D1.139 - Dupilumab was Effective in Black and Non-Black Patients with Asthma Completing 1 Year of the RAPID Registry

Dupilumab, a fully human monoclonal antibody that blocks IL-4 and IL-13 signaling, has shown efficacy and safety in uncontrolled, moderate-to-severe asthma; however, real-world evidence across racial subgroups remains limited. This analysis evaluated dupilumab efficacy and safety over 12 months in Black vs non-Black patients from the RAPID registry.

The global, prospective RAPID registry (NCT04287621) includes patients ≥12 years initiating dupilumab for asthma in clinical practice. This interim analysis included Black and non-Black patients with ≥12 months of follow-up. Baseline characteristics and 12-month outcomes were summarized descriptively, including severe exacerbation rate, pre-BD ppFEV₁, ACQ-6 and MiniAQLQ responder rates, and safety.

643 patients were analyzed (Black, N=86; non-Black, N=557). Of these, 11.6% (Black) and 6.6% (non-Black) were aged ≥12 to <18 years. Former smokers comprised 14% and 23.9%, respectively; among smokers, 14.3% vs 2.0% consumed  2-3 packs/day. The majority (Black: 93%; non-Black: 93.9%) had a history of type 2 inflammatory conditions. Mean (SD) baseline characteristics in Black vs non-Black patients were: BMI, 32.7 (8.9) vs 29.3 (7.4) kg/m²; pre-BD ppFEV₁, 70.7% (20.9) vs 77.3% (22.9); age at asthma diagnosis, 26.4 (21.8) vs 31.5 (22.1) years; asthma duration, 17.7 (15.7) vs 20.2 (17.9) years; and ACQ-6 score, 2.4 (1.2) in both groups. Severe exacerbations in the prior year averaged 2.3 (3.5) vs 2.2 (3.3).

Over the first 12 months, most patients (Black: 84.9%; non-Black: 83.1%) did not experience a severe exacerbation, while 15.1% vs 16.9% had ≥1 severe exacerbation (unadjusted annualized rate, 0.234 vs 0.255). Data for pre-BD ppFEV₁ change were available for 10 Black and 132 non-Black patients; mean (SD) pre-BD ppFEV₁ change from baseline was +6.3 (35.8) vs +6.4 (14.5) percentage points, respectively. At Month 12, 60.0% vs 62.0% achieved a reduction from baseline of ACQ-6 ≥0.75, 46.7% vs 34.4% achieved a reduction from baseline of ACQ-6 >1.5, and 67.4% vs 71.6% achieved MiniAQLQ ≥0.5-point increase. AEs leading to permanent treatment discontinuation occurred in 4.7% (4/86) vs 4.0% (22/553), respectively.

Baseline characteristics were largely comparable between Black and non-Black patients from RAPID, except for a higher BMI and lower lung function in Black patients. Dupilumab was effective and well-tolerated in both subgroups during the first year of RAPID.