key: cord-354902-t9df8vhc
authors: Kearns, Donovan G.; Uppal, Shelley; Chat, Vipawee S.; Wu, Jashin J.
title: Assessing the risk of dupilumab use for atopic dermatitis during the COVID-19 pandemic
date: 2020-06-10
journal: J Am Acad Dermatol
DOI: 10.1016/j.jaad.2020.06.015
sha: 
doc_id: 354902
cord_uid: t9df8vhc

nan

In the midst of the COVID-19 pandemic, physicians are using what's known of the SARS-CoV-2 2 virus to establish practice guidelines for dermatologic conditions, particularly in regard to the 3 use of immunosuppressive medications. 1 The effect of immunosuppressive medications on the 4 clinical course of COVID-19 infection is currently unclear. While there is some evidence to 5 support the use of targeted immunosuppressive medications against cytokine storm, there is 6

concern that patients treated with biologic medications may have worse outcomes. 1 Though 7

knowledge regarding the risk of biologic use during the COVID-19 pandemic is extremely 8 limited, we can use data from previous trials to extrapolate a medication's potential risk based on 9

its infection rate when compared to placebo. 10 Dupilumab, an interleukin 4 alpha receptor antagonist that inhibits IL-4 and IL-13 signaling, is a 11 treatment for patients >12 years with moderate to severe atopic dermatitis (AD). Interleukin-4 12

(IL-4) is critical in mediating Th2 polarization and regulating humoral immunity. 2 Given that IL-13 4 and IL-13 are significant in orchestrating and maintaining adaptive immunity, we sought to 14

identify and address the risks associated with dupilumab use during the COVID-19 pandemic. 15 16

In three randomized, placebo-controlled phase III clinical trials (SOLO 1, SOLO 2, and 18 CHRONOS), adults with moderate-to-severe AD received dupilumab (300 mg) weekly (qw), 19

dupilumab 300 mg every 2 weeks (q2w), or placebo. By week 16, "infection or infestations," as 20 classified by Medical Dictionary for Regulatory Activities, developed in 35% of the patients 21 receiving dupilumab q2w and in 34% of those receiving dupilumab qw, compared to 28% of 22 patients receiving placebo in SOLO 1 and in 28%, 29%, and 32% of patients, respectively, in 23 SOLO 2. In CHRONOS, where all three groups were allowed the use of concomitant topical 24 corticosteroids (TCS) with or without topical calcineurin inhibitors (TCIs), infection or 25

infestations developed in 57% of the patients receiving dupilumab q2w and in 53% of those 26 receiving dupilumab qw, compared to 58% of patients receiving placebo. Nasopharyngitis was 27 the most commonly reported infection among all treatment groups ( Table 1) . 3 Furthermore, in 28 all three trials, it was concluded that the rate of infection was not increased in dupilumab-treated 29 patients compared to placebo. 4 30 31

This study's analysis was limited to the data from the original dupilumab trials, as the authors 32 did not specify whether infections were bacterial or viral. However, these findings support the 33 notion that healthy AD patients without risk factors using dupilumab during the COVID-19 34 pandemic should not be predisposed to infection, upper respiratory tract infection, or 35 nasopharyngitis ( 

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Two Phase 3 Trials of Dupilumab versus 58 Placebo in Atopic Dermatitis

Long-term management of 60 moderate-to-severe atopic dermatitis with dupilumab and concomitant topical 61 corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-62 controlled, phase 3 trial

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