Treatment with tezepelumab was associated with significant improvements in asthma control, health-related quality of life (QoL), and daily asthma symptoms compared with placebo in patients with uncontrolled asthma, according to findings from a post hoc analysis of the phase 2B PATHWAY trial published in the Annals of Allergy, Asthma & Immunology.
The PATHWAY trial (ClinicalTrials.gov Identifier: NCT02054130) included current nonsmoking adults between the ages of 18 and 75 years who had uncontrolled asthma for at least 6 months despite use of inhaled corticosteroids. Patients in the study were randomly assigned to either tezepelumab 70 mg every 4 weeks (n=138), 210 mg every 4 weeks (n=137), 280 mg every 2 weeks (n=137), or placebo every 2 weeks (n=138) for 52 weeks.
Asthma control was assessed using the Asthma Control Questionnaire 6 (ACQ-6), and health-related QoL was assessed with the Asthma Quality of Life Questionnaire (standardized) for patients aged 12 years or older (AQLQ[S]+12). The Asthma Daily Diary questionnaire was also used to examine daily asthma-related health status of these participants.
The proportion of ACQ-6 responders, defined as a reduction of 0.5 or more in the ACQ-6 total score, was higher for tezepelumab 70 mg (75.0%), 210 mg (81.8%), and 280 mg (80.4%) groups compared with placebo (69.6%) at week 50. Compared with patients treated with placebo, the odds of being an ACQ-6 responder were higher for patients treated with tezepelumab 210 mg (odds ratio [OR], 1.94; 95% CI, 1.08-3.47) and 280 mg (OR, 1.86; 95% CI, 1.03-3.36).
At the 48-week follow-up, the proportion of AQLQ(S)+12 responders, defined as an increase in overall AQLQ(S)+12 score of 0.5 or more, was 71.8% in the tezepelumab 70 mg group, 76.3% in the tezepelumab 210 mg group, and 76.8% in the tezepelumab 280 mg dose group vs 63.8% in the placebo arm. The odds of being an AQLA(S)+12 responder were higher in patients who received tezepelumab 210 mg (OR, 1.96; 95% CI, 1.08-3.57) or 280 mg (OR, 2.02; 95% CI, 1.11-3.67).
Asthma Daily Diary response was defined as patients who had an improvement of 0.5 to 1 point in the Asthma Daily Diary score. At week 52, the cumulative proportion of responders was higher in all tezepelumab groups relative to the placebo group. Approximately 23.7% of patients in the placebo group were Asthma Daily Diary responders at week 52 compared with 28.6%, 36.2%, and 33.0% of patients in the tezepelumab 70 mg, 210 mg, and 280 mg dose groups, respectively.
The investigators stated that their findings offer further support that blocking thymic stromal lymphopoietin “with tezepelumab is an effective strategy for the treatment of severe, uncontrolled asthma and further support the benefits of tezepelumab in this patient population.”
Disclosure: This clinical trial was supported by AstraZeneca and Amgen, Inc. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Corren J, Garcia Gil E, Griffiths JM, et al. Tezepelumab improves patient-reported outcomes in patients with severe, uncontrolled asthma in PATHWAY. Ann Allergy Asthma Immunol. Published online October 23, 2020. doi:10.1016/j.anai.2020.10.008