Comparative Safety of Systemic Immuno-modulatory Medications in Adults with Atopic Dermatitis.


Department of Dermatology and Department of Medicine, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital; Harvard Medical School, Boston, MA. Electronic address: [Email]


BACKGROUND : Severe atopic dermatitis (AD) is increasingly treated with systemic immuno-modulatory drugs yet their safety is unclear.
OBJECTIVE : We evaluated the comparative risk of serious bacterial and opportunistic infections among users of systemic immuno-modulatory medications in patients with severe AD in routine care.
METHODS : 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 using ICD diagnosis codes. Relative risks were computed after 1:1 propensity score matching.
RESULTS : Up to 232,611 patients with AD were eligible. The incidence of serious infections was 7.53 per 1,000 (7.18-7.89) among systemic non-biologics and 7.38 per 1,000 (5.68-9.57) among phototherapy treated patients, and 2.6 per 1,000 (0.45-14.3) dupilumab users. After matching, compared to methotrexate, cyclosporine had significantly reduced 6-month risk (RR=0.87), while prednisone, azathioprine and mycophenolate showed increased risks (RR= 1.78, 1.89 and 3.31, respectively). Small numbers of dupilumab users showed no increase in risk (RR=0.33; 0.03 - 3.20).
CONCLUSIONS : 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.


Atopic dermatitis,adult atopic dermatitis,epidemiology,immuno-modulating drugs,opportunistic infections,safety,serious bacterial infections,systemic medications,

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