(411) Real-world outcomes after 2 years of dupilumab therapy for severe asthma: the ProVENT study

Background: : Dupilumab (DPL) is approved as add-on therapy for severe asthma with type 2 inflammation. ProVENT is a prospective, non-interventional study of real-world DPL therapy for severe asthma in Germany, Austria, and Switzerland.

Objective: : To describe DPL treatment efficacy, safety, and remission after 2 years (y) in ProVENT.

Methods: : Since February 2020, ProVENT has included 399 patients (pts) ≥12 y with severe uncontrolled asthma; 259 pts had baseline (BL) and post-BL assessments, and 100 pts completed 2 y of therapy. Median (Q1–Q3) values are reported unless otherwise stated.

Results: : Among pts aged 56 (46–62) years (53% female), BL FeNO: 42 (25–72) ppb and total IgE: 160 (57–527) IU/mL, normalized rapidly at Month (Mo) 3 after DPL start (18 [13–26] ppb; 76 [35–395] IU/mL), remaining low until Y 2 (22 [12–26] ppb; 28 [11–65] IU/mL). Blood eosinophil levels were 320 (120–648) cells/μL at BL and 184 (160–640) cells/μL at Y 2. Asthma control steadily improved from BL to Y 2 (ACQ-5 decrease: 2.6 to 0.9 points; ACT increase: 14 to 22 points). Lung function quickly improved then stabilized (pre-bronchodilator [BD] forced expiratory volume in 1 second [FEV1] increase: 2.08 to 2.39 L BL to Mo 3; 2.36 L at Y 2). At Y 1 and Y 2, 89% of pts had no exacerbations (vs at least 50% with ≥1 exacerbation [median: 1.00] in the 2 y before DPL start). 56% of pts at Y 1 and 58% at Y 2 achieved remission (no oral corticosteroid use; no exacerbations; Asthma Control Test [ACT] ≥20 or Asthma Control Questionnaire [ACQ] ≤1.5; and pre-BD FEV1 ≥80% or reduced by ≤5% vs BL). Safety was in line with known DPL safety profile.

Conclusions: : Real-world DPL therapy sustainably improves asthma control, exacerbation rate, and lung function in pts with severe asthma, with 58% in remission after 2 y.

Sponsorship:: Sanofi and Regeneron Pharmaceuticals, Inc.