Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen 
Welcome,         Profile    Billing    Logout  
 11 Diseases   24 Trials   24 Trials   1081 News 


«12...234567891011121314»
  • ||||||||||  Xolair (omalizumab) / Roche, Novartis
    Journal:  Targeted Molecular Therapies in Allergy and Rhinology. (Pubmed Central) -  Jun 26, 2021   
    Biologic agents are now available for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP), asthma, eosinophilic granulomatosis with polyangiitis (EGPA), atopic dermatitis (AD), and chronic spontaneous urticaria (CSU). This paper summarizes the diagnosis and management of these conditions and critically reviews the clinical trial data that has led to regulatory approval of biologic agents for these conditions.
  • ||||||||||  Dupixent (dupilumab) / Sanofi, Regeneron, tezepelumab (AMG 157) / AstraZeneca, Amgen
    Journal:  Severe asthma: what is new in the new millennium. (Pubmed Central) -  Jun 16, 2021   
    Novel anti-IL5 agents have changed the management of T2-high asthma resulting in improved disease control, QoL and lung function and importantly, fewer exacerbations. Nevertheless, there is still the need to find new treatments, particularly for T2-low asthma, which remains a challenge.
  • ||||||||||  Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
    Trial completion:  Effects of Anti-TSLP in Patients With Asthma (clinicaltrials.gov) -  Jun 2, 2021   
    P2,  N=40, Completed, 
    Nevertheless, there is still the need to find new treatments, particularly for T2-low asthma, which remains a challenge. Recruiting --> Completed
  • ||||||||||  tezepelumab (AMG 157) / AstraZeneca, Amgen
    Clinical, Review, Journal:  Tezepelumab: A Potential New Biological Therapy for Severe Refractory Asthma. (Pubmed Central) -  May 29, 2021   
    Tezepelumab is a fully human monoclonal antibody that binds to TSLP, thereby preventing its interaction with the TSLP receptor complex. Preliminary results of randomized clinical trials suggest that tezepelumab is characterized by a good safety and efficacy profile in patients with severe, uncontrolled asthma.
  • ||||||||||  Journal:  Biologics for Treatment of Atopic Dermatitis: Current Status and Future Prospect. (Pubmed Central) -  May 25, 2021   
    Dupilumab is the only biologic therapy that is Food and Drug Administration approved for the treatment of moderate-to-severe AD in patients 6 years and older, with consistent long-term efficacy and safety trial data. In this article, we review the mechanisms, safety, and efficacy of dupilumab from recent clinical trials, and we review the current data, mechanism of action, clinical efficacy, and limitations of new biologics currently in phase 2 and 3 clinical trials (lebrikizumab, tralokinumab, nemolizumab, tezepelumab, and ISB 830).
  • ||||||||||  Xolair (omalizumab) / Roche, Novartis
    Journal:  Biologics for the Use in Chronic Spontaneous Urticaria: When and Which. (Pubmed Central) -  May 25, 2021   
    Guidelines for the treatment of chronic spontaneous urticaria (CSU) recommend the use of the IgE-targeted biologic omalizumab in patients with antihistamine-refractory disease...We provide information on the effects of the off-label use, in CSU, of biologics licensed for the treatment of other diseases, including dupilumab, benralizumab, mepolizumab, reslizumab, and secukinumab...These include IgE/ligelizumab, IgE/GI-310, thymic stromal lymphopoietin/tezepelumab, C5a receptor/avdoralimab, sialic acid-binding Ig-like lectin 8/lirentelimab, CD200R/LY3454738, and KIT/CDX-0159. Our aim is to provide updated information and guidance on the use of biologics in the treatment of patients with CSU, now and in the near future.
  • ||||||||||  tezepelumab (AMG 157) / AstraZeneca, Amgen
    Clinical, Journal:  Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma. (Pubmed Central) -  May 13, 2021   
    P3
    Patients with severe, uncontrolled asthma who received tezepelumab had fewer exacerbations and better lung function, asthma control, and health-related quality of life than those who received placebo. (Funded by AstraZeneca and Amgen; NAVIGATOR ClinicalTrials.gov number, NCT03347279.).
  • ||||||||||  A COMPUTATIONAL MODEL TO INVESTIGATE DRUG TARGETS IN AD PATIENTS WITH HETEROGENOUS RESPONSE TO BIOLOGIC DRUGS () -  Apr 23, 2021 - Abstract #ISAD2021ISAD_148;    
    The mathematical model will serve as a computational platform for model-informed drug development for precision medicine, as it allows us to evaluate the validity of potential drug targets, including combinations of multiple targets, in stratified patients as well as the influence of pathophysiological backgrounds of patients on variability in drug response. Similar mathematical models can be developed for other diseases and drugs by conducting model-based meta-analysis on reported clinical efficacies of multiple drugs.
