to First Severe Exacerbation and Number Needed to Treat

Authors: M Patel, et al.

This pooled analysis from the Phase 3 KALOS and LOGOS studies evaluated the effect of budesonide/glycopyrrolate/formoterol fumarate (BGF), a fixed-dose inhaled corticosteroid (ICS)/long-acting β2 agonist (LABA)/long-acting muscarinic antagonist (LAMA) triple therapy, on severe asthma exacerbations in patients with inadequately controlled asthma. A total of 4,311 patients aged ≥12 years receiving ICS/LABA therapy were randomized to BGF 36, BGF 18 (320/18/9.6 µg), budesonide/formoterol fumarate delivered via Aerosphere technology (BFFA - 320/9.6 µg), or standard budesonide/formoterol fumarate suspension (BFFS - 320/9 µg) for 24–52 weeks. Compared with BFFA, BFFS, and the combined ICS/LABA comparator group (BFFCombined), BGF reduced severe exacerbation rates. For BGF 36, severe exacerbation rates were 10% lower versus BFFA, 18% lower versus BFFS, and 14% lower versus BFF Combined. For BGF 18, rates were approximately 12% lower versus BFFA, 20% lower versus BFFS, and 16% lower versus BFFCombined. BGF also delayed time to first severe exacerbation compared with BFFCombined. Hazard ratios were 0.84 (95% confidence interval [CI]: 0.75–0.95) for BGF 36 and 0.86 (95% CI: 0.75–0.99) for BGF 18. The number needed to treat (NNT) to prevent one severe exacerbation was 11 for BGF 36 versus BFFCombined and 10 for BGF 18 versus BFF Combined.

BGF reduced severe exacerbations versus ICS/LABA, demonstrating the benefits of single-inhaler triple therapy. The results support BGF as a treatment option for patients with inadequately controlled asthma, including those without recent exacerbations, to lower future exacerbation risk.

Depemokimab Demonstrates Sustained Long-term Efficacy and Consistent Patient-reported Outcomes Over 2 Years in Patients with Type 2 Asthma and Chronic Rhinosinusitis with Nasal Polyps: An Integrated Analysis of the Phase III SWIFT-1/-2 and the Open-label Extension AGILE Studies

Authors: I D Pavord, et al.

This integrated post hoc analysis of the Phase III SWIFT-1/-2 and AGILE open-label extension studies evaluated the long-term efficacy of depemokimab in patients with type 2 (T2) asthma, including those with comorbid chronic rhinosinusitis with nasal polyps (CRSwNP). In the SWIFT-1/-2 studies, 762 patients aged ≥12 years were randomized (2:1) to receive depemokimab 100 mg or placebo every 26 weeks for up to 52 weeks. Patients completing these studies could enter the AGILE extension study for a total follow-up period of 104 weeks. Among patients with CRSwNP, depemokimab reduced annualized exacerbation rates (AER) by 69% versus placebo, with an AER of 0.51 in the depemokimab group compared with 1.61 in the placebo group. In patients without CRSwNP, depemokimab reduced exacerbations by 51%, with an AER of 0.51 versus 1.03 for placebo. Improvements in St George’s Respiratory Questionnaire (SGRQ) and Asthma Control Questionnaire-5 (ACQ-5) scores were greater in patients with CRSwNP than in the overall study population.

Overall, 641 patients entered the AGILE extension study, and 629 received at least one depemokimab dose. Among patients continuing depemokimab treatment for 2 years, the reductions in exacerbation rates and improvements in patient-reported outcomes were maintained regardless of CRSwNP status. Over 2 years, AER was 0.45 in patients with CRSwNP and 0.54 in those without CRSwNP.

In conclusion, depemokimab demonstrated sustained efficacy over 2 years in patients with T2 asthma, with greater clinical benefit observed in patients with comorbid CRSwNP.

Efficacy and Safety of Tezepelumab Versus Placebo in Reducing OCS Use in OCS-Dependent Patients With Severe Asthma: Results from the Phase 3 Sunrise Study

Authors: M E Wechsler, et al.

The Phase 3 SUNRISE study evaluated the efficacy and oral corticosteroid (OCS)-sparing effect of tezepelumab in patients with severe, OCS-dependent asthma. In this multicenter, double-blind, placebo-controlled study, 122 patients aged 18–80 years were randomized to receive tezepelumab 210 mg (n=83) or placebo (n=39) every 4 weeks for 28 weeks. The study was terminated early because of recruitment challenges. Baseline mean daily OCS doses were 14.4 mg in the tezepelumab group and 12.6 mg in the placebo group. The primary endpoint was achieved, with tezepelumab showing greater reductions in daily OCS dose compared with placebo at week 28. The odds of achieving a greater percentage reduction in OCS dose were significantly higher with tezepelumab versus placebo (cumulative odds ratio: 2.93; 95% confidence interval [CI]: 1.43–6.03; p=0.003). Tezepelumab also improved pre-bronchodilator forced expiratory volume in 1 second (pre-BD FEV1) from baseline to week 28. Mean change in FEV1 was 0.24 L with tezepelumab compared with -0.02 L with placebo. Greater numerical improvements were also observed with tezepelumab in asthma control, health-related quality of life, peak expiratory flow, blood eosinophil count (BEC), fractional exhaled nitric oxide (FeNO), and serum immunoglobulin E (IgE) levels. No new safety concerns were identified.

