Nemolizumab for Atopic Dermatitis



Title: Anti–Interleukin-31 Receptor A Antibody for Atopic Dermatitis

Ruzicka, Thomas et al.


 

What You Need to Know:

All monthly doses of nemolizumab, a humanized antibody against interleukin-31 receptor A, significantly improved pruritus in patients with moderate-to-severe atopic dermatitis.

Trial Design:

  • Phase 2, randomized, double-blind, placebo-controlled, 12-week trial assessed the safety and efficacy of nemoliuzumab (CIM331) for the treatment of atopic dermatitis
  • 264 adults with moderate-to-severe atopic dermatitis inadequately controlled by topical treatments enrolled
  • Patients randomized to SC nemolizumab 0.1mg/kg, 0.5mg/kg, or 2.0mg/kg or placebo every 4 weeks or an exploratory dose of nemolizumab 2.0mg/kg every 8 weeks
  • Primary endpoint was the percentage improvement from baseline in the score on the pruritus visual-analog scale at Week 12
  • Secondary endpoints included changes in score on the Eczema Area and Severity Index (EASI) and body-surface area of atopic dermatitis

Key Outcomes:

  • 82% of patients (216/264) completed the study
  • At Week 12, patients taking nemolizumab every 4 weeks had changes on the pruritus visual-analog scale of -43.7% (0.1mg group), -59.8% (0.5mg group), and -63.1% (2.0mg group) vs. -20.9% (placebo)
  • Changes in EASI were −23.0% (0.1mg group), −42.3% (0.5mg group), and −40.9% (2.0mg group) vs. −26.6% (placebo), respectively
  • Changes in body-surface area affected by atopic dermatitis were −7.5% (0.1mg group), −20.0% (0.5mg group), and −19.4% (2.0mg group) with nemolizumab vs. −15.7% (placebo), respectively
  • Treatment discontinuations occurred in 17% of the nemolizumab 0.1mg and 0.5mg groups, and in 13% of the 2.0mg group vs. 17% in the placebo group