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Am J Clin Dermatol. 2019 May 7. doi: 10.1007/s40257-019-00445-7. [Epub ahead of print]

Infections in Dupilumab Clinical Trials in Atopic Dermatitis: A Comprehensive Pooled Analysis.

Author information

1
Departments of Dermatology and Pediatrics, University of California, San Diego, San Diego, CA, 92123, USA. Leichenfield@rchsd.org.
2
Division of Pediatric and Adolescent Dermatology, Rady Children's Hospital, 3020 Children's Way, Mail Code 5092, San Diego, CA, 92123, USA. Leichenfield@rchsd.org.
3
Department of Dermatology and Allergy, Christine Kühne-Center for Allergy Research and Education, University of Bonn, Bonn, Germany.
4
Department of Dermatology, University of Rochester Medical Center, Rochester, NY, USA.
5
Department of Dermatology, Oregon Health and Science University, Portland, OR, USA.
6
Comprehensive Center for Inflammation Medicine, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.
7
University Medical Center Utrecht, Utrecht, The Netherlands.
8
Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark.
9
Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
10
Servicio de Dermatología, Hospital Universitario Germans Trias i Pujol, Badalona Universidad Autónoma de Barcelona, Barcelona, Spain.
11
University Hospital Schleswig-Holstein, Dermatology, Campus Kiel, Kiel, Germany.
12
Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
13
Sanofi, Bridgewater, NJ, USA.

Abstract

BACKGROUND:

Patients with moderate-to-severe atopic dermatitis (AD) have increased infection risk, including skin infections and systemic infections. Immunomodulators (e.g., anti-tumor necrosis factors, anti-interleukin [anti-IL]-23, anti-IL-17, Janus kinase inhibitors) increase risk of infections. Dupilumab (a monoclonal antibody blocking the shared receptor component for IL-4 and IL-13) is approved for inadequately controlled moderate-to-severe AD and for moderate-to-severe eosinophilic or oral corticosteroid-dependent asthma.

OBJECTIVE:

The aim was to determine the impact of dupilumab on infection rates in patients with moderate-to-severe AD.

METHODS:

This analysis pooled data from seven randomized, placebo-controlled dupilumab trials in adults with moderate-to-severe AD. Exposure-adjusted analyses assessed infection rates.

RESULTS:

Of 2932 patients, 1091 received placebo, 1095 dupilumab 300 mg weekly, and 746 dupilumab 300 mg every 2 weeks. Treatment groups had similar infection rates overall per 100 patient-years (placebo, 155; dupilumab weekly, 150; dupilumab every 2 weeks, 156; dupilumab combined, 152), and similar non-skin infection rates. Serious/severe infections were reduced with dupilumab (risk ratio 0.43; p < 0.05), as were bacterial and other non-herpetic skin infections (risk ratio 0.44; p < 0.001). Although herpesviral infection rates overall were slightly higher with dupilumab than placebo, clinically important herpesviral infections (eczema herpeticum, herpes zoster) were less common with dupilumab (risk ratio 0.31; p < 0.01). Systemic anti-infective medication use was lower with dupilumab.

CONCLUSIONS:

Dupilumab is associated with reduced risk of serious/severe infections and non-herpetic skin infections and does not increase overall infection rates versus placebo in patients with moderate-to-severe AD. CLINICALTRIALS.

GOV IDENTIFIERS:

NCT01548404, NCT02210780, NCT01859988, NCT02277743, NCT02277769, NCT02260986, and NCT02755649.

PMID:
31066001
DOI:
10.1007/s40257-019-00445-7

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