Research published at the ATS 2022 International Conference shows that a greater proportion of patients with severe uncontrolled asthma have more significant clinical responses to tezepelumab than placebo. The study showed that nearly half of the enrollees achieved a complete treatment response via measures of exacerbation reduction, asthma control, lung function, and physician evaluation.
The study is a pre-selected treatment analysis of responses to tezepelumab using data from the completed Phase 3, double-blind, and NAVIGATOR trial (NCT03347279). The trial results were presented at ATS 2021 and published in a peer-reviewed medical journal.
“Overall, these findings are consistent with the NAVIGATOR findings reported at ATS 2021 and add an important patient-level perspective to the initial study findings,” said introductory author Njira Lugogo, associate professor of internal medicine and medical director at Michigan Clinical. Research Unit and Director of the Asthma Program, Department of Pulmonary and Critical Care Medicine, University of Michigan, Ann Arbor. “Across each scale, tezepelumab recipients were more likely to respond; the largest difference observed was reduction in exacerbations. In addition, 48 percent of patients receiving tezepelumab had a complete response and achieved significant and clinically relevant improvements in all four response measures.”
Both tezepelumab and placebo patients continued to take medium- or high-dose corticosteroid inhalers and at least one asthma-control drug during the study.
Four hundred and seventy-one patients receiving tezepelumab and 449 patients receiving placebo completed the treatment period and were included in the analysis. Across response criteria, the proportion of responders in tezepelumab was higher than in the placebo group to reduce exacerbations (85.4 percent vs. 67.5 percent); Asthma Control Questionnaire (ACQ) – score 6 (86.9 percent vs. 76.6 percent); Improving forced expiratory volume before a primary bronchodilator in 1 second (FEV1) (60.3% vs. 49.9%); and in the Clinical Global Impression of Change (CGI-C) score (81.5 percent vs. 67.7 percent). The proportion of complete responders (those with significant improvement on all measures) was higher in the tezepelumab group than in the placebo group (48.2 percent versus 25.3 percent).
Tezepelumab is a biologic therapy-; A medical treatment made from living cells.
Dr. Lugogo stated, “Responses to biologics in asthma are heterogeneous and the effect of biology on major asthma outcomes can vary between patients. We were interested in determining the effect of tezepelumab on the four most significant clinical outcomes, which included reduction in exacerbations, improvement in symptoms and lung function, and impression of the treating physician. whether or not clinical improvement has occurred. There is a growing interest in determining the responses of patients with severe asthma to biopharmaceuticals. In this study, we identified both responses in each measure and pooled responses overall.”
She also indicated that these findings could be used for joint decision-making when discussing the initiation of treatment with teziplumab. “Patients are always interested in understanding potential outcomes after initiating treatment and our findings can guide clinicians in informing patients of the likelihood of an individual and complete response to treatment.”
This study was supported by AstraZeneca and AMGEN.
American Thoracic Society