Tezepelumab is a monoclonal antibody with specific inhibition of thymic stromal lymphopoietin (TSLP) resulting in hindering TSLP to cooperate with its receptor thus acting upstream of various cytokines involved not only in type 2 inflammation, but also in neutrophil activation and mast cell effects [1,2]. So, why is this so interesting for the treatment of asthma? “Inflammation in asthma remains a complex heterogeneous and dynamic process and even with biologic treatment, 60% of US patients with severe asthma have suboptimal controlled disease and there is a need for alternative treatments for severe asthma that treat a wider spectrum of inflammation,” Prof. Michael E. Wechsler (National Jewish Health, Denver, CO, USA) described the current situation [3].
The results of the phase 3 NAVIGATOR (NCT03347279) study were one of breaking news of the ATS 2021 congress [3]. NAVIGATOR included patients with severe, poorly controlled asthma and ≥2 exacerbations in the last 12 months. Among the study participants were equal rates of patients with blood eosinophil counts <300 cells/µL and ≥300 cells/µL at screening. Over 1,000 patients were randomised to receive either 210 mg of tezepelumab or placebo every 4 weeks over 52 weeks while continuing their background controller medication. They were followed for 12 more weeks thereafter. The study met its primary endpoint by a significant reduction of 56% in the annualised asthma exacerbation rate (AAER): 2.10 and 0.93 in the placebo and the tezepelumab arm, respectively (P<0.001). “Exciting about the NAVIGATOR study was that tezepelumab reduced exacerbation in the overall population and in patients with a broad range of inflammatory profiles,” stated Prof. Wechsler. Among those groups were patients with high and low eosinophil counts, high and low exhaled nitric oxide levels, as well as positive and negative perennial-specific IgE status. AAER leading to hospitalisation or emergency room visits were significantly reduced by 79%. Lung function improved overall, with greatest differences to placebo in those with eosinophils ≥300 cells/µL. The efficacy of tezepelumab also resulted in significant amelioration in asthma control (P<0.001), asthma symptom diary score (P=0.002), and asthma quality of life (P<0.001). “Importantly, tezepelumab also reduced blood eosinophil counts, exhaled nitric oxide, and IgE levels over the 52 weeks of this treatment study,” emphasised Prof. Wechsler.
Overall, adverse events were more frequent in placebo patients than in the tezepelumab receivers (80.8% vs 77.1%) [4]. Most common in both groups were nasopharyngitis, upper respiratory tract infection, and headache. Serious adverse events also occurred more often in the placebo group compared with the tezepelumab arm (13.7% vs 9.8%). Discontinuation of treatment was induced by adverse events in 3.6% (placebo) and 2.1% (tezepelumab).
- Gauvreau GM, et al. N Engl J Med. 2014;370(22):2102-10.
- Corren J, et al. N Engl J Med. 2017;377(10):936-46.
- Wechsler ME. Latest clinical evidence from phase 3 tezepelumab trials in severe asthma. Session B007: Breaking news: clinical trial results in pulmonary medicine. ATS 2021 International Conference, 14-19 May.
- Menzies-Gow A, et al. N Engl J Med. 2021;384(19):1800-09.
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Table of Contents: ATS 2021
Featured articles
Letter from the Editor
COVID-19: What Pulmonologists Need to Know
Antibody treatment for COVID-19: a combination is successful
Air pollution: an underestimated negative prognostic factor for COVID-19
Healthcare workers vulnerable to SARS-CoV-2 infections
Genetic risk variants responsible for COVID-19 predisposition
Asthma – An Update
“As-needed” inhaled corticosteroid therapy for mild asthma – what is the evidence?
IL-4/13 blocker successful in treatment of paediatric moderate-to-severe asthma
Benralizumab lives up to its phase 3 results in real-world findings
Tezepelumab – good success rates in various types of severe asthma
Sleep Disorders – An Underestimated Problem
OSA: A risk factor for earlier cognitive decline
Subgroup of patients with high heart rate response and coronary artery disease benefit from CPAP
Association between positive airway pressure treatment adherence and COVID-19 infection rates
COPD – What Is New
Possible aetiologies for COPD exacerbations – more evidence is needed
Does COPD plus COVID-19 equal higher mortality?
Biomarkers for acute exacerbations in COPD are required
Severe exacerbations: A key driver of all-cause mortality in COPD patients
Men and women with COPD differ in many ways
Younger adults with COPD at higher health risk than previously thought
Metabolic Dysregulation and Lung Disease
Obesity: A risk factor for new-onset asthma and worse asthma control
Metabolic dysfunction and lung disease: children are no small adults
Best of the Posters
Air pollution in winter linked to more hospital admissions in ILD patients
Tobacco biomarkers do not improve prediction of lung cancer risk
Vaping identified as risk factor for asthma
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