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Lisa A Beck¹, Eric L Simpson², Diamant Thaçi³

¹Department of Dermatology, University of Rochester Medical Center, Rochester, NY, USA. Lisa_Beck@URMC.Rochester.edu.

Advances in Therapy

|April 18, 2026

Abstract

Introduction:

Patients with atopic dermatitis (AD) are at an increased risk for infections. Here, we report a confirmatory follow-up study analyzing the incidence of infections in adults with moderate-to-severe AD treated with dupilumab for up to 5 years.

Methods:

Infections in adults with moderate-to-severe AD treated with dupilumab 300 mg weekly (qw) or every 2 weeks (q2w; approved regimen) were assessed for up to 5 years in the open-label extension study, LIBERTY AD OLE. Topical corticosteroids (TCS) and calcineurin inhibitors (TCI) were permitted. Exposure-adjusted incidence rates [number of patients with at least one event per 100 patient-years (nP/100 PY)] are reported. Since the OLE had no control arm, safety results from the placebo + TCS arm of the 1-year LIBERTY AD CHRONOS study are included for comparisons.

Results:

Of the 2677 patients included, 2207 (82.4%) completed up to week 52, 557 (20.8%) up to week 148, and 334 (12.5%) up to week 260; 226 patients (8.4%) switched from qw to q2w during the trial due to a protocol amendment. Overall infections (70.69 nP/100 PY), serious infections (0.87 nP/100 PY), severe infections (0.92 nP/100 PY), and infections leading to treatment discontinuation (0.34 nP/100 PY) were consistent with previous 4-year open-label extension (OLE) analyses and were low compared with 1-year results from the CHRONOS placebo + TCS arm. The cumulative number of patients with treatment-emergent serious or severe infections, non-herpetic or herpetic infections, and total skin infections decreased throughout the OLE study period. Limitations of this study include the absence of a placebo arm in the OLE, decreasing sample size at later time points, inclusion of qw dosing analyses (different from approved q2w dosing), and possible confounding effects of TCS/TCI use that may impact infection rates.

Conclusions:

Long-term dupilumab treatment for up to 5 years in adults with moderate-to-severe AD is not associated with an increased overall risk of infections. Graphical abstract available for this article.

Trial Registration:

ClinicalTrials.gov Identifier: NCT01949311, NCT02260986.

Insights

Long-term dupilumab treatment in adults with moderate-to-severe atopic dermatitis (AD) did not increase the overall risk of infections over five years. This study confirms the safety profile of dupilumab for AD patients regarding infection incidence.

Area of Science:

Dermatology
Immunology
Pharmacology

Background:

Atopic dermatitis (AD) patients face heightened infection risks.
Dupilumab is a biologic treatment for moderate-to-severe AD.
Understanding long-term infection risk with dupilumab is crucial for patient safety.

Purpose of the Study:

To assess the incidence of infections in adults with moderate-to-severe AD treated with dupilumab for up to 5 years.
To compare infection rates with historical data from a placebo group.

Main Methods:

A 5-year open-label extension study (LIBERTY AD OLE) evaluated infections in adults with moderate-to-severe AD receiving dupilumab.
Exposure-adjusted incidence rates were calculated.
Safety data from the CHRONOS study placebo arm were used for comparison.

Main Results:

Overall infections, serious infections, and severe infections remained low and consistent with previous analyses.
Infection rates were lower compared to the CHRONOS study's placebo group.
The cumulative number of patients experiencing infections decreased over the study period.

Conclusions:

Long-term dupilumab treatment (up to 5 years) in adults with moderate-to-severe AD is not associated with an increased overall risk of infections.
The safety profile of dupilumab regarding infection risk is maintained over extended treatment durations.

Read full analysis

Keywords:

Atopic dermatitis Dupilumab Infections

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