Nucala (mepolizumab) / GSK - LARVOL DELTA

Nucala (mepolizumab) receives positive CHMP opinion for treatment of chronic obstructive pulmonary disease (COPD) (GSK Press Release) - "The European Commission decision on approval is expected in Q1 2026....The positive opinion is based on data from the MATINEE phase III trial..."

CHMP • EMA approval • Chronic Obstructive Pulmonary Disease • Immunology

Baseline Epigenetics as a Biomarker of Mepolizumab Response in Severe Asthma. (PubMed, Clin Exp Allergy) - No abstract available

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

Redefining hematology referral thresholds for eosinophilia: A 10-year experience at an academic medical center (ASH 2025) - "Treatment was initiated in 42.2% (n=60) of patientsand included systemic medications for asthma, parasitic infections, autoimmune disease, and HES.Eosinophilia-specific therapy with prednisone, mepolizumab, and/or hydroxyurea were administered in22.5% (n=32) of patients. In patients referred for eosinophilia, an AEC threshold of 1.5 x 109/L has a high sensitivity forclinically meaningful eosinophilia and treatment need. The higher thresholds offer greater specificity, butmay reduce sensitivity and risk missed cases. These findings support raising the threshold forhematology referral to 1.5 x 109/L or higher, especially in low risk and asymptomatic patients.Incorporating refined AEC cutoffs to guide hematologic evaluation may reduce unnecessary diagnosticworkup in low-risk patients."

Asthma • Eosinophilia • Hematological Malignancies • Hypereosinophilic Syndrome • Immunology • Infectious Disease • Respiratory Diseases

Treatment With Mepolizumab on Patients With Severe Refractory Eosinophilic Asthma (clinicaltrials.gov) - P=N/A | N=15 | Completed | Sponsor: Istituti Clinici Scientifici Maugeri SpA | Active, not recruiting ➔ Completed | N=10 ➔ 15 | Trial completion date: Dec 2025 ➔ Sep 2025

Biomarker • Enrollment change • Trial completion • Trial completion date • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • CSF2

Bullous Wells' Syndrome: Case Report and Systematic Review. (PubMed, J Clin Med) - "Recent studies described the efficacy of the anti-interleukin-5 monoclonal antibody Mepolizumab in refractory cases of WS...Integrating clinical features with laboratory and histopathological findings is essential for achieving a definitive diagnosis. Although the causal link between WS and underlying neoplastic/autoimmune/infective conditions is not always present, this possibility should be taken into account and investigated for the best patient management."

Journal • Review • Chronic Lymphocytic Leukemia • Dermatitis • Dermatology • Eosinophilia • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Oncology • Rare Diseases • Urticaria • IL5

Efficacy and safety of mepolizumab in severe eosinophilic asthma: a systematic review and meta-analysis. (PubMed, J Thorac Dis) - "Baseline blood eosinophil count serves as a predictive biomarker for therapeutic response, supporting individualized treatment approaches. Further research is required to establish optimal dosing and evaluate long-term safety."

Journal • Retrospective data • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • IL5

Uniform clinical benefit of biologic therapy across a regional severe asthma network (BTS WM 2025) - "Patients were prescribed: benralizumab n=442, dupilumab n=69, mepolizumab n=146, omalizumab n=51, tezepelumab n=69, not recorded n=29. Download figure Open in new tab Download powerpoint Abstract P196 Figure 1 Conclusions Following the initiation of asthma biologic therapies, acute hospital attendances, health-related quality of life and both acute and chronic corticosteroid usage improved. Whilst acknowledging both the limitations of this unblinded, non-controlled observational study but also the strengths of real-world clinical service data, the positive impact of asthma biologics on multiple patient-centred clinical endpoints is profound."

Clinical • Asthma • Immunology • Respiratory Diseases

Clinical outcomes after switching from omalizumab to anti-IL-5/IL-5R biologics in severe asthma: a retrospective cohort study. (PubMed, BMC Pulm Med) - "In severe asthma patients who do not achieve adequate control with omalizumab, switching to interleukin-5 (IL-5) targeted biological therapies may provide clinically significant improvements. Baseline clinical parameters can serve as useful predictors for the need to change biological treatment."

Clinical data • Journal • Retrospective data • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases • IL5

Modifying the course of asthma: mechanisms and strategies for clinical remission. (PubMed, Curr Opin Allergy Clin Immunol) - "Clinical remission in asthma is now a feasible target. Achieving this goal requires a multidimensional approach that integrates biologics, early treatment, comorbidity management, and lifestyle interventions. Standardized definitions and biomarkers are essential to guide therapeutic decisions and predict long-term outcomes."

IO biomarker • Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases • Tobacco Cessation

The frequency and predictability of switching biologic agents in severe asthma: A real-world perspective. (PubMed, Asia Pac Allergy) - "In the first-line treatment, 111 patients (68%) were started on omalizumab, 43 patients (26%) on mepolizumab, and 11 patients (6%) on benralizumab. Patients with higher annual attacks at baseline and lower responsiveness at the first postbiologic efficacy assessment can be useful in predicting switching status. However, further well-designed studies involving a larger number of patients and conducted over a longer term are needed to identify additional factors that could assist in selecting the most appropriate biologic."

