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

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

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

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

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

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

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

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

Urinary LTE4 Level as a Biomarker for the Treatment Response of Biologics in Severe Asthma (AAAAI-WAO 2025) - "47 patients were prescribed mepolizumab and reslizumab, while 22 received dupilumab. Only responders in the mepolizumab and reslizumab group showed a higher AUC compared to baseline eosinophils (0.962 vs. 0.914, p=0.58). Conclusions Urinary LTE4 levels might be potential biomarkers for the treatment response of biologics in severe asthma."

Biomarker • Asthma • Immunology • Respiratory Diseases

Evolution Of Real-World Biologic Use Among Adults With Severe Asthma Treated By United States Subspecialists: Results From The CHRONICLE Study (AAAAI-WAO 2025) - P | "Biologic initiations (as percentage of all within the interval) from 2H-2018 to 2H-2023 decreased for benralizumab (42% to 16%), mepolizumab (21% to 9%), omalizumab (26% to 7%), and reslizumab (3% to 1%). Conclusions Biologic initiation among patients with SA in the US has changed as new biologic therapies have been approved. In recent years, dupilumab and tezepelumab were the most commonly initiated biologics."

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

Associations Between Absolute Eosinophil Counts and Cardiovascular Diseases (AAAAI-WAO 2025) - "Retrospective patient-level blood pressure (BP) data on 85 patients treated with mepolizumab, benralizumab, or reslizumab were analyzed using paired t-tests to assess for pre- and post-treatment differences in BP. Our preliminary analysis did not find an effect of anti-eosinophil therapy on BP in a small sample of patients. Future analyses will compare rates of incident CVD in patients with high AECs and explore whether anti-eosinophil therapy impacts outcomes."

Cardiovascular • Coronary Artery Disease • Heart Failure • Hypertension

A Systematic Literature Review of Real-World Anti-Interleukin-5 and Anti-interleukin-5 Receptor Alpha Treatment Outcomes for Hypereosinophilic Syndrome: Case Reports and Cohort Studies (AAAAI-WAO 2025) - "Methods Systematic literature review of articles published during 11/4/2015–10/31/2023 and abstracts published during 1/1/2021–10/31/2023 of patients with HES receiving an anti-IL-5/Rα treatment (mepolizumab [approved], benralizumab or reslizumab). In cohort studies, nine patients switched from mepolizumab to benralizumab due to failure to respond to mepolizumab (n=8) or adverse events (n=1). Conclusions Real-world anti-IL-5/Rα treatments in patients with HES were associated with significant reductions of eosinophils and OCS dose."

Case report • Clinical • Real-world • Real-world evidence • Review • Hypereosinophilic Syndrome • Immunology • IL5

Serum and urine eosinophil-derived neurotoxin (EDN) levels predict biologic response in severe asthma. (PubMed, World Allergy Organ J) - P | "This research was conducted over 24 weeks on 56 patients with severe asthma treated with mepolizumab, reslizumab, and dupilumab. Blood eosinophil counts and EDN levels show potential as predictive markers for treatment responses in patients with severe asthma undergoing biologic therapies. However, further comprehensive studies are warranted to enhance the reliability and applicability of EDN as an effective asthma treatment biomarker."

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

Anti-IL-5 treatment, but not neutrophil interference, attenuates inflammation in a mixed granulocytic asthma mouse model, elicited by air pollution. (PubMed, Respir Res) - "Inhibition of IL-5 signalling, but not neutrophil interventions, significantly attenuates eosinophilic inflammation in a mouse model of mixed granulocytic asthma, elicited by air pollution exposure."

Journal • Preclinical • Asthma • Immunology • Inflammation • Pneumonia • Pulmonary Disease • Respiratory Diseases • ELANE • IL5

Poor agreement among asthma specialists on the choice and timing of initiation of a biologic treatment for severe asthma patients. (PubMed, J Allergy Clin Immunol Pract) - "The inter-observer agreement among asthma specialists in both the decision to initiate a biological treatment in patients with severe asthma and in the selection of treatment is weak. These results highlight the need for studies seeking reliable predictors for optimal response to biological therapies."

Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Use of biologics to treat asthma during pregnancy and adverse events in pregnant women and newborns: A global pharmacovigilance analysis. (PubMed, Int Arch Allergy Immunol) - "This global case-non-case study underscores the critical need for further well-designed research to investigate these over-reported outcomes and emphasizes the importance of more rigorous monitoring efforts for these adverse events."

Adverse events • Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Impact of smoking on biological treatment response in patients from the German Severe Asthma (GAN) Registry. (PubMed, J Allergy Clin Immunol Pract) - "In summary, ex-smokers with severe asthma experienced similar improvements in asthma control, exacerbations, lung function and biomarkers as NS after one year of biologics, suggesting that severe asthmatics even with a substantial smoking history can benefit from biologic therapy."

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

Single-cell RNA sequencing reveals transcriptional changes in circulating immune cells from patients with severe asthma induced by biologics. (PubMed, Exp Mol Med) - P | "We conducted single-cell RNA sequencing (scRNA-seq) of peripheral blood mononuclear cells (PBMCs) from eight patients with severe eosinophilic asthma treated with mepolizumab, reslizumab, or dupilumab. In conclusion, regardless of the type of biologics used, suppression of T2-mediated pathways ultimately reduces the expression of genes related to NF-κB signaling in circulating immune cells. Further studies are warranted to identify potential biomarkers related to treatment response and long-term outcomes.Clinical trial registration number: NCT05164939."

Immune cell • Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases • IL13 • IL1B • IL4 • IL5