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

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

Anti-IL5/IL-5 receptor therapies for eosinophilic granulomatosis with polyangiitis: an updated Systematic Review. (PubMed, Front Immunol) - "The explored treatments consisted in Benralizumab 30 mg every 4 weeks, Mepolizumab 100 mg or 300 mg every 4 weeks and Reslizumab 3mg/Kg every 4 weeks. All the anti-IL-5/IL-5 receptor molecules proved efficacious in remission control and corticosteroid tapering. The available data strongly suggests integrating anti IL-5/IL-5 receptor therapies into EGPA treatment strategies, to enhance patients' outcomes and reduce the long term side effects of prolonged corticosteroid therapy."

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

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

The Era of Multiple Biologics: Is Combination and Switching an Option in the Management of Severe Asthma? (PubMed, Pulm Pharmacol Ther) - "Patients may benefit from the early and systematic consideration of combination and switching of biologic therapies in severe asthma."

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

Cost-effectiveness of mepolizumab vs anti-interleukin-5/5r biologic therapies for the treatment of adults with severe asthma with an eosinophilic phenotype: a Chilean healthcare system perspective. (PubMed, J Med Econ) - "Additionally, the absence of data on continuation criteria required estimating relative risks for the overall population. Mepolizumab offers greater efficacy and cost savings compared to benralizumab and reslizumab for eosinophilic asthma, providing essential insights for improving asthma management and informing healthcare policies in Chile."

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

IL-5 PATHWAY INHIBITORS DURING PREGNANCY IN EOSINOPHILIC DISORDERS: PRELIMINARY RESULTS OF A RETROSPECTIVE MULTICENTER STUDY (EULAR 2025) - " This retrospective, observational, multicenter study included adult women with a diagnosis of ED (i.e., EGPA, HES, EA or CRSwNP) treated with an IL-5i (mepolizumab, benralizumab, or reslizumab) during pregnancy. ED may represent a challenging condition in pregnancy, as uncontrolled disease and high GC use could seriously affect maternal and fetal outcomes. In our retrospective study, IL-5i have proven to be an effective treatment in pregnancy of ED patients, ensuring both persistent disease control and steroid sparing. No adverse events directly attributable to IL-5i treatment have been reported."

Retrospective data • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Diabetes • Eosinophilia • Eosinophilic Granulomatosis With Polyangiitis • Genetic Disorders • Gestational Diabetes • Hematological Disorders • Hypereosinophilic Syndrome • Immunology • Inflammatory Arthritis • Langerhans Cell Histiocytosis • Metabolic Disorders • Nasal Polyps • Otorhinolaryngology • Rare Diseases • Respiratory Diseases • Sinusitis • Small for Gestational Age • Vasculitis • IL5

Registry on Severe Asthma with and without biological treatment in Spain: Results of a 2 year follow-up of AlergoDATA (EAACI 2025) - "During the second year, regarding biological treatments prior to inclusion:First-line treatment was administered to 84 patients, primarily omalizumab (69.0%), followed by mepolizumab (19.0%), reslizumab (2.38%), benralizumab (5.95%), dupilumab (2.38%), and other drugs such as adalimumab (1.19%). Conclusion In the first 2 years of Alergodata, patients with severe asthma, whether or not receiving biological therapy, present a T2 endotype. They are more frequently women and commonly have comorbidities such as rhinitis, conjunctivitis, rhinosinusitis, gastroesophageal reflux, and psychiatric disorders."

Immunology • Inflammation

Exploratory analysis of the economically justifiable price of reslizumab for asthma severe in Colombia. (PubMed, BMC Public Health) - "The economically justifiable cost for reslizumab in Colombia is between U106 to U$349per dose, depending on the WTP used to decide its implementation. This result should encourage more studies in the region that optimize decision-making processes when incorporating this drug into the health plans of each country."

Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

New Therapeutic Challenges in Pediatric Gastroenterology: A Narrative Review. (PubMed, Healthcare (Basel)) - "For CeD, therapies like gluten-degrading enzymes (latiglutenase, Kuma030) and zonulin inhibitors (larazotide acetate) show promise, though clinical outcomes are inconsistent...Transglutaminase 2 inhibitors like ZED-1227 could help prevent gluten-induced damage. Monoclonal antibodies targeting immune pathways, such as AMG 714 and larazotide acetate, require further validation in pediatric populations. In EoE, biologics like dupilumab, cendakimab, dectrekumab (IL-13 inhibitors), and mepolizumab, reslizumab, and benralizumab (IL-5/IL-5R inhibitors) show varying efficacy, while thymic stromal lymphopoietin (TSLP) inhibitors like tezepelumab are also being investigated...For IBD, biologics like vedolizumab, ustekinumab, and risankizumab, as well as small molecules like tofacitinib, etrasimod, and upadacitinib, are emerging treatments...Personalized therapy, integrating precision medicine, therapeutic drug monitoring, and lifestyle changes, is increasingly guiding pediatric..."

Journal • Review • Autoimmune Hepatitis • Celiac Disease • Eosinophilic Esophagitis • Gastroenterology • Gastrointestinal Disorder • Hepatitis B • Hepatology • Immunology • Inflammation • Inflammatory Bowel Disease • Pediatrics • Transplantation • IL13 • IL5 • TGM2 • TSLP

Real-World Persistence to Biologic Therapies and Its Impact on Outcomes in Patients With Asthma (ATS 2025) - "Persistence was highest among patients initiating IL-5/5R biologics, benralizumab (72.2%), followed by reslizumab (69.0%), and mepolizumab (68.0%). More patients initiating tezepelumab (33.2%) and omalizumab (29.6%) discontinued treatment... Lack of persistence to biologic therapies varied by agent and led to increased rates of asthma exacerbations and OCS use in patients with asthma, suggesting that many patients may not clinically benefit from biology therapy due to the frequency of administration. Funding: GSK (223657)."

Clinical • Late-breaking abstract • Real-world • Real-world evidence • Asthma • Immunology • Respiratory Diseases • IL5

Comprehensive Evaluation of Biologic Therapies in Severe Asthma: A Meta-analysis on Exacerbation Reduction, Lung Function Improvement, and Quality of Life Enhancement (ATS 2025) - "Among those on biologics, 9,754 received omalizumab (anti-IgE), 2,242 mepolizumab (anti-IL5), 968 reslizumab (anti-IL5), 6451 benralizumab (anti-IL5Rα), 8245 dupilumab (anti-IL4Rα), 1587 tezepelumab (anti-TSLP) and Lebrikizumab (IL-13). Biologic treatments lowered exacerbations and symptoms, enhanced lung function, and boosted quality of life for individuals with severe asthma, while maintaining an acceptable safety profile."

HEOR • Retrospective data • Asthma • Immunology • Inflammation • Respiratory Diseases • IL13 • IL5

Asthma Biologics Utilization in Patients With Obesity (ATS 2025) - "Thereafter, we identified patients as "eligible" (cohort entry date) for new use of biologics (benralizumab, dupilumab, mepolizumab, omalizumab, reslizumab, tezepelumab) based on FDA-approved prescribing criteria. Patients with obesity need steroid-sparing approaches for asthma treatment. Our results demonstrate that this population is eligible for, and responsive to, T2-biologics, supporting trial data. Yet only a fraction of this eligible population receives biologics and omit patients at greatest risk from steroid-induced adverse effects."

Clinical • Asthma • Diabetes • Genetic Disorders • Immunology • Obesity • Respiratory Diseases • Type 2 Diabetes Mellitus

Biologics Disrupt the Association Between Cytokines and Clinical/Lifestyle Factors in Severe Asthma Patients (ATS 2025) - " Serum proteomics assay (Olink) of 15 Th1/2/17 cytokines were conducted in 59 severe asthma patients currently on 'T2-only' biologics (omalizumab, mepolizumab, benralizumab, reslizumab, and dupilumab) and 59 matched biologics-naïve severe asthma controls. We replicated the IL-6:BMI:Severe Asthma relationship shown in the Severe Asthma Research Program (SARP) and other studies. Importantly, we show that while BMI was the leading clinical variable influencing cytokine levels in severe asthma patients not yet on biologics, the T2 biologics potentially disrupt this association with smoking status playing a larger role in explaining the variance in Th1/2/17 cytokine levels in this group. These findings can be leveraged as we seek to identify predictive features of response to T2 biologics."

