Fasenra (benralizumab) / AstraZeneca, Kyowa Kirin - LARVOL DELTA

Benralizumab Plus Dupilumab: A Dual Approach to Refractory EGPA Sinusitis (AAAAI 2026) - "Dupilumab, an IL-4Rα antagonist, is effective for CRSwNP but carries risks of eosinophilia and EGPA flares as monotherapy. Dual biologic therapy may offer complementary benefit."

Asthma • Chronic Rhinosinusitis With Nasal Polyps • Eosinophilia • Eosinophilic Granulomatosis With Polyangiitis • Immunology • Langerhans Cell Histiocytosis • Nasal Polyps • Otorhinolaryngology • Rare Diseases • Respiratory Diseases • Sinusitis • Vasculitis • IL5

Improvements in Hypereosinophilic Syndrome (HES) Symptoms and Impacts with Benralizumab: Mixed-Methods Analysis of the NATRON In-Trial Interview Sub-Study (AAAAI 2026) - P3 | "Qualitative analyses were consistent with the patients' quantitative Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue and Short Form 36 (SF-36) data and the broader efficacy conclusions of the main study. Conclusions Patients living with HES reported improvements in symptoms with benralizumab treatment, which directly translated to improvements in overall HRQoL."

Interview • Hypereosinophilic Syndrome • Immunology • Rare Diseases

Continuation vs. Discontinuation of Biologics in Pregnancy: Impact on Maternal Disease and Neonatal Outcomes (AAAAI 2026) - "Methods We retrospectively reviewed women treated for atopic disease within our clinics who received ≥1 dose of a biologic (dupilumab, omalizumab, or benralizumab) during pregnancy or within 4 weeks of conception. Conclusions Exposure to monoclonal antibodies for chronic urticaria, asthma and atopic dermatitis was not associated with adverse outcomes in most patients. Discontinuation often led to maternal disease worsening, supporting individualized risk–benefit discussions on therapy continuation during pregnancy."

Asthma • Atopic Dermatitis • Chronic Spontaneous Urticaria • Dermatitis • Dermatology • Diabetes • Gestational Diabetes • Gynecology • Immunology • Metabolic Disorders • Obstetrics • Respiratory Diseases • Urticaria

Efficacy of Benralizumab by Organ Involvement in Hypereosinophilic Syndrome (HES): Exploratory Analyses from the NATRON Study (AAAAI 2026) - P3 | "HRs vs placebo with/without involvement were: pulmonary 0.24 (0.08–0.72)/0.52 (0.21–1.25); dermatologic 0.45 (0.18–1.10)/0.34 (0.13–0.90); gastrointestinal 0.24 (0.10–0.62)/0.64 (0.25–1.65); musculoskeletal 0.50 (0.18–1.37)/0.33 (0.14–0.80), and sinus 0.38 (0.11–1.26)/0.41 (0.18–0.89). Conclusions Benralizumab treatment reduced the risk of first HES flare regardless of baseline organ involvement, highlighting the therapeutic potential of benralizumab in a broad range of disease manifestations in patients with HES."

Clinical • Hypereosinophilic Syndrome • Immunology • Musculoskeletal Diseases • FIP1L1 • PDGFRA

Content Validity and Meaningful Change Thresholds of the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7a in Adults with Hypereosinophilic Syndrome (HES) (AAAAI 2026) - P3 | "Methods NATRON (NCT04191304) is a randomized, 24-week, placebo-controlled trial evaluating the efficacy and safety of benralizumab in patients with HES (N=133)...Participants in the interview study reported that SF7a items were appropriate for assessing fatigue in HES, with few clarifications needed. Conclusions The qualitative and psychometric analyses confirm that the PROMIS Fatigue SF7a is valid for assessing fatigue in HES and that a within-patient change threshold of 6 points is meaningful."

