tezepelumab ocs reduction

U.S. Department of Health and Human Services. In the PATHWAY phase 2b study ( NCT02054130 ), tezepelumab significantly reduced exacerbations by up to 71% in adults with severe, uncontrolled asthma. New Tezepelumab Data Show 86% Reduction In Exacerbations In Patients With Severe Asthma And Comorbid Nasal Polyps. You have reached the maximum number of saved studies (100). Tuberculosis requiring treatment within the 12 months prior to Visit 1. The total score is the mean of the responses. Subjects will be randomized in a 2:1 ratio to either tezepelumab or matching placebo both administered subcutaneously. Sign up here for the top articles of the week delivered straight to your inbox. Tezepelumab is a humanized monoclonal antibody, which prevents binding of TSLP to its receptor. Change from baseline in total serum IgE at Week 28. You may report side effects related to AstraZeneca . Percent change from baseline is defined as {(final dose-baseline dose)/baseline dose}*100%. Documented physician diagnosed asthma requiring continuous treatment with high-dose ICS plus a LABA for at least 6 months prior to Visit 1. Triple (Participant, Care Provider, Investigator), 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 (SUNRISE, 18 Years to 80 Years (Adult, Older Adult), Contact: AstraZeneca Clinical Study Information Center, Newport Beach, California, United States, 92663, Miami Lakes, Florida, United States, 33014, Bloomington, Indiana, United States, 47408, Grand Rapids, Michigan, United States, 49546, Woodhaven, New York, United States, 11421, Columbia, South Carolina, United States, 29204, Knoxville, Tennessee, United States, 37919, Vancouver, British Columbia, Canada, V6Z 1Y6. Oral glucocorticoid-sparing effect of benralizumab in severe asthma. Home PEF testing will be performed by the subject in the morning upon awakening and in the evening at bedtime using an electronic, hand-held spirometer. Rate of asthma exacerbation is based on exacerbations reported by the investigator in eCRF that are associated with a hospitalization or an emergency room visit over 52 weeks. Chronic Rhinosinusitis with Nasal Polyps. Tezepelumab is being developed by AstraZeneca in collaboration with Amgen. The 48-week trial 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. The aim of asthma management is the control of the disease, and the cornerstone of asthma treatment is inhaled corticosteroids [ 1 ]. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared. Inject Tezspire 210 mg (contents of one vial or one pre-filled syringe as described below) subcutaneously into the upper arm, thigh, or abdomen, except for the 2 inches (5 cm) around the navel. Besides the overall results, which showed that tezepelumab reduced exacerbations by 56% overall and 41% in those with eosinophils less than 300 cells/mcL, Wechsler said the trial also showed that. The annualized exacerbation rate is based on exacerbations reported by the investigator in the eCRF over 28 weeks. Change from baseline in fractional exhaled nitric oxide (FeNO) at Week 28. Building on the positive Phase IIb PATHWAY trial, the Phase III PATHFINDER programme included two trials, the registrational NAVIGATOR study and SOURCE. Tezepelumab efficacy in patients with severe, uncontrolled asthma and comorbid nasal polyps in NAVIGATOR. In spite of . 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. . Tezepelumab in adults with uncontrolled asthma. Usual Pediatric Dose for Asthma: 12 years or older: 210 mg subcutaneously every 4 weeks Comments: Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05398263. FEV1 is defined as as the volume of air exhaled from the lungs in the first second of a forced expiration. Treatment boosted ADA defined as baseline positive ADA that was boosted to a 4 fold or higher level following treatment. . Kupczyk M, Wenzel S. U.S. and European severe asthma cohorts: what can they teach us about severe asthma? To update your cookie settings, please visit the, Academic & Personal: 24 hour online access, Corporate R&D Professionals: 24 hour online access, https://doi.org/10.1016/S2213-2600(21)00537-3, Evaluation of the oral corticosteroid-sparing effect of tezepelumab in adults with oral corticosteroid-dependent asthma (SOURCE): a randomised, placebo-controlled, phase 3 study, https://ginasthma.org/wp-content/uploads/2020/06/GINA-2020-report_20_06_04-1-wms.pdf, Correction to Lancet Respir Med 2022; 10: 65060, The Lancet Regional Health Southeast Asia, For academic or personal research use, select 'Academic and Personal', For corporate R&D use, select 'Corporate R&D Professionals'. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. 2 soc was medium- or high-dose inhaled corticosteroids (ics) plus at least one additional controller medication with or without Percent change from baseline is derived as {(final dose-baseline dose)/baseline dose}*100 and the categories of percent change from baseline are defined as 90% to 100% reduction, 75% to < 90% reduction, 50% to < 75% reduction, > 0% to < 50% reduction, no change or any increase. Tezepelumabs effect on other efficacy parameters was similar to those observed in previous studies, including the registrational Phase III NAVIGATOR study. AQLQ[s]+12 is 7 point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment). Any disorder that is not stable in the opinion of the Investigator and could: a. 