Clinical • Allergic Rhinitis • Asthma • Atopic Dermatitis • Chronic Rhinosinusitis With Nasal Polyps • Dermatitis • Dermatology • Immunology • Inflammation • Metabolic Disorders • Respiratory Diseases • IL1B • IL6

Exploring Global Geographic Variation in Exacerbation Rates in Randomized Controlled Trials of Biologics in Patients With Severe Asthma: A Systematic Literature Review (ATS 2025) - P3 | "Subgroup and post hoc analyses by geographic region of RCTs for tezepelumab (NAVIGATOR), benralizumab (CALIMA/SIROCCO), reslizumab (NCT02452190), dupilumab (TRAVERSE open-label extension), and depemokimab (SWIFT-1/2) consistently reported the smallest treatment effects on exacerbation rates in Central East European countries (Table). Geographical variation in exacerbation rate was consistently observed across biologic RCTs in patients with severe asthma. Lower biologic treatment effects were observed in Central East Europe versus other regions due to lower exacerbation rates in the placebo arm. This could lead to misinterpretation of efficacy results if not considered in future studies."

Clinical • Review • Asthma • Immunology • Respiratory Diseases • IL5

Efficacy of Biologics in Reducing Exacerbations Requiring Hospitalization or an Emergency Department Visit in Patients with Moderate or Severe, Uncontrolled Asthma. (PubMed, Adv Ther) - "These findings suggest that there may be differential effects of biologics in reducing exacerbations that require hospitalization or an ED visit in patients with moderate or severe, uncontrolled asthma."

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

Biologic Therapies for Severe Asthma: Current Insights and Future Directions. (PubMed, J Clin Med) - "The current biologics for severe asthma treatment include omalizumab (anti-IgE), mepolizumab and reslizumab (anti-IL-5), benralizumab (anti-IL-5 receptor), dupilumab (anti-IL-4/IL-13), and tezepelumab (anti-TSLP)...Depemokimab is an ultra-long-acting anti-IL-5 antibody with promising results in phase III trials as a twice-yearly biologic for T2-high asthma. Verekitug follows a similar dosing concept, targeting TSLP, but is still undergoing phase II trials. Itepekimab and astegolimab are two anti-IL-33 antibodies that could have a role in the future treatment of severe asthma. Tezepelumab is in a phase III clinical trial for CRSwNP. Besides new drugs, there is still a need for major research into biologics in severe asthma cases, namely with comparative studies, better biomarkers for predicting response, and the determination of optimal treatment duration."

Journal • Review • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Inflammation • Nasal Polyps • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases • Sinusitis • IL13 • IL33 • IL4 • IL5

Adverse effects of biologics used to treat asthma. (PubMed, Ther Adv Respir Dis) - "In this review, we discuss the risks and adverse effects reported for the current Food and Drug Association (FDA)-approved biologics used in the management of asthma, including omalizumab, benralizumab, dupilumab, mepolizumab, reslizumab, and tezepelumab. We also review currently available data regarding the use of biologics in the context of pregnancy. Our goal is to provide a comprehensive resource for providers utilizing these agents, so that they may adequately counsel patients about the risks of therapy and identify adverse events if they occur."

Adverse events • Journal • Review • Asthma • Cardiovascular • Eosinophilia • Immunology • Infectious Disease • Oncology • Pulmonary Disease • Respiratory Diseases

Severe Asthma and Active SARS-CoV-2 Infection: Insights into Biologics. (PubMed, Biomedicines) - "Biologic therapies, including omalizumab, dupilumab, mepolizumab, reslizumab, benralizumab, and tezepelumab, which target specific pathways in severe asthma, have revolutionized asthma management by improving symptom control and reducing exacerbation rates. Despite their proven benefits, the intersection of biologic therapy and active SARS-CoV-2 infection has prompted questions regarding potential immunomodulatory effects and risks. This review aimed to synthesize the current literature on the antiviral effects and safety of biologic drugs in severe asthmatic patients with active SARS-CoV-2 infection, encompassing both pediatric and adult populations."

