NAVIGATOR steers asthma patients to tezepelumab

Patients with severe, uncontrolled asthma demonstrated overall 2.8-fold higher odds of improved clinical responses to tezepelumab than placebo, including exacerbation reduction, better asthma control, improved lung function, and clinician assessment.

Prof. Njira Lugogo (University of Michigan, MI, USA) presented a prespecified, on-treatment analysis of responses to tezepelumab using data from the completed phase 3, double-blind, placebo-controlled NAVIGATOR trial (NCT03347279) [1]. Participants aged 12–80 years were randomised to receive either subcutaneous injections of 210 mg tezepelumab (n=528) or subcutaneous placebo (n=531) every 4 weeks for 52 weeks while continuing to take their medium- or high-dose corticosteroid inhalers and at least 1 other asthma-control medication during the study.

The primary endpoint of annual asthma exacerbation rate at week 52 was met (see Figure). Across response criteria, the proportion of responders was higher in the tezepelumab than in the placebo group for exacerbation reduction (85.4% vs 67.5%; OR 2.73; 95% CI 2.04–3.90); Asthma Control Questionnaire (ACQ)-6 total score (86.9% vs 76.6%; OR 2.05; 95% CI 1.98–3.77); an improvement from baseline pre-bronchodilator forced expiratory volume in 1 second (FEV₁; 60.3% vs 49.9%; OR 1.52; 95% CI 1.15–2.01); and in Clinical Global Impression of Change (CGI-C) score (81.5% vs 67.7%; OR 2.25; 95% CI 1.61–3.14). The proportion of complete responders (those who achieved significant improvement on all measures) was also greater in the tezepelumab group (46.2% vs 24.3%; OR 2.83; 95% CI 2.10–3.82).

Figure: Proportions of participants meeting clinical response criteria were higher with tezepelumab than placebo at week 52 in the on-treatment population [1]



ACQ, Asthma Control Questionnaire; CI, confidence interval; CGI-C, Clinical Global Impression of Change; pre-BD FEV_1, pre-bronchodilator forced expiratory volume in 1 second; OR, odds ratio; Q4W, every 4 weeks.

Prof. Lugogo concluded that “overall, these results add an important patient-level perspective to the primary study results.” Across each measure, tezepelumab recipients were more likely to have a response; the greatest difference observed was for exacerbation reduction. In addition, 48% of participants receiving tezepelumab had a complete response and achieved significant and clinically relevant improvements in all 4 response measures.

1. Lugogo N, et al. Clinical Responses to Treatment with Tezepelumab Among Patients with Severe, Uncontrolled Asthma in the Phase 3 NAVIGATOR Study. Session B93, ATS International Conference 2022, San Francisco, CA, USA, 13–18 May.

 

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Posted on 18 July, 2022