Cinqair (reslizumab) / Merck (MSD), UCB, Teva - LARVOL DELTA

Siglec-8 as a Biomarker for Predicting Anti-IL-5 Response in Severe Asthma. (PubMed, Allergy Asthma Immunol Res) - P | "Baseline serum Siglec-8 levels showed a trend toward better predictive performance than other parameters for predicting 6- and 12-month responses to anti-IL-5 therapies in patients with SA. These findings suggest that Siglec-8 may have the potential as a biomarker for guiding treatment decisions, although further validation in larger, prospective studies is warranted."

Biomarker • Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases • IL5 • SIGLEC8

Proteomic Identification of Plasma Biomarkers of Response to IL-5 Inhibitor Biologics in Healthy Subjects. (PubMed, Clin Transl Sci) - "In this study, we profiled over 7000 plasma proteins to identify potential PD biomarkers for the interleukin-5 (IL-5) inhibitors mepolizumab and reslizumab, which are approved for treating eosinophilic asthma. Both biomarkers showed dose-response trends and comparable variability to placebo. Our study identified EMBP and PRG3 as promising plasma PD biomarkers for IL-5 inhibitors, warranting further validation for early phase trials and biosimilar development programs."

Biomarker • Clinical • Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases • AIFM2 • IL5

Impact of SARS-CoV-2 on Severe Asthma Patients Undergoing Biological Therapy: A Multicenter Study. (PubMed, J Clin Med) - "Participants received omalizumab, mepolizumab, benralizumab, or reslizumab. Patients receiving biologics did not experience worse outcomes than the general population, and no biologic was linked to poorer COVID-19 prognosis. Vaccination further contributed to protection against severe disease."

Clinical • Journal • Asthma • Immunology • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

Glucocorticoid Treatment in Severe Asthma. (PubMed, Semin Respir Crit Care Med) - "Biologic therapies targeting IgE (omalizumab), IL-5 (mepolizumab, reslizumab), IL-5Rα (benralizumab), IL-4Rα (dupilumab), and TSLP (tezepelumab) have shown substantial OCS-sparing effects in clinical trials, enabling dose reduction or discontinuation in many patients with steroid-dependent asthma. In conclusion, while glucocorticoids remain essential for acute exacerbations and as bridging therapy, their chronic use should be minimized. Biologic therapies offer a transformative opportunity to reduce glucocorticoid burden, improving long-term outcomes and quality of life in patients with severe asthma."

Journal • Asthma • Diabetes • Eosinophilia • Genetic Disorders • Immunology • Infectious Disease • Inflammation • Metabolic Disorders • Obesity • Osteoporosis • Psychiatry • Pulmonary Disease • Respiratory Diseases • Rheumatology • HDAC2 • IL13 • IL4 • IL5 • TSLP

Comparative Analysis of Patient-Reported Outcomes (PROs) in Asthma Biologic Late-Phase Studies and Approved Labels: Implications for Entry and Product Differentiation (ISPOR-EU 2025) - "This analysis aims to inform endpoint selection for future clinical development and labelling. A review of FDA and EMA labels, regulatory feedback, health authority reviews, and pivotal trial designs was conducted for approved asthma biologics (omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, tezepelumab) and trial designs for late phase studies (depemokimab, dexpremispexole) in May 2025. ACQ-5 and AQLQ responder and change from baseline endpoints are established entry criteria for asthma biologics, with regulatory precedent supporting their inclusion. Symptom diary endpoints and other novel endpoints addressing patient-prioritized outcomes offer opportunities for differentiation. This review provided cross-asset competitive and regulatory intelligence supporting strategic clinical design for best-in-class labelling."

Clinical • Patient reported outcomes • Asthma • Immunology • Respiratory Diseases

Dual Biologic Therapy in Refractory Eosinophilic Esophagitis with Systemic Hypereosinophilia: A Case Report (ACAAI 2025) - "Despite trials of anti-IL-5 therapies (reslizumab and benralizumab) for eosinophilic asthma, his EoE symptoms persisted. Combination biologic therapy with dupilumab and benralizumab was pursued to target systemic eosinophilia. This case underscores the need for personalized treatment strategies in refractory eosinophilic disorders and supports the role of dual biologic therapy in selected cases."

