Tezepelumab efficacy in patients with severe, uncontrolled asthma and comorbid nasal polyps in NAVIGATOR

Menzies‐Gow, Andrew; Corren, Jonathan; Israel, Elliot; Welte, Tobias; Ambrose, Christopher S.; Cook, Bill; Hunter, Gillian; Llanos-Ackert, Jean-Pierre; Colice, Gene

doi:10.1183/13993003.congress-2021.pa876

Cited by 7 publications

(5 citation statements)

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“…Conversely, CRSwNP is crucial in considering a potential response to dupilumab, mepolizumab, and omalizumab, which are also the three biological agents to have obtained authorisation for use in this case. Benralizumab and tezepelumab do not yet have a prescription indication for NP, although many data support the efficacy of these agents in patients with this condition—which, when associated with asthma, makes the benefits even better (similar to dupilumab, for example) [ 88 , 92 ]. It is hoped that ongoing RCTs will also lead to authorisation of these two biologics for the treatment of CRSwNP [ 90 , 93 ].…”

Section: Discussionmentioning

confidence: 99%

“…A subsequent exploratory analysis also evaluated the effects of tezepelumab in NP+ or NP− patients enrolled in the phase 3 NAVIGATOR study. The analysis showed that tezepelumab achieved an 86% reduction in AAER in NP+ patients and 52% in NP- patients compared to the placebo [ 92 ]. To confirm the efficacy and safety of tezepelumab in patients with CRSwNP, the WAYPOINT trial (ClinicalTrials.gov Identifiers: NCT04851964), whose primary endpoints are the change from baseline in total NPS and nasal congestion score, is ongoing.…”

Section: Overview Of Clinical Trials According To Patient Characteris...mentioning

confidence: 99%

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Baseline Characteristics of Patients Enrolled in Clinical Trials of Biologics for Severe Asthma as Potential Predictors of Outcomes

Menzella¹

2023

JCM

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(1) Background: Over the past 20 years, monoclonal antibodies have been developed for the treatment of severe asthma, with numerous randomised controlled trials (RCTs) conducted to define their safety and efficacy. The growing availability of biologics, which until now have only been available for T2-high asthma, has been further enriched by the arrival of tezepelumab. (2) Methods: This review aims to evaluate the baseline characteristics of patients enrolled in RCTs of biologics for severe asthma to understand how they could potentially predict outcomes and how they can help differentiate between available options. (3) Results: The studies reviewed demonstrated that all biologic agents are effective in improving asthma control, especially with regard to reducing exacerbation rates and OCS use. As we have seen, in this regard, there are few data on omalizumab and none yet on tezepelumab. In analysing exacerbations and average doses of OCSs, pivotal studies on benralizumab have enrolled more seriously ill patients. Secondary outcomes, such as improvement in lung function and quality of life, showed better results—especially for dupilumab and tezepelumab. (4) Conclusion: Biologics are all effective, albeit with important differences. What fundamentally guides the choice is the patient’s clinical history, the endotype represented by biomarkers (especially blood eosinophils), and comorbidities (especially nasal polyposis).

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Section: Discussionmentioning

confidence: 99%

Section: Overview Of Clinical Trials According To Patient Characteris...mentioning

confidence: 99%

Baseline Characteristics of Patients Enrolled in Clinical Trials of Biologics for Severe Asthma as Potential Predictors of Outcomes

Menzella¹

2023

JCM

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“…45 Tezepelumab also demonstrated high efficacy in patients with severe uncontrolled asthma and comorbid NPs, which is a phenotypic marker of eosinophilic disease. [46][47][48] In NAVIGATOR, tezepelumab reduced exacerbations by 86% (95% CI: 70-93), 46 and improved SNOT-22 scores with an LS mean change from baseline of −11.08 (−17.80 to −4.35) versus placebo in patients with severe uncontrolled asthma and a history of NPs, over 52 weeks of treatment. 47…”

Section: Dovepressmentioning

confidence: 99%

Tezepelumab for Severe Asthma: One Drug Targeting Multiple Disease Pathways and Patient Types

