Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease: a Single-center, Triple-blinded, Placebo-controlled, Exploratory, Phase 2, Pilot Trial

The development of coronary atherosclerosis is closely related to inflammation, and CD147 may play an important role in its process. The present study was designed to evaluate the effects of long-term administration of mepolizumab (humanized anti-CD147 antibody) on lipid deposition and inflammation in coronary atherosclerotic plaques in patients with high-risk coronary artery disease, and to preliminarily explore the efficacy, safety, and dosage of long-term administration of mepolizumab in this population.

Start Date16 Oct 2024

Sponsor / Collaborator

Xijing Hospital

NCT06501807 / Not yet recruitingNot ApplicableIIT

Real Life Assessment of Biologics Efficacy in Severe Chronic Rhinosinusitis With Nasal Polyps

With a prevalence of 2-4% in western countries, Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) is of major concern regarding its substantial impact on the social and physical quality of life. So far, endoscopic sinus surgery remains the treatment of choice when the first line of medical treatment with corticosteroid has failed.
During the last 15 years, several studies have shown that CRSwNP is associated with a T helper 2 (T2) immune response leading to B cell release of IgE, mucosal recruitment of eosinophils from bone marrow via Interleukin (IL)-5, IL-4 and IL-13 mediated chemoattractant production.
New biologic agents capable of blocking T2 cytokines have been developed in the field of eosinophil-associated diseases, shifting the paradigm of treatment for patients with CRSwNP. In the near future, endotype profiling with accurate biomarkers will be mandatory to tailor the treatment of nasal polyposis with specific biologic therapies.
Herein the investigators propose a prospective study monitoring medical records of CRSwNP patients who undergo biologic treatments. The objectives are to assess treatment efficacy on quality of life, to report clinical and biological criteria for prescription and to measure tolerance and compliance.Patient-reported outcomes will be addressed according to their initial clinical profile (allergy, asthma, NSAID, gastroesophageal reflux disease, obstructive apnea, otologic disorder, smoke habit).

Start Date02 Sep 2024

Sponsor / Collaborator-

CTIS2023-508069-34-01 / RecruitingIIT

Biomarkers for the prediction of individual CRSwNP patients' responses to mepolizumab

Start Date12 Aug 2024

Sponsor / Collaborator-

100 Clinical Results associated with Mepolizumab

100 Translational Medicine associated with Mepolizumab

100 Patents (Medical) associated with Mepolizumab

1,352

Literatures (Medical) associated with Mepolizumab

01 Jan 2025·JOINT BONE SPINE

Update on targeted treatments for ANCA-associated vasculitis

Article

Author: Puéchal, Xavier

Targeted therapy has revolutionized the management of ANCA-associated vasculitis (AAV) over the last fifteen years. Rituximab, an approved induction and maintenance agent for severe AAV, is no less effective than cyclophosphamide as induction therapy and particularly useful in relapsing or refractory disease, or in women. In patients with relapsing AAV, granulomatosis with polyangiitis or PR3-ANCA, it is more effective than cyclophosphamide. Rituximab maintenance is superior to the conventional immunosuppressive drugs that it replaces. Low-dose preemptive rituximab infusions are recommended every 6months for 18months, followed by re-evaluation to decide whether 4 additional biannual infusions should be administered, balancing the probability of relapse and the risk of serious infections on rituximab. A growing body of experimental and clinical data shows that C5a pathway inhibition is a promising therapeutic option for AAV, which could reduce glucocorticoids needs. Avacopan is a first approved oral C5A receptor antagonist, used when there is a high risk that glucocorticoids will cause serious adverse events. In eosinophilic granulomatosis with polyangiitis, the importance of IL-5 for eosinophil activation and survival led to evaluation and approval of mepolizumab, a humanized monoclonal antibody directed against IL-5. Mepolizumab showed a steroid-sparing effect. Its effectiveness in active vasculitis remains uncertain and is currently being evaluated. Benralizumab targeting the IL-5 receptor was recently shown to be noninferior to mepolizumab. Rituximab has had disappointing results in non-severe active vasculitis and is being evaluated as maintenance therapy. Plasma exchange is not indicated as first-line treatment but remains recommended when creatinine levels exceed 300μmol/L.

31 Dec 2024·Annals of medicine

Clinical characteristics of complete responders versus non-complete responders to omalizumab, benralizumab and mepolizumab in patients with severe asthma: a long-term retrospective analysis

Article

Author: Abad, Jorge ; Basagaña, Maria ; Carabias, Lídia ; Padró, Clara ; Pardo, Laura ; Roger, Albert ; Cardona Peitx, Gloria ; Rosell, Antoni ; Navarro, Juan ; Martínez-Rivera, Carlos ; Garcia-Olivé, Ignasi ; Cruz, Paula ; Martínez-Colls, Mimar

BACKGROUND:

Some patients with severe asthma may benefit from treatment with biologics, but evidence has been mostly collected from randomized controlled trials (RCTs), in which patients' characteristics are different from those encountered in asthma patients in the real-world setting. The aim of this study was to describe the clinical features of complete responders versus non-complete responders to long-term treatment with biologics in patients with severe asthma attended in routine daily practice.

METHODS:

Data of a cohort of 90 patients with severe asthma who were treated with biologics (omalizumab, benralizumab, and mepolizumab) for at least 12 months and were followed up to March 2022. Data recorded included clinical characteristics and effectiveness of treatment (exacerbation, Asthma Control Test [ACT] score, lung function, use of maintenance oral corticosteroids [mOCS]), FeNO, and blood eosinophils at baseline, at 12 months, and at the end of follow-up. Complete response is considered if, in addition to not presenting exacerbations or the use of mOCS, the ACT score was >20 and, the FEV₁ >80% predicted.

