Treatment with systemic immunosuppressive/immunomodulating drugs, except for OCS used in the treatment of asthma/asthma exacerbations, within the last 12 weeks or 5 half-lives (whichever is longer) prior to Visit 1. (Clinical Trial), A Multicentre, Single-arm, Phase 3b Efficacy and Safety Study of Tezepelumab 210 mg Administered Subcutaneously to Reduce Oral Corticosteroid Use in Adult Participants With Severe Asthma on High-dose Inhaled Corticosteroid Plus Long-acting 2 Agonist and Long-term Oral Corticosteroid Therapy (WAYFINDER), 18 Years to 80 Years (Adult, Older Adult), Contact: AstraZeneca Clinical Study Information Center, Newport Beach, California, United States, 92663, Loxahatchee Groves, Florida, United States, 33470, Ann Arbor, Michigan, United States, 48109, Riverdale, New Jersey, United States, 07457, Toms River, New Jersey, United States, 08755, DuBois, Pennsylvania, United States, 15801, San Miguel de Tucuman, Argentina, T4000IAQ, Brussels (Woluw-St-Lambert), Belgium, 1200. Other exclusion criteria per protocol apply. Tezepelumab is a potential first-in-class medicine that blocks the action of thymic stromal lymphopoietin (TSLP), . participants and 65 (86%) of 76 placebo-assigned participants reported an adverse event. Comorbidity in severe asthma requiring systemic corticosteroid therapy: cross-sectional data from the Optimum Patient Care Research Database and the British Thoracic Difficult Asthma Registry. Participants with evidence of active COVID-19 infection during run-in period and optimisation. 2021 Elsevier Ltd. All rights reserved. Tezepelumab is a humanized monoclonal antibody, which prevents binding of TSLP to its receptor. Morning pre- bronchodilator (BD) FEV1 must be < 80% predicted normal at Visit 1 or Visit 2. a) Post-BD responsiveness test result: FEV1 12% and 200 mL documented either in the previous 60 months prior to or at Visit 1 or at Visit 2 or at Visit 3; OR b)Airway hyperresponsiveness (methacholine: provocative concentration that causes a positive reaction [PC20] of <8 mg/mL) documented in the 60 months prior to Visit 1. Proportion of participants who did not experience an exacerbation associated with hospitalization over 52 weeks. Choosing to participate in a study is an important personal decision. Participants must have received a physician-prescribed medium- or high-dose ICS for at least 12 months prior to Visit 1. Change from baseline in SGRQ as compared to placebo at Week 28. Approximately 207 subjects will be randomized globally. The AQLQ(S)+12 is a questionnaire that measures the health-related quality of life experienced by asthma subjects. Rate of asthma exacerbation is based on exacerbations reported by the investigator in eCRF that are associated with a hospitalization over 52 weeks. (ICS) plus at least one additional controller medication with or without OCS . The ACQ-6 score is the mean of the responses. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. During the 36-week reduction phase, oral corticosteroid dose reduction was required at the first visit and subsequent changes in dose were assessed at visits every 4 weeks. Tezepelumab, a potential first-in-class medicine, when added to SoC achieved a 56% reduction (p<0.001) in AAER over 52 weeks in the overall patient population, compared to placebo when added to SoC. Absolute and percent change from baseline in daily maintenance OCS dose at Week 28. Tezepelumab, a potential first-in-class medicine, when added to standard of care (SoC) achieved a 56% reduction (p<0.001) in AAER over 52 weeks in the overall patient population, compared to placebo when added to SoC. FROM ATS 2021. Tezepelumab's effect on other efficacy parameters was similar to those observed in previous trials, including the registrational Phase III NAVIGATOR trial. tezepelumab is a subcutaneously administered humanized monoclonal antibody that blocks the action of thymic stromal lymphopoietin (tslp), an epithelial cytokine.28,29 tslp sits at the top of multiple inflammatory cascades and plays a critical role in the initiation and persistence of allergic, eosinophilic, and other types of airway inflammation You may report side effects related to AstraZeneca . Oral corticosteroid dose changes and impact on peripheral blood eosinophil counts in patients with severe eosinophilic asthma: a post hoc analysis. World Allergy Organization(WAO). Proportion of participants who did not experience an exacerbation associated with hospitalization over 28 weeks. Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score at Week 52. Change from baseline in pre-BD FEV1 at Week 28. Tezepelumab is a human monoclonal antibody that binds to TSLP, inhibiting its stimulatory action on dendritic . Treatment boosted ADA defined as baseline positive ADA that was boosted to a 4 fold or higher level following treatment. (Clinical Trial). After randomisation and the first dose of tezepelumab or placebo, there was a 4-week induction period, during which the oral corticosteroid dose was kept stable. For details of the timelines, please rerefer to the disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Expression and cellular provenance of thymic stromal lymphopoietin and chemokines in patients with severe asthma and chronic obstructive pulmonary disease. Why Should I Register and Submit Results? Abdalla S, Alreefy H, Hopkins C. Prevalence of sinonasal outcome test (SNOT-22) symptoms in patients undergoing surgery for chronic rhinosinusitis in the. TEZSPIRE (tezepelumab-ekko) injection, for subcutaneous use Initial U.S. Approval: 2021. . Absolute and percent change from baseline in daily maintenance OCS dose at Week 52. The PATHWAY trial achieved its primary efficacy endpoint, showing annual asthma exacerbation rate reductions of 61%, 71% and 66% in the tezepelumab arms receiving either 70mg or 210mg every four weeks or 280mg every two weeks, respectively (p<0.001 for all comparisons to placebo). History of chronic alcohol or drug abuse within 12 months prior to Visit 1. tezepelumab, a potential first-in-class medicine, when added to standard of care (soc) achieved a 56% reduction (p<0.001) in aaer over 52 weeks in the overall patient population, compared to placebo when added to soc. The effect of tezepelumab on these biomarker levels may be related to decreased interleukin-5 and interleukin-13 levels. Non-eosinophilic asthma: current perspectives. Participants who have had basal cell carcinoma, localised squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible to participate in the study provided that curative therapy was completed at least 12 months prior to Visit 1; b. Proportion of participants who reduced daily prescribed maintenance OCS dose to 5 mg/day without loss of asthma control at Week 52. TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. Information provided by (Responsible Party): A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled 28-week Phase 3 Efficacy and Safety Study of Tezepelumab in Reducing Oral Corticosteroid Use in Adults with Oral Corticosteroid Dependent Asthma. Tezepelumab is a human monoclonal antibody that blocks the activity of the epithelial cytokine thymic stromal lymphopoietin. According to Amgen, the recent results from the NAVIGATOR trial were impressive, both in terms of the overall clinical data and the reduction in exacerbation rate with tezepelumab treatment, and it continues to work with AstraZeneca on planned regulatory filings in 2021. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration. Absolute change from baseline is defined as (final dose-baseline dose). (expressed as a percentage) of subjects with 100% reduction from baseline in daily OCS dose at Week 48. Amgen and AstraZeneca have reported that the SOURCE Phase III trial for tezepelumab in patients with severe, oral corticosteroid (OCS)-dependent asthma did not meet the primary endpoint of a statistically significant reduction in the daily OCS dose, without loss of asthma control, with tezepelumab compared to placebo. Tezepelumab reduced OCS use in patients with OCS-dependent asthma, but statistical significance versus placebo was not achieved. Proportion of participants who did not experience an exacerbation over 28 weeks. Data to be presented show the number of patients that achieved a 90% reduction in OCS dose was numerically higher for tezepelumab-treated patients at 54.1% compared to 46.1% in the placebo group. following ocs dose optimization, the 48-week treatment period comprises: a 4-week induction phase during which tezepelumab is introduced; a 36-week ocs reduction phase during which the ocs dose is tapered (dependent on the patient continuing to meet asthma control criteria); and an 8-week maintenance phase in which patients continue on their New Tezepelumab Data Show 86% Reduction In Exacerbations In Patients With Severe Asthma And Comorbid Nasal Polyps. Tezepelumab increased the odds of a reduction in OCS use versus placebo in patients with high baseline blood eosinophil counts. The 48-week trial assessed the efficacy and safety of the potential new . Tezepelumab in adults and adolescents with severe, uncontrolled asthma. Coexistent inflammatory conditions for which long-term OCS doses are part of their maintenance treatment. 13]). Systematic literature review of systemic corticosteroid use for asthma management. Why Should I Register and Submit Results? U.S. Department of Health and Human Services. Available at: https://www.worldallergy.org/educational_programs/world_allergy_forum/anaheim2005/blaiss.php [Last accessed:April 2021]. In the PATHWAY phase 2b study ( NCT02054130 ), tezepelumab significantly reduced exacerbations by up to 71% in adults with severe, uncontrolled asthma. The AAERs over 52 weeks were 0.68 and 0.97 per patient-year in the tezepelumab and placebo groups, respectively (30% reduction vs placebo [95% CI: 46, 66]). The total score is the mean of the responses. Participant should be on a stable OCS dose for at least 4 weeks prior to Visit 1. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. 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