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Clinical Summary

Atopic dermatitis: dupilumab not tied to infection in pooled analysis

Takeaway

  • Dupilumab (Dupixent) does not increase overall infection risk and is associated with reduced risk for serious/severe infection in patients with atopic dermatitis (AD), according to pooled data from 7 randomized controlled trials.

Why this matters

  • Other immunomodulators have been linked to increased infection risk.

Key results

  • Dupilumab and placebo were associated with similar rates of overall infection (rates given per 100 patient-years):
    • 150 for dupilumab weekly.
    • 156 for dupilumab every 2 weeks.
    • 152 for dupilumab combined.
    • 155 for placebo.
  • Dupilumab and placebo were associated with similar risk for overall infection (risk ratio [RR], 1.00; P=.98) and nonskin infection (RR, 1.06; P=.33).
  • Dupilumab was associated with reduced risk for serious/severe infection (RR, 0.43; P=.02), bacterial/other nonherpetic skin infections (RR, 0.44; P<.001), and clinically important herpesviral infection (eczema herpeticum, herpes zoster; RR, 0.31; P=.004).

Study design

  • 2932 patients with AD, 1095 treated with dupilumab 300 mg weekly, 746 with dupilumab 300 mg every 2 weeks, and 1091 with placebo, were included.
  • Funding: Sanofi, Regeneron Pharmaceuticals, Inc.

Limitations

  • Higher dropout rate in placebo group.
  • No accounting for effects of rescue medication.

References


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