Identification of clinical predictors for dupilumab dose spacing in adults with atopic dermatitis: a real-world study

Figures & data

Table 1. Clinical and demographic characteristics of the study population.

Number of patients	818*
Sex
Male n (%)	432 (52.8)
Female n (%)	386 (47.2)
Age at treatment initiation (mean ± SD)	46.32 (±21.3)
Age at onset (mean ± SD)	25.79 (27.1)
Early onset (0–18 years) n (%)	418 (52.5)
Adult onset (18–65 years) n (%)	284 (36.7)
Very late onset (>65 years) n (%)	94 (11.8)
Disease duration (mean ± SD)	20.28 (15.9)
Disease phenotype
Flexural n (%)	606 (89.5)
Erythrodermic n (%)	22 (3.2)
Prurigo nodularis n (%)	37 (5.5)
Nummular eczema n (%)	12 (1.8)
Disease localization in sensisitive areas
Yes n (%)	625 (83.2)
No n (%)	126 (16.8)
Head/neck n (%)	549 (67.1)§
Hands n (%)	405 (49.5)§
Genitalia n (%)	86 (10.5)§
Non-cutaneous atopic manifestations
Yes n (%)	382 (66.7)
No n (%)	191 (33.3)
Rhinitis n (%)	296 (36.2)§
Asthma n (%)	174 (21.3)§
Conjunctivitis n (%)	159 (19.4)§
Total IgE
IgE ≥ 100 I.U./ml, n (%)	148 (52.7)§
IgE < 100 I.U./ml, n (%)	133 (47.3)§
Non-atopic comorbidities
Yes n (%)	217 (49.0)
No n (%)	226 (51.0)
Hypertension n (%)	107 (49.3)
Autoimmune disease (hashimoto thyroiditis, alopