Late Breaking Abstract - Dupilumab improves lung function and reduces exacerbations despite withdrawal of inhaled corticosteroids/long-acting beta agonists

<bold>Background:</bold> Inhaled corticosteroid (ICS) and long-acting beta-agonist (LABA) dose reduction is recommended in patients (pts) who respond to biologics, but the safety of tapering is not well known. <bold>Aims/Objectives</bold>: The impact of ICS/LABA withdrawal on exacerbations and lung function was studied in pts with asthma and baseline (BL) eosinophils ≥300 cells/µL in 2 studies (Phase 2a [Ph2a, <ext-link>NCT01312961</ext-link>] and Phase 2 [Ph2, <ext-link>NCT03387852</ext-link>]). <bold>Methods:</bold> Pts (≥18 years) received dupilumab 300 mg qw (Ph2a) or dupilumab 300 mg q2w (Ph2) or placebo for 12 weeks. LABA was discontinued at Week 4, and ICS tapered over Weeks 6 to 9. Exacerbation rates, changes from BL in pre-bronchodilator forced expiratory volume in 1 second (FEV₁), and proportions of pts who maintained 5-item Asthma Control Questionnaire (ACQ-5) scores <1.5 were assessed. <bold>Results:</bold> Dupilumab vs placebo significantly reduced severe exacerbation rates in both studies (<bold>Table</bold>). Pre-bronchodilator FEV₁ significantly improved from BL to Week 12, with improvements becoming significant at Weeks 2 (Ph2a) and 3 (Ph2), and remaining stable from Weeks 4 to 12 (after LABA discontinuation). Significantly more pts receiving dupilumab vs placebo were able to withdraw ICS while maintaining asthma control. <bold>Conclusions:</bold> Dupilumab reduced exacerbations and significantly improved lung function despite LABA withdrawal for 8 weeks and ICS withdrawal for 3 weeks. <fig><object-id>erj;64/suppl_68/PA1172/F1</object-id><object-id>F1</object-id><object-id>F1</object-id><graphic></graphic></fig>