Case report • Clinical • Allergic Rhinitis • Asthma • Eosinophilia • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Inflammation • Respiratory Diseases • IL5

Real-world clinical effectiveness of Benralizumab for Eosinophilic Granulomatosis with Polyangiitis: a National multicenter study (ACR Convergence 2025) - "Previous immunosuppressive therapies included azathioprine (22%), methotrexate (13.6%), mycophenolate mofetil (9%), and cyclophosphamide (9%)...Most commonly were Mepolizumab (50%), Omalizumab (40%), and Reslizumab (10%).Benralizumab was initiated a mean of 4.6±4 years post-EGPA diagnosis (30 mg subcutaneously every 4 weeks). Showed a rapid and sustained improvements over 60 months: a) FEV₁ increased from median 1935 [1545-2680] to 2270 [2192.5-2460] mL (p=0.0312), b) eosinophil counts dropped from 850 [740-1100]/mm³ to 0 [0-0] (p< 0.0001), c) serum IgE levels decreased from 225 [57-360] (IU/mL) to 158.5 [115-217] IU/mL; (p=0.125) and, d) prednisone dose from 5 mg/day [2.5-10] to 0 [0-0]; (p=< 0.0001)After a mean follow-up of 42.4±20.7 months 78.2% of patients remained in remission. Benralizumab demonstrated rapid and sustained effectiveness, even in patients with severe and refractory EGPA, consistent with findings from clinical trials. These..."

Clinical • Real-world • Real-world evidence • Asthma • Eosinophilia • Eosinophilic Granulomatosis With Polyangiitis • Immunology • Langerhans Cell Histiocytosis • Rare Diseases • Respiratory Diseases • Vasculitis

COMPARATIVE OUTCOMES OF BIOLOGICS IN ASTHMA-COPD OVERLAP VS ASTHMA: A REAL-WORLD ANALYSIS (CHEST 2025) - "We identified patients with either asthma-COPD overlap or bronchial asthma receiving omalizumab, dupilumab, reslizumab, mepolizumab, tezepelumab, or benralizumab for at least six months. Despite biologic therapy, those with asthma-COPD overlap had worse outcomes than purely asthmatic patients, indicating a more severe disease phenotype. Higher rates of respiratory failure, exacerbations, and healthcare utilization underscore an unmet need for integrated care pathways addressing the combined features of asthma and COPD. Although biologics target key inflammatory pathways, concurrent COPD-related pathophysiology may limit their efficacy."

Clinical • Real-world • Real-world evidence • Asthma • Cardiovascular • Chronic Obstructive Pulmonary Disease • Diabetes • Genetic Disorders • Hypertension • Immunology • Infectious Disease • Inflammation • Metabolic Disorders • Obesity • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder • Tobacco Cessation

IMPACT OF PSYCHOLOGICAL STRESS ON DISEASE CONTROL AMONG SUBJECTS TREATED BY BIOLOGICAL THERAPIES FOR SEVERE ASTHMA (CHEST 2025) - "Biological therapies were benralizumab 13/44 (29.5%), dupilumab 11/44 (25%), mepolizumab 10/44 (22.7%), tezepelumab 5/44 (11.4%), omalizumab 4/44 (9.1%), and reslizumab in 1 patient (2.3%). Worsening of asthma occurred in the majority of patients receiving biological therapies for severe asthma following the October 7 th events, including individuals on remission. CLINICAL IMPLICATIONS: Biological therapy does not protect from the deleterious effects of emotional stress on asthma. The mechanisms of asthma worsening following emotional stress does not seem to include eosinophilic inflammation."

Clinical • Asthma • Immunology • Inflammation • Mood Disorders • Psychiatry • Respiratory Diseases

Safety and efficacy of biological drugs in bronchiectasis patients: the BIO-BRO study (WBC 2024) - " The BIO-BRO study was an international, multi-centre, observational, retrospective study enrolling adults with clinically significant bronchiectasis from 20 Bronchiectasis Programs across 9 countries worldwide who underwent at least one dose of any biologicals (Benralizumab, Dupilumab, Mepolizumab, Omalizumab or Reslizumab) from January 1st 2005 to December 31st 2021 for different indications. Biological drugs targeting T2-high related inflammation seem to be safe and effective in bronchiectasis patients across different outcomes including exacerbation rates."