RESULTS:

An improvement in all asthma control parameters was observed after 12 months of treatment and a mean follow-up of 55 months. After 12 months of treatment 27.2% of patients met the criteria of complete response and this percentage even increased to 35.3% at the end of follow-up. Long-term complete response was associated to better lung function with mepolizumab and omalizumab treatment and to less previous exacerbations in the benralizumab group. The main cause of not achieving a complete response was the persistence of an airflow obstructive pattern.

CONCLUSIONS:

This study shows that omalizumab, benralizumab, and mepolizumab improved the clinical outcomes of patients with severe asthma in a clinic environment with similar effect sizes to RCTs in the long term follow-up. Airflow obstruction, however, was a predictor of a non-complete response to biologics.

31 Dec 2024·ANNALS OF MEDICINE

Improvement in health-related quality of life questionnaires with biologic treatment in severe asthma and comorbid chronic rhinosinusitis with or without nasal polyposis: a real-life experience

Article

Author: Santus, Pierachille ; Busatto, Paolo ; Danzo, Fiammetta ; Saad, Marina ; Radovanovic, Dejan ; Casartelli, Anna ; Lorusso, Rosaria ; Milani, Lisa

BACKGROUND:

Patients with severe asthma frequently have comorbid chronic rhinosinusitis (CRS) with or without nasal polyps, that can increase the symptom burden and complicate treatment. Real-life clinical data on the impact of biologic treatments on CRS-specific quality-of-life questionnaires are still lacking.

MATERIALS AND METHODS:

In this retrospective real-life study, we collected data from patients with severe asthma with comorbid CRS with/without nasal polyposis at baseline, and after 3, 6 and 12 months of treatment with omalizumab, mepolizumab, benralizumab or dupilumab. In particular, we evaluated improvements in HRQoL as measured by SinoNasal Outcome Test-22 (SNOT-22, 0 - 110), Visual Analog Scale symptom scores (VAS, 0-10), and Asthma Control Test (ACT, 5-25) and the proportion of patients meeting the minimal clinically important difference (MCID).

RESULTS:

Disease-specific HRQoL, as measured by SNOT 22 and VAS score improved in all patients at 3, 6, and 12 months of treatment compared with baseline (SNOT-22: 14, IQR: 0-52 vs 10, IQR:0-30 vs 0, IQR:0-15 vs 0, IQR:0-12, p < 0.001, VAS score: 1, IQR: 0-5 vs 0, IQR:0-3 vs 0, IQR:0-2 vs 0, IQR 0-1, p < 0.001). After 3 months of treatment >80% of patients reached the MCID for ACT, while only patients on dupilumab showed to reach a MCID in 100% of cases. The effect size depended upon the symptom burden at baseline.

CONCLUSIONS:

The study confirms the efficacy of omalizumab, mepolizumab, benralizumab, and dupilumab in a real-life setting, with a rapid improvement in CRS-specific HRQoL and general health status. These data highlight the importance of targeting type 2 inflammation in asthmatic patients with co-existing upper and lower airways disease.The Authors disclose that preliminary data and analysis of the present study have been presented in abstract form during the "X International Workshop on Lung Health - Respiratory Disease and Immune Response", held in Nice on 19-21 January 2023.

News (Medical) associated with Mepolizumab

08 Nov 2024

·endpts.com

Amgen and AstraZeneca share positive results in chronic rhinosinusitis

Amgen and AstraZeneca said on Friday that their asthma drug Tezspire reduced nasal congestion and the size of nasal polyps in patients with a different but sometimes related inflammatory condition. Tezspire, also known as tezepelumab, met its co-primary endpoints in a Phase 3 study for patients with chronic rhinosinusitis with nasal polyps, a condition caused by inflammation of the nasal lining that can lead to loss of smell or pressure in the face. The topline results pit the partners against GSK, which reported positive data for its own experimental antibody depemokimab last month. Tezspire would also contend with a handful of biologics already approved for the condition, including Sanofi and Regeneron’s Dupixent, Genentech and Novartis’ Xolair and GSK’s Nucala. Other patients treated with surgery or oral corticosteroids “have a significant side effect profile,” according to Andrew Menzies-Gow, VP of respiratory and immunology on AstraZeneca’s global biopharmaceutical medical team. While Amgen and AstraZeneca have not released any specific data from the Phase 3 trial, the companies said they will present full results to regulators soon, as well as “at an upcoming medical meeting.” Patients in the trial had failed on standard-of-care intranasal corticosteroids. “Tezepelumab has a unique mechanism of action. It targets right at the top of the inflammatory cascade, so it clearly differentiates in its mechanism from the other available drugs,” Menzies-Gow told Endpoints News on Friday. Pablo Panella, AstraZeneca’s global head of respiratory and immunology, added that “we’ll be able to have a more informed discussion” about competition when the companies are able to share the full data. Tezspire was first approved in 2021 as a subcutaneous treatment for severe asthma, followed by another approval in 2023 for a self-administered formulation in a prefilled pen. AstraZeneca and Amgen will seek approval for both formulations in chronic rhinosinusitis with nasal polyps, as “some patients in the US prefer to be administered the drug at the clinic,” Panella said. The drug generated $653 million in combined 2023 sales for Amgen and AstraZeneca.

