Retrospective Study of Dupilumab Treatment for Moderate to Severe Atopic Dermatitis in Korea: Efficacy and Safety of Dupilumab in Real-World Practice.

Dong Hyek Jang,Seong Jun Seo,Hye Jung Jung,Mi Yeon Park,Jiyoung Ahn,Seok Jae Heo

doi:10.3390/jcm9061982

Abstract

Among biological agents for the treatment of atopic dermatitis (AD), dupilumab is a front-runner. Although many studies have been conducted on the real-world use of dupilumab, the sample size is often small and data is primarily on Western people. Therefore, we investigated the efficacy and safety of dupilumab in patients with moderate-to-severe AD in Korea. All patients with moderate-to-severe AD treated with dupilumab from September 2018 to June 2019 in this institution were included and analyzed by medical records. They were evaluated using the Eczema Area and Severity Index (EASI), Numerical Rating Scale (NRS), Patient Oriented Eczema Measure (POEM), and Dermatology Quality of Life Index (DLQI), respectively on admission, after two weeks (only EASI and NRS) and after 16 weeks. Laboratory tests were measured before and 16 weeks after treatment. A total of 101 patients were included. All efficacy tools showed a significant decrease after 16 weeks; EASI 77.4%, NRS 70.0%, POEM 60.7%, and DLQI 65.0%. EASI was characterized by a marked improvement of 51.5% in just two weeks. The treatment response was not significantly different according to the interval of treatment. Elevated Lactate Dehydrogenase (LDH) at 16 weeks was associated with poor treatment response. Moreover, a high eosinophil count was related to a lower change in EASI and POEM. In the correlation analysis, EASI was not correlated to DLQI before treatment. For changes after 16 weeks, POEM showed the highest correlation with DLQI. (R = 0.66, p < 0.001) In the additional analysis for factors affecting treatment response, the female gender was associated with good treatment response. (odds ratio = 5.4, p = 0.04) Adverse events from treatment included facial erythema (9.9%) and conjunctivitis (5.0%). Overall, it was confirmed that the efficacy of dupilumab in the real-world is similar to that of the existing clinical trials. We suggest that POEM is a useful tool for identifying the quality of life. The female gender was associated with a good treatment response. Both an elevated LDH and a high eosinophil count could be a therapeutic biomarker. Further research will be needed for a long-term period.

Highlights

Dupilumab is the first approved biologic agent for atopic dermatitis (AD)
77 patients (76.2%) had allergic diseases other than AD, of which, allergic rhinitis accounted for 67.5%, allergic conjunctivitis 18.2%, and asthma 14.3%
The antigens causing the allergy had been identified in 75 patients (74.3%): 57.3% were house dust mite and 22.7% were mold

Summary

Introduction

Dupilumab is the first approved biologic agent for atopic dermatitis (AD). It acts by inhibiting the differentiation of naive T-cells into T helper (Th) 2 cells and inhibits the proliferation of Th 2 cells by blocking interleukin (IL)-4 and IL-13 simultaneously [1,2,3]. Many real-world studies of dupilumab have been conducted, most studies [4,5,6,7] have used small sample sizes, and have usually been conducted using a Western sample. This study included the largest sample size from a single institution in Korea, and evaluated various efficacy measures during the treatment, it was not a clinical study. We performed correlation analysis between efficacy measures to see the correlation between them, and identified the variables affecting the treatment outcomes

Methods

Results

Discussion

Conclusion