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Conjunctivitis in dupilumab clinical trials

British Journal of Dermatology · 2019 · Vol. 181(3) · pp. 459–473
Bolanle AkinladeEmma Guttman‐YasskyMarjolein de Bruin‐WellerEric L. SimpsonAndrew BlauveltMichael J. CorkErrol P. PrensPenny A. AsbellEsen K. AkpekJonathan CorrenClaus BachertIkuo HiranoJonathan WeyneAndrew KorotzerZ. ChenThomas HultschXiaoping ZhuJohn D. DavisLeda MannentJennifer D. HamiltonAriel TeperHeribert StaudingerE. RizovaGianluca PirozziNeil M.H. GrahamBrad ShumelMarius ArdeleanuAndreas Wollenberg

Abstract

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, the incidence of conjunctivitis was associated with AD severity and prior history of conjunctivitis. The aetiology and treatment of conjunctivitis in dupilumab-treated patients require further study. What's already known about this topic? Ocular disorders, including allergic conjunctivitis, are common in patients with atopic dermatitis (AD). In most dupilumab AD trials, dupilumab-treated patients had higher conjunctivitis incidence than those receiving placebo. Most cases were mild to moderate and recovered or were recovering during study treatment; study treatment discontinuation due to conjunctivitis was rare. Conjunctivitis incidence was very low and similar for dupilumab and placebo in clinical trials in asthma, chronic rhinosinusitis with nasal polyps and eosinophilic oesophagitis. What does this study add? This analysis confirms and extends the results of the individual clinical trials. Baseline disease-related factors, including AD severity, prior conjunctivitis history and certain biomarkers (thymus and activation-regulated chemokine, IgE, eosinophils), were associated with increased incidence of conjunctivitis. Patients who responded well to dupilumab had reduced incidence of conjunctivitis. Further study is needed to elucidate the aetiology and treatment of conjunctivitis in dupilumab-treated patients with AD.

Dermatology and Skin DiseasesAsthma and respiratory diseasesAllergic Rhinitis and SensitizationDupilumabMedicinePlaceboNasal polypsAtopic dermatitisIncidence (geometry)DermatologyClinical trialAllergic conjunctivitisAsthma

MeSH terms

AdultAsthmaConjunctivitisDermatitis, AtopicHumansNasal PolypsPlacebosRhinitisRisk FactorsSeverity of Illness IndexSinusitisIncidenceRandomized Controlled Trials as TopicInterleukin-4 Receptor alpha SubunitYoung Adult

Funding

  • Sanofi
  • Regeneron Pharmaceuticals
  • Sanofi Genzyme
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