Association between baseline characteristics and oral corticosteroid reduction in patients with oral corticosteroid-dependent severe asthma

IntroductionAlmost a third of patients with severe asthma are oral corticosteroid (OCS)-dependent, yet only 4% receive biologics, despite known adverse effects of continued OCS use. We assessed the association between baseline disease characteristics and OCS elimination in patients with OCS-dependent severe asthma in VENTURE (NCT02528214).MethodsPatients received dupilumab 300mg q2w or placebo for 24 weeks; those who eliminated OCS at Week 24 were stratified by baseline pre-bronchodilator (BD) percent predicted (pp) FEV1 ≥60% or post-BD FEV1 ≤/>median (1.78L) and odds ratios (OR) were calculated for achieving OCS elimination (Week 24).ResultsIn patients with baseline pre-BD ppFEV1 <60% the odds ratio for achieving OCS elimination was 6.8 for dupilumab vs placebo, in patients with baseline pre-BD ppFEV1 ≥60%, OR was 1.3 (Pint<0.03). Similarly, in patients with baseline post-BD FEV1 ≤median the odds ratio of achieving OCS elimination were 6.1 for dupilumab vs placebo, whereas those with baseline post-BD FEV1 >median had an OR of 1.8 (Pint=0.08). (Table) Additionally, in the subgroup with pre-BD ppFEV1 ≥60% and post-BD FEV1 >median a higher proportion of patients on placebo also achieved OCS elimination, thus reducing the differences between treatment arms.ConclusionDupilumab versus placebo showed a strong statistically significant association with achieving OCS elimination at Week 24 in patients with OCS-dependent severe asthma and pre-BD ppFEV1 <60% or post-BD FEV1 equal to or below median at baseline. Moderate associations, which did not reach statistical significance, were observed in patients with baseline pre-BD ppFEV1 ≥60% or post-BD FEV1 above median at baseline.