TY - JOUR T1 - Long-term effect of dupilumab on prevention of lung function decline in patients with uncontrolled moderate-to-severe asthma: ATLAS trial design JF - ERJ Open Research JO - erjor DO - 10.1183/23120541.00417-2022 SP - 00417-2022 AU - Lucia De Prado Gomez AU - Ian Pavord AU - William Busse AU - Christopher E Brightling AU - Michael E Wechsler AU - Klaus F Rabe AU - Mei Zhang AU - Jun Xing AU - Juby A Jacob-Nara AU - Paul J Rowe Y1 - 2022/01/01 UR - http://openres.ersjournals.com/content/early/2022/10/13/23120541.00417-2022.abstract N2 - Background Many patients with asthma experience loss of lung function over time, and in certain patients this can lead to progressive obstructive patterns. similar to chronic obstructive pulmonary disease. Patients with severe asthma may experience accelerated lung function decline (LFD). However, characteristics and risk factors for LFD in asthma have not been well described. Dupilumab may prevent or slow the rate of LFD in patients with uncontrolled, moderate-to-severe asthma. ATLAS trial is designed to evaluate the role of dupilumab in preventing/slowing LFD over a period of 3 years versus standard-of-care therapy.Methods ATLAS (NCT05097287) is a randomised, double-blind, placebo-controlled, multicenter study that will include adult patients with uncontrolled moderate-to-severe asthma. Approximately 1828 patients will be randomised (2:1) to dupilumab 300 mg or placebo in combination with maintenance therapy every 2 weeks for 3 years. The primary objective is to assess the effect of dupilumab on preventing or slowing LFD by Year 1 in FeNO population (patients with FeNO ≥35 ppb). The effect of dupilumab in slowing the rate of LFD by Year 2 and Year 3 in both FeNO and total populations, exacerbations, asthma control, quality of life, biomarker changes, and utility of FeNO as a biomarker of LFD will also be evaluated.Discussion ATLAS is the first trial assessing the effect of a biologic on LFD, designed to establish the role of dupilumab in prevention of long-term loss of lung function and its potential effect on disease modification, which may provide unique insights into asthma pathophysiology, including predictive and prognostic factors of LFD.FootnotesThis manuscript has recently been accepted for publication in the ERJ Open Research. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJOR online. Please open or download the PDF to view this article.Conflict of interests: Lucia De Prado Gomez: Sanofi − employees, may hold stock and/or stock options in the company.Conflict of interests: Ian Pavord: Aerocrine, Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Novartis, Sanofi/Regeneron, Teva – speaker fees; AstraZeneca, GSK, Sanofi/Regeneron, Teva – payments for organizing educational events; AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Genentech, GSK, Knopp Biosciences, Merck, Novartis, Sanofi/Regeneron, Teva – consultant fees; AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Teva – international scientific meeting sponsorship; Chiesi – research grant; GSK − payments to support FDA approval meetings; Bayer, Insmed, Merck − payments for use of the Leicester Cough Questionnaire (to which he is a co-patent holder of the rights) in clinical trials; expert witness for a patent dispute involving AstraZeneca and Teva.Conflict of interests: William Busse: GlaxoSmithKline, Novartis, Sanofi, Teva – consultant, speaker fees.Conflict of interests: Christopher E Brightling: Received grants and consultancy from GSK, AZ, Novartis, Chiesi, BI, Genentech, Roche, Sanofi, Regeneron, Mologic, 4DPharma paid to his Institution.Conflict of interests: Michael E Wechsler: Consulting and honoraria from : AstraZeneca, Amgen, Glaxosmithkline, Sanofi, Regeneron, Boehringer Ingelheim, Novartis, genentech, Pulmatrix, Teva, Equillium, cytoreason, Restorbio, Cohero Health, cerecor, incyte, sound biologics, kinasetConflict of interests: Klaus F Rabe: AstraZeneca, Boehringer Ingelheim, Novartis, Sanofi, Teva – consultant, speaker fees.Conflict of interests: Mei Zhang: Sanofi – employees, may hold stock and/or stock options in the company.Conflict of interests: Jun Xing: Sanofi – employees, may hold stock and/or stock options in the company.Conflict of interests: Juby A Jacob-Nara: Sanofi − employees, may hold stock and/or stock options in the company.Conflict of interests: Paul J Rowe: Sanofi – employees, may hold stock and/or stock options in the company. ER -