An 18-week randomized, double-blind, placebo-controlled crossover trial evaluated aspirin (600 mg/day) after desensitization (ATAD) in 14 AERD patients and 13 healthy controls over 8-week treatment arms, assessing clinical response, predictive biomarkers, and molecular effects via blood, sputum, nasal lavage, and urine samples.
57.1% of AERD patients (8/14) responded to aspirin, but the same proportion responded to placebo with substantial overlap; higher baseline sputum SERPINB9 expression independently predicted clinical improvement (OR 62.3; p-adj=0.03). No consistent molecular changes were seen after either treatment.
Very small sample size (n=14 AERD, n=13 controls) limits statistical power and generalizability. The response rate to aspirin equaled that of placebo, raising questions about true treatment effect. SERPINB9 as a biomarker requires validation in larger, independent cohorts.
ATAD did not outperform placebo for clinical improvement in this small trial, so clinicians should temper expectations for high-dose aspirin as a broadly effective AERD treatment. Baseline sputum SERPINB9 expression is a candidate biomarker worth investigating to identify which AERD patients are most likely to benefit.
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