Appraisal of the Real-World Effectiveness of Biologic Therapies in Aspirin-Exacerbated Respiratory Disease.

Abstract

BACKGROUND\nThere are no head-to-head studies for patients with aspirin-exacerbated respiratory disease (AERD) comparing any of the five FDA approved respiratory biologic therapies.\n\n\nOBJECTIVE\nExplore outcomes in AERD subjects using biologic therapies in a real-world clinic setting.\n\n\nMETHODS\nA retrospective pilot study was conducted for AERD subjects who had been prescribed omalizumab (anti-Ig-E), mepolizumab (anti-IL-5), reslizumab (anti-IL-5), benralizumab (anti-IL-5Rα), or dupilumab (anti-IL-4Rα). Clinical outcomes pre- versus post-initiation of biologic therapy were explored including symptoms, 22-item sino-nasal outcome test (SNOT-22) scores, systemic corticosteroid (CS) and antibiotic prescriptions, and emergency room (ER) visits related to AERD.\n\n\nRESULTS\nOf the N = 74 subjects, 58.1% (n = 43) had used one biologic, though many (41.9%, n = 31) trialed more than one biologic. Of the n = 50 subjects who had used anti-IL-4Rα therapy, 98% (49/50) still had this therapy prescribed at study completion compared to 48.6% (17/35) and 26.9% (7/26) of those who used anti-IgE and anti-IL-5/IL-5Rα therapies, respectively. Among those on anti-IL-4Rα therapy, there was a significant reduction in median total SNOT-22 scores (51 to 19, p=0.0002), CS bursts (2 to 0, p<0.0001) and median number of antibiotics courses for respiratory disease (1 to 0, p=0.0469) pre-versus post-biologic initiation. No statistically significant difference in those outcomes was observed for individuals on anti-IgE or anti-IL-5/IL-5Rα therapy.\n\n\nCONCLUSION\nAnti-IL-4Rα therapy led to significantly higher rates of clinical improvement in AERD when compared to anti-IL-5/IL-5Rα and anti-IgE biologic therapies. Prospective studies would help clarify best practices for the use of biologic therapies in AERD.