  • ||||||||||  Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
    Enrollment open:  INCEPTION: Study to Evaluate Tezepelumab in Adults With Chronic Spontaneous Urticaria (clinicaltrials.gov) -  Apr 23, 2021   
    P2b,  N=270, Recruiting, 
    Similar mathematical models can be developed for other diseases and drugs by conducting model-based meta-analysis on reported clinical efficacies of multiple drugs. Not yet recruiting --> Recruiting
  • ||||||||||  Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
    Trial completion date, Trial primary completion date:  DIRECTION: Study to Evaluate Tezepelumab in Adults With Severe Uncontrolled Asthma (clinicaltrials.gov) -  Apr 22, 2021   
    P3,  N=396, Recruiting, 
    Not yet recruiting --> Recruiting Trial completion date: Dec 2023 --> May 2025 | Trial primary completion date: Dec 2023 --> May 2025
  • ||||||||||  tezepelumab (AMG 157) / AstraZeneca, Amgen, Xolair (omalizumab) / Roche, Novartis
    The effect of tezepelumab in patients with allergic and non-allergic asthma: results from the NAVIGATOR phase 3 study (Hall S3A / Channel 3) -  Apr 20, 2021 - Abstract #EAACI2021EAACI_1074;    
    P3
    Conclusion Tezepelumab reduced exacerbations versus placebo in adults and adolescents with allergic and non-allergic asthma, further supporting its potential benefits in a broad population of patients with severe, uncontrolled asthma. The reduction in AAER with tezepelumab in OMA-eligible patients appears to compare favourably with that reported with OMA in randomized, placebo-controlled studies of patients with severe asthma.
  • ||||||||||  tezepelumab (AMG 157) / AstraZeneca, Amgen
    Efficacy of tezepelumab in patients with perennial allergic asthma: results from the NAVIGATOR phase 3 study () -  Apr 20, 2021 - Abstract #EAACI2021EAACI_296;    
    P3
    Tezepelumab reduced the AAER over 52 weeks versus placebo by 60% (95% confidence interval [CI]: 4371) and 54% (95% CI: 4263) in patients with and without perennial allergic asthma, respectively (Figure) . Conclusion Tezepelumab reduced exacerbations versus placebo in adults and adolescents with severe, uncontrolled asthma, irrespective of allergic status, further supporting its potential benefits in a broad population of patients.
  • ||||||||||  Eucrisa (crisaborole) / Pfizer
    OVERVIEW OF NEW THERAPIES IN AD () -  Mar 31, 2021 - Abstract #ISAD2021ISAD_40;    
    Licensed systemic antihistamines (H1R-blockers) only have limited effects on AD related itch and eczema lesions, whereas only little data on the novel H4R-blockers is available. Combining the new therapies with existing adjuvant therapy including UV irradiation and topical anti-inflammatory treatment, as well as therapeutic patient education is an essential aspect of the art of dermatology.
  • ||||||||||  Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
    Enrollment open:  TRAILHEAD: Study to Evaluate the Pharmacokinetics of Tezepelumab in Children With Asthma (clinicaltrials.gov) -  Mar 16, 2021   
    P1,  N=14, Recruiting, 
    Combining the new therapies with existing adjuvant therapy including UV irradiation and topical anti-inflammatory treatment, as well as therapeutic patient education is an essential aspect of the art of dermatology. Not yet recruiting --> Recruiting
  • ||||||||||  tezepelumab (AMG 157) / AstraZeneca, Amgen
    [VIRTUAL] Reductions in Inflammatory Biomarkers in Patients with Oral Corticosteroid-Dependent Asthma Treated with Tezepelumab () -  Mar 14, 2021 - Abstract #ATS2021ATS_2292;    
    P3
    CONCLUSIONS Treatment with tezepelumab reduced blood eosinophil counts, FeNO and serum total IgE compared with placebo in patients with OCS-dependent asthma, despite reductions in maintenance OCS dose. Reductions in these biomarkers were consistent with observations made in other clinical studies of tezepelumab and demonstrate that tezepelumab may have an effect on multiple inflammatory pathways.
  • ||||||||||  tezepelumab (AMG 157) / AstraZeneca, Amgen
    Clinical, Journal:  Tezepelumab improves patient-reported outcomes in patients with severe, uncontrolled asthma in PATHWAY. (Pubmed Central) -  Feb 13, 2021   
    P2
    Tezepelumab treatment improved PROs vs placebo, as indicated by the higher proportion of ACQ-6 and AQLQ(S)+12 responders and improvements in symptom severity in the tezepelumab dose groups. These data further support the benefits of tezepelumab in patients with severe, uncontrolled asthma.
