Moderate‐to‐severe atopic dermatitis in adolescents treated with dupilumab: A multicentre Italian real‐world experience

Abstract

Background Moderate‐to‐severe atopic dermatitis (AD) in the adolescence is a high burden disease, and its treatment can be very challenging due to paucity of approved systemic drugs for this age and their side‐effects. Dupilumab was recently approved for treatment of adolescent AD. Objectives A multicentre, prospective, real‐world study on the effectiveness and safety of dupilumab in adolescents (aged from ≥12 to <18 years) with moderate‐to‐severe AD was conducted. The main AD clinical phenotypes were also examined. Methods Data of adolescents with moderate‐to‐severe AD treated with dupilumab at label dosage for 16 weeks were collected. Treatment outcome was assessed by EASI, NRS itch, NRS sleep loss and CDLQI scores at baseline and after 16 weeks of treatment. The clinical scores were also evaluated according to clinical phenotypes. Results One hundred and thirty‐nine adolescents were enrolled in the study. Flexural eczema and head and neck eczema were the most frequent clinical phenotypes, followed by hand eczema and portrait‐like dermatitis. Coexistence of more than 1 phenotype was documented in 126/139 (88.5%) adolescents. Three patients (2.1%) contracted asymptomatic SARS‐CoV‐2 infection and 1 of the discontinued dupilumab treatment before the target treatment period. A significant improvement in EASI, NRS itch, NRS sleep loss and CDLQI was observed after 16 weeks of treatment with dupilumab. This outcome was better than that observed in clinical trials. Dupilumab resulted effective in all AD phenotypes, especially in diffuse eczema. Twenty‐eight (20.1%) patients reported adverse events, conjunctivitis and flushing being the most frequent. None of patients discontinued dupilumab due to adverse event. Conclusions Dupilumab in adolescent AD showed excellent effectiveness at week 16 with consistent improvement of all clinical scores. Moreover, dupilumab showed a good safety profile also in this COVID‐19 pandemic era.

Dupilumab Treatment in Adults with Moderate-to-Severe Atopic Dermatitis is Efficacious Regardless of Age of Disease Onset: a Post Hoc Analysis of Two Phase 3 Clinical Trials

“…Previous analyses of clinical studies also showed that dupilumab significantly improved clinical signs, symptoms, and QoL across patients with AD in different life stages, for adults and adolescents with moderate-to-severe AD and for children with severe AD, with an acceptable safety profile [ 26 – 29 ]. These findings are supported by real-world experiences with dupilumab in children, adolescents, adults, and elderly with AD [ 21 , 30 – 32 ]. The similar efficacy of dupilumab, which inhibits key drivers of type 2-mediated inflammation, in the different age-of-onset subgroups analyzed in this study confirms the high clinical relevance of dysregulated type 2 inflammation in AD among different age-of-onset groups [ 14 , 15 ].…”

“…Of note, in the earliest age-of-onset group (under 5 years), with correspondingly the longest mean disease duration, dupilumab-treated patients had differentiating improvements versus placebo in both pruritus NRS and DLQI at week 1. Interestingly, a recent real-world study of adolescents with moderate-to-severe AD treated with dupilumab found that early age of onset (≤ 1 year of age) may positively influence the effectiveness of dupilumab in terms of EASI-75, EASI-90, and EASI-100 [ 21 ].…”

Dupilumab in daily practice for the treatment of pediatric atopic dermatitis: 28‐week clinical and biomarker results from the BioDay registry

“…[21][22][23][24][25][26][27] After 16-24 weeks of treatment, EASI-50 was achieved by 67.0%-99.3% of the patients. 21,23,24 EASI-75 was achieved by 42.0%-66.7% of the patients. [21][22][23][24] In the current study, the proportions of patients Regarding safety analysis, side effects reported in clinical trials and previous daily practice studies were in line with our study (e.g., conjunctivitis, headache, head neck dermatitis, joint pain, and siteinjection reaction).…”

Children atopic dermatitis: Diagnosis, mimics, overlaps, and therapeutic implication

“…1,6,21,22 In adults and adolescents besides flexural eczema, head and neck eczema and hand eczema, which are the most frequent clinical phenotypes (84.9% and 84.2%, respectively), there are also other possible presentation such us portrait-like dermatitis (20.1%), diffuse eczema (6.5%), eczema nummulare-like (5.8%), prurigo nodularis-like (2.1%), and erythrodermia (0.7%). 23…”