Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen - LARVOL DELTA

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

Tezepelumab can Restore Normal Lung Function in Patients with Severe, Uncontrolled Asthma: Pooled Results from the PATHWAY and NAVIGATOR Studies. (PubMed, Pulm Ther) - P2, P3 | "In patients with severe, uncontrolled asthma, a greater proportion of tezepelumab than placebo recipients with abnormal lung function at baseline achieved normal lung function at week 52."

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

Clarification of the efficacy of tezepelumab in the phase 2a COURSE trial. (PubMed, J Allergy Clin Immunol) - No abstract available

Journal • P2a data

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

Efficacy Evaluation of Novel Therapeutics Targeting TSLP or TSLPRDrug Candidates Using TSLP/TSLPR Double Humanized Mouse Model on BALB/c Background (IMMUNOLOGY 2025) - "Tezepelumab, an approved monoclonal antibody against TSLP, as well as other therapeutic antibodies that target TSLP, significantly alleviated the phenotypes induced by MC903. In addition, in both the OVA- and HDM-induced asthma models, we found anti-TSLP antibody significantly reduced the infiltration of eosinophils and other lymphocytes in the lung."

Preclinical • Asthma • Dermatitis • Dermatology • Immunology • Respiratory Diseases • CRLF2 • IL2 • TSLP

Efficacy of Biologic Agents in Management of Pediatric Asthma (PAS 2025) - "Control of severe asthma has always been a challenge, and the advent of biologic therapy (omalizumab, mepolizumab, dupilumab, benralizumab, and tezepelumab) has revolutionized the treatment of this category of asthma. These factors will also be assessed for the year following initiation for evaluation of outcomes. Outcomes pre and post-biologic initiation will be compared using dependent sample t-testing, conducted with IBM SPSS."

Clinical • Asthma • Immunology • Pediatrics • Respiratory Diseases • IL4 • IL5 • TSLP

The impact of Tezepelumab therapy on perceived asthma triggers: a multicentre real-life study. (PubMed, J Asthma) - "Tezepelumab positively impacts patients' perception of asthma triggers and their HRQoL, supporting its role in managing triggers hypersensitivity as a treatable trait in severe asthma. Further research is warranted to investigate underlying mechanisms and long-term effects."

Journal • Asthma • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases • TSLP

Blue Cross Blue Shield now requires prior approval for severe asthma drugs in some states (Yahoo News) - "Patients in five states who have severe asthma and are covered by Blue Cross Blue Shield are facing a new obstacle to getting treatment...On Tuesday, BCBS began mandating that severe asthma patients self-administer their drugs at home, unless their provider gets prior approval from the insurance company....The patients affected are those covered in Illinois, Texas, Oklahoma, New Mexico, and Montana, but not those with Medicare or Medicaid, the insurance giant says. Those five states are included in a combined BCBS plan which is owned by Health Care Service Corporation...Given as injections, the treatments in question are Fasenra (benralizumab), Tezspire (tezepelumab), Nucala (mepolizumab) and Xolair (omalizumab). All belong to a class of drugs known as biologics."

Commercial • Asthma • Immunology

AstraZeneca Gets CDSCO Panel Nod To study Tezepelumab (Medical Dialogues) - "Pharmaceutical major AstraZeneca Pharma India has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the Phase III clinical trial of Tezepelumab. This came after AstraZeneca Pharma India presented phase III clinical study protocol no. D5241C00006 CSP version 1.0 dated 02 Dec 2024 and Local CSP Addendum IND-1 version 1.0 dated 03 Jan 2025. Tezepelumab is a human monoclonal antibody used to treat severe asthma, specifically targeting thymic stromal lymphopoietin (TSLP) to reduce airway inflammation and asthma exacerbations."

New P3 trial • Asthma

Effectiveness of tezepelumab in preventing relapse of eosinophilic granulomatosis with polyangiitis: A case report. (PubMed, Respir Investig) - "A 54-year-old woman diagnosed with eosinophilic granulomatosis accompanied by polyangiitis (EGPA) was in remission with prednisolone (PSL) and mepolizumab treatment. Consequently, the treatment with benralizumab was changed to tezepelumab, after which her symptoms immediately improved and her ANCA levels decreased, enabling reduction in the PSL dosage. This case highlights the potential of tezepelumab to reduce ANCA levels in EGPA-related severe asthma."

