Incidence of autoimmune diseases in children with atopy treated with dupilumab

Background: The type 2 inflammation-blocking agent dupilumab has gained traction as an effective treatment of multiple atopic diseases. New-onset autoimmune manifestations have been infrequently reported in dupilumab-treated atopic patients, primarily among adults. Autoimmune outcomes in atopic children on dupilumab are less clear. Objective: We aimed to determine if dupilumab treatment of atopic children is associated with increased autoimmune or autoinflammatory disease diagnosis risk. Methods: Using a multi-institutional electronic health record database composed of 10 PEDSnet academic health systems, we performed a retrospective cohort study of children aged 6-17 with atopy (ie, moderate-to-severe atopic dermatitis and/or persistent asthma, as defined by diagnosis codes and prescriptions) with or without (n = 4,189 and n = 4,195 in inverse-probability-of-treatment–weighted cohorts, respectively) dupilumab prescription between October 1, 2018, and November 29, 2023. Poisson regression estimated autoimmune disease incidence rates and rate differences, and Cox proportional hazards models estimated relative associations between dupilumab exposure and disease diagnosis. Results: Among atopic children, the adjusted incidence rate difference (dupilumab-treated minus untreated) for any autoimmune disease was 2.47 (95% confidence interval, 0.82, 4.30) per 1,000 person-years, driven primarily by cutaneous autoimmune diseases (rate difference, 2.20 [95% confidence interval 0.77, 3.70] per 1,000 person-years). The rates of any or cutaneous autoimmune disease within 4 years of dupilumab treatment were 1.45-fold and 1.57-fold higher, respectively, in treated compared with untreated atopic children. Conclusion: We detected a modest association between dupilumab and cutaneous autoimmune disease diagnosis in atopic children. These findings help address knowledge gaps about clinical outcomes in atopic children treated with this biologic.