- |||||||||| tezepelumab (AMG 157) / AstraZeneca, Amgen
[VIRTUAL] EFFECT OF TEZEPELUMAB ON EXACERBATIONS IN PATIENTS WITH SEVERE, UNCONTROLLED ASTHMA, ACCORDING TO BASELINE BODY MASS INDEX: RESULTS FROM THE PHASE 2B PATHWAY STUDY () - Jan 23, 2021 - Abstract #BTSWM2021BTS_WM_195; P2 In the 210 mg Q4W dose group, AAER was reduced by 83% (95% CI: 49–94) (n=39), 62% (95% CI: 4– 85) (n=45) and 68% (95% CI: 13–89) (n=53), respectively, versus placebo. Conclusions Tezepelumab reduced exacerbations in patients with severe, uncontrolled asthma irrespective of baseline BMI, providing further evidence that tezepelumab can meaningfully reduce exacerbations in a broad population of patients with severe asthma.
- |||||||||| Clinical, Journal: Efficacy of biologics in atopic dermatitis. (Pubmed Central) - Dec 23, 2020
Recent advancements in understanding AD pathogenesis resulted in the exponential expansion of its therapeutic pipeline, particularly following the success and FDA-approval of dupilumab...Nevertheless, this biologic does not work for everyone, highlighting the need for a more precise approach to address the unique immune fingerprints of each AD subset. Ultimately targeted therapeutics will complement our understanding of the AD molecular map and help push AD management into an era of personalized medicine.
- |||||||||| tezepelumab (AMG 157) / AstraZeneca, Amgen
Review, Journal: Anti-TSLP antibodies: Targeting a master regulator of type 2 immune responses. (Pubmed Central) - Dec 18, 2020 Tezepelumab (AMG-157/MEDI9929) is a human anti-TSLP antibody that prevents TSLP-TSLPR interactions...A blockade of the TSLP-TSLPR pathway likely will exert significant clinical effects on AD, asthma, and other allergic diseases. The efficacy of anti-TSLP antibodies compared to other biologics needs to be further examined.
- |||||||||| CSJ117 / Novartis, tezepelumab (AMG 157) / AstraZeneca, Amgen
Journal: TSLP Inhibitors for Asthma: Current Status and Future Prospects. (Pubmed Central) - Dec 17, 2020 Since new information suggests that targeting TSLP may be more likely to improve day-to-day asthma symptoms, in contrast to targeting mediators of the adaptive immune system, approaches that primarily act to ameliorate asthma exacerbations, novel approaches capable of blocking TSLP (for example, fully human single-chain fragment variables against TSLP, bifunctional drugs such as the one that combines an anti-IL-13 mAb with an anti-TSLP mAb, a fusion protein consisting of the ectodomains of TSLPR and IL-7Ra that extend into the extracellular space, also known as a TSLP-trap, fragments capable of disrupting the TSLP:TSLPR complex) are under preclinical investigation. However, some critical aspects remain to be clarified before being able to define this approach as the one that will probably better help patients suffering from severe asthma because of its holistic effects.
- |||||||||| Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
Enrollment open, Trial completion date, Trial primary completion date: COURSE: Tezepelumab COPD Exacerbation Study (clinicaltrials.gov) - Nov 30, 2020 P2a, N=282, Recruiting, Active, not recruiting --> Completed Active, not recruiting --> Recruiting | Trial completion date: May 2022 --> Mar 2023 | Trial primary completion date: Feb 2022 --> Dec 2022
- |||||||||| Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
Trial completion: DIRECTION-CK: Tezepelumab Phase 1 PK Study in Healthy Chinese Subjects (clinicaltrials.gov) - Nov 16, 2020 P1, N=48, Completed, Active, not recruiting --> Recruiting | Trial completion date: May 2022 --> Mar 2023 | Trial primary completion date: Feb 2022 --> Dec 2022 Active, not recruiting --> Completed
- |||||||||| Xolair (omalizumab) / Roche, Novartis
Journal: Immunobiologic treatments for severe asthma, atopic dermatitis, and chronic urticaria. (Pubmed Central) - Nov 7, 2020 In this article, we reviewed the most relevant studies that addressed the use of anti-immunoglobulin E (omalizumab), anti-IL-5 (mepolizumab, reslizumab, and benralizumab), and anti-IL-4/IL-13 (dupilumab) treatments for these allergic diseases. In addition, we discussed emerging immunobiologic therapies, such as tezepelumab.