  • ||||||||||  Journal:  Novel Therapeutic Approaches and Targets for Treatment of Atopic Dermatitis. (Pubmed Central) -  Feb 9, 2021   
    The extreme clinical heterogeneity and the chronic progression of Atopic Dermatitis need for newer, safer and more effective treatments, able to control the disease and to improve the quality of life of affected patients. Dupilumab, and the other monoclonal antibodies and small molecules currently under investigation aim to improve the clinical management of Atopic Dermatitis.
  • ||||||||||  tezepelumab (AMG 157) / AstraZeneca, Amgen, Xolair (omalizumab) / Roche, Novartis
    [VIRTUAL] Tezepelumab Efficacy in Patients with Allergic and Non-Allergic Asthma: A Post Hoc Analysis of the PATHWAY Phase 2b Study () -  Feb 3, 2021 - Abstract #AAAAI2021AAAAI_1180;    
    P2
    For pooled tezepelumab doses, AAER was reduced by 65% (95% CI: 28-83) and 69% (95% CI: 51-81), respectively . Tezepelumab improved FEV1 in both eligibility subgroups.  Conclusions Tezepelumab reduced exacerbations and improved FEV1 versus placebo in patients with allergic and non-allergic asthma, supporting its potential benefits in a broad population of patients with severe asthma.
  • ||||||||||  tezepelumab (AMG 157) / AstraZeneca, Amgen
    [VIRTUAL] Treatment with Tezepelumab Reduces Serum Interleukin (IL)-5 and IL-13 in Patients with Severe, Uncontrolled Asthma to Levels Approaching those Observed in Healthy Individuals () -  Feb 3, 2021 - Abstract #AAAAI2021AAAAI_1069;    
    P2
    Baseline IL-13 levels were 0.06 (±0.09) and 0.06 (±0.08) in the tezepelumab 210mg (n=89) and placebo (n=101) groups, respectively, versus 0.02 (±0.02) in healthy individuals. At week 52, serum levels of IL-5 and IL-13 in placebo patients were similar to baseline levels (IL-5, 1.03 [±1.06], n=120; IL-13, 0.06 [±0.10], n=93), whereas levels in the tezepelumab 210mg group were nominally significantly reduced (IL-5, 0.45 [±0.58], n=112; IL-13, 0.03 [±0.03], n=80; p<0.0001) and approached those observed in healthy individuals.  Conclusions In patients with severe, uncontrolled asthma, tezepelumab reduced serum IL-5 and IL-13 to levels approaching those observed in healthy individuals.
  • ||||||||||  Erbitux (cetuximab) / Eli Lilly, EMD Serono
    Journal:  Antibodies to watch in 2021. (Pubmed Central) -  Jan 28, 2021   
    Despite the pandemic, 10 antibody therapeutics had been granted the first approval in the US or EU in 2020, as of November, and 2 more (tanezumab and margetuximab) may be granted approvals in December 2020.* In addition, prolgolimab and olokizumab had been granted first approvals in Russia and cetuximab saratolacan sodium was first approved in Japan...Based on the information publicly available as of November 2020, 44 antibody therapeutics are in late-stage clinical studies for non-cancer indications, including 6 for COVID-19, and marketing applications for at least 6 (leronlimab, tezepelumab, faricimab, ligelizumab, garetosmab, and fasinumab) are planned in 2021...Of these 44, marketing application submissions for 13 may be submitted by the end of 2021. *Note added in proof on key events announced during December 1-21, 2020: margetuximab-cmkb and ansuvimab-zykl were approved by FDA on December 16 and 21, 2020, respectively; biologics license applications were submitted for ublituximab and amivantamab.
  • ||||||||||  tezepelumab (AMG 157) / AstraZeneca, Amgen
    [VIRTUAL] EFFICACY OF TEZEPELUMAB IN PATIENTS WITH LOW AND HIGH BRONCHODILATOR REVERSIBILITY IN PATHWAY () -  Jan 23, 2021 - Abstract #BTSWM2021BTS_WM_196;    
    P2
    Exacerbations resulting in hospitalizations or ER visits were reduced by 85% (95% CI: 21, 97) and 78% (95% CI: >= 32, 96) versus placebo in patients with low and high FEV1 reversibility, respectively, for tezepelumab 210 mg, and by 84% (95% CI: 51, 94) and 64% (95% CI: >= 18, 89) in the pooled tezepelumab group, respectively. Conclusions Tezepelumab treatment reduced AAER irrespective of baseline bronchodilator reversibility, further supporting its potential benefits in a broad population of patients with severe asthma.