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. Newton JR, Ah-See KW. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access.For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. The total score is expressed as a percentage of overall impairment, where 100 represents the worst possible health status and 0 indicates the best possible health status. ERS poster number: PA876. Proportion of participants who did not experience an exacerbation associated with hospitalization over 28 weeks. Blood eosinophils at Visit 1 150 cells/L or documented EOS 300 cells/L within 12 months prior to Visit 1. Fahy JV. The annualised asthma exacerbation rate is based on exacerbations reported by investigator in eCRF over 28 weeks. Absolute and percent change from baseline in daily maintenance OCS dose at Week 28. Percent change from baseline is defined as {final dose-baseline dose)/baseline dose}*100%, and the categories of percent change from baseline in daily OCS dose are defined as: 90% to 100% reduction, 75% to <90% reduction, 50% to <75% reduction, >0% to <50% reduction, and, no change or any increase. Proportion of subjects with 100% reduction from baseline in daily OCS dose at Week 28. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Positive hepatitis B surface antigen, or hepatitis C virus antibody serology at screening, or a positive medical history for hepatitis B or C. Pregnant, breastfeeding, or lactating women. Increased mortality in patients with corticosteroid-dependent asthma: a nationwide population-based study. this is a multicentre, single-arm, phase 3b study designed to evaluate efficacy and safety of reducing daily oral corticosteroid use after initiation of 210 mg dose of tezepelumab administered subcutaneously in patients with severe asthma receiving high-dose inhaled corticosteroid plus long-acting 2 agonist and oral corticosteroids with or Peters MC, Mekonnen ZK, Yuan S, et al. On November 10 2020, AstraZeneca and Amgen announced positive results from the NAVIGATOR Phase III trial which met the primary endpoint and demonstrated a statistically significant and clinically meaningful reduction in the annualised asthma exacerbation rate in a broad population of patients with severe asthma, including those with low levels of eosinophils. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). https://astrazenecagroup-dt.pharmacm.com/DT/Home. without loss of asthma control, with tezepelumab compared to placebo. This total score is expressed as a percentage of overall impairment, in which 100 represents the worst possible health status and 0 indicates the best possible health status. Proportion of participants who did not experience an exacerbation over 52 weeks. For general information, Learn About Clinical Studies. event. Categorised percent reduction from baseline in the daily maintenance OCS dose at Week 28. 2 The ACQ-6 captures asthma symptoms and short-acting 2 agonists use via subject-report. Amgen and AstraZeneca announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo. Stevens WW, Schleimer RP, Kern RC. According to Amgen and AstraZeneca, who are jointly developing the biologic, when added to standard of care (SOC) tezepelumab demonstrated a statistically significant and clinically meaningful reduction in the annualised asthma exacerbation rate (AAER), compared to placebo. 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 Receipt of any marketed or investigational biologic agent within 4 months or 5 half-lives (whichever is longer) prior to Visit 1 or receipt of any investigational nonbiologic agent within 30 days or 5 half-lives (whichever is longest) prior to Visit 1. 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. Absolute change from baseline is defined as (final dose-baseline dose). The 48-week trial assessed the efficacy and safety of the potential new medicine . Tezepelumab: 0.98 (95% CI: 0.84, 1.14), Clinical Trial Diversity and Representation, Clinical Trial Transparency, Data Sharing and Disclosure Practices, Adverse Event and Product Complaint Reporting, Environmental, Social & Governance Report 2021, Environment, Social and Governance Strategy, Community Investment and Amgen Foundation, New Tezepelumab Data Show 86% Reduction In Exacerbations In Patients With Severe Asthma And Comorbid Nasal Polyps, U.S.Food and Drug Administration Breakthrough Therapy Designation, https://clinicaltrials.gov/ct2/show/NCT04851964, https://clinicaltrials.gov/ct2/show/NCT03406078, https://clinicaltrials.gov/ct2/show/NCT03706079, https://www.prnewswire.com/news-releases/new-tezepelumab-data-show-86-reduction-in-exacerbations-in-patients-with-severe-asthma-and-comorbid-nasal-polyps-301368866.html, Menzies-Gow A, et al.