Association between Baseline Lung Function and Oral Corticosteroid Elimination in Patients with Oral Corticosteroid-Dependent Severe Asthma

Speaker(s)

Domingo C1, Hanania NA2, Canonica GW3, Halpin DMG4, Lugogo NL5, Rhee CK6, Altincatal A7, Pandit-Abid N8, Nash S9, Deniz Y9, Rowe PJ8, Sacks H9, Reed C7, Jacob-Nara JA8
1Corporació Sanitària Parc Taulí, Sabadell, Autonomous University of Barcelona, Barcelona, Catalonia, Spain, 2Baylor College of Medicine, Houston, TX, USA, 3Humanitas University and Research Hospital, Milan, Lombardy, Italy, 4College of Medicine and Health, University of Exeter, Exeter, Devon, UK, 5University of Michigan, Ann Arbor, MI, USA, 6College of Medicine, The Catholic University of Korea, Seoul St. Mary’s Hospital, Seoul, Gyeonggi, Korea, Republic of (South), 7Sanofi, Cambridge, MA, USA, 8Sanofi, Bridgewater, NJ, USA, 9Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA

Presentation Documents

OBJECTIVES: Despite known adverse effects of continued oral corticosteroid (OCS) use, almost one-third of patients with severe asthma are OCS-dependent, whereas only 4% receive biologics. In the LIBERTY ASTHMA VENTURE study (NCT02528214), add-on dupilumab reduced OCS maintenance dose while reducing the rate of exacerbations and improving lung function in patients with OCS-dependent, severe asthma. This post-hoc analysis investigated the association between baseline lung function characteristics and OCS elimination in patients with OCS-dependent severe asthma.

METHODS: Patients received dupilumab 300 mg every 2 weeks or placebo for 24 weeks. In patients with an optimized OCS dose of <35 mg/day at baseline, those who eliminated OCS at Week 24 were stratified by baseline pre-bronchodilator forced expiratory volume in 1 second (FEV1) ≤/>1.75 L, pre-bronchodilator percent predicted (pp) FEV1, </≥60%, and post-bronchodilator FEV1 ≤/>median (1.78 L). Odds ratios (OR) were calculated for achieving OCS elimination (Week 24).

RESULTS: The ORs for achieving OCS elimination at Week 24 for dupilumab vs placebo were 4.95 (P=0.0004) and 2.85 (P=0.0665) for patients with baseline pre-bronchodilator FEV1 ≤1.75 L and >1.75 L, respectively (Pint=0.4445). The ORs for the same outcome were 6.76 (P<0.0001) and 1.29 (P=0.63) in patients with baseline pre-bronchodilator ppFEV1 <60% and ≥60%, respectively (Pint=0.03), and 6.06 (P=0.0007) and 1.81 (P=0.19) in patients with baseline post-bronchodilator FEV1 ≤median and >median, respectively (Pint=0.08). In the subgroups with pre-bronchodilator FEV1 >1.75 L, pre-bronchodilator ppFEV1 ≥60%, and post-bronchodilator FEV1 >median, a higher proportion of patients receiving dupilumab achieved OCS elimination, though the treatment effects were not significant.

CONCLUSIONS: In patients with OCS-dependent severe asthma, those with low baseline lung function were significantly more likely to achieve OCS elimination with dupilumab vs placebo at Week 24.

Code

CO134

Topic

Study Approaches

Topic Subcategory

Clinical Trials

Disease

No Additional Disease & Conditions/Specialized Treatment Areas, Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)