Assessment of Efficacy and Safety Outcomes Beyond Week 16 in Clinical Trials of Systemic Agents Used for the Treatment of Moderate to Severe Atopic Dermatitis in Combination with Topical Corticosteroids

Authors

Jonathan I. Silverberg, Department of Dermatology, George Washington University School of Medicine, Washington, DC, USA. jsilverberg@mfa.gwu.edu.
April Armstrong, Department of Dermatology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
Andrew Blauvelt, Oregon Medical Research Center, Portland, OR, USA.
Kristian Reich, Center for Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg, Eppendorf, Hamburg, Germany.

Document Type

Journal Article

Publication Date

9-11-2023

Journal

American journal of clinical dermatology

DOI

10.1007/s40257-023-00809-0

Abstract

Atopic dermatitis (AD) is a chronic inflammatory disease requiring efficacious and safe long-term therapy. Several new systemic treatments have recently been approved for use in patients with moderate to severe AD. However, head-to-head comparisons have not been conducted for all the currently available treatments for AD. Multiple network meta-analyses have compared efficacy of these different therapies during the initial 16-week treatment period, but not beyond week 16. Therefore, understanding the differences in key trial design and statistical methods is essential for evaluating long-term efficacy, making cross-trial comparisons, and informing treatment decisions. This focused narrative review provides an overview of data and trial methodology to guide clinicians in evaluating longer-term efficacy and safety of currently approved systemic treatments for patients with AD. We discuss important elements of longer-term trial designs and statistical analysis strategies that should be considered based on our experience as clinical trialists. In addition, a summary of key efficacy results of published, longer-term, phase III clinical trials of US Food and Drug Administration-approved, novel systemic treatments (i.e., dupilumab, tralokinumab, abrocitinib, and upadacitinib) is provided, including the design and data handling methods used. Long-term safety considerations and differences in the time-effect and safety profiles of various medications are also noted to help inform clinical decisions for individual patients. Overall, the findings of these trials support efficacy in long-term treatment with novel systemic agents for patients with AD.

APA Citation

Silverberg, Jonathan I.; Armstrong, April; Blauvelt, Andrew; and Reich, Kristian, "Assessment of Efficacy and Safety Outcomes Beyond Week 16 in Clinical Trials of Systemic Agents Used for the Treatment of Moderate to Severe Atopic Dermatitis in Combination with Topical Corticosteroids" (2023). GW Authored Works. Paper 3429.
https://hsrc.himmelfarb.gwu.edu/gwhpubs/3429

Department

Dermatology