Comparative safety of systemic immunomodulatory medications in adults with atopic dermatitis.

Abstract

Severe atopic dermatitis (AD) is increasingly treated with systemic immunomodulatory drugs, yet their safety is unclear. We evaluated the comparative risk of serious bacterial and opportunistic infections among patients with severe AD using systemic immunomodulatory medications in routine care. In a population-based claims data study, we identified adult patients with AD who were treated with systemic drugs. The incidence of serious bacterial and opportunistic infections leading to hospitalization was computed by using International Classification of Disease diagnosis codes. Relative risks (RRs) were computed after 1-to-1 propensity score matching. Up to 232,611 patients with AD were eligible. The incidence of serious infections was 7.53 (7.18-7.89) risk per 1,000 patients among systemic nonbiologic-treated patients, 7.38 (5.68-9.57) risk per 1,000 patients among phototherapy-treated patients, and 2.6 (0.45-14.3) risk per 1,000 patients among dupilumab users. After matching, cyclosporine had a significantly reduced 6-month risk (RR 0.87) and prednisone (RR 1.78), azathioprine (RR 1.89), and mycophenolate (RR 3.31) showed increased risks compared with methotrexate. A small number of dupilumab users showed no increased risk (RR 0.33, 95% confidence interval 0.03-3.20). Some comparisons involved small population sizes. In this population-based study of adult AD patients, cyclosporine and methotrexate have the lowest 6-month risks of serious infections. Increased risks were observed for prednisone, azathioprine, and mycophenolate relative to methotrexate.