Body of manuscript:
To the Editor:
Dupilumab is a monoclonal antibody approved for moderate-to-severe
atopic dermatitis (AD) in patients aged >6 years in
China1-3. Recently, a phase 3 clinical trial of
dupilumab in children aged 6 months to 6 years with AD demonstrated
significant efficacy and safety profiles4, real-world
data are scarce, especially in Asian populations. We conducted a
retrospective, real-world, “off-label” observational study to evaluate
the efficacy and safety of dupilumab in patients with AD aged
< 6 years and compared the data with those aged 6-12 years.
A total of 120 pediatric patients with moderate-to-severe AD treated
with dupilumab in China were included and divided into two groups by
age: <6 years (n=50) and 6-12 years (n=70) (inclusion criteria
and exclusion criteria can be found in Supporting Information). Informed
consent was signed by the parents or legal guardians. This study was
approved by the Ethics Review Committee of Xiangya Hospital (ethical
approval number:2021030471).
The demographic and clinical characteristics of the two groups are shown
in Table 1. There was no statistical difference in sex or baseline
disease severity between the two groups (p>0.05). From
baseline to week-16, increasing improvements were observed in the IGA,
EASI, SCORAD, and CDLQI (IDQoL) (Fig. 1A and B, Fig. S1, Table S1).
Patients aged <6 years responded to dupilumab earlier and
better than those aged 6-12 years (p<0.05) at week-4, with
higher EASI-50 and EASI-75 scores (78.79% vs. 44.00% and 45.45% vs.
16.00%, respectively) (Fig. 1B). However, with continuous dupilumab
treatment till week-16, however, the therapeutic efficacy was comparable
between the two groups, with similar EASI-75, EASI-90, and IGA0/1
(75.00% vs. 75.51%, 46.88% vs.
48.98%, 78.13% vs. 79.59%, respectively) (Fig. 1A and B).
Representative photos of pediatric AD patients in the <6 and
6-12 years old groups after treatment with dupilumab are shown in Fig. 1
C and D.
Erythemato-desquamative and head and neck dermatitis were the most
frequent clinical phenotypes in both groups (36.00% vs. 30.00%; 32.86
vs. 28.57%, respectively) (Table 1). patients aged <6 years
with head and neck dermatitis as the main clinical phenotype had a
higher EASI-50 (90.91%) than those aged 6-12 years (50.00%) at week-4
after dupilumab treatment (p<0.05) (Table S2). There was a
statistical difference in blood eosinophil counts between the two groups
at week-4 (0.38±0.25×10^9/L vs
0.93±0.80×10^9/L, p<0.05) (Fig. S1).
No adverse events (AE) were observed in the <6 years group.
Two patients (2.86%) in the 6-12 years group developed conjunctivitis
during treatment (Table S3), which may be associated with their previous
history of conjunctivitis5,6.
In conclusion, our real-life cohort data demonstrated that dupilumab has
a significant efficacy and tolerable safety profile in patients aged
< 6 years with uncontrolled moderate-to-severe AD. The
efficacy of dupilumab was better in the first 4 weeks in patients aged
<6 years when compared with those in patients aged 6-12 years,
but comparable therapeutic efficacy at week -16. Compared to the
efficacy in phase III clinical trials aged 6 months to younger than 6
years4, higher EASI-75 and EASI-90 on week-16 were
showed in our study (75% vs. 53% and 47% vs. 25%, respectively),
which may be related to differences in race, prior medication history,
sample size, etc. The first limitation of this study was that it was a
single-center study, the second was the lack of patients aged 6 months
to 2 years, and the third was the short follow-up period. Therefore,
further studies with multi-centers and large samples are needed to
provide more data and evidence for a more rational application of
dupilumab in pediatric patients with AD.