Journal • Review • Asthma • Immunology • Infectious Disease • Novel Coronavirus Disease • Pediatrics • Pulmonary Disease • Respiratory Diseases

Effectiveness of biological therapy in severe asthma: a retrospective real-world study. (PubMed, Croat Med J) - "Both anti-IgE and anti-IL-5 treatments effectively reduced exacerbation rates, OCS daily needs, and symptom burden. Multiple predictive biomarkers are needed for the best individual monitoring."

Clinical • Journal • Real-world evidence • Retrospective data • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases • IL5

Results of personalized biological therapy in patients with chronic rhinosinusitis with nasal polyps and severe uncontrolled bronchial asthma - real-life study. (PubMed, Otolaryngol Pol) - "New therapeutic options using the knowledge of Th2 inflammatory endotype are based on anti-IL5 (mepolizumab, reslizumab), anti-IL5R (benralizumab), anti-IgE (omalizumab), and anti-IL4/IL13 (dupilumab) monoclonal antibodies. Due to the small group of patients treated with dupilumab, statistical analysis in this group was not performed.<b></b> Our real-life observation confirmed that biological therapy based on phenotyping enables achieving optimal therapeutic effects for patients with CRSwNP and severe bronchial asthma. Biological therapy should be conducted through a collaborative and multidisciplinary approach."

Journal • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Inflammation • Nasal Polyps • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases • Sinusitis • IL13 • IL4 • IL5

UNITED STATES PRESCRIBING TRENDS FOR BIOLOGIC AGENTS FOR CHILDREN HOSPITALIZED FOR CRITICAL ASTHMA (SCCM 2025) - "The primary outcome was overall and annual biologic prescription rate including antibodies for immunoglobulin-E (IgE, omalizumab), interleukin (IL)-5 (mepoluzimab and reslizumab), IL-5 receptor (IL-5R, benraluzimab), IL-4/13 (dupilumab), and thymic stromal lymphopoetin (TSLP, tezepulimab). In this multicenter study, the prescription rate of biologic agents for children with CA was rare and appeared more common among children with severe asthma classification and worse clinical trajectory."

Clinical • Asthma • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pediatrics • Respiratory Diseases • IL4 • IL5 • TSLP

Hypersensitivity Reactions to Biologics for Atopic Diseases: A Retrospective Cohort Study (AAAAI-WAO 2025) - "Methods We performed a retrospective review of Mayo Clinic Health System records from 1/1/2009 to 8/15/2024, to identify patients using the search term "anaphylaxis" in the "allergies/contraindications" section related to biologics (benralizumab, dupilumab, mepolizumab, omalizumab, reslizumab, and tezepelumab). Understanding these reactions helps manage and prevent adverse events. Further research is needed to enhance patient safety."

Retrospective data • Asthma • Atopic Dermatitis • Chronic Rhinosinusitis With Nasal Polyps • Dermatitis • Dermatology • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis • Urticaria

Low Adherence to Current Biologic Therapies in Asthma: Insights From a Retrospective Cohort Analysis of Claims Data (AAAAI-WAO 2025) - "Results Overall, 10,088 patients were identified (omalizumab, both 2-/4-weekly, [n=5048]; dupilumab [n=2096]; mepolizumab [n=1545]; benralizumab [n=1301]; reslizumab [n=84]; tezepelumab [n=14]). Conclusions This study reveals diverse adherence patterns among patients with asthma using biologics, highlighting the need for better data collection, adherence monitoring, and barrier mitigation. Insights from these findings may guide personalized interventions to improve long-term asthma management."

Adherence • Late-breaking abstract • Retrospective data • Asthma • Immunology • Respiratory Diseases

A Global Survey Evaluating Barriers To Prescribing Biologics For Atopic Diseases During Pregnancy (AAAAI-WAO 2025) - "The most frequently prescribed biologics during pregnancy were omalizumab (79.2%) and dupilumab (32.5%), followed by benralizumab (7.8%), mepolizumab (7.8%), tralokinumab (3.9%), tezepelumab (2.6%), and reslizumab (1.3%). Conclusions Significant barriers exist in prescribing biologics for atopic diseases during pregnancy. Clinicians, researchers, and pharmaceutical companies must collaborate to develop strategies that overcome these barriers and improve access to biologic therapy for pregnant women."

Clinical • Gynecology • Immunology