Nucala (mepolizumab) / GSK - LARVOL DELTA

Pipeline progress and investment delivering future growth opportunities (GSK Press Release) - "US Approvals now received for...Nucala, anti-IL5 biologic for COPD; Blenrep (for multiple myeloma) approved in EU, Japan, UK, Canada and Switzerland. Constructive discussion ongoing with FDA with new PDUFA date set for 23 October 2025; US regulatory decision on depemokimab (for asthma with type 2 inflammation, nasal polyps) expected in December 2025"

Regulatory • Asthma • Chronic Obstructive Pulmonary Disease • Inflammation • Multiple Myeloma • Nasal Polyps

Targeted Biologic Therapies in Severe Asthma: Mechanisms, Biomarkers, and Clinical Applications. (PubMed, Pharmaceuticals (Basel)) - "Monoclonal antibodies targeting IgE (omalizumab) and IL-5 (mepolizumab, benralizumab, reslizumab, depemokimab) have demonstrated the ability to reduce exacerbation frequency and improve lung function, with newer agents such as depemokimab offering extended dosing intervals. Itepekimab, an anti-IL-33 antibody, effectively engages its target and mitigates tissue eosinophilia, while CM310-stapokibart, tralokinumab, and lebrikizumab inhibit IL-4/IL-13 signaling with variable efficacy depending on patient biomarkers. Comparative analyses of these biologics, encompassing affinity, dosing regimens, and trial outcomes, underscore the imperative of personalized therapy to optimize disease control in severe asthma."

Biomarker • Journal • Review • Asthma • Eosinophilia • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • IL13 • IL17A • IL33 • IL4 • IL5

An overview of switching biological therapies for chronic rhinosinusitis with nasal polyposis (CRSwNP). (PubMed, Eur Arch Otorhinolaryngol) - "Biological treatments for CRSwNP have good real-life efficacy in managing nasal symptoms and improving quality of life. Multidisciplinary consensus from immunologists or allergists, otorhinolaryngologists, and pulmonologists is essential for aiding decision-making regarding switching biologics."

Journal • Review • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Inflammation • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis • IL4 • IL5

Clinical Remission Outcome in Chinese Patients With Severe Asthma With an Eosinophilic Phenotype Receiving Mepolizumab: A Post-hoc Analysis of a Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial. (PubMed, Allergy Asthma Immunol Res) - P3 | "A higher proportion of Chinese SA-EP patients treated with mepolizumab achieved CR compared to those receiving placebo. Certain baseline characteristics are potentially predictive of CR."

Clinical • Journal • P3 data • Retrospective data • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Nucala: Regulatory decision in EU/China for COPD (based on MATINEE trial) in H1 2026 (GSK) - Q2 2025 Results

China approval • EMA approval • Chronic Obstructive Pulmonary Disease • Immunology

Carbon Footprint Impact, of Monoclonal Antibodies for Severe Asthma, Administered in Italy. (PubMed, Biomedicines) - "We analyzed data from three studies, all conducted in real life in Italy, of patients treated with mepolizumab, benralizumab and dupilumab, for the control of severe asthma. Disease control, clinical remission of disease, in patients with severe asthma is certainly a determining factor in assessing the effectiveness of a treatment. Provided these goals are achieved, biological drug therapy has also proved to be particularly virtuous from the fundamental environmental point of view, allowing a significant reduction in CO2 production for the management of these patients."

Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Biologic Therapy in Severe Asthma: A Phenotype-Driven and Targeted Approach. (PubMed, J Clin Med) - "Furthermore, we present a practical decision-making platform, including a clinical table matching phenotypes with biologic agents, such as omalizumab, mepolizumab, benralizumab, dupilumab, and tezepelumab. By integrating biomarker analysis with clinical assessment, based on current guidelines and our extensive real-life experience, we aim to offer a logical framework to help clinicians select the most suitable biologic treatment for patients with uncontrolled severe asthma. Future research should focus on identifying novel biomarkers, refining patient stratification, and evaluating long-term outcomes to further advance precision medicine in the management of severe asthma."