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

Oscillometry and spirometry derived ratios to assess small airways dysfunction in severe asthma patients taking tezepelumab (EAACI 2025) - No abstract available

Clinical • Late-breaking abstract • Immunology

Worse airflow obstruction but not type 2 biomarkers identifies super-responders to tezepelumab in a real life clinic setting (EAACI 2025) - No abstract available

Biomarker • Clinical • Late-breaking abstract • Immunology

A real-world study of tezepelumab in severe asthmatics of a French cohort (EAACI 2025) - No abstract available

Clinical • Real-world • Real-world evidence • Immunology

In silico system pharmacology modeling provides insights into a mechanism for greater potency of TSLP/TSLPR pathway inhibition with verekitug, a novel antibody antagonist of TSLPR, as compared to tezepelumab (EAACI 2025) - No abstract available

Immunology • CRLF2 • TSLP

Early Real-World Outcomes of Tezepelumab in Severe Asthma Patients Unresponsive to Prior Biologics (EAACI 2025) - No abstract available

Clinical • Real-world • Real-world evidence • Immunology

Real-life experience with tezepelumab in severe allergic asthma (EAACI 2025) - No abstract available

Clinical • Allergy • Immunology

Clinical Effectiveness of Tezepelumab on Upper and Lower Airway Symptoms in Patients with Asthma and Co-morbid Nasal Polyposis (EAACI 2025) - No abstract available

Clinical • Immunology

Real-life experience after 6 months with Tezepelumab in specialized asthma units across northern Spain (EAACI 2025) - No abstract available

Clinical • Immunology

Efficacy and safety of tezepelumab in adults with severe chronic rhinosinusitis with nasal polyps overall and in patients with and without co-morbid asthma: results from the phase 3 WAYPOINT study (EAACI 2025) - No abstract available

Clinical • P3 data • Immunology

Tezepelumab reduces OCS use and improves sino-nasal symptoms in OCS-dependent patients with severe asthma and comorbid chronic rhinosinusitis (overall and with nasal polyps): results from the phase 3b WAYFINDER study (EAACI 2025) - No abstract available

Clinical • P3 data • Immunology

Baseline characteristics and main clinical outcomes of patients receiving tezepelumab in the framework of use in Special Situations prior to commercialization in Spain (T-ROSS Study) (EAACI 2025) - No abstract available

Clinical • Clinical data • Immunology

Effectiveness of Tezepelumab in uncontrolled severe asthma. ADVANCAT (Advancing severe asthma care with Tezepelumab in Catalonia) (EAACI 2025) - No abstract available

Immunology

Treatment of allergic bronchopulmonary aspergillosis with biologics. (PubMed, Chin Med J Pulm Crit Care Med) - "Data on dupilumab and tezepelumab are limited; however, they may be effective in patients who are resistant to treatment with omalizumab/mepolizumab/benralizumab. Future studies examining the effects of these biologics in preventing the recurrences/exacerbations of ABPA are warranted."

Journal • Review • Allergic Bronchopulmonary Aspergillosis • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Tezepelumab achieves improvement of severe uncontrolled asthma and rhinosinusitis: Case series. (PubMed, J Allergy Clin Immunol Glob) - "Tezepelumab, a mAb targeting thymic stromal lymphopoietin (TSLP), reduces exacerbations in severe asthma. Four cases in which patients with severe asthma and chronic rhinosinusitis with nasal polyps showed improvements in both conditions after receiving tezepelumab treatment are presented."

Journal • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases • Sinusitis • TSLP

SUNRISE: Tezepelumab Efficacy and Safety in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma (clinicaltrials.gov) - P3 | N=125 | Terminated | Sponsor: AstraZeneca | Active, not recruiting ➔ Terminated; The study was discontinued due to slow recruitment, resulting from evolving clinical practices that reduced the use of maintenance oral corticosteroids for severe asthma treatment. The termination decision was not related to safety concerns.

Trial termination • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases