Efficacy of Tezepelumab in Patients with Severe, Uncontrolled Asthma with Respiratory Comorbidities: Results from the Phase 3 NAVIGATOR Study

Carr, Tara F.; Bernstein, Jonathan A.; Cook, Bill; Hunter, Gillian; Ambrose, Chris; Llanos-Ackert, Jean-Pierre; Lindsley, Andrew; Colice, Gene

doi:10.1016/j.jaci.2021.12.510

Cited by 2 publications

(1 citation statement)

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“…Additional post hoc analyses of NAVIGATOR data (Figure 4) have demonstrated that tezepelumab reduced the AAER over 52 weeks compared with placebo in patients who would have been eligible for omalizumab (reductions of 60% [95% CI: 44, 71] and 68% [95% CI: 55, 77] with treatment according to the United States [US] label and European Union [EU] label, respectively) 29 ; patients with reported comorbid allergic rhinitis (reduction of 58% [95% CI: 47, 67]) 47 ; and patients with a history of allergy and confirmed sensitization to dust mite or animal allergen (reduction of 60% [95% CI: 43, 71]) 48 . Tezepelumab also reduced the AAER over 52 weeks compared with placebo irrespective of the threshold of serum specific IgE positivity to any perennial aeroallergen (Figure S1) 49 ; the season (reductions in winter, spring, summer and autumn of 63% [95% CI: 52, 72], 46% [95% CI: 26, 61], 62% [95% CI: 48, 73] and 54% [95% CI: 41, 64], respectively) 50 ; and age at asthma onset (reductions for childhood‐onset, adult‐onset and late‐onset of 48% [95% CI: 29, 62], 63% [95% CI: 49, 73] and 56% [95% CI: 37, 69], respectively) 51 .…”

Section: Efficacy Of Tezepelumab On Exacerbations In Allergic Asthmamentioning

confidence: 99%

Tezepelumab in patients with allergic and eosinophilic asthma

Caminati,

Buhl,

Corren

et al. 2023

Allergy

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Asthma is a heterogeneous disease commonly driven by allergic and/or eosinophilic inflammation, both of which may be present in severe disease. Most approved biologics for severe asthma are indicated for specific phenotypes and target individual downstream type 2 components of the inflammatory cascade. Tezepelumab, a human monoclonal antibody (immunoglobulin G2λ), binds specifically to thymic stromal lymphopoietin (TSLP), an epithelial cytokine that initiates and sustains allergic and eosinophilic inflammation in asthma. By blocking TSLP, tezepelumab has demonstrated efficacy across known asthma phenotypes and acts upstream of all current clinically used biomarkers. In a pooled analysis of the phase 2b PATHWAY (NCT02054130) and phase 3 NAVIGATOR (NCT03347279) studies, compared with placebo, tezepelumab reduced the annualized asthma exacerbation rate over 52 weeks by 62% (95% confidence interval [CI]: 53, 70) in patients with perennial aeroallergen sensitization (allergic asthma); by 71% (95% CI: 62, 78) in patients with a baseline blood eosinophil count ≥300 cells/μL; and by 71% (95% CI: 59, 79) in patients with allergic asthma and a baseline blood eosinophil count ≥300 cells/μL. This review examines the efficacy and mode of action of tezepelumab in patients with allergic asthma, eosinophilic asthma and coexisting allergic and eosinophilic phenotypes.

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