A 52‐week update of a multicentre Italian real‐world experience on effectiveness and safety of dupilumab in adolescents with moderate‐to‐severe atopic dermatitis

Stingeni, Luca; Bianchi, Leonardo; Antonelli, Elettra; Caroppo, Elena Sofia; Ferrucci, Silvia; Gurioli, Carlotta; Ortoncelli, Michela; Fabbrocini, Gabriella; Nettis, Eustachio; Schena, Donatella; Napolitano, Maddalena; Gola, Massimo; Bonzano, Laura; Fortina, Anna Belloni; Balato, Anna; Peris, Ketty; Foti, Caterina; Guarneri, Fabrizio; Romanelli, Marco; Patruno, Cataldo; Savoia, Paola; Esposito, Maria; Russo, Filomena; Errichetti, Enzo; Bianchelli, Tommaso; Pellacani, Giovanni; Feliciani, Claudio; Offidani, Annamaria; Corazza, Monica; Micali, Giuseppe; Milanesi, Nicola; Malara, Giovanna; Chiricozzi, Andrea; Tramontana, Marta; Hansel, Katharina; Buligan, Cinzia

doi:10.1111/jdv.18648

Cited by 16 publications

(11 citation statements)

References 8 publications

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“…One of the main therapeutic goals for AD is achieving pruritus control as early as possible. The efficacy of dupilumab in relieving pruritus has been verified in several studies (10,(18)(19)(20). According to the current recommendation, the therapeutic and loading dose of dupilumab in children depend on their body weight.…”

Section: Introductionmentioning

confidence: 93%

High loading-dose of dupilumab resulted in rapid disease control in pediatric patients with atopic dermatitis

et al. 2023

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BackgroundThe real-world experience of dupilumab in Chinese is limited, and the initial loading dose has not yet been deeply explored in patients aged <6 years.ObjectiveTo explore the efficacy and safety of dupilumab in Chinese patients with moderate-to-severe atopic dermatitis and investigate the effect of higher loading dose for disease control in patients aged <6 years.MethodsA total of 155 patients were divided into three groups according to age: <6 years, 6-11 years, and >11 years. Among patients aged <6 years, 37 patients received a high loading dose of 300 mg for body weight <15kg or 600 mg for body weight ≥15kg, and another 37 patients received a standard loading dose of 200 mg for body weight <15kg or 300 mg for body weight ≥15kg. Multiple physicians and patient-reported outcome measures were evaluated at baseline and 2, 4, 6, 8, 12, and 16 weeks after dupilumab treatment.ResultsThe proportion of patients showing an improvement of ≥75% in the Eczema Area and Severity Index was 68.0% (17/25), 76.9% (10/13), and 62.5% (25/40) in the aged <6, 6-11, and >11 years groups, respectively, at week 16. After increasing the loading dose, 69.6% (16/23) of patients aged <6 years achieved 4-point improvement in Pruritus Numerical Rating Scale at week 2, compared with 23.5% (8/34) of patients receiving standard loading dose (P < 0.001). Obesity (odds ratio=0.12, 95% confidence interval: 0.02-0.70) was predictive of a poor response to dupilumab treatment, while female (odds ratio=3.94, 95% confidence interval: 1.26-12.31) predicted good response at week 16. The change of serum C-C motif ligand 17(CCL17/TARC) could reflect the response to dupilumab (r = 0.53, P = 0.002 in EASI) among patients aged <18 years. No major adverse events were reported during the treatment.ConclusionsDupilumab was effective and well-tolerated in Chinese patients with atopic dermatitis. The increased loading dose helped achieve rapid pruritus control in patients aged <6 years.

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Section: Introductionmentioning

confidence: 93%

High loading-dose of dupilumab resulted in rapid disease control in pediatric patients with atopic dermatitis

et al. 2023

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“…Currently, dupilumab is a biologic drug approved for the treatment of moderate to severe AD in children, adolescents, and adults in several countries 1–9 . In both clinical trials and real‐world studies, dupilumab demonstrated high efficacy on skin lesions, also reducing the risk of cutaneous infection and improving quality of life 1–9,16–19 .…”

Section: Discussionmentioning

confidence: 99%

“…[1][2][3][4][5] Its efficacy and safety have been demonstrated by clinical trials and real-life experiences. [1][2][3][4][5][6][7][8][9] A recent meta-analysis including 22 observational real-life studies and encompassing 3303 patients with AD, showed that the pooled proportion of patients included in real-life studies achieving an Eczema Area and Severity Index (EASI) 50, EASI 75 and EASI 90 after 16 weeks of dupilumab therapy was, respectively, 85.1%, 59.8%, and 26.8% higher than that reported in clinical trials. 9Conjunctivitis was the most frequent adverse event (AE) both in clinical trials and real-life experiences (relative risk [RR], 3.26).…”

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confidence: 93%

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Dupilumab‐associated cutaneous adverse events among adult patients with atopic dermatitis: A retrospective study

Napolitano

Fabbrocini

Patruno

2023

The Journal of Dermatology

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Dupilumab, 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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“…The increased knowledge of the role played by IL-4 and IL-13 in the pathogenesis of AD, resulted in the development of new targeted therapies (58). Dupilumab, the first approved biological agent for the treatment of AD, which acts by blocking IL-4Rα and thus the activity of both IL-4 and IL-13, demonstrated the effectiveness of blocking type 2 cytokines, their receptors, or their intracellular signal transducers JAK/STAT pathway (8,(59)(60)(61).…”

Section: Therapeutic Implicationsmentioning

confidence: 99%

The hidden sentinel of the skin: An overview on the role of interleukin-13 in atopic dermatitis

et al. 2023

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Recent evidence suggests that interleukin (IL)-13 is a crucial cytokine involved in the pathogenesis of atopic dermatitis (AD). It is a central driver of type-2 T-helper inflammation and is overexpressed in lesional skin of AD patients. Upon release in peripheral skin, IL-13 activates its receptors, recruits inflammatory cells, and modifies the skin microbiome. IL-13 also reduces the expression of epidermal barrier proteins and activates sensory nerve mediating the itch transmission signal. Novel therapeutics that target IL-13 seem to be efficacious and safe for the treatment of patients with moderate-to-severe AD. The aim of our manuscript is to review the role that IL-13 plays in AD immunopathogenesis.

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A 52‐week update of a multicentre Italian real‐world experience on effectiveness and safety of dupilumab in adolescents with moderate‐to‐severe atopic dermatitis

Cited by 16 publications

References 8 publications

High loading-dose of dupilumab resulted in rapid disease control in pediatric patients with atopic dermatitis

High loading-dose of dupilumab resulted in rapid disease control in pediatric patients with atopic dermatitis

Dupilumab‐associated cutaneous adverse events among adult patients with atopic dermatitis: A retrospective study

The hidden sentinel of the skin: An overview on the role of interleukin-13 in atopic dermatitis

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