No Increased Risk of Overall Infection in Adults with Moderate-to-Severe Atopic Dermatitis Treated for up to 4 Years with Dupilumab

Andrew Blauvelt, Andreas Wollenberg, Lawrence F Eichenfield, Haixin Zhang, Debra Sierka, Faisal A Khokhar, Jignesh Vakil, Arsalan Shabbir, Ainara Rodríguez Marco, Sonya L Cyr, Andrew Blauvelt, Andreas Wollenberg, Lawrence F Eichenfield, Haixin Zhang, Debra Sierka, Faisal A Khokhar, Jignesh Vakil, Arsalan Shabbir, Ainara Rodríguez Marco, Sonya L Cyr

Abstract

Introduction: Patients with atopic dermatitis (AD) have an increased risk for infections. This open-label extension study, LIBERTY AD OLE, reports the incidence of infections in adults with moderate-to-severe AD treated with dupilumab for up to 4 years.

Methods: We evaluated infections in adults with moderate-to-severe AD treated with dupilumab 300 mg weekly (qw) or every 2 weeks (q2w; approved regimen) for up to 4 years. 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.

Results: Overall, 2677 patients were enrolled and treated with dupilumab: 352 (13.1%) completed up to week 204; 226 patients (8.4%) switched from qw to q2w during the trial. Rates of overall infections (71.27 nP/100 PY), serious and/or severe infections (1.39 nP/100 PY), and infections leading to discontinuation (0.34 nP/100 PY) were consistent with a previous 3-year analysis of this study and low compared with 1-year results in adults with AD treated with placebo + TCS. The cumulative number of patients with treatment-emergent serious or severe infections, non-herpetic or herpetic infections, and total skin infections decreased year-over-year. Limitations included open-label study design with no placebo arm; decreasing sample size at later time points due to sponsor decision to close sites following regulatory approval; qw dosing differs from approved q2w dosing; and patients could use TCS/TCI throughout the study, which may have impacted infection rates.

Conclusions: Continuous long-term dupilumab treatment in adults with moderate-to-severe AD is not associated with an increased risk of overall systemic or cutaneous infections.

Trial registration: ClinicalTrials.gov Identifier: NCT01949311. Video Abstract INFOGRAPHIC.

Keywords: Adults; Atopic dermatitis; Clinical trials; Dupilumab; Infections; Long-term; Safety.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
a Cumulative number of patients with treatment-emergent serious or severe infections per 100 PY through each time point. Data presented are reported under the SOC “Infections and Infestations.” b Cumulative number of patients with treatment-emergent non-herpetic skin infections per 100 PY through each time point. Data presented are reported under the SOC “Infections and Infestations.” c Cumulative number of patients with treatment-emergent herpes viral infections per 100 PY through each time point. Data presented are reported under the MedDRA HLT “Herpes viral infections.” d Cumulative number of patients with treatment-emergent skin infections (herpes viral infections + non-herpetic skin infections) per 100 PY through each time point. Data presented are herpes viral infections (reported under the MedDRA HLT “Herpes viral infections”) + non-herpetic skin infections (adjudicated PTs reported under the SOC “Infections and Infestations”). HLT high level term, MedDRA Medical Dictionary for Regulatory Activities, nP number of patients with an event, nP/100 PY number of patients with ≥ 1 event per 100 PY, PT preferred term, PY patient-years, qw weekly, SOC system organ class

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