Clinical ResultPhase 3Drug Approval

08 Nov 2024

·www.businesswire.com

TEZSPIRE met both co-primary endpoints in the Phase III WAYPOINT trial in patients with chronic rhinosinusitis with nasal polyps

WILMINGTON, Del.--( BUSINESS WIRE )--Positive high-level results from the Phase III WAYPOINT trial in patients with chronic rhinosinusitis with nasal polyps (CRSwNP [nasal polyps]) showed that AstraZeneca and Amgen’s TEZSPIRE ® (tezepelumab) demonstrated a statistically significant and clinically meaningful reduction in the size of nasal polyps and reduced nasal congestion compared to placebo. WAYPOINT is a randomized, double-blind trial that evaluated the efficacy and safety of TEZSPIRE administered subcutaneously compared to placebo in adults with severe CRSwNP. Participants in the trial were symptomatic despite treatment with standard of care (intranasal corticosteroids [INCS]). 1 Dr. Joseph Han, Vice Chair of Rhinology & Endoscopic Sinus and Skull Base Surgery, and Allergy, Otolaryngology-Head and Neck Surgery, Eastern Virginia Medical School, US, and co-primary investigator in the trial, said: “ Chronic rhinosinusitis with nasal polyps negatively impact patients’ daily lives with obstructions leading to disturbances in smell, taste and sleep as well as pain and fatigue. The impressive data from the WAYPOINT trial demonstrate tezepelumab’s potential as a new treatment for patients whose lives are disrupted by this debilitating disease.” Dr. Brian Lipworth, Professor of Allergy and Pulmonology, Scottish Centre for Respiratory Research, and Tayside Rhinology Ear, Nose and Throat Clinic, Ninewells Hospital University of Dundee in Scotland, UK, and co-primary investigator in the trial, said: “ Patients diagnosed with nasal polyps continue to experience significant burden including repeat surgeries and frequent treatment with high doses of oral corticosteroids, which are associated with serious systemic side effects. The tezepelumab data are clinically meaningful and offer patients with nasal polyps hope for a potential new treatment option that may reduce the burden on patients and healthcare systems.” Sharon Barr, Executive Vice President, BioPharmaceuticals R&D said: “ We are excited by the positive results from the Phase III WAYPOINT trial, which show that patients with nasal polyps strongly benefitted from treatment with tezepelumab. These results reinforce that tezepelumab’s first-in-class mode of action, targeting TSLP at the top of the inflammatory cascade, effectively addresses the multiple drivers of epithelial-driven inflammatory diseases.” The safety profile and tolerability of TEZSPIRE in this trial were consistent with the known profile of the medicine. Full results will be shared with regulatory authorities and the scientific community at an upcoming medical meeting. TEZSPIRE is currently approved for the treatment of severe asthma in the US, EU, Japan, and nearly 60 countries across the globe. 2-5 It is approved as a single-use pre-filled syringe and auto-injector for self-administration in the US and EU. 2,3 INDICATIONS AND LIMITATIONS OF USE / ISI TEZSPIRE ® (tezepelumab-ekko) INDICATION TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus. CONTRAINDICATIONS Known hypersensitivity to tezepelumab-ekko or excipients. WARNINGS AND PRECAUTIONS Hypersensitivity Reactions Hypersensitivity reactions were observed in the clinical trials (eg, rash and allergic conjunctivitis) following the administration of TEZSPIRE. Postmarketing cases of anaphylaxis have been reported. These reactions can occur within hours of administration, but in some instances have a delayed onset (ie, days). In the event of a hypersensitivity reaction, consider the benefits and risks for the individual patient to determine whether to continue or discontinue treatment with TEZSPIRE. Acute Asthma Symptoms or Deteriorating Disease TEZSPIRE should not be used to treat acute asthma symptoms, acute exacerbations, acute bronchospasm, or status asthmaticus. Abrupt Reduction of Corticosteroid Dosage Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with TEZSPIRE. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy. Parasitic (Helminth) Infection It is unknown if TEZSPIRE will influence a patient’s response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with TEZSPIRE. If patients become infected while receiving TEZSPIRE and do not respond to anti-helminth treatment, discontinue TEZSPIRE until infection resolves. Live Attenuated Vaccines The concomitant use of TEZSPIRE and live attenuated vaccines has not been evaluated. The use of live attenuated vaccines should be avoided in patients receiving TEZSPIRE. ADVERSE REACTIONS The most common adverse reactions (incidence ≥3%) are pharyngitis, arthralgia, and back pain. USE IN SPECIFIC POPULATIONS There are no available data on TEZSPIRE use in pregnant women to evaluate for any drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Placental transfer of monoclonal antibodies such as tezepelumab-ekko is greater during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy. Please see full Prescribing Information , including Patient Information and Instructions for Use . You may report side effects related to AstraZeneca products. Notes Chronic Rhinosinusitis with Nasal Polyps (CRSwNP (nasal polyps)) CRSwNP is a complex inflammatory disorder, characterized by persistent inflammation of the nasal mucosa accompanied by benign growths, called nasal polyps. 6,7 Nasal polyps can block nasal passages and lead to breathing problems, difficulty in sense of smell, nasal discharge, facial pain, sleep disturbance and other adverse effects on quality of life. 8-10 Epithelial dysfunction and inflammation are important characteristics of chronic rhinosinusitis and impede the ability of the epithelium to act as a physical and immunological barrier against the external environment. 11 Thymic stromal lymphopoietin (TSLP) is an epithelial cytokine that has been implicated in shared pathophysiological processes underlying severe asthma and CRSwNP. 10,12 Current treatments for CRSwNP include intranasal and/or systemic corticosteroids, surgery and biologics. 8,13-16 Phase III WAYPOINT trial WAYPOINT is a double-blind, multi-centre, randomized, placebo-controlled, parallel group trial designed to evaluate the efficacy and safety of tezepelumab in adults with severe CRSwNP. 1 Participants received tezepelumab or placebo, administered via subcutaneous injection. The trial also included a post-treatment follow-up period of 12-24 weeks for participants who completed the 52-week treatment period. 