Asthma Therapy Reduces Hospital/Emergency-Room Visits for Severe Asthma
By Alex Morrisson
DALLAS -- May 24, 2019 -- Asthma exacerbations requiring hospitalisation were reduced 79% in patients taking tezepelumab compared with placebo, according to an exploratory analysis of the phase 2b PATHWAY study presented at the 2019 Annual Meeting of the American Thoracic Society (ATS).
Jonathan Corren, MD, UCLA Medical Center, Los Angeles, California and UCLA Medical Center-Santa Monica, Santa Monica, California and colleagues enrolled 550 patients in the analysis; 138 patients diagnosed with severe, uncontrolled asthma had been assigned to placebo; 138 patients had been assigned to the 70-mg dose of tezepelumab; 137 patients had been assigned to the 210-mg dose of tezepelumab and 137 patients had been assigned to receive the 280-mg dose of the drug.
The exacerbation rate was 0.14 in the placebo group -- 19 events among 9 of the 138 patients -- compared with 12 events in 12 of 412 patients on doses of tezepelumab or a rate of 0.03 (P
Similarly, overall hospitalisations were reduced by 61% among patients on tezepelumab, and all-cause emergency-room visits were reduced by 60%. The percentage of patients who went to the emergency room with asthma exacerbation was 3.6% among the placebo patients and 1.2% among those on tezepelumab.
The mean number of days placebo patients spent in hospital per admission was 23 compared with 9 for patients on tezepelumab (P
At Week 52, the annualised asthma exacerbation rate was reduced 66% from baseline in the pooled tezepelumab cohorts compared with placebo. The pooled cohorts comprised patients receiving 70 mg, 210 mg, or 280 mg subcutaneously every 4 weeks (every 2 weeks for the higher dose).
The annualised exacerbation rate among the 138 patients assigned to placebo was 0.72 compared with a rate of 0.24 among the 412 patients assigned to the various doses of tezepelumab, a relative risk reduction of 66% (P
“These data provide further evidence that blocking TLSP [thymic stromal lymphopoietin] is an effective strategy for the treatment of severe, uncontrolled asthma,” said Dr. Corren.
Patients in this study were about 51 years old, and about 65% were women. In the year before enrolling in the study, 80% of the patients had experienced 1 to 2 asthma exacerbations, while 20% had experienced 3 or more asthma attacks.
Based on the phase 2 trial, a phase 3 trial will move ahead using the 210 mg dose delivered subcutaneously every 4 weeks.
Tezepelumab is a thymic stromal lymphopoietin (TSLP), an epithelial cell-derived cytokine produced in response to environmental and mechanical triggers, activating multiple cell types and downstream inflammatory pathways associated with asthma. Tezepelumab is a human monoclonal antibody (IgG2lambda) that selectively blocks TSLP from interacting with its receptor complex.
Funding for this study was provided by Amgen, Thousand Oaks, California and AstraZeneca, Cambridge, United Kingdom.
[Presentation title: The Impact of Tezepelumab on Hospitalization and Emergency Department Visits in Patients with Severe Uncontrolled Asthma: Results from the Pathway Phase 2b Trial. Abstract: 2622]