- |||||||||| tezepelumab (AMG 157) / AstraZeneca, Amgen
[VIRTUAL] TEZEPELUMAB EFFICACY IN SEVERE ASTHMA BY SPECIFIC ALLERGEN SENSITIVITY: RESULTS FROM THE PATHWAY STUDY () - Sep 18, 2020 - Abstract #ACAAI2020ACAAI_253; P2 For pooled tezepelumab doses, AAER was reduced by 72% (95% CI: 53, 84) and 63% (95% CI: 30, 81) versus placebo, respectively. Across all allergen types, reductions versus placebo in AAER were observed with tezepelumab in both FEIA+ and FEIA− patients (Figure).Conclusion Tezepelumab reduced exacerbations versus placebo in patients with different allergen sensitivities and those without allergy, supporting its potential benefits in a broad population of patients with severe asthma.
- |||||||||| Stelara (ustekinumab) / J&J
Clinical, Review, Journal: Revisiting Therapies for Atopic Dermatitis that Failed Clinical Trials. (Pubmed Central) - Sep 10, 2020 Agents that did not meet their trial endpoints for AD may still hold therapeutic value in certain subpopulation groups or other diseases. Validating phase II trials based off subgroup analyses from previous trials may be warranted as our understanding of the pathophysiology of AD continues to grow.
- |||||||||| tezepelumab (AMG 157) / AstraZeneca, Amgen
[VIRTUAL] Efficacy of tezepelumab in patients with low and high bronchodilator reversibility in PATHWAY (Pre-congress content) - Jul 15, 2020 - Abstract #ERS2020ERS_904; 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 210mg, 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.
- |||||||||| tezepelumab (AMG 157) / AstraZeneca, Amgen
[VIRTUAL] High TSLP Bronchoalveolar Lavage Levels Are Linked to Disease Severity in a Subset of Children with Severe Asthma (ATS 2020 Virtual) - Jul 6, 2020 - Abstract #ATSI2020ATS-I_1508; High TSLP levels in this population was also associated with increased IL-5 levels, suggesting that TSLP may play a key role in mediating allergic TH2 bronchopulmonary responses in children as previously demonstrated in adults with asthma. These data indicate that TSLP may play a role in the pathogenesis of pediatric asthma and thus provide initial support to investigate the potential use of anti-TSLP biologics to treat severe asthma in children.
- |||||||||| Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
Enrollment closed: DIRECTION-CK: Tezepelumab Phase 1 PK Study in Healthy Chinese Subjects (clinicaltrials.gov) - Jun 29, 2020 P1, N=45, Active, not recruiting, Tezepelumab treatment resulted in similar reductions in AAER in patients with high and low baseline levels of IL-5 and IL-13, providing further evidence that tezepelumab can meaningfully reduce exacerbations in a broad population of patients with severe asthma. Recruiting --> Active, not recruiting
- |||||||||| Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
Trial completion: PATH-HOME: Tezepelumab Home Use Study (clinicaltrials.gov) - Jun 22, 2020 P3, N=216, Completed, Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- |||||||||| tezepelumab (AMG 157) / AstraZeneca, Amgen, Xolair (omalizumab) / Roche, Novartis
[VIRTUAL] The effect of tezepelumab in patients with allergic asthma: Results from the PATHWAY phase IIb study () - May 19, 2020 - Abstract #EAACI2020EAACI_457; P2 This post hoc analysis evaluated the effect of tezepelumab in patients with allergic asthma who were eligible for omalizumab (OMA) treatment according to the European union (EU) label. Treatment with tezepelumab reduced exacerbations and improved FEV1 compared with placebo in patients with allergic and non-allergic asthma, further supporting its potential benefits in a broad population of patients with severe asthma.
- |||||||||| Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen
Enrollment closed: COURSE: Tezepelumab COPD Exacerbation Study (clinicaltrials.gov) - May 17, 2020 P2a, N=282, Active, not recruiting, Tezepelumab reduced exacerbations and inflammatory biomarkers and improved FEV1 and ACQ-6 score in patients with and without NP, supporting its efficacy in a broad population of patients with severe asthma. Recruiting --> Active, not recruiting
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