1 The co-primary endpoints of the trial, were change from baseline in total nasal polyp size, measured by the endoscopic total Nasal Polyp Score, and change from baseline in bi-weekly mean nasal congestion, measured by the participant reported Nasal Congestion Score evaluated as part of the daily Nasal Polyposis Symptom Diary. 1 Key secondary endpoints included loss of smell; improvement in disease specific health-related quality of life as measured by SinoNasal Outcome Test (SNOT-22) score; Lund-Mackay score; time to surgery decision and/or systemic corticosteroids for nasal polyposis; time to nasal polyposis surgery decision; time to systemic corticosteroids for nasal polyposis; Nasal Polyposis Symptom Diary total symptom score and, in the population with co-morbid asthma, pre-bronchodilator FEV1 at Week 52. TEZSPIRE TEZSPIRE (tezepelumab) is being developed by AstraZeneca in collaboration with Amgen as a first-in-class human monoclonal antibody that inhibits the action of TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and is critical in the initiation and persistence of allergic, eosinophilic and other types of airway inflammation associated with severe asthma, including airway hyperresponsiveness. 17,18 TEZSPIRE is approved in the US, EU, Japan and other countries for the treatment of severe asthma. 19-21 Amgen collaboration In 2020, Amgen and AstraZeneca updated a 2012 collaboration agreement for TEZSPIRE. Both companies will continue to share costs and profits equally after payment by AstraZeneca of a mid single-digit inventor royalty to Amgen. AstraZeneca continues to lead development and Amgen continues to lead manufacturing. All aspects of the collaboration are under the oversight of joint governing bodies. Under the amended agreement, Amgen and AstraZeneca will jointly commercialize TEZSPIRE in North America. Amgen will record product sales in the US, with AZ recording its share of US profits as Collaboration Revenue. Outside of the US, AstraZeneca will record product sales, with Amgen recording profit share as Other/Collaboration revenue. AstraZeneca in Respiratory & Immunology Respiratory & Immunology, part of AstraZeneca BioPharmaceuticals, is a key disease area and growth driver to the Company. AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases. The Company is committed to addressing the vast unmet needs of these chronic, often debilitating, diseases with a pipeline and portfolio of inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets. Our ambition is to deliver life-changing medicines that help eliminate COPD as a leading cause of death, eliminate asthma attacks and achieve clinical remission in immune-mediated diseases. AstraZeneca AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit www.astrazeneca-us.com and follow us on social media @AstraZeneca . References Clinicaltrials.gov. Efficacy and Safety of Tezepelumab in Participants With Severe Chronic Rhinosinusitis With Nasal Polyposis (WAYPOINT). Available at: https://clinicaltrials.gov/ct2/show/NCT04851964 . [Last accessed: November 2024]. Tezspire (tezepelumab) US prescribing information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761224s003lbl.pdf . [Last accessed: November 2024]. Tezspire (tezepelumab) Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/tezspire-epar-product-information_en.pdf . [Last accessed: November 2024]. AstraZeneca plc. Tezspire approved in Japan for the treatment of severe asthma. Available at: https://www.astrazeneca.com/media-centre/press-releases/2022/tezspire-approved-in-japan-for-severe-asthma.html [Last accessed: November 2024]. Data on File. AstraZeneca. 2024. REF-251231. Bachert C, et al . Phenotypes and Emerging Endotypes of Chronic Rhinosinusitis. J Allergy Clin Immunol Pract. 2016; 4 (4): 621-628. Del Toro E, Portela J. Nasal Polyps. [Updated 2023 Jul 31]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK560746/ [Last accessed: November 2024]. Stevens WW, et al . Chronic Rhinosinusitis with Nasal Polyps. J Allergy Clin Immunol Pract . 2016; 4 (4): 565-572. Abdalla S, et al . Prevalence of sinonasal outcome test (SNOT-22) symptoms in patients undergoing surgery for chronic rhinosinusitis in the England and Wales National prospective audit. Clin Otolaryngol . 2012; 37 (4): 276-282. Laidlaw TM, et al . Chronic Rhinosinusitis with nasal polyps and asthma. J Allergy Clin Immunol Pract 2021;9:1133–1141. Wynne M, et al . Contribution of epithelial cell dysfunction to the pathogenesis of chronic rhinosinusitis with nasal polyps. Am J Rhinol Allergy . 2019;33:782–790. Liao B, et al. Interaction of thymic stromal lymphopoietin, IL-33, and their receptors in epithelial cells in eosinophilic chronic rhinosinusitis with nasal polyps. Allergy . 2015;70:1169–1180. Xolair (omalizumab) Summary of Product Characteristics; Available at: https://www.ema.europa.eu/en/documents/product-information/xolair-epar-product-information_en.pdf [Last accessed November 2024]. Xolair (omalizumab) US prescribing information; Available at: https://www.gene.com/download/pdf/xolair_prescribing.pdf [Last accessed: November 2024]. Nucala (mepolizumab) US prescribing information; Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761122s006,125526s018lbl.pdf . [Last accessed November 2024]. Dupixent (dupilumab) US prescribing information; Available at: https://www.regeneron.com/downloads/dupixent_fpi.pdf . [Last accessed: November 2024]. Corren J , et al . Tezepelumab in adults with uncontrolled asthma . N Engl J Med . 2017;377:936-946. Varricchi G, et al . Thymic Stromal Lymphopoietin Isoforms, Inflammatory Disorders, and Cancer. Front Immunol . 2018;9:1595. AstraZeneca plc. Tezspire (tezepelumab) approved in the US for severe asthma. Available at: https://www.astrazeneca.com/media-centre/press-releases/2021/tezspire-tezepelumab-approved-in-the-us-for-severe-asthma.html . [Last accessed: November 2024]. AstraZeneca plc. Tezspire approved in the EU for the treatment of severe asthma. 2022. Available at: https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2022/tezspire-approved-in-the-eu-for-the-treatment-of-severe-asthma.html . [Last accessed: November 2024]. AstraZeneca plc. Tezspire approved in Japan for the treatment of severe asthma. Available at: https://www.astrazeneca.com/media-centre/press-releases/2022/tezspire-approved-in-japan-for-severe-asthma.html . [Last accessed: November 2024].