Despite a reduced sample size, SUNRISE met its primary endpoint, with tezepelumab enabling greater OCS dose reduction versus placebo at Week 28. Numerical improvements were also observed in lung function, asthma control, quality of life, and key inflammatory biomarkers, with no new safety concerns identified.

Safety and Efficacy of Omalizumab in Severe Asthma Patients With Elevated IgE Levels: A Two-year Retrospective Review from Mumbai

Authors: J P Nair et al.

This retrospective study evaluated the safety and effectiveness of omalizumab in patients with severe asthma and serum immunoglobulin E (IgE) levels >1500 IU/mL, a population with limited available evidence. The analysis included 13 patients with severe asthma uncontrolled despite high-dose inhaled corticosteroids (ICS), long-acting β2-agonists (LABA), and inhaled tiotropium therapy between 2023 and 2025. Patients had a mean age of 38.5 years, and 7 were female. Patients with elevated IgE levels were screened for allergic bronchopulmonary aspergillosis (ABPA) using modified International Society for Human and Animal Mycology (ISHAM) criteria. All eligible patients received omalizumab 300 mg subcutaneously every month for 6 months. After treatment, improvements were observed in Modified Medical Research Council (MMRC) dyspnea scores and Asthma Control Questionnaire-5 (ACQ-5) scores. Mean forced expiratory volume in 1 second (FEV₁) improved significantly from 0.83 L to 1.04 L, with a mean increase of 210 mL (p=0.005). Mean serum IgE levels decreased from 5701 IU/mL to 4127 IU/mL, representing a mean reduction of 1574 IU/mL (p=0.022). No adverse reactions were reported during treatment.

Overall, omalizumab was associated with improved symptom control, better lung function, and reduced serum IgE levels in patients with severe asthma and IgE levels >1500 IU/mL, supporting its potential use beyond current guideline-recommended IgE limits.

Clinical Remission at 12 Months with Dupilumab in Severe Asthma: A Real-world Cohort from Brazilian Private Practice

Authors: M Gomes, et al.

This retrospective observational study evaluated 12-month clinical remission rates in adults with severe asthma treated with dupilumab in a specialized private clinic in Brazil between 2020 and 2024. Clinical remission was defined as an Asthma Control Test (ACT) score ≥20, no exacerbations, and no daily oral corticosteroid (OCS) use. Among 23 patients who initiated dupilumab, 13 completed at least 12 months of follow-up and were included in paired analyses. Baseline median age was 63 years, 60.9% of patients were male, median eosinophil count was 280 cells/µL, and median total immunoglobulin E (IgE) level was 128 IU/mL. Common comorbidities included chronic rhinosinusitis with nasal polyps (CRSwNP; 30.4%), chronic obstructive pulmonary disease (COPD; 13.0%), chronic rhinosinusitis (CRS; 8.7%), allergic bronchopulmonary aspergillosis (ABPA; 8.7%), and gastroesophageal reflux disease (GERD; 8.7%). Nearly half of patients (47.8%) had previously received biologic therapy.

At 12 months, median ACT scores improved significantly from 9 to 25 (p<0.05), while annualized exacerbations decreased from 4.0 to 1.0 (p<0.05). Ten patients showed improvement in exacerbation status, while none worsened (p=0.00195). Daily OCS use decreased, with 5 patients discontinuing OCS therapy. Clinical remission was achieved in 6 of 13 patients (46.2%; 95% confidence interval [CI]: 19–75). Remission rates varied by comorbidity, including 40% in patients with CRSwNP, 50% with CRS, 100% with ABPA, and 66.7% in patients without comorbidities. Remission rates were similar between biologic switchers and biologic-naïve patients.

Overall, dupilumab was associated with improved asthma control, reduced exacerbations, and achievement of clinical remission in nearly half of evaluated patients.

Prescription Patterns of Maintenance and Reliever Therapy (MART) in Pediatric Asthma

Authors: J Peled, et al.

This retrospective cohort study evaluated maintenance and reliever therapy (MART) prescribing patterns among pediatric asthma patients across a large healthcare system between December 2020 and June 2025. The study included 490 randomly selected asthma visits among children aged 5–17 years from pulmonology, allergy, and primary care clinics. Maintenance and reliever therapy eligibility was defined as Global Initiative for Asthma (GINA) Step ≥3 treatment or at least two exacerbations in the prior year. Among all visits, 331 patients (67.6%) were eligible for MART, but only 107 (32.3%) received a MART prescription documented in at least one electronic medical record (EMR) component. Of those prescribed MART, 58.8% had MART documented consistently across all EMR components. Short-acting beta agonist (SABA) prescriptions were rarely removed after MART initiation, with only 19 patients (5.7%) having SABA removed from their medication list. MART prescribing rates varied by specialty, occurring most frequently among allergists (43.1%), followed by pulmonologists (27.6%) and primary care providers (5%).

Overall, MART prescribing and documentation remained limited despite guideline recommendations supporting its use in pediatric asthma management.

ATS 2026, May15 –20, Orlando, Florida