Clinical • Allergic Bronchopulmonary Aspergillosis • Asthma • Bronchiectasis • Dermatology • Eosinophilic Granulomatosis With Polyangiitis • Immunology • Infectious Disease • Inflammation • Langerhans Cell Histiocytosis • Pulmonary Disease • Rare Diseases • Respiratory Diseases • Vasculitis

CLINICAL CHARACTERISTICS OF PATIENTS WITH ASTHMA WITH HYPERSENSITIVITY REACTIONS TO MULTIPLE ASTHMA BIOLOGICS: A REAL-LIFE, MULTICENTER RETROSPECTIVE STUDY (CHEST 2025) - " Retrospective review of all patients with asthma who received at least one asthma biologic (omalizumab, mepolizumab, benralizumab, dupilumab, reslizumab and tezepelumab) and developed an HSR (immediate or delayed reactions including anaphylaxis, angioedema, urticaria, bronchospasm, serum sickness, or other systemic allergic symptoms documented by a physician) at any Mayo Clinic campus between 2009 and 2024. In our cohort, the rate of HSRs to asthma biologics was higher than what is reported in randomized controlled trials. As a result, 50% of patients discontinued biologic therapy and relied on oral steroids, leading to additional adverse reactions. CLINICAL IMPLICATIONS: Further research is needed to understand cross-reactivity, identify predictive patient characteristics, and guide safer biologic prescription."

Retrospective data • Asthma • Cardiovascular • Dermatology • Immunology • Respiratory Diseases • Urticaria

RACIAL DISPARITIES IN CLINICAL OUTCOMES AMONG ASTHMA PATIENTS TREATED WITH BIOLOGIC THERAPIES: A PROPENSITY-MATCHED COHORT ANALYSIS (CHEST 2025) - "Patients diagnosed with asthma (on or after Januar 1, 2014) and treated with biologic agents (dupilumab, reslizumab, tezepelumab, benralizumab, or omalizumab) were included Individuals with cystic fibrosis, idiopathic pulmonary fibrosis, or bronchiectasis were excluded. These findings align with previous reports that Black patients with asthma face disproportionately high rate of exacerbations and severe presentations. Socioeconomic factors, genetic influences, and limited access to specialized care ma contribute to these disparities. Although biologic agents represent an important treatment advance, gaps in real-world outcome persist."

Clinical • Clinical data • Allergic Rhinitis • Asthma • Atopic Dermatitis • Bronchiectasis • Cardiovascular • Cough • Cystic Fibrosis • Dermatitis • Dermatology • Genetic Disorders • Idiopathic Pulmonary Fibrosis • Immunology • Infectious Disease • Inflammation • Obesity • Obstructive Sleep Apnea • Pneumonia • Pulmonary Arterial Hypertension • Pulmonary Disease • Pulmonary Embolism • Respiratory Diseases • Sleep Disorder

COMPARATIVE ANALYSIS OF THE ADVERSE EFFECTS AMONG BIOLOGICS IN TREATMENT OF ALLERGIC AND EOSINOPHILIC DISORDERS IN ASTHMA (CHEST 2025) - "PURPOSE: Biologic therapies have revolutionized the treatment of asthma, offering targeted mechanisms of action with improved efficacy. The pharmacovigilance data reveal distinct adverse event profiles among monoclonal antibodies used for allergic and eosinophilic disorders in asthma. Injection site reactions were significantly more frequent with omalizumab, dupilumab, and tezepelumab, with omalizumab exhibiting the highest rate, while benralizumab and mepolizumab had the lowest. URTIs were most common with anti-IgE, anti-IL-5 and anti-TSLP agents."

Adverse events • Asthma • Eosinophilia • Hematological Disorders • Immunology • Infectious Disease • Musculoskeletal Pain • Respiratory Diseases • IL4 • IL5

META-ANALYSIS: IMPACT OF BIOLOGIC TREATMENTS ON STEROID REDUCTION, OCS WITHDRAWAL, AND EXACERBATION RATE IMPROVEMENTS IN SEVERE ASTHMA PATIENTS (CHEST 2025) - "6 different biologics (Dupilumab, Tezepelumab, Omalizumab, Reslizumab, Benralizumab and Tralokinumab) were considered in the analysis. This meta-analysis demonstrates significant reductions in steroid use and exacerbation rates, indicating tha steroid-sparing strategies may improve patient outcomes. However, heterogeneity remains a major challenge, which emphasize the need for standardized treatment approaches. While OCS withdrawal trends toward improvement, statistical significance wa not reached."