Clinical ResultPhase 3Drug ApprovalLicense out/in

08 Nov 2024

·www.prnewswire.com

TEZSPIRE MET BOTH CO-PRIMARY ENDPOINTS IN PHASE 3 TRIAL FOR CHRONIC RHINOSINUSITIS WITH NASAL POLYPS

Statistically Significant Reduction in Nasal Polyp Size, Nasal Congestion Compared to Placebo THOUSAND OAKS, Calif., Nov. 7, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and AstraZeneca today announced positive top-line results from the Phase 3 WAYPOINT trial in patients with chronic rhinosinusitis with nasal polyps (CRSwNP [nasal polyps]). The trial demonstrated patients treated with TEZSPIRE® (tezepelumab-ekko) had a statistically significant and clinically meaningful reduction in the size of nasal polyps and reduced nasal congestion compared to placebo. The safety profile and tolerability of TEZSPIRE in the trial were consistent with the known profile of the medicine. WAYPOINT was a randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of TEZSPIRE administered subcutaneously in adults with severe CRSwNP. Participants in the trial were symptomatic despite treatment with standard of care, intranasal corticosteroids (INCS).1 CRSwNP is a complex inflammatory condition characterized by persistent inflammation of the nasal mucosa accompanied by soft tissue growths, called nasal polyps, and is most commonly treated with INCS and surgery, if required.2,3 "Chronic rhinosinusitis with nasal polyps negatively impact patients' daily lives with the obstructions leading to disturbances in smell, taste and sleep, as well as pain and fatigue," said Dr. Joseph Han, vice chair of Rhinology & Endoscopic Sinus and Skull Base Surgery, and Allergy, Otolaryngology-Head and Neck Surgery, Eastern Virginia Medical School, US, and co-primary investigator in the trial. "The impressive data from the WAYPOINT trial demonstrate tezepelumab's potential as a new treatment for patients whose lives are disrupted by this debilitating disease." "The top-line results from our Phase 3 WAYPOINT study represent a significant step forward in our commitment to enhancing the lives of those affected by chronic rhinosinusitis with nasal polyps," said Jay Bradner, M.D., executive vice president of Research and Development and chief scientific officer at Amgen. "The data highlight tezepelumab's unique capacity to target multiple inflammatory pathways by acting directly at the epithelium, resulting in meaningful symptom relief that can improve patients' daily experiences." "Patients diagnosed with nasal polyps continue to experience significant burden including repeat surgeries and frequent treatment with high doses of oral corticosteroids, which are associated with serious systemic side effects," said Dr. Brian Lipworth, Professor of Allergy and Pulmonology, Scottish Centre for Respiratory Research, and Tayside Rhinology Ear, Nose and Throat Clinic, Ninewells Hospital University of Dundee in Scotland, UK, and co-primary investigator in the trial. "The tezepelumab data are clinically meaningful and offer patients with nasal polyps hope for a potential new treatment option that may reduce the burden on patients and healthcare systems." The full results will be shared with regulatory authorities and the scientific community at an upcoming medical meeting. About the Phase 3 WAYPOINT Trial WAYPOINT is a double-blind, multi-center, randomized, placebo-controlled, parallel group trial designed to evaluate the efficacy and safety of tezepelumab in adults with severe CRSwNP.1 Participants received tezepelumab or placebo, administered via subcutaneous injection. The trial also included a post-treatment follow-up period of 12-24 weeks for participants who completed the 52-week treatment period.1 The co-primary endpoints of the trial were change from baseline in total nasal polyp size, measured by the endoscopic total Nasal Polyp Score, and change from baseline in bi-weekly mean nasal congestion, measured by the participant-reported Nasal Congestion Score evaluated as part of the daily Nasal Polyposis Symptom Diary.1 Key secondary endpoints included loss of smell; improvement in disease-specific health-related quality of life as measured by SinoNasal Outcome Test (SNOT-22) score; Lund-Mackay score; time to surgery decision and/or systemic corticosteroids for nasal polyposis; time to nasal polyposis surgery decision; time to systemic corticosteroids for nasal polyposis; Nasal Polyposis Symptom Diary total symptom score and pre-bronchodilator FEV1 in patients with comorbid asthma and aspirin-exacerbated respiratory disease/NSAID-exacerbated respiratory disease (NSAID-ERD) at Week 52.1 About Chronic Rhinosinusitis with Nasal Polyps (C RSwNP [nasal polyps]) CRSwNP is a complex inflammatory disorder characterized by persistent inflammation of the nasal mucosa accompanied by benign growths, called nasal polyps.2,3 Nasal polyps can block nasal passages and lead to breathing problems, difficulty in sense of smell, nasal discharge, facial pain, sleep disturbance and other adverse effects on quality of life.4-6 Epithelial dysfunction and inflammation are important characteristics of chronic rhinosinusitis and impede the ability of the epithelium to act as a physical and immunological barrier against the external environment.7 Estimates suggest that up to 56% of patients with CRSwNP have comorbid asthma. Thymic stromal lymphopoietin (TSLP) is an epithelial cytokine that has been implicated in shared pathophysiological processes underlying severe asthma and CRSwNP.6,8 Current treatments for CRSwNP include intranasal and/or systemic corticosteroids, surgery and biologic medication.4,9-12 About TEZSPIRE® (tezepelumab-ekko) TEZSPIRE is a first-in-class human monoclonal antibody that works on the primary source of inflammation: the airway epithelium, which is the first point of contact for viruses, allergens, pollutants and other environmental insults. Specifically, TEZSPIRE targets and blocks TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and initiates an overreactive immune response to allergic, eosinophilic and other types of airway inflammation associated with severe asthma.13,14 TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles. Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity.6,16 Blocking TSLP may prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of asthma exacerbations and improved asthma control.14-16 By working at the top of the cascade, TEZSPIRE helps stop inflammation at the source and has the potential to treat a broad population of severe asthma patients.16-18 TEZSPIRE is currently approved for the treatment of severe asthma in the US, EU, Japan, and more than 50 countries across the globe.19-22 It is approved as a pre-filled, single-use pen and auto-injector for self-administration in the US and EU.19,20 Beyond severe asthma and CRSwNP, TEZSPIRE is also in development for other potential indications including chronic obstructive pulmonary disease (COPD) and eosinophilic esophagitis (EoE).23, 24 In October 2021, tezepelumab was granted Orphan Drug Designation by the FDA for the treatment of EoE. In July 2024, the U.S. FDA granted a Breakthrough Therapy Designation for tezepelumab for the add-on maintenance treatment of patients with moderate to very severe COPD characterised by an eosinophilic phenotype. About the Amgen and AstraZeneca Collaboration In 2020, Amgen and AstraZeneca updated the 2012 collaboration agreement for TEZSPIRE. Both companies will continue to share costs and profits equally after payment by AstraZeneca of a mid-single-digit royalty to Amgen. AstraZeneca continues to lead development and Amgen continues to lead manufacturing. All aspects of the collaboration are under the oversight of joint governing bodies. Under the amended agreement, Amgen and AstraZeneca will jointly commercialize TEZSPIRE in North America. Amgen will record product sales in the U.S., with AstraZeneca recording its share of U.S. profits as Collaboration Revenue. Outside of the U.S., AstraZeneca will record product sales, with Amgen recording profit share as Other/Collaboration revenue. TEZSPIRE® (tezepelumab-ekko) U.S. Indication TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus. TEZSPIRE® (tezepelumab-ekko) Important Safety Information CONTRAINDICATIONS Known hypersensitivity to tezepelumab-ekko or excipients. WARNINGS AND PRECAUTIONS Hypersensitivity Reactions Hypersensitivity reactions were observed in the clinical trials (e.g., rash and allergic conjunctivitis) following the administration of TEZSPIRE. Postmarketing cases of anaphylaxis have been reported. These reactions can occur within hours of administration, but in some instances have a delayed onset (i.e., days). In the event of a hypersensitivity reaction, consider the benefits and risks for the individual patient to determine whether to continue or discontinue treatment with TEZSPIRE. Acute Asthma Symptoms or Deteriorating Disease TEZSPIRE should not be used to treat acute asthma symptoms, acute exacerbations, acute bronchospasm, or status asthmaticus. Abrupt Reduction of Corticosteroid Dosage Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with TEZSPIRE. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy. Parasitic (Helminth) Infection It is unknown if TEZSPIRE will influence a patient's response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with TEZSPIRE. If patients become infected while receiving TEZSPIRE and do not respond to anti-helminth treatment, discontinue TEZSPIRE until infection resolves. Live Attenuated Vaccines The concomitant use of TEZSPIRE and live attenuated vaccines has not been evaluated. The use of live attenuated vaccines should be avoided in patients receiving TEZSPIRE. ADVERSE REACTIONS The most common adverse reactions (incidence ≥3%) are pharyngitis, arthralgia, and back pain. USE IN SPECIFIC POPULATIONS There are no available data on TEZSPIRE use in pregnant women to evaluate for any drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Placental transfer of monoclonal antibodies such as tezepelumab-ekko is greater during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy. Please see the full Prescribing Information including Patient Information and Instructions for Use . You may report side effects related to AstraZeneca products by clicking here. About Amgen Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases. In 2024, Amgen was named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes, among other external recognitions. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average®, and it is also part of the Nasdaq-100 Index®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization. For more information, visit Amgen.com and follow Amgen on X, LinkedIn, Instagram, TikTok, YouTube and Threads. Amgen Forward-Looking Statements This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), Amgen's acquisitions of Teneobio, Inc., ChemoCentryx, Inc., or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon's business, performance and opportunities, any potential strategic benefits, synergies or opportunities expected as a result of such acquisition, and any projected impacts from the Horizon acquisition on Amgen's acquisition-related expenses going forward), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on Amgen's business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including its most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise. No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with its products, including its devices, after they are on the market. Amgen's results may be affected by its ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing its products and global economic conditions. In addition, sales of Amgen's products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, Amgen's research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Amgen's business may be impacted by government investigations, litigation and product liability claims. In addition, Amgen's business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If Amgen fails to meet the compliance obligations in the corporate integrity agreement between Amgen and the U.S. government, Amgen could become subject to significant sanctions. Further, while Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors, or Amgen may fail to prevail in present and future intellectual property litigation. Amgen performs a substantial amount of its commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depends on third parties for a portion of its manufacturing activities, and limits on supply may constrain sales of certain of its current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for Amgen's manufacturing activities, the distribution of Amgen's products, the commercialization of Amgen's product candidates, and Amgen's clinical trial operations, and any such events may have a material adverse effect on Amgen's product development, product sales, business and results of operations. Amgen relies on collaborations with third parties for the development of some of its product candidates and for the commercialization and sales of some of its commercial products. In addition, Amgen competes with other companies with respect to many of its marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for Amgen's products are supplied by sole third-party suppliers. Certain of Amgen's distributors, customers and payers have substantial purchasing leverage in their dealings with Amgen. The discovery of significant problems with a product similar to one of Amgen's products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on its business and results of operations. Amgen's efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology Amgen has acquired, may not be successful. There can be no guarantee that Amgen will be able to realize any of the strategic benefits, synergies or opportunities arising from the Horizon acquisition, and such benefits, synergies or opportunities may take longer to realize than expected. Amgen may not be able to successfully integrate Horizon, and such integration may take longer, be more difficult or cost more than expected. A breakdown, cyberattack or information security breach of Amgen's information technology systems could compromise the confidentiality, integrity and availability of Amgen's systems and Amgen's data. Amgen's stock price may be volatile and may be affected by a number of events. Amgen's business and operations may be negatively affected by the failure, or perceived failure, of achieving its environmental, social and governance objectives. The effects of global climate change and related natural disasters could negatively affect Amgen's business and operations. Global economic conditions may magnify certain risks that affect Amgen's business. Amgen's business performance could affect or limit the ability of the Amgen Board of Directors to declare a dividend or its ability to pay a dividend or repurchase its common stock. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all. Any scientific information discussed in this news release relating to new indications for Amgen's products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. CONTACT: Amgen, Thousand Oaks Kate Meyer, 872-867-0754 (media) Elissa Snook, 609-251-1407 (media) Justin Claeys, 805-313-9775 (investors) References: Clinicaltrials.gov. Efficacy and Safety of Tezepelumab in Participants With Severe Chronic Rhinosinusitis With Nasal Polyposis (WAYPOINT). Available at: . [Last accessed: November 2024]. Bachert C, et al. Phenotypes and Emerging Endotypes of Chronic Rhinosinusitis. J Allergy Clin Immunol Pract. 2016; 4 (4): 621-628. Del Toro E, Portela J. Nasal Polyps. [Updated 2023 Jul 31]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: [Last accessed: November 2024]. Stevens WW, et al. Chronic Rhinosinusitis with Nasal Polyps. J Allergy Clin Immunol Pract. 2016; 4 (4): 565-572.  Abdalla S, et al. Prevalence of sinonasal outcome test (SNOT-22) symptoms in patients undergoing surgery for chronic rhinosinusitis in the England and Wales National prospective audit. Clin Otolaryngol. 2012; 37 (4): 276-282.  Laidlaw TM, et al. Chronic Rhinosinusitis with nasal polyps and asthma.  J Allergy Clin Immunol Pract 2021;9:1133–1141. Wynne M, et al. Contribution of epithelial cell dysfunction to the pathogenesis of chronic rhinosinusitis with nasal polyps. Am J Rhinol Allergy. 2019;33:782–790. Liao B, et al. Interaction of thymic stromal lymphopoietin, IL-33, and their receptors in epithelial cells in eosinophilic chronic rhinosinusitis with nasal polyps. Allergy. 2015;70:1169–1180. Xolair (omalizumab) Summary of Product Characteristics; Available at: [Last accessed November 2024]. Xolair (omalizumab) US prescribing information; Available at: [Last accessed: November 2024]. Nucala (mepolizumab) US prescribing information; Available at: . [Last accessed November 2024]. Dupixent (dupilumab) US prescribing information; Available at: . [Last accessed: November 2024]. Menzies-Gow A, et al. Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma. N Engl J Med. 2021;384:1800-1809. DOI: 10.1056/NEJMoa2034975. Varricchi G, et al. Thymic Stromal Lymphopoietin Isoforms, Inflammatory Disorders, and Cancer. Front Immunol. 2018; 9: 1595. Li Y, et al. Elevated Expression of IL-33 and TSLP in the Airways of Human Asthmatics In Vivo: A Potential Biomarker of Severe Refractory Disease. J Immunol. 2018; 200: 2253–2262. Corren J, et al. Tezepelumab in adults with uncontrolled asthma . N Engl J Med. 2017;377:936-946. Menzies-Gow A, et al. Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma. N Engl J Med. 2021;384:1800-1809. Laidlaw TM et al. Tezepelumab Efficacy in Patients with Severe, Uncontrolled Asthma with Comorbid Nasal Polyps in NAVIGATOR. J Asthma Allergy. 2023 Sep 4:16:915-932. Tezspire (tezepelumab) US prescribing information. Available at: . [Last accessed: November 2024]. Tezspire (tezepelumab) Summary of Product Characteristics. Available at: . [Last accessed: November 2024]. AstraZeneca plc. Tezspire approved in Japan for the treatment of severe asthma. Available at: [Last accessed: November 2024]. Data on File. AstraZeneca. 2024. REF-251231. Clinicaltrials.gov. Tezepelumab COPD Exacerbation Study (COURSE) [Online]. Available at: . [Last accessed: November 2024]. Clinicaltrials.gov. Efficacy and Safety of Tezepelumab in Patients with Eosinophilic Esophagitis (CROSSING). Available at: . [Last accessed: November 2024]. SOURCE Amgen WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3Drug ApprovalLicense out/inOrphan Drug

