Scholarlink

Introduction <p>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.</p> Methods <p>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.</p> Results <p>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.</p> Conclusions <p>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.</p> <p>Graphical abstract available for this article.</p> Trial Registration <p>ClinicalTrials.gov Identifier: NCT01949311, NCT02260986.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Long-Term Dupilumab Treatment Is Not Associated with an Increased Overall Risk of Infections in Adults with Moderate-to-Severe Atopic Dermatitis: Results from an Open-Label 5-Year Extension Study

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年4月18日

查看全文
  • Lisa A. Beck,
  • Eric L. Simpson,
  • Diamant Thaçi,
  • Marjolein de Bruin-Weller,
  • Mette Deleuran,
  • Yoko Kataoka,
  • Andrew Blauvelt,
  • Andreas Wollenberg,
  • Lawrence F. Eichenfield,
  • Faisal A. Khokhar,
  • Anna Coleman,
  • Michael Van Spall,
  • Yonghao Ma,
  • Elena Avetisova,
  • Annie Zhang,
  • Tien V. Nguyen

摘要

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.