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

Kevin Sheng-Kai Ma, B. Brumbaugh, R. Saff, W. Phipatanakul, Serena Yun-Chen Tsai, M. Westmeijer, A. Holt, J. Ebriani et al.

European Respiratory Journal, 2025

29 citations

Abstract

Graphical abstract Summary of the study findings. IL4-R: interleukin-4 receptor; ICS: inhaled corticosteroids; LABA: long-acting β-agonists; NK: natural killer. Created with BioRender.com. 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…

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Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.

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