Journal • Real-world evidence • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Persistent airway obstruction in severe eosinophilic asthma: targeting interleukin-5 and eosinophils. (PubMed, Eur Respir Rev) - "A few studies evaluating the effectiveness of benralizumab and mepolizumab were able to identify cohorts of patients with SEA and PAO who had a significant response to these IL-5/Rα-targeted biologics. PAO in patients with SEA represents a distinct clinical entity, one which could be referred to as "persistent eosinophilic airway obstruction". Patients with persistent eosinophilic airway obstruction are likely to be responsive to targeted biologic treatment, although additional clinical studies and real-world data are needed to further assess treatment efficacy and safety in this population and provide guidance to clinical practice."

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

How to choose a biologic agent considering comorbidities of bronchial asthma. (PubMed, Respir Investig) - "Herein, we summarize recent evidence on the prevalence of comorbidities associated with type 2 inflammation, including chronic spontaneous urticaria, atopic dermatitis, prurigo nodularis, chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis, eosinophilic otitis media, aspirin-exacerbated respiratory disease, allergic rhinitis, allergic bronchopulmonary mycosis, obesity, and chronic obstructive pulmonary disease, and review the efficacy of five major biologics (omalizumab, mepolizumab, benralizumab, dupilumab, and tezepelumab) in these settings. In conclusion, the assessment of comorbidities in addition to biomarkers is essential for tailoring biologic therapies for severe asthma. Integrating comorbidity profiles into treatment strategies allows for a more precise and effective use of biologics, ultimately improving outcomes in complicated asthma cases."

Journal • Review • Allergic Rhinitis • Asthma • Atopic Dermatitis • Chronic Obstructive Pulmonary Disease • Chronic Rhinosinusitis With Nasal Polyps • Chronic Spontaneous Urticaria • Dermatitis • Dermatology • Eosinophilic Granulomatosis With Polyangiitis • Genetic Disorders • Immunology • Inflammation • Langerhans Cell Histiocytosis • Nasal Polyps • Obesity • Otorhinolaryngology • Prurigo Nodularis • Pulmonary Disease • Rare Diseases • Respiratory Diseases • Sinusitis • Urticaria • Vasculitis • IL5 • TSLP

Impact of type 2-targeted therapies on respiratory infection risk. (PubMed, Curr Opin Allergy Clin Immunol) - "T2-modulating biologics not only control allergic inflammation but also restore epithelial and immune homeostasis, contributing to maintained or reduced respiratory infection risk. These therapies represent a dual benefit of barrier repair and immune rebalancing. Further studies are warranted to evaluate long-term infection outcomes in high-risk populations."

Journal • Allergy • Infectious Disease • Inflammation • Respiratory Diseases • IL13 • IL4 • IL5

Dominant clinical improvements and durability of biologic response in severe asthma (BTS WM 2025) - "Quadruple-domain response (ACQ+OCS+FEV 1 +admission reduction) increased from 18.0% to 38.7% for benralizumab, 27.3% to 36.4% for dupilumab, 24.2% to 40.9% for mepolizumab, and 11.1% to 33.3% for omalizumab from Year 1 to Year 3. Quadruple-domain response was observed irrespective of biomarker profile but was less frequent among those on maintenance steroids at baseline. Tracking cumulative, multidomain outcomes is essential for optimal biologic selection and asthma management."

Clinical • Asthma • Immunology • Respiratory Diseases

Adjunctive dual biologic therapy for persistent nasal symptoms in eosinophilic granulomatosis with polyangiitis (EGPA). (PubMed, Am J Otolaryngol) - "Although anti-IL-5/IL-5R biologics such as mepolizumab and benralizumab are established therapies for maintaining systemic remission, a subset of patients continues to experience refractory sinonasal symptoms. We report two EGPA cases with well-controlled systemic disease under anti-IL-5/IL-5R therapy but persistent uncontrolled CRSwNP, who were treated with add-on dupilumab...Careful patient selection and close multidisciplinary monitoring are essential to ensure safety and optimize efficacy. Further studies are warranted to confirm long-term effectiveness and safety profiles."

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

Distinct Effects of Biological Treatments on Eosinophils and Neutrophils in Chronic Rhinosinusitis With Nasal Polyp Patients. (PubMed, Clin Transl Allergy) - "Biological treatments effectively reduced eosinophilic inflammation in nasal polyps. However, most biologics could induce an eosinophil-to-neutrophil shift, indicating that solely targeting eosinophils may be insufficient as a treatment approach. Understanding these secondary effects on local immune pathways is critical for optimizing CRSwNP treatment strategies."

