Dupilumab and lymphoma risk among patients with asthma: a population-based cohort study

Abstract

Background Dupilumab is approved for the treatment of atopic dermatitis, asthma, and other allergic diseases. Recent studies suggest that patients with atopic dermatitis receiving dupilumab are at a higher risk of developing cutaneous lymphoma. This study aimed to investigate the risk of lymphoma among patients with asthma receiving dupilumab. Methods This population-based cohort study included patients in the United States with asthma who initiated dupilumab or the active comparator (combination therapy with inhaled corticosteroids (ICS) plus long-acting β-agonists (LABA), or ICS/LABA), between 2018 and 2024. Propensity score matching was used to balance baseline characteristics between groups. The primary outcome was new-onset lymphoma, and secondary outcomes included other malignancies and all-cause mortality. Results A total of 14 936 dupilumab-treated and 734 126 ICS/LABA-treated patients with asthma were included. After propensity score matching, dupilumab-treated patients were found to have a higher risk of lymphoma (54 versus 43 cases, hazard ratio (HR) 1.79, 95% CI 1.19–2.71), especially T-cell and natural killer (NK)-cell lymphomas (19 versus ≤10 cases, HR 4.58, 95% CI 1.82–11.53). There was no significant difference in incidence of other malignant neoplasms. Dupilumab was also associated with significantly lower all-cause mortality (328 versus 793 deaths, HR 0.65, 95% CI 0.57–0.74). Conclusions Dupilumab treatment was associated with lower all-cause mortality among patients with asthma, despite increased risk of lymphoma, particularly T-cell and NK-cell lymphomas. These findings highlight the need for long-term surveillance and further research into the immunological mechanisms underlying dupilumab-associated lymphoma in asthma.