Comparative safety of systemic immunomodulatory medications in adults with atopic dermatitis

J Am Acad Dermatol. 2021 Aug;85(2):321-329. doi: 10.1016/j.jaad.2019.05.073. Epub 2019 May 31.

Abstract

Background: Severe atopic dermatitis (AD) is increasingly treated with systemic immunomodulatory drugs, yet their safety is unclear.

Objective: We evaluated the comparative risk of serious bacterial and opportunistic infections among patients with severe AD using systemic immunomodulatory medications 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 by using International Classification of Disease diagnosis codes. Relative risks (RRs) were computed after 1-to-1 propensity score matching.

Results: 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).

Limitations: Some comparisons involved small population sizes.

Conclusion: 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.

Keywords: adult atopic dermatitis; atopic dermatitis; epidemiology; immunomodulating drugs; opportunistic infections; safety; serious bacterial infections; systemic medications.

Publication types

  • Comparative Study

MeSH terms

  • Adult
  • Aged
  • Bacterial Infections / epidemiology
  • Bacterial Infections / etiology*
  • Cohort Studies
  • Dermatitis, Atopic / drug therapy*
  • Female
  • Humans
  • Immunologic Factors / adverse effects
  • Immunologic Factors / therapeutic use*
  • Incidence
  • Male
  • Middle Aged
  • Opportunistic Infections / epidemiology
  • Opportunistic Infections / etiology*
  • Risk Assessment
  • Severity of Illness Index

Substances

  • Immunologic Factors