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

NLRP3 inflammasome expression in pediatric asthma: sputum-based insights, inflammatory mechanisms, and targeted therapeutic strategies. (PubMed, Allergy Asthma Clin Immunol) - "Biologics such as mepolizumab, benralizumab, and dupilumab are well known for their corticosteroid-sparing effects especially in cases of severe eosinophilic asthma. Although promising data, application of this data in clinical practice is still challenging due to many causes, including diagnostic challenges, ethical considerations in trials involving children, and the lack of approved NLRP3 inhibitors for use in children. More research is required and essential to confirm that NLRP3 could be used as a biomarker or therapeutic target in pediatric asthma."

Journal • Review • Asthma • Immunology • Inflammation • Pediatrics • Pulmonary Disease • Respiratory Diseases • NLRP3

Biologic Therapy for Chronic Rhinosinusitis with Nasal Polyps: Case Analysis and Proposal of a Qualification Scheme. (PubMed, Otolaryngol Pol) - "Baseline peripheral blood eosinophil count was significantly higher in the mepolizumab-treated group. In the dupilumab-treated group, increases in eosinophil counts up to 3500 cells/μl were observed during therapy; however, no patient developed clinical features of hypereosinophilic syndrome.<b></b> When selecting a biologic drug for the treatment of CRSwNP, it is recommended to consider not only the values of available biomarkers, but also the degree of asthma control, the cumulative dose of oral corticosteroids (OCSs), the patient's age, and treatment convenience for the patient."

Journal • Allergy • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Eosinophilia • Hypereosinophilic Syndrome • Immunology • Inflammation • Nasal Polyps • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases • Sinusitis • IL4 • IL5

Effective Use of Mepolizumab in a Rare Case of Eosinophilic Granulomatosis With Polyangiitis Complicated by Pulmonary Tuberculosis. (PubMed, Cureus) - "She received oral prednisolone (PSL) monotherapy (10 mg/day) for these symptoms from her previous physician. In the present case, mepolizumab was effective in treating EGPA and preventing pulmonary TB exacerbation. This is a valuable report suggesting the crucial role of mepolizumab in combined cases of both conditions."

Journal • Asthma • Dermatology • Eosinophilic Granulomatosis With Polyangiitis • Immunology • Infectious Disease • Inflammation • Langerhans Cell Histiocytosis • Otorhinolaryngology • Pain • Pulmonary Disease • Rare Diseases • Respiratory Diseases • Sinusitis • Tuberculosis • Vasculitis • IL5

Impact of mepolizumab on airway remodeling and inflammation in severe eosinophilic asthma. (PubMed, Chest) - P=N/A | "In addition to its anti-inflammatory effects, mepolizumab may also attenuate structural airway changes in SEA, which could contribute to its clinical benefits."

Journal • Asthma • Eosinophilia • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • FBLN1 • IL5 • PCNA

Assessing the Impact of GLP-1R Agonists in Post-sinus Surgery Management. (PubMed, Otolaryngol Head Neck Surg) - "Our results indicate that GLP-1RAs are associated with reduced postoperative revision FESS at up to a 5-year follow-up in CRSwNP patients. Future mechanistic and prospective studies are needed to confirm the association between GLP-1R agonists and improved post-sinus surgery outcomes identified in this study."

Journal • Chronic Rhinosinusitis With Nasal Polyps • Genetic Disorders • Immunology • Nasal Polyps • Obesity • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Complete Remission After Treatment With Biologics for Nasal Polyps (clinicaltrials.gov) - P4 | N=66 | Recruiting | Sponsor: Rigshospitalet, Denmark

New P4 trial • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

A Study to Evaluate the Efficacy and Safety of SHR-1703 in Subjects With Eosinophilic Granulomatosis With Polyangiitis （EGPA） (clinicaltrials.gov) - P2/3 | N=166 | Recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | N=112 ➔ 166 | Trial completion date: May 2027 ➔ Dec 2028 | Trial primary completion date: Mar 2026 ➔ Dec 2028

Enrollment change • Trial completion date • Trial primary completion date • Eosinophilic Granulomatosis With Polyangiitis • Immunology • Langerhans Cell Histiocytosis • Rare Diseases • Vasculitis

Study in Pediatrics With HypEREosinophilic Syndrome (SPHERE) (clinicaltrials.gov) - P3 | N=16 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed

Trial completion • Hypereosinophilic Syndrome • Immunology • Pediatrics

Prognostic utility of pre-biologic treatment correlates of childhood severe asthma exacerbation risk: Real world evidence. (PubMed, Pediatr Allergy Immunol) - "Beyond biologic treatment eligibility, using routinely collected clinical parameters to stratify pre-treatment SAE risk could improve prognostic accuracy and aid clinicians in tailoring therapy based on a patient's individual risk factors and likelihood of responding to a specific agent to maximize treatment effectiveness."

HEOR • Journal • Real-world evidence • Asthma • Immunology • Pediatrics • Pulmonary Disease • Respiratory Diseases