Retrospective data • Asthma • Immunology • Osteoporosis • Respiratory Diseases • Rheumatology

EVALUATING THE EFFICACY AND SAFETY OF ANTI-EOSINOPHILIC THERAPIES IN EOSINOPHILIC GRANULOMATOSIS WITH POLYANGIITIS: A BAYESIAN NETWORK META-ANALYSIS OF BIOLOGIC TREATMENTS (CHEST 2025) - "Regarding the reduction in oral corticosteroid dose, omalizumab showed the highest reduction (MD: 7.52 mg, 95 CrI: [-211.29 to 226.66]), followed by rituximab (MD: 13.14 mg, 95% CrI: [-313.47 to 331.88]), reslizumab (MD: 13.74 mg, 95 CrI: [-314.84 to 333.02]), benralizumab (MD: 6.75 mg, 95% CrI: [-211.34 to 225.24]), and mepolizumab (MD: 6.20 mg, 95% CrI [-211.88 to 224.57]), compared to placebo. Benralizumab and rituximab demonstrate the most significant benefits in achieving complete response an preventing relapse in EGPA. Omalizumab provides the greatest reduction in oral corticosteroid dose, making it an effective option for minimizing steroid-related side effects. Mepolizumab, while beneficial in reducing BVAS scores, had a relatively lowe impact on relapse prevention and steroid reduction."

Retrospective data • Eosinophilia • Eosinophilic Granulomatosis With Polyangiitis • Immunology • Inflammation • Langerhans Cell Histiocytosis • Rare Diseases • Vasculitis • IL5

REAL-WORLD OUTCOMES OF ASTHMA BIOLOGIC USE IN OLDER ADULTS (CHEST 2025) - "Older adults with moderate-severe asthma who initiated biologic therapy (namely omalizumab, mepolizumab, benralizumab, reslizumab, dupilumab or tezepelumab) were compared to a cohort of older adults with moderate to severe asthma not receiving biologics. This study demonstrates that asthma biologic therapy is associated with significant improvements in key outcomes, including reduced 12- month asthma exacerbations and lower mortality rates, among older adults with severe asthma. Despite concerns about the safety and efficacy of biologics in this population, our findings suggest that these therapies can also decrease ratef of hospitalization. ER visits, inhaled corticosteroids as well as reduce rates of pulmonary infections namely pneumonia."

Clinical • Real-world • Real-world evidence • Asthma • Immunology • Infectious Disease • Pneumonia • Respiratory Diseases

LUNG CANCER AND ILD INCIDENCE IN PATIENTS WITH ASTHMA USING AND NOT USING BIOLOGICS: A US COHORT RETROSPECTIVE ANALYSIS (CHEST 2025) - "Two cohorts were created, cohort 1 included patients with severe persistent asthma and biologics use (including benralizumab, mepolizumab, reslizumab, tezepelumab, dupilumab, omalizumab), and cohort 2 with no biologics use. We performed propensity score matching, accounting for demographics (age at index, sex, and race), comorbidities (respiratory, cardiovascular, metabolic, and cerebrovascular diseases), and medications (montelukast, bronchodilators, anti-inflammatories, bronchodilators, antitussives, and antihistamines)... Our research shows a non-statistically significant decrease in the incidence of lung cancer or ILD in patients with severe persistent asthma and biologic use. Further prospective studies with larger sample sizes are needed to clarify these findings and describe possible correlations between lung cancer and ILD with asthma. CLINICAL IMPLICATIONS: Our findings suggest that there may be some added benefit to using biologics in patients with severe..."

Retrospective data • Asthma • Bronchiectasis • Chronic Obstructive Pulmonary Disease • CNS Disorders • Diabetes • Hypertension • Immunology • Interstitial Lung Disease • Lung Cancer • Metabolic Disorders • Oncology • Respiratory Diseases • Solid Tumor • Vascular Neurology

Anti-cytokine biologics for asthma in adults. (PubMed, Lancet) - "Three biologics, mepolizumab, reslizumab, and benralizumab, inhibit the IL-5 or IL-5 receptor pathway; dupilumab blocks IL-4 and IL-13 through its activity on the IL-4 receptor-alpha; and tezepelumab prevents activation of the thymic stromal lymphopoietin cytokine production cascade. The effect of ACBs varies by the degree of T2 inflammation, which is most easily assessed by blood eosinophil counts and exhaled nitric oxide. The use of ACBs guided by these biomarkers and phenotypic characteristics of patients with severe asthma allows a personalised medicine approach that increases the likelihood of improvement."

