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Dupilumab-Associated Cutaneous Adverse Events Among Adults With Atopic Dermatitis
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- This retrospective study of 916 patients receiving dupilumab for the treatment of atopic dermatitis found that 16.15% of the patients developed cutaneous adverse events (cAEs). Facial redness accounted for over half of the cAEs. Other cAEs included psoriasis, alopecia areata, parapsoriasis, vitiligo, and skin peeling. In total, 3.38% of patients discontinued dupilumab due to cAEs.
- cAEs occurred in 16.15% of the patients with atopic dermatitis treated with dupilumab but rarely resulted in treatment discontinuation.
abstract
This abstract is available on the publisher's site.
Access this abstract nowDupilumab, a monoclonal antibody inhibiting interleukin (IL) 4 and IL-13, is approved for the treatment of moderate to severe atopic dermatitis (AD) in children aged ≥6 years, adolescents, and adults. Both clinical trials and real-life data demonstrate its efficacy and safety. However, some cutaneous adverse events (cAEs) have been observed during real-world experiences. The authors' aim was to analyze the spectrum of cAEs in patients receiving dupilumab for the treatment of AD in a real-world setting. A retrospective review of electronic medical records was conducted for 916 patients (475 males and 541 females; mean age, 50.23 ± 19.66 years [range, 18-91 years]) who had received dupilumab for a minimum of 1 month for the treatment of AD from December 2018 to November 2022 at the Department of Dermatology of University Federico II of Naples (Italy). The mean duration of dupilumab treatment was 27.31 ± 21.26 months. A total of 148 of 916 (16.15%) (90 males; mean age, 50.91 ± 15.34 years) patients reported other cAEs apart of AD flare; namely, facial redness (82 of 916; 8.95%), psoriasis (39 of 916; 4.25%), alopecia areata (11 of 916; 1.2%), skin peeling (11 of 916; 1.2%), parapsoriasis (three of 916; 0.32%), and vitiligo (two of 916; 0.21%). Thirty-one of 916 (3.38%) patients discontinued dupilumab because of cAEs (18 of 916; 1.96%) for facial redness, 10 of 916 (1.09%) for psoriasis, and three of 916 (0.32%) for parapsoriasis. In our population, most of the cAEs were mild and did not require discontinuation of dupilumab. These findings would enable dermatologists understand the cutaneous side effects of dupilumab better, resulting in improved treatment plan decisions in clinical practice.
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Dupilumab-associated cutaneous adverse events among adult patients with atopic dermatitis: A retrospective study
J Dermatol 2023 Mar 13;[EPub Ahead of Print], M Napolitano, G Fabbrocini, C PatrunoFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
Despite being one of the most common and burdensome chronic inflammatory skin disorders, atopic dermatitis (AD) was lacking safe and effective targeted treatments – until recently. Dupilumab, a monoclonal antibody that binds to the IL-4Rɑ protein that blocks the type 2 inflammation central to AD immunopathogenesis, was the first of several new therapeutic options for individuals with moderate to severe AD. Data from multiple randomized controlled trials not only revealed a very promising efficacy profile (which has since been confirmed by real world-studies) but also outlined an encouraging safety profile highlighted primarily by low rates of conjunctivitis and injection site reactions. In the past few years, however, multiple clinical reports have highlighted cutaneous adverse events (cAE) presumed secondary to dupilumab that were not reported in the original clinical trials.
In this retrospective study, the authors examined the electronic health records of 916 individuals treated with dupilumab for AD for variable lengths of time to better characterize the nature and prevalence of these cAE. They observed that 16% of patients experienced some type of cAE (beyond AD) while on dupilumab, including facial redness, psoriasis, alopecia areata, parapsoriasis, and vitiligo. While most cases were mild and largely didn’t affect treatment considerations or clinical outcome, several cAE (namely facial redness) led to several instances of treatment discontinuation. This study is limited by its retrospective, single-center design (making it difficult to prove causality) as well as the inherent limitation of electronic health record data – although it does suggest that additional larger studies are needed. As dupilumab has become a first-line AD treatment option, it’s important for clinicians to understand the full spectrum of potential adverse events with this therapy.