IgE Depletion With Ligelizumab Does Not Significantly Improve Clinical Symptoms in Patients With Moderate-to-Severe Atopic Dermatitis.

BACKGROUND: The value, if any, of anti-IgE approaches in the treatment of atopic dermatitis (AD) has not been fully clarified. Studies using the anti-IgE omalizumab have yielded conflicting results.

OBJECTIVE: Antibodies with an IgE-suppressive capacity stronger than omalizumab might be more efficacious.

STUDY DESIGN: We assessed safety and efficacy of the high-affinity anti-IgE antibody ligelizumab (280mg s.c., every other week) in 22 adult patients with moderate-to-severe atopic dermatitis in a placebo and active (cyclosporine A) controlled, randomized, multicenter, double-blind clinical trial for twelve weeks.

RESULTS: We found that ligelizumab treatment resulted in either complete (patients with baseline IgE<1500IU/ml) or partial (baseline IgE>1500IU/ml) suppression of serum and cell-bound IgE as well as of allergic skin prick tests. On the other hand, ligelizumab- as opposed to cyclosporine A -was not significantly superior to placebo in inducing Eczema Area and Severity Index 50 response or significantly reducing pruritus and sleep disturbance. Interestingly though, patients with high baseline IgE exhibited a slightly, but not significantly better treatment response than those with low baseline IgE.

CONCLUSION: Our study shows that an immunologically efficacious anti-IgE approach is not clearly superior to placebo in treating AD. Larger studies are needed to determine whether certain patient subgroups may benefit from this strategy.

TRIAL REGISTRATION: The study was registered in 2011 at clinicaltrialsregister.eu, EudraCT Number 2011-002112-84.

Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.

PMID: 37004878