Atopic dermatitis: tralokinumab shows benefit in phase 2b trial

  • Wollenberg A & al.
  • J Allergy Clin Immunol
  • 12 Jun 2018

  • curated by Brian Richardson, PhD
  • Clinical Essentials
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Takeaway

  • Tralokinumab, an anti-interleukin (IL)-13 antibody, is associated with early and sustained improvements in patients with atopic dermatitis (AD) in a phase 2b study.

Why this matters

  • Tralokinumab represents a promising new treatment option for AD and is now in phase 3 trials.

Key results

  • Tralokinumab was associated with greater improvements in the Eczema Area Severity Index (EASI) compared with placebo at week 12 (adjusted mean difference, −4.94 [P=.01] for 300 mg and −4.36 [P=.03] for 150 mg).
  • Tralokinumab was nonsignificantly associated with a higher rate of Investigator’s Global Assessment response (0/1 score and reduction of ≥2 grades from baseline) at week 12 (26.7% vs 11.8% [P=.06] for 300 mg).
  • Tralokinumab was associated with higher rates of ≥50% improvement in EASI (EASI50, 73.4% vs 51.9% [P=.03] for 300 mg) and EASI75 (42.5% vs 15.5% [P=.003] for 300 mg) compared with placebo.
  • 17.6% of participants reported drug-related treatment-emergent adverse events.

Study design

  • 204 patients with AD were randomly assigned to receive tralokinumab 45 mg (n=50), 150 mg (n=51), 300 mg (n=52), or placebo (n=51) for 12 weeks with concomitant glucocorticoids and analyzed for efficacy and safety outcomes.
  • Funding: MedImmune, a member of the AstraZeneca Group.

Limitations

  • No active comparator.

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