100 Deals associated with Mepolizumab

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KEGG	Wiki	ATC	Drug Bank
D04923	Mepolizumab	R03DX09	DB06612

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Granulomatosis With Polyangiitis	CN	GlaxoSmithKline Trading Services Ltd.	19 Nov 2021
Eosinophilic Granuloma	JP	GlaxoSmithKline KK	25 Mar 2020
Eosinophilic Asthma	KR	GSK Plc	01 Apr 2016
Chronic rhinosinusitis with nasal polyps	EU	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Chronic rhinosinusitis with nasal polyps	IS	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Chronic rhinosinusitis with nasal polyps	LI	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Chronic rhinosinusitis with nasal polyps	NO	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Churg-Strauss Syndrome	EU	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Churg-Strauss Syndrome	IS	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Churg-Strauss Syndrome	LI	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Churg-Strauss Syndrome	NO	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Hypereosinophilic Syndrome	EU	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Hypereosinophilic Syndrome	IS	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Hypereosinophilic Syndrome	LI	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Hypereosinophilic Syndrome	NO	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Pulmonary Eosinophilia	EU	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Pulmonary Eosinophilia	IS	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Pulmonary Eosinophilia	LI	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Pulmonary Eosinophilia	NO	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Asthma	US	GlaxoSmithKline LLC	04 Nov 2015

