%0 Journal Article
%T Biomarkers and clinical outcomes after tezepelumab cessation: Extended follow-up from the 2-year DESTINATION study.
%A Brightling CE
%A Caminati M
%A Llanos JP
%A Caveney S
%A Kotalik A
%A Griffiths JM
%A Lundahl A
%A Israel E
%A Pavord ID
%A Wechsler ME
%A Porsbjerg C
%A Corren J
%A Gołąbek M
%A Martin N
%A Ponnarambil S
%J Ann Allergy Asthma Immunol
%V 0
%N 0
%D 2024 Apr 30
%M 38697286
%F 6.248
%R 10.1016/j.anai.2024.04.031
%X <B>BACKGROUND: </B>Long-term tezepelumab treatment in the DESTINATION study (NCT03706079) resulted in reduced asthma exacerbations, reduced biomarker levels, and improved lung function and symptom control in patients with severe, uncontrolled asthma.<BR><B>OBJECTIVE: </B>To explore the time course of changes in biomarkers and clinical manifestations after treatment cessation after 2 years of tezepelumab treatment.<BR><B>METHODS: </B>DESTINATION was a 2-year, phase 3, multicenter, randomized, placebo-controlled, double-blind study of tezepelumab treatment in patients (12-80 years old) with severe asthma. Patients received their last treatment doses at week 100 and could enroll in an extended follow-up period from weeks 104 to 140. Change over time in key biomarkers and clinical outcomes were assessed in tezepelumab vs placebo recipients for 40 weeks after stopping treatment.<BR><B>RESULTS: </B>Of 569 patients enrolled in the extended follow-up period, 426 were included in the analysis (289 received tezepelumab and 137 placebo). In the 40-week period after the last tezepelumab dose, blood eosinophil counts, fractional exhaled nitric oxide levels, and Asthma Control Questionnaire-6 scores gradually increased from weeks 4 to 10, with a gradual reduction in pre-bronchodilator forced expiratory volume in 1 second such that blood eosinophil counts, fractional exhaled nitric oxide levels, and clinical outcomes returned to placebo levels; however, none of these outcomes returned to baseline levels. Total IgE levels increased later from week 28 and remained well below placebo and baseline levels during the 40-week period after the last tezepelumab dose.<BR><B>CONCLUSIONS: </B>This analysis reveals the benefits of continued tezepelumab treatment in the management of patients with severe, uncontrolled asthma, compared with stopping treatment after 2 years.<BR><B>BACKGROUND: </B>ClinicalTrials.gov Identifier: NCT03706079.