Tezepelumab reduced annual exacerbations in patients with severe, uncontrolled asthma regardless of their use of additional controller medications, according to study results presented at the American College of Chest Physicians (CHEST) 2022 Annual Meeting, held from October 16 to 19, 2022, in Nashville, Tennessee.
Presentation findings were based on a post hoc analysis of the phase 3, 52-week NAVIGATOR study (ClinicalTrials.gov Identifier: NCT03347279), which assessed the efficacy of the human monoclonal antibody tezepelumab. The multicenter, randomized, placebo-controlled NAVIGATOR study, which included 1059 patients aged 12 to 80 years receiving either tezepelumab 210 mg (n=528) or placebo (n=531) assessed the annualized asthma exacerbation rate (AAER) and the change in prebronchodilator (BD) forced expiratory volume in 1 second (FEV1) in patients receiving medium- or high-dose inhaled corticosteroids and at least 1 other asthma controller with or without oral corticosteroids.
In the post hoc analysis, investigators assessed the efficacy of tezepelumab in NAVIGATOR participants according to the number of additional asthma controller medications they used. Among participants, 493 received 1 additional asthma controller; 381 received 2; and 185 received 3 or more. Long-acting β-agonists were the most frequently received additional asthma medications.
Investigators for the post hoc analysis found that in the 12 months preceding the initiation of NAVIGATOR, a greater proportion of patients receiving at least 3 additional controllers (60%) had more than 2 exacerbations compared with those who received 2 (41%) or 1 (32%) additional controllers. Moreover, during the course of the 52-week NAVIGATOR study, the AAERs for participants in the placebo group using 3 or more vs 2 vs 1 additional controllers were 3.3 (95% CI, 2.5-4.5) vs 2.5 (95% CI, 2.1-3.1) vs 1.4 (95% CI, 1.1-1.7) respectively.
The use of tezepelumab over the course of the 52-week NAVIGATOR study was associated with a reduction in AAER in all participants receiving tezepelumab vs placebo, regardless of the number of additional controllers used, researchers for the post hoc analysis found. Reductions associated with tezepelumab vs placebo for participants using 1, 2, or at least 3 additional controllers were 41% (95% CI, 21-55), 68% (95% CI, 56-76), and 61% (95% CI, 40-74), respectively. Moreover, tezepelumab was associated with improvement in pre-BD FEV1 vs placebo in all subgroups (least squares mean difference, 0.10 L [95% CI, 0.03-0.18], 0.13 L [95% CI, 0.05-0.22], and 0.22 L [95% CI, 0.10-0.34], respectively).
“This analysis demonstrates the efficacy of tezepelumab in a broad population of patients with severe, uncontrolled asthma, including those receiving multiple additional asthma controller medications,” stated the researchers.
Disclosure: Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Kraft M, Colice GL, Ambrose C, et al. Efficacy of tezepelumab in patients with severe, uncontrolled asthma grouped by number of additional asthma controller medications: results from the phase 3 NAVIGATOR study. Abstract presented at: CHEST 2022 Annual Meeting; October 16-19, 2022; Nashville, TN.