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      A Literature Review of Real-World Effectiveness and Safety of Dupilumab for Atopic Dermatitis

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          Abstract

          Atopic dermatitis (AD) is a chronic inflammatory skin disease with pruritus, characterized by recurrent eczema with exacerbations and remissions. AD impairs patients’ QOL and places a heavy burden on patients. Recently, dupilumab, an anti–IL-4Rα antibody, was approved for the treatment of patients with moderate-to-severe AD who are refractory to topical agents and/or conventional systemic therapy. Clinical trials of dupilumab for AD demonstrated high efficacy and tolerable safety profiles. Furthermore, real-world evidence of dupilumab for AD is accumulating. Most of these data show favorable effectiveness and safety profile; however, they also clarified issues, including conjunctivitis and facial redness. There are still a certain number of patients with significant failure. In this article, we review real-world evidence of dupilumab for AD, identify concerns specific to dupilumab, and discuss unmet needs and issues to be addressed in the future.

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          Dupilumab Efficacy and Safety in Moderate-to-Severe Uncontrolled Asthma

          Jingdong Chao, Mario Castro, Jonathan Corren … (2018)
          Dupilumab is a fully human anti-interleukin-4 receptor α monoclonal antibody that blocks both interleukin-4 and interleukin-13 signaling. We assessed its efficacy and safety in patients with uncontrolled asthma.
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            Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis.

            Eric Simpson, Thomas Bieber, Emma Guttman-Yassky … (2016)
            Background Dupilumab, a human monoclonal antibody against interleukin-4 receptor alpha, inhibits signaling of interleukin-4 and interleukin-13, type 2 cytokines that may be important drivers of atopic or allergic diseases such as atopic dermatitis. Methods In two randomized, placebo-controlled, phase 3 trials of identical design (SOLO 1 and SOLO 2), we enrolled adults with moderate-to-severe atopic dermatitis whose disease was inadequately controlled by topical treatment. Patients were randomly assigned in a 1:1:1 ratio to receive, for 16 weeks, subcutaneous dupilumab (300 mg) or placebo weekly or the same dose of dupilumab every other week alternating with placebo. The primary outcome was the proportion of patients who had both a score of 0 or 1 (clear or almost clear) on the Investigator's Global Assessment and a reduction of 2 points or more in that score from baseline at week 16. Results We enrolled 671 patients in SOLO 1 and 708 in SOLO 2. In SOLO 1, the primary outcome occurred in 85 patients (38%) who received dupilumab every other week and in 83 (37%) who received dupilumab weekly, as compared with 23 (10%) who received placebo (P<0.001 for both comparisons with placebo). The results were similar in SOLO 2, with the primary outcome occurring in 84 patients (36%) who received dupilumab every other week and in 87 (36%) who received dupilumab weekly, as compared with 20 (8%) who received placebo (P<0.001 for both comparisons). In addition, in the two trials, an improvement from baseline to week 16 of at least 75% on the Eczema Area and Severity Index was reported in significantly more patients who received each regimen of dupilumab than in patients who received placebo (P<0.001 for all comparisons). Dupilumab was also associated with improvement in other clinical end points, including reduction in pruritus and symptoms of anxiety or depression and improvement in quality of life. Injection-site reactions and conjunctivitis were more frequent in the dupilumab groups than in the placebo groups. Conclusions In two phase 3 trials of identical design involving patients with atopic dermatitis, dupilumab improved the signs and symptoms of atopic dermatitis, including pruritus, symptoms of anxiety and depression, and quality of life, as compared with placebo. Trials of longer duration are needed to assess the long-term effectiveness and safety of dupilumab. (Funded by Sanofi and Regeneron Pharmaceuticals; SOLO 1 ClinicalTrials.gov number, NCT02277743 ; SOLO 2 ClinicalTrials.gov number, NCT02277769 .).
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              Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial.

              Andrew Blauvelt, Marjolein de Bruin-Weller, Melinda Gooderham … (2017)
              Dupilumab (an anti-interleukin-4-receptor-α monoclonal antibody) blocks signalling of interleukin 4 and interleukin 13, type 2/Th2 cytokines implicated in numerous allergic diseases ranging from asthma to atopic dermatitis. Previous 16-week monotherapy studies showed that dupilumab substantially improved signs and symptoms of moderate-to-severe atopic dermatitis with acceptable safety, validating the crucial role of interleukin 4 and interleukin 13 in atopic dermatitis pathogenesis. We aimed to evaluate the long-term efficacy and safety of dupilumab with medium-potency topical corticosteroids versus placebo with topical corticosteroids in adults with moderate-to-severe atopic dermatitis.
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                Author and article information

                Contributors
                Yayoi Tada
                Journal
                Journal ID (nlm-ta): JID Innov
                Journal ID (iso-abbrev): JID Innov
                Title: JID Innovations
                Publisher: Elsevier
                ISSN (Electronic): 2667-0267
                Publication date PMC-release: 30 July 2021
                Publication date Collection: September 2021
                Publication date (Electronic): 30 July 2021
                Volume: 1
                Issue: 3
                Electronic Location Identifier: 100042
                Affiliations
                [1 ]Department of Dermatology, Teikyo University School of Medicine, Tokyo, Japan
                Author notes
                [∗ ]Correspondence: Yayoi Tada, Department of Dermatology, Teikyo University School of Medicine, 2-11-1 Kaga, Itabashi-ku, Tokyo 173-8605, Japan. ytada-tky@ 123456umin.ac.jp
                Article
                Publisher Item ID: S2667-0267(21)00043-6 Publisher ID: 100042
                DOI: 10.1016/j.xjidi.2021.100042
                PMC ID: 8659403
                PubMed ID: 34909737
                SO-VID: 56e9efce-08c4-4dba-ac72-f66af959fb20
                Copyright © © 2021 The Authors
                License:

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                Date received : 27 April 2021
                Date revision received : 1 July 2021
                Date accepted : 14 July 2021
                Categories
                Subject: Review

                Keywords: aa, alopecia areata,ad, atopic dermatitis,csa, cyclosporin a,easi, eczema area and severity index,hsv, herpes simplex virus,iga, investigator’s global assessment,ldh, lactate dehydrogenase,q2w, every other week,qw, weekly,tcs, topical corticosteroid,th, t helper type
                Data availability:
                Keywords: aa, alopecia areata, ad, atopic dermatitis, csa, cyclosporin a, easi, eczema area and severity index, hsv, herpes simplex virus, iga, investigator’s global assessment, ldh, lactate dehydrogenase, q2w, every other week, qw, weekly, tcs, topical corticosteroid, th, t helper type

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