Panettieri Jr,

Lugogo,

Corren

et al. 2024

JAA

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Asthma is a heterogeneous inflammatory disease of the airways, affecting many children, adolescents, and adults worldwide. Up to 10% of people with asthma have severe disease, associated with a higher risk of hospitalizations, greater healthcare costs, and poorer outcomes. Patients with severe asthma generally require high-dose inhaled corticosteroids and additional controller medications to achieve disease control; however, many patients remain uncontrolled despite this intensive treatment. The treatment of severe uncontrolled asthma has improved with greater understanding of asthma pathways and phenotypes as well as the advent of targeted biologic therapies. Tezepelumab, a monoclonal antibody, blocks thymic stromal lymphopoietin, an epithelial cytokine that has multifaceted effects on the initiation and persistence of asthma inflammation and pathophysiology. Unlike other biologic treatments, tezepelumab has demonstrated efficacy across severe asthma phenotypes, with the magnitude of effects varying by phenotype. Here we describe the anti-inflammatory effects and efficacy of tezepelumab across the most relevant phenotypes of severe asthma. Across clinical studies, tezepelumab reduced annualized asthma exacerbation rates versus placebo by 63-71% in eosinophilic severe asthma, by 58-68% in allergic severe asthma, by 67-71% in allergic and eosinophilic severe asthma, by 34-49% in type 2-low asthma, and by 31-41% in oral corticosteroid-dependent asthma. Furthermore, in all these asthma phenotypes, tezepelumab demonstrated higher efficacy in reducing exacerbations requiring hospitalizations or emergency department visits versus placebo. In patients with severe uncontrolled asthma, who commonly have multiple drivers of inflammation and disease, tezepelumab may modulate airway inflammation more extensively, as other available biologics block only specific downstream components of the inflammatory cascade.Plain Language Summary: Asthma is characterized by an immune response leading to airway inflammation. People with severe asthma may react to different triggers and develop different types of airway inflammation. In patients with asthma, a protein called thymic stromal lymphopoietin (TSLP) plays an important role in the immune response that leads to the signs and symptoms of asthma. TSLP is released by the airway lining in response to different asthma triggers, driving an immune chain reaction, leading to airway narrowing and tightening, increased airway inflammation, worsening asthma symptoms, and asthma attack. Tezepelumab is a monoclonal antibody (a type of protein) that prevents TSLP from attaching to its receptor, thereby blocking its activity, reducing airway inflammation and asthma symptoms. Tezepelumab is an add-on medicine for the treatment of people aged 12 years or older with severe asthma that is not controlled with their current medicines.In this article, we discuss how tezepelumab may work in different types of asthma, for example allergic asthma, eosinophilic asthma, and T2-low asthma. We also describe ho...

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“…Current available data demonstrate a significant efficacy in patients with T2 inflammation, as well as partial efficacy in those with T2-low characteristics [ 44 , 45 , 87 , 88 , 89 , 90 , 91 , 92 ]. Clinical trial data show the efficacy of tezepelumab, principally in patients with high levels of eosinophils; however, for the first time in severe asthmatic therapies, interesting results have been obtained on patients with less than 150 eosinophils/mcl, despite having a slightly lower efficacy score, if compared to the sample with a range higher than the above-mentioned eosinophils range.…”

Section: T2 Targeted Therapies In Asthmamentioning

confidence: 99%

Personalized and Precision Medicine in Asthma and Eosinophilic Esophagitis: The Role of T2 Target Therapy

Bagnasco,

Savarino,

Yacoub

et al. 2023

Pharmaceutics

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The role of type 2 inflammation has been progressively associated with many diseases, including severe asthma, atopic dermatitis, nasal polyposis, eosinophilic granulomatosis with polyangiitis, and, recently, eosinophilic esophagitis. Despite this, the association between asthma and esophagitis is still poorly known, and this is probably because of the low prevalence of each disease and the even lower association between them. Nonetheless, observations in clinical trials and, subsequently, in real life, have allowed researchers to observe how drugs acting on type 2 inflammation, initially developed and marketed for severe asthma, could be effective also in treating eosinophilic esophagitis. For this reason, clinical trials specifically designed for the use of drugs targeted to type 2 inflammation were also developed for eosinophilic esophagitis. The results of clinical trials are presently promising and envisage the use of biologicals that are also likely to be employed in the field of gastroenterology in the near future. This review focuses on the use of biologicals for type 2 inflammation in cases of combined severe asthma and eosinophilic esophagitis.

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Tezepelumab efficacy in patients with severe, uncontrolled asthma and comorbid nasal polyps in NAVIGATOR

Cited by 7 publications

References 0 publications

Baseline Characteristics of Patients Enrolled in Clinical Trials of Biologics for Severe Asthma as Potential Predictors of Outcomes

Baseline Characteristics of Patients Enrolled in Clinical Trials of Biologics for Severe Asthma as Potential Predictors of Outcomes

Tezepelumab for Severe Asthma: One Drug Targeting Multiple Disease Pathways and Patient Types

Personalized and Precision Medicine in Asthma and Eosinophilic Esophagitis: The Role of T2 Target Therapy

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