Journal • Review • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • IL13 • IL4 • IL4R • IL5 • TSLP

Depemokimab reduces exacerbations in severe asthma versus other biologics: A multilevel network meta-regression (ERS 2025) - "Depemokimab showed a statistically significant reduction in the risk of clinically significant exacerbations across all models versus placebo, against benralizumab, dupilumab (300 mg) and omalizumab in unadjusted models, and against omalizumab in partially adjusted models (Figure). No significant differences were observed between depemokimab and dupilumab 200 mg/mepolizumab/reslizumab/tezepelumab. Our results show no statistically significant differences in annual exacerbation rates across assessed biologics, suggesting comparable benefits for asthma. Funding: GSK (212680)."

Asthma • Immunology • Inflammation • Respiratory Diseases • IL5

Progress on biologic therapies for severe asthma (PubMed, Zhonghua Jie He He Hu Xi Za Zhi) - "The approved biologics include Omalizumab, Mepolizumab, Benralizumab, Reslizumab, Dupilumab, and Tezepelumab. It also discussed common challenges and future trends in biologic therapies. This review aimed to provide clinical and research insights for optimizing the application of biologics in asthma management."

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

Biologic Management in Severe Asthma for Adults: An American College of Chest Physician Clinical Practice Guideline. (PubMed, Chest) - "Characteristics such as quality of life impairment, baseline lung function, frequency of exacerbation, baseline oral corticosteroid use, asthma endotype, biomarkers and comorbid conditions can impact the biologic choice. Evidence for selecting biologic agents in severe asthma is limited by the absence of comparative effectiveness trials. Additional high-quality evidence is needed to inform choice of biologic agents in these patients."

Clinical guideline • Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Variability in time to response in severe asthma biologics: a SHARP survey (ERS 2025) - "Patients reported using Benralizumab (29%), Dupilumab (24%), Mepolizumab (17%), Tezepelumab (17%), Omalizumab (11%) and Reslizumab (2%). This study showed a variability in the time to observe any changes as well as in the time get peak benefit of biologics."

Asthma • Immunology • Respiratory Diseases

Eosinophilic adverse reactions associated with different biologics targeting type 2 inflammation: a disproportionality analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS) (ERS 2025) - " Data from the FAERS database from Q1 2004 to Q2 2024 were analyzed for omalizumab, mepolizumab, benralizumab, reslizumab, dupilumab, and tezepelumab. Biologics for type 2 inflammation has distinct EAR risks, particularly dupilumab and anti-IL-5/IL-5R agents. Despite low incidence, EARs are ofen severe, highlighting the need for monitoring, especially during initial treatment phases."

Adverse events • Asthma • Eosinophilic Esophagitis • Gastrointestinal Disorder • Inflammation • Respiratory Diseases • IL5

Biologic Therapies in Severe Asthma and EGPA: Targeted Therapy and Personalized Care. (PubMed, Tuberc Respir Dis (Seoul)) - "Five monoclonal antibodies-omalizumab, mepolizumab, reslizumab, benralizumab, and dupilumab-are currently used widely, with the recently approved Tezepelumab, an anti-thymic stromal lymphopoietin, expanding treatment options to include the type 2 inflammation‑low phenotype. In addition, emerging therapeutic innovations of biologics are discussed for their potential to enhance accessibility and effectiveness. In the future, integrating evolving evidence with patient-specific characteristics may facilitate disease modification in severe asthma."

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

Towards personalised dosing intervals of biologics in severe asthma: a Dutch nationwide survey on interval extensions (ERS 2025) - "Dosing interval extensions were reported by 78%, including dupilumab (66%), omalizumab (60%), benralizumab (43%), mepolizumab (44%), reslizumab (13%) and tezepelumab (6%). Most clinicians wish to apply this more often, highlighting the need for evidence-based guidelines. FUNDING ZonMW"

Asthma • Immunology • Respiratory Diseases