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Eosinophilia	Phase 3	GB	GSK Plc	07 Sep 2020
Eosinophilic Esophagitis	Phase 3	CN	GSK Plc	29 Aug 2018
Severe asthma	Phase 3	CN	GlaxoSmithKline Trading Services Ltd.	29 Aug 2018
Severe asthma	Phase 3	CN	GlaxoSmithKline (China) Investment Co., Ltd.	29 Aug 2018
Nasal Polyps	Phase 3	US	GSK Plc	25 May 2017
Nasal Polyps	Phase 3	AR	GSK Plc	25 May 2017
Nasal Polyps	Phase 3	AU	GSK Plc	25 May 2017
Nasal Polyps	Phase 3	CA	GSK Plc	25 May 2017
Nasal Polyps	Phase 3	DE	GSK Plc	25 May 2017
Nasal Polyps	Phase 3	NL	GSK Plc	25 May 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00244686 (Pubmed) Manual	Phase 3	Severe asthma	514	Mepolizumab 100 mg SC (Adults/adolescents (≥12 years of age))	xrmiumkinh(gnhveldfjx) = gacqtfjbai ddmxyttqrf (btbquboobp )	Positive	28 Oct 2024
				Mepolizumab 40 mg or 100 mg SC (bodyweight <40 or ≥40 kg, respectively) (Pediatric patients (6-11 years of age))	-
NCT04133909 (MATINEE, NEWS) Manual	Phase 3	Pulmonary Disease, Chronic Obstructive	-	Nucala	gnvhadayrh(jspybhvaol) = The trial met its primary endpoint. bedauupqoq (costhckngg ) Met View more	Positive	06 Sep 2024
				Placebo
EULAR2024 Manual	Not Applicable	Eosinophilic Granuloma interleukin 5 (IL-5) \| IL-5α receptor	67	Mepolizumab 300 mg	zarbbcpyms(hjfvejkjyx) = wgzbqctbuv kxpugdimed (vvvttcyxhg ) View more	Positive	05 Jun 2024
				Mepolizumab 100 mg	zarbbcpyms(hjfvejkjyx) = ofsegblxuk kxpugdimed (vvvttcyxhg ) View more
EULAR2024 Manual	Not Applicable	Churg-Strauss Syndrome Maintenance \| Induction IL-5	48	Mepolizumab (maintenance phase for relapsing and refractory EGPA)	wlfuixiyte(jsbuoxwljr) = ivjbjtychr yarzamwjft (tcgvmdeuga ) View more	Positive	05 Jun 2024
				Mepolizumab (in the remission induction phase for severe EGPA)	wlfuixiyte(jsbuoxwljr) = cscihpsmdt yarzamwjft (tcgvmdeuga ) View more
EULAR2024	Not Applicable	Churg-Strauss Syndrome	-	Mepolizumab 300mg	nmaenvgpns(vhnzqhfqqg) = A total of 118 patients were enrolled, 91% completed the study and 9% discontinued treatment. Of these, 55% were female, the mean (standard deviation [SD]) age was 62 (13.2) years and the mean (SD) time since diagnosis was 5.6 (4.4) years. Over 99% of patients had comorbidities at baseline (28% osteoporosis; 22% hypertension; 15% hyperlipidemia). Most patients (97%) used 300mg mepolizumab with a mean (SD) duration of 4.2 (0.68) years during the treatment period; 2 patients who continued from the MIRRA trial (NCT04551989) used mepolizumab for ≤7.4 years. AEs were reported in 69 patients (58%) and SAEs were reported in 26 patients (22%) over the observation period, infections were the most commonly reported (AEs: 36 patients [31%]; SAEs: 8 patients [7%]). There were no drug-related AEs. iarxugeumv (ruovloexmx )	-	05 Jun 2024
EULAR2024	Not Applicable	Churg-Strauss Syndrome Maintenance MPO-ANCA-associated vasculitis (MPO-AAV)	25	MEPOLIZUMAB (Early administration group)	wqjkupuykf(hudfvjzccg) = 0 in both groups pkouvfabuf (ulfsvhenet ) View more	Positive	05 Jun 2024
				MEPOLIZUMAB (During maintenance group)
NCT03298061 (LAP/MEA116841, ATS2024) Manual	Phase 3	Granulomatosis With Polyangiitis	100	Mepolizumab	cqkdljydao(gkdfatgmuy) = vccksuoiah wzouaskrsi (ruiunwzgza )	Positive	19 May 2024
EHA2024	Not Applicable	Hypereosinophilic Syndrome Second line PDGFRΑ-negative	3	Mepolizumab	ovppbeszei(oaadfjpdxr) = pdpvlfrcrk auhpixbdca (iyslkmbyig )	Positive	14 May 2024
NCT03298061 (MEA116841 \| LAP/MEA116841, CTgov)	Phase 3	Churg-Strauss Syndrome	100	Mepolizumab	reylktvbhn(zhjzqkkagc) = hgbpytvzgw sjauwufuhb (jbuklagbpa, hmekreojco - hiiuqycwkj) View more	-	12 Mar 2024
Pubmed \| J Allergy Clin Immunol	Not Applicable	IL-5-driven eosinophilia	5	Mepolizumab 700 mg intravenously monthly for 3 months	zkhgmbixmf(oxyjuxwcby) = psxtjfejme hlijhwrdbi (nbjulchoax )	Negative	01 Mar 2024
				Mepolizumab 300 mg subcutaneously monthly	zkhgmbixmf(oxyjuxwcby) = mfapaddsoh hlijhwrdbi (nbjulchoax )

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