Dupilumab-treated patients with moderate-to-severe asthma are more likely to meet clinical remission criteria: results from the VESTIGE trial

<bold>Introduction:</bold> Clinical remission is an emerging treatment goal in asthma and could become a gold standard for biologics. <bold>Aims and objectives:</bold> This analysis evaluated the proportion of patients meeting 4 key criteria for on-treatment clinical remission after 6 months of dupilumab. <bold>Methods:</bold> 109 individuals, 18–70 years old, as per inclusion criteria of VESTIGE (<ext-link>NCT04400318</ext-link>), with ≥1 exacerbation(s) in the previous year, pre-BD ppFEV₁ <80%, and blood eosinophil ≥300 cells/µL and FeNO ≥25 ppb, underwent 2:1 randomization to receive dupilumab 300 mg (n=72) or placebo (n=37) q2w for 24 weeks. Endpoints included % of patients meeting all 4 clinical remission criteria at Wk4 and 24. The 4 criteria were absence of severe asthma exacerbations during the study intervention period, absence of systemic corticosteroid use during the study intervention period, ACQ-5 score <1.5, and pre-BD ppFEV₁ ≥80% or improvement from BL in pre‑BD FEV₁ ≥100 mL. <bold>Results:</bold> By the end of the study, 38.9% of patients on dupilumab and 18.9% of patients on placebo met all 4 remission criteria (OR: 2.83; 95% CI: 1.07, 7.47; P < 0.05, Table 1). Safety findings were consistent with the known dupilumab safety profile. <bold>Conclusions:</bold> Results suggest that patients on dupilumab are more likely to meet key clinical remission criteria after 6 months compared to patients on SOC, indicating substantial patient benefit. <bold>Table 1</bold>. <bold>Proportion of patients meeting all 4 clinical remission criteria.</bold> <table-wrap><object-id>erj;64/suppl_68/PA1202/TB1</object-id><object-id>T1</object-id><object-id>TB1</object-id><table><colgroup><col></col><col></col><col></col><col></col><col></col></colgroup><tbody><tr><td></td><td> <bold>Dupilumab</bold> <bold>n (%)</bold> </td><td> <bold>Placebo</bold> <bold>n (%)</bold> </td><td><bold>OR (CI)</bold></td><td><bold><italic>Nominal</italic> <italic>p</italic> value</bold></td></tr><tr><td><bold>Week 4</bold></td><td>20 (27.8)</td><td>6 (16.2)</td><td>2.05 (0.73, 5.78)</td><td>0.170</td></tr><tr><td><bold>Week 24</bold></td><td>28 (38.9)</td><td>7 (18.9)</td><td>2.83 (1.07, 7.47)</td><td>0.034</td></tr></tbody></table></table-wrap> <bold>Note:</bold> CI, confidence interval; OR, odds ratio.