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Br J Dermatol. 2019 Mar 9. doi: 10.1111/bjd.17869. [Epub ahead of print]

Conjunctivitis in dupilumab clinical trials.

Author information

1
Regeneron Pharmaceuticals, Inc.,, Tarrytown, NY, USA.
2
Department of Dermatology, Icahn School of the Medicine at Mount Sinai Medical Center, New York, NY, USA.
3
Department of Dermatology & Allergology, University Medical Center Utrecht, Utrecht, The Netherlands.
4
Department of Dermatology, Oregon Health & Science University, Portland, OR, USA.
5
Oregon Medical Research Center, Portland, OR, USA.
6
Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Disease, The University of Sheffield Medical School, Sheffield, UK.
7
Department of Dermatology, Erasmus MC, Rotterdam, The Netherlands.
8
Hamilton Eye Institute, University of Tennessee Health Science Center, Memphis, TN, USA.
9
Wilmer Eye Institute at Johns Hopkins University School of Medicine, Baltimore, MD, USA.
10
David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
11
ENT Department, Ghent University Hospital, Ghent, Belgium.
12
Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden.
13
Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
14
Sanofi Genzyme, Cambridge, MA, USA.
15
Sanofi R&D, Chilly-Mazarin, France.
16
Sanofi, Bridgewater, NJUSA.
17
Ludwig-Maximilian University, Munich, Germany.

Abstract

BACKGROUND:

Dupilumab, which blocks the shared receptor component for interleukin (IL)-4 and IL-13, is approved for inadequately-controlled moderate-to-severe atopic dermatitis (AD) and moderate-to-severe eosinophilic or oral corticosteroid-dependent asthma. AD trials reported increased conjunctivitis incidence for dupilumab vs. placebo.

OBJECTIVES:

To further characterise conjunctivitis occurrence and risk factors in dupilumab clinical trials. Methods We evaluated randomised placebo-controlled trials of dupilumab in AD (n=2629), asthma (n=2876), chronic rhinosinusitis with nasal polyps (CRSwNP) (n=60), and eosinophilic esophagitis (EoE) (n=47).

RESULTS:

In most AD trials, dupilumab-treated patients had higher conjunctivitis incidence than placebo controls. Higher baseline AD severity and previous conjunctivitis history were associated with increased conjunctivitis incidence. Conjunctivitis was mostly mild to moderate. Most cases recovered/resolved during the treatment period; 2 patients permanently discontinued dupilumab due to conjunctivitis/keratitis. Common treatments included ophthalmic corticosteroids, antibiotics, and anti-histamines/mast cell stabilisers. Most cases were diagnosed by investigators. In asthma and CRSwNP trials, conjunctivitis incidence was lower for both dupilumab and placebo than in AD trials; dupilumab did not increase incidence vs. placebo. In the EoE trial, no patients had conjunctivitis.

CONCLUSIONS:

Conjunctivitis was more frequent with dupilumab treatment in most AD trials. In dupilumab trials in other type 2 diseases, incidence of conjunctivitis was overall very low, and was similar for dupilumab and placebo. In AD, conjunctivitis incidence was associated with AD severity and prior history of conjunctivitis. The aetiology and treatment of conjunctivitis in dupilumab-treated patients require further study. This article is protected by copyright. All rights reserved.

KEYWORDS:

Dupilumab; asthma; atopic dermatitis; conjunctivitis; nasal polyps

PMID:
30851191
DOI:
10.1111/bjd.17869

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