Clinical • Patient reported outcomes • Fatigue • Hypereosinophilic Syndrome • Immunology

Sputum as a Diagnostic Tool for the Treatment of Asthma (AAAAI 2026) - "Results We found that fluorescently labeled dupilumab and benralizumab specifically bound to CD124 and CD125 receptors, respectively, in both cell lines and sputum-derived cells, with receptor expression levels varying among individual sputum donors. Conclusions Our data suggest that fluorescently labeled biologics, applied in a flow cytometric sputum test, can be used as probes to quantify the levels of receptors targeted by the corresponding drug, enabling assessment of therapeutic response, and providing dosage guidance for physicians."

Asthma • Eosinophilia • Immunology • Respiratory Diseases • IL4R

An Observational Study Assessing Sustained Tolerance with Biologic Therapies (AAAAI 2026) - "Biologics used included omalizumab, dupilumab, mepolizumab, benralizumab, and tezepelumab-ekko. This suggests that patients with more severe disease may remain on biologics longer, indicating possible immune-modulating mechanisms. Larger prospective studies are needed to validate predictors of sustained tolerance of biologics."

Clinical • Observational data • Asthma • Atopic Dermatitis • Chronic Spontaneous Urticaria • Dermatitis • Dermatology • Immunology • Inflammation • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Urticaria

Type 2 Biomarkers as Mediators of Clinical Remission with Biologics in Severe Asthma (AAAAI 2026) - "Methods A total of 342 patients with SA were followed for ≥12 months: 51 received conventional therapy (Con-Tx), 123 received anti-IL5/IL5R therapy (benralizumab n=47, mepolizumab n=48, reslizumab n=28), and 168 received anti-IL4R therapy (dupilumab). MA confirmed statistically significant mediation by FeNO (p=0.045) and Sp-EOS (p=0.002). Conclusions Anti-IL5/IL5R therapy promotes CR via reductions in BEC and Sp-EOS, whereas anti-IL4R therapy achieves CR primarily through reductions in Sp-EOS and FeNO."

Biomarker • Clinical • Asthma • Immunology • Respiratory Diseases • IL5

Biochemical Efficacy of Biologics in Severe Pediatric Asthma: A Systematic Review and Meta Analysis (AAAAI 2026) - "Randomized and non-randomized studies with pediatric (mean age<18 years) asthma patients receiving a biologic (benralizumab, dupilumab, omalizumab or mepolizumab) was included. Conclusions To our knowledge, this is the first review to summarize the biochemical efficacy of biologics in pediatric asthma, measured by changes in FeNO and peripheral eosinophil counts. Future research is required to address the comparative efficacy between biologics, and identify tools and guidelines to bolster evidence-based decision making in choosing between biologics for specific asthma phenotypes."

Retrospective data • Review • Asthma • Immunology • Pediatrics • Respiratory Diseases

Benralizumab for Severe Eosinophilic Asthma in Pediatric Patients: Rationale and Design of the Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 DOMINICA Study (AAAAI 2026) - P3 | "Results N/A. Conclusions The DOMINICA study incorporates an innovative study design to minimize patient exposure to placebo and is currently recruiting."

Clinical • P3 data • Asthma • Immunology • Pediatrics • Respiratory Diseases

Real-life effectiveness of biologics use for severe Asthma in the context of treatment interruption (AAAAI 2026) - "Treatment with omalizumab, dupilumab or benralizumab was initiated according to phenotypes and GINA guidelines. Conclusions Interruption of biologics in severe asthma leads to asthma exacerbations and increase of oral corticosteroid use. Despite economic challenges, an allocation of a budget by health authorities is important to support severe asthmatics who require the use of biologics."

Clinical • Asthma • Immunology • Respiratory Diseases

Long-Term Efficacy of Benralizumab in Patients with Severe Eosinophilic Asthma (SEA) and Persistent Airflow Obstruction (PAO) (AAAAI 2026) - "Of the patients who were PAO+ at baseline, 20.4% (42/206) became PAO−. Conclusions Benralizumab maintained improvements in pre-/post-BD FEV1 and FVC in patients with SEA over a second year of treatment, regardless of PAO status."

Clinical • Asthma • Immunology • Respiratory Diseases

Stopping biologic therapies in Severe Asthma: A Real-World Study in a Community Setting (AAAAI 2026) - "The most frequently discontinued biologics were omalizumab and benralizumab. The most common reason for discontinuation among all biologics was non-clinical, such as payer challenges, followed by side effects in omalizumab and lack of treatment effectiveness in tezepelumab and mepolizumab...Conclusions The most common reasons for stopping were non-clinical, such as payer challenges. These data highlight the complexity of care for this patient group and the need for continuous assessment of the clinical and non-clinical challenges to biologic continuation."

Clinical • Real-world • Real-world evidence • Asthma • Immunology • Respiratory Diseases

Trends in Biologic Therapy Initiation Among Severe Asthma Patients in a Community Real-World Setting (AAAAI 2026) - "Since then, the initiation of these two biologics has declined to 19.8% for omalizumab and 6.8% for mepolizumab in 2025. Dupilumab initiation was 1.2% in 2017, increased to 26.7% in 2019, and has remained overall steady since then. In contrast, benralizumab initiation was 23.4% in 2018, remained steady until 2023, and declined to 11.3% in 2025...Conclusions Trends in biologic therapy initiation have significantly evolved in the last decade. The initiation of tezepelumab has rapidly grown since 2022, highlighting the need for alternatives to treat non-T2 asthma."

Clinical • Real-world • Real-world evidence • Asthma • Immunology • Respiratory Diseases

Biologic Adherence and Exacerbation Risk Among Patients With Severe Asthma in the CHRONICLE Study (AAAAI 2026) - P | "This analysis included data from participants enrolled between February 2018 and February 2024 who initiated a biologic (benralizumab, dupilumab, mepolizumab, omalizumab, reslizumab, or tezepelumab) and remained on treatment for ≥52 weeks. Among patients with ≥2 exacerbations in the prior year, higher biologic adherence was associated with higher biologic effectiveness. Conclusions Among US adults with uncontrolled SA, lower biologic adherence was associated with reduced real-world treatment effectiveness in terms of reducing exacerbations."

Adherence • Clinical • Asthma • Immunology • Respiratory Diseases

Eosinophilic granulomatosis with polyangiitis: recent therapeutic advances. (PubMed, Curr Opin Rheumatol) - "Biological drug therapy targeting IL-5 consolidated its role in the management of EGPA, becoming the cornerstone of the treatment of this rare disease. Future guidelines should consider these recent findings to improve the management of EPGA. Notably, while selective IL-5 targeting is highly effective for remission maintenance, its role in inducing remission in EGPA remains to be fully established. Rituximab was non-superior to standard therapy in induction of remission in patients with EGPA, demonstrating a similar rate of response. The role of other targeted therapies, albeit promising in some cases, remains a matter of debate."

Journal • Asthma • Eosinophilic Granulomatosis With Polyangiitis • Immunology • Langerhans Cell Histiocytosis • Pulmonary Disease • Rare Diseases • Respiratory Diseases • Vasculitis • IL5

CLIPS: A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases (clinicaltrials.gov) - P3 | N=14 | Recruiting | Sponsor: AstraZeneca | Trial primary completion date: Oct 2026 ➔ Jul 2027

Trial primary completion date • Eosinophilia • Eosinophilic Granulomatosis With Polyangiitis • Hematological Disorders • Immunology • Langerhans Cell Histiocytosis • Rare Diseases • Vasculitis • FIP1L1 • PDGFRA

Six-Month Benralizumab Maintenance for Relapsing Chronic Eosinophilic Pneumonia Guided by Eosinophil Kinetics. (PubMed, Respirol Case Rep) - "The patient has remained relapse-free with zero eosinophils for over 2 years under this biannual regimen. This case suggests that benralizumab offers superior durability compared to mepolizumab in CEP due to deep depletion, enabling an extended, cost-effective dosing interval guided by individual eosinophil recovery kinetics."

Journal • Infectious Disease • Pneumonia • Respiratory Diseases • IL5

Former smokers with severe eosinophilic asthma respond to benralizumab as effectively as never-smokers: a post hoc analysis of the ANANKE study. (PubMed, ERJ Open Res) - "Benralizumab improves outcomes in severe eosinophilic asthma patients regardless of smoking history, with former smokers achieving similar benefits in exacerbation reduction, oral corticosteroid sparing, asthma control and lung function to never-smokers https://bit.ly/4grFy7e."

Journal • Retrospective data • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Comparative Efficacy and Safety of Biologic Therapies in Pediatric Asthma: A comprehensive Systematic Review (Front Med) - "Dupilumab consistently showed the most robust outcomes, significantly reducing exacerbations (by up to 64.7%), improving ACQ-7 scores, pulmonary function, and QoL. Omalizumab also showed reduced exacerbations and improved symptom control and QoL, with debatable results in pulmonary function. Mepolizumab demonstrated moderate benefits with variable efficacy and higher SAE rates. Benralizumab and Lebrikizumab yielded modest improvements in clinical outcomes."

Retrospective data • Asthma • Immunology

Treatment of EGPA - Do we need immunosuppressives? (PubMed, J Allergy Clin Immunol Pract) - "Conventional immunosuppressive agents such as cyclophosphamide (CYC), azathioprine, and methotrexate have been widely used, and rituximab has shown similar remission rates to CYC for induction therapy...Biologic therapies targeting eosinophils through IL-5 or IL-5R blockade, notably mepolizumab and benralizumab, have markedly reduced relapse rates, steroid exposure, and improved remission rates in relapsing or refractory disease, with excellent tolerability...Future priorities include clarifying the contribution of vasculitic versus non-vasculitic mechanisms, the significance of ANCA status, and the immunobiology of relapse. Despite therapeutic inertia in the absence of definitive trials, the collective drive of clinicians and researchers promises to transform and advance management of EGPA in the years ahead."

Journal • Review • ANCA Vasculitis • Eosinophilic Granulomatosis With Polyangiitis • Immunology • Langerhans Cell Histiocytosis • Rare Diseases • Vasculitis • IL5 • TSLP

PRAC adopted an extension of indication for FASENRA to include adults and adolescents with hypereosinophilic syndrome (HES), based on interim results from the Phase III D3254C00001 (NATRON) study. SmPC sections 4.1, 4.2, 4.4, 4.8, 5.1, 5.2 and 6.5 and the Package Leaflet were updated accordingly. RMP version 8 was submitted, with editorial and administrative PI updates. (European Medicines Agency) - Pharmacovigilance Risk Assessment Committee (PRAC)-Draft agenda for the meeting on 9 – 12 Feb 2026: [AI generated summary]

PRAC • Hypereosinophilic Syndrome • Immunology

Role of biological therapies targeting eosinophils in eosinophilic granulomatosis with polyangiitis: current evidence and future perspectives. (PubMed, Curr Med Res Opin) - "This review summarizes the current evidence on the efficacy and safety of anti-IL-5 therapies, focusing on mepolizumab and benralizumab. Overall, anti-L-5 therapies represent an effective and safe option for EGPA. Future research should focus on larger, multicenter trials to clarify the pathophysiology of the disease and facilitate the identification of predictive biomarkers, leading for personalized therapeutic strategies."

Journal • Review • ANCA Vasculitis • Eosinophilic Granulomatosis With Polyangiitis • Immunology • Langerhans Cell Histiocytosis • Rare Diseases • Vasculitis • IL5

Eosinophilic Bronchiolitis Diagnosed by a Transbronchial Lung Cryobiopsy and Successfully Treated with Biologic Agents: A Report of Two Cases and Literature Review. (PubMed, Intern Med) - "To our knowledge, these are among the first reported cases of EB that were successfully managed with dupilumab and benralizumab. These cases underscore the diagnostic utility of TBLCs and suggest the potential use of biologic agents as corticosteroid-sparing options for EB."

Journal • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Functional respiratory imaging reveals early structural and functional airway responses to benralizumab in severe eosinophilic asthma. (PubMed, BMJ Open Respir Res) - "Benralizumab treatment in SEA was associated with early improvements in airway volume, resistance, mucus and air-trapping, correlating with better lung function and quality of life. These findings support FRI to monitor early treatment effects."

Journal • Asthma • Eosinophilia • Immunology • Pulmonary Disease • Respiratory Diseases