Tezepelumab treatment for severe uncontrolled asthma was associated with significant reductions in health care utilization, according to study findings published in Annals of Allergy, Asthma & Immunology.
Researchers sought to assess the extent to which the human monoclonal antibody tezepelumab reduced health care utilization in patients with severe uncontrolled asthma, using data from the phase 3 NAVIGATOR trial (ClinicalTrials.gov Identifier: NCT03347279).
The randomized, placebo-controlled NAVIGATOR trial was conducted from November 2017 to November 2020 at multiple centers in 18 countries to determine the efficacy of tezepelumab in adults and adolescents with asthma. Patients (aged 12 to 80 years of age, with women outnumbering men 2:1) were randomly assigned to receive tezepelumab (n=528) 210 mg subcutaneously every 4 weeks for 1 year or placebo (n=531). Clinical characteristics and demographics at baseline were balanced between treatment groups.
In the current assessment of health care utilization among patients in NAVIGATOR, researchers found tezepelumab recipients vs placebo needed fewer telephone calls with a health care provider (234 vs 599), fewer asthma-related unscheduled specialist visits (285 events vs 406 events), fewer emergency department visits (16 vs 37 without subsequent hospitalization; 14 vs 78 with hospitalizations), fewer ambulance transports (5 vs 22), and fewer days in the intensive care unit (0 vs 31). Patients taking tezepelumab vs placebo also required fewer rehospitalizations (1 vs 19).
“
Tezepelumab treatment resulted in substantial reductions in the incidence and severity of potentially life-threatening exacerbations that required an ED visit, hospitalization, or ICU days compared with placebo.
Hospitalization with a severe asthma-related exacerbation event occurred in 38% (5/13) of patients receiving tezepelumab vs 82% (32/39) of patients receiving placebo. Annualized rates of all-cause ED visits were reduced 28% with tezepelumab vs placebo (95% CI, 2-46), and all-cause hospitalizations were reduced 59% with tezepelumab vs placebo (95% CI, 35-74). Annualized rates of exacerbations requiring an ED visit without hospitalization were reduced 61% with tezepelumab vs placebo (95% CI, 23-80).
Study limitations include the use of underpowered sample sizes for several statistical analyses and lack of evaluation of the cost-effectiveness of tezepelumab.
“Tezepelumab substantially reduced [health care utilization] across all outcomes measured compared with placebo,” researchers concluded. “Tezepelumab treatment resulted in substantial reductions in the incidence and severity of potentially life-threatening exacerbations that required an ED visit, hospitalization, or ICU days compared with placebo.”
Disclosure: This research was supported by AstraZeneca and Amgen Inc. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
