Investigating Efficacy of Atopic Dermatitis Systemic Therapeutics After Discontinuation Part I: Biologics.

Abstract

Objective: The authors sought to review published literature on the efficacy of biologics as monotherapy for atopic dermatitis (AD) following discontinuation.

Methods: A comprehensive search of PubMed/MEDLINE was conducted examining drug withdrawal in AD clinical trials where participants were treated with biologics. Trials were included if they exclusively involved participants with AD that reported the maintenance or achievement of Eczema Area and Severity Index (EASI)-75 and Investigator Global Assessment (IGA) scores of 0 or 1 after withdrawal of biologic therapy. Clinical trials involving multidrug regimens, including those investigating concomitant topical therapeutics, were excluded from our analysis.

Results: Five clinical trial programs met our inclusion criteria, each investigating a different biologic: dupilumab, tralokinumab, lebrikizumab, amlitelimab, and rocatinlimab.

Limitations: Limitations to this review include a small number of trials that met the inclusion criteria, variations in study design that hinder direct comparisons, and the absence of long-term follow up data.

Conclusion: The variability in eligibility criteria, treatment durations, and withdrawal periods across trials presents a major challenge in assessing biologics for AD, complicating the comparison of their sustained responses in the absence of head-to-head studies. This heterogeneity, combined with factors such as disease duration and prior use of systemic medications before trial enrollment, hampers the identification of key pathways in AD pathogenesis and impedes efforts to better understand and characterize the disease.