Journal • Review • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases • POSTN

Whole blood transcriptomic profile effects of benralizumab or mepolizumab in eosinophilic granulomatosis with polyangiitis (ERS 2025) - No abstract available

Eosinophilic Granulomatosis With Polyangiitis • Immunology • Langerhans Cell Histiocytosis • Rare Diseases • Vasculitis

FAERS-Based Disproportionality Analysis of Diabetes Mellitus in Patients Treated with Biologics for Asthma and Related Conditions. (PubMed, Pulm Pharmacol Ther) - "This FAERS-based analysis identified a potential pharmacovigilance signal for DM associated with several biologics used to treat asthma and related conditions, most notably omalizumab and benralizumab. Similar patterns were observed for metabolic AEs, which reinforces the need for post-marketing studies and clinical awareness in patients with or at risk for metabolic disorders."

Journal • Asthma • Diabetes • Immunology • Metabolic Disorders • Pulmonary Disease • Respiratory Diseases

Achieving remission in severe asthma. (PubMed, Chin Med J Pulm Crit Care Med) - "Biologic treatments such as omalizumab, mepolizumab, reslizumab, benralizumab, and dupilumab have demonstrated efficacy in reducing exacerbations, improving lung function, and achieving clinical remission in a subset of patients. Future research focused on making advanced biomarkers more accessible and feasible for point-of-care testing will enhance treatment precision. The next step will be integrating a multiomics approach into personalized asthma management for severe disease, further improving asthma control, achieving sustained remission, and ultimately reducing the burden of severe asthma."

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

Choosing biologic therapy in children with severe asthma. (PubMed, Paediatr Respir Rev) - "Omalizumab, a monoclonal antibody targeting IgE, was the first biologic therapy approved in 2003 for treating severe, allergen-driven, therapy-resistant asthma. Since then, many new biologics have been approved for use in children, targeting specific pathways, including anti-interleukin (IL)-5 (mepolizumab), IL-5 receptor (benralizumab), IL-4/IL-13 receptor (dupilumab), and thymic stromal lymphopoietin (TSLP) (tezepelumab)...These include accurately identifying the endotype/phenotype of asthmatic inflammation and determining response criteria. Here, we summarise findings from phase 3 trials, discuss practical considerations for individual patients, and propose an algorithm for initiating biologics in children and adolescents with severe asthma."

Journal • Review • Asthma • Eosinophilia • Immunology • Inflammation • Pediatrics • Pulmonary Disease • Respiratory Diseases • IL13 • IL4 • IL5 • TSLP

Transcriptomics in T2-High Severe Asthmatics Treated with Biologics: Comparison Between Anti-IgE, Anti-IL-5 and Anti-IL-5R-Targeted Treatments. (PubMed, Am J Respir Cell Mol Biol) - No abstract available

Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases • IL5

Effects of benralizumab on serum biomarkers and biomarker response after shifting from mepolizumab to benralizumab in eosinophilic granulomatosis with polyangiitis (EGPA) (ERS 2025) - No abstract available

Biomarker • Eosinophilic Granulomatosis With Polyangiitis • Immunology • Langerhans Cell Histiocytosis • Rare Diseases • Vasculitis

A Study of 10 Cases of Eosinophilic Otitis Media Treated with Biologics (AAO-HNSF 2025) - "The use of biologics for eosinophilic otitis media is expected to improve both the eosinophilic otitis media severity score and the pure tone threshold.In the chronic otitis media type with granulation, the granulation improved, but there was little improvement in severity score and hearing level."

Clinical • Asthma • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Long-term efficacy and safety of different biologics in treatment of chronic rhinosinusitis with nasal polyps: A network meta-analysis. (PubMed, Braz J Otorhinolaryngol) - "Treatment with dupilumab in patients with CRSwNP has shown superior long-term efficacy in reducing NPS and various symptom scores compared to other biologics. However, the results should be interpreted with caution due to the heterogeneity of patient characteristics across the included studies (e.g., disease severity, history of surgery, use of oral corticosteroids)."

Journal • Retrospective data • Review • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Real-World Respiratory Effectiveness of mepolizumab in Severe Eosinophilic Asthma and Eosinophilic Granulomatosis with Polyangiitis. (PubMed, Respir Med) - "In this real-world Chinese cohort, mepolizumab was well tolerated and associated with substantial reductions in exacerbations and OCS requirement, significant lung function gains, particularly in SEA, and marked symptom improvement in both SEA and EGPA."

Journal • Real-world evidence • Retrospective data • Asthma • Eosinophilic Granulomatosis With Polyangiitis • Immunology • Inflammation • Langerhans Cell Histiocytosis • Musculoskeletal Pain • Pain • Pulmonary Disease • Rare Diseases • Respiratory Diseases • Vasculitis

Dupilumab-induced Eosinophilic Granulomatosis with Polyangiitis Complicated by Peripheral Neuropathic Pain: a Case Report and Literature Review. (PubMed, J Clin Immunol) - "We present a case of EGPA with peripheral neuropathic pain induced by Dupilumab, and mepolizumab has a good therapeutic effect on this patient. Our literature review shows that although dupilumab is effective in treating eosinophilic airway inflammatory diseases, clinicians must pay attention to the possibility of dupilumab inducing or aggravating EGPAs."

Journal • Review • Asthma • Eosinophilic Granulomatosis With Polyangiitis • Immunology • Inflammation • Langerhans Cell Histiocytosis • Neuralgia • Otorhinolaryngology • Pain • Peripheral Neuropathic Pain • Pulmonary Disease • Rare Diseases • Respiratory Diseases • Rheumatology • Sinusitis • Vasculitis

Late Breaking Abstract - CosMx™ subcellular spatial molecular imaging of bronchial biopsies from patients with severe eosinophilic asthma treated with mepolizumab. Preliminary results of the MESILICO study. (ERS 2025) - No abstract available

Biopsy • Clinical • Late-breaking abstract • Asthma • Immunology • Respiratory Diseases

Late Breaking Abstract - Long-term effect of Mepolizumab on airway remodeling in patients with late-onset severe eosinophilic asthma with obstructive pattern: a 3-Year Follow-Up of the MESILICO study. (ERS 2025) - No abstract available

Clinical • Late-breaking abstract • Asthma • Immunology • Respiratory Diseases

Late Breaking Abstract - Sustained FEV1 improvements with mepolizumab up to 104 weeks in patients with COPD and less severe airflow obstruction: Post hoc analysis of the MATINEE Phase III study (ERS 2025) - No abstract available

Clinical • Late-breaking abstract • P3 data • Retrospective data • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Mepolizumab treatment in children and adolescents with severe eosinophilic asthma (CASAM)-A real-world study: 12 months analysis (ERS 2025) - No abstract available

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

Evaluation of omalizumab to mepolizumab switch in children and adolescents with severe allergic eosinophilic asthma (ERS 2025) - No abstract available

Clinical • Asthma • Immunology • Respiratory Diseases

Effectiveness of mepolizumab in patients with severe asthma with high immunoglobulin E (IgE) or chronic rhinosinusitis with nasal polyps (CRSwNP): A post-hoc analysis of NEST (ERS 2025) - No abstract available

Clinical • Retrospective data • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

COMPARATIVE STUDY OF CLINICAL FUNCTIONAL CHARACTERISTICS AND TREATMENT EFFECTIVENESS BETWEEN PATIENTS WITH SEVERE UNCONTROLLED ASTHMA (SUA) AND EOSINOPHILIC GRANULOMATOSIS WITH POLYANGIITIS (EGPA) TREATED WITH MEPOLIZUMAB (ERS 2025) - No abstract available

Clinical • Asthma • Eosinophilic Granulomatosis With Polyangiitis • Immunology • Langerhans Cell Histiocytosis • Rare Diseases • Respiratory Diseases • Vasculitis

Mepolizumab-induced changes in patients with nasal polyps and comorbid asthma: preliminary results on airway microbiome and transcriptome (ERS 2025) - No abstract available

Clinical • Asthma • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases