Real‐world efficacy and safety of dupilumab in Chinese patients with atopic dermatitis: a single‐centre, prospective, open‐label study

Abstract

Background Dupilumab, an antibody against interleukin-4 receptor a, has demonstrated elegant efficacy and safety profiles in patients with moderate-to-severe atopic dermatitis (AD). However, the efficacy of dupilumab varies among AD patients, and compared with the Caucasian population, the data of dupilumab for Asian people, especially Chinese AD patients, is very limited.Objective To investigate the efficacy and safety of dupilumab for AD in a real-world Chinese single-centre prospective cohort.Methods We enrolled 138 moderate-to-severe AD patients receiving dupilumab treatment at Huashan Hospital, Shanghai, China in this 16-week, single-centre, prospective, open-label study. The patients were evaluated at baseline, 2, 4, 8 and 16 weeks after first dupilumab administration for multiple physician-and patient-reported outcome measures. Blood eosinophil counts and total serum IgE were measured.Results There were early and sustained improvement in all the efficacy measures evaluated after dupilumab administration. 64.5% AD patients achieved an improvement of ≥75% in the Eczema Area and Severity Index from baseline, and 60.9% patients achieved the Investigator's Global Assessment 0/1 (or a reduction of ≥2 points from baseline) at week 16. The trunk demonstrated the most significantly decreased efficacy score [median decreased 96.24% (interquartile range, 89.04 to 100%)] compared with other body sites. Female (adjusted OR: 2.12, 95% confidence interval: 0.79-5.74) and body mass index (BMI) <24 (3.03; 1.19-7.68) were identified as potential predictive factors of good response; while age >60 (0.57; 0.10-3.28) predicted poor response. Adverse events were reported by 34.1% patients, and facial erythema (13%) and ocular symptoms (10.9%) were the most common. Conclusions Dupilumab demonstrated favourable efficacy and well-tolerated safety in Chinese AD patients in realworld practice.

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

“…Although patients aged <6 years were treated with a high loading dose, the incidence of AEs did not increase during the treatment. Conjunctivitis and facial erythema were the most common AEs, consistent with previous studies ( 8 , 14 – 17 ). Our study suggested that dupilumab was a safe treatment for children, and a high loading dose could help to achieve rapid pruritus control.…”

“…The EASI75 response rate in patients aged >11 years of this study was comparable to the 42-84.6% rate reported in previous real-world studies in China (14-16). Weight, sex, age, clinical phenotypes, and serum lactate dehydrogenase levels might affect the efficacy of dupilumab treatment (14,34,35). Our study also highlighted that obesity predicted poor treatment outcomes, and females responded better to dupilumab treatment, which was in line with the findings of another study in China (14).…”

“…However, due to the strict inclusion criteria of clinical trials, the actual conditions of dupilumab in the real world are not reflected in the studies. Although dupilumab has been approved for treatment of moderate to severe pediatric AD patients in China, real-world data from the Chinese pediatric population are still lacking (14)(15)(16)(17).…”

Dupilumab Improves Clinical Scores in Pediatric Patients Aged 2 to <18 Years with Uncontrolled Atopic Dermatitis: A Single‐Center, Real‐World Study

“…In fact, a larger regimen (Table 3) was partly administrated in our cohorts, which might further prove dupilumab a safe choice in pediatric patients, considering the low occurrence of adverse events. Conjunctivitis was the most commonly reported AE, with incidence rates in real-life studies ranging from 4.95% to 12.15% [12,[19][20][21][22][23][24], which was observed in 5.1% patients in our study. In the ≥2 to <6 years old group, one child experienced the injection-site reaction after the 2 nd injection, which resolved by itself.…”

Dupilumab improves clinical symptoms in children with Netherton syndrome by suppressing Th2-mediated inflammation

“…Several novel systematic treatments have been suggested in the recent literature, including immunoglobulins and biologicals that target specific inflammatory pathways (4). Dupilumab, a monoclonal antibody that blocks the IL-4 receptor (IL-4R), has been used to treat moderate to severe atopic dermatitis with a good safety and efficacy profile (5). A few recent case report displayed clinical effect with improving skin symptoms in patients with NS who treated with dupilumab (6)(7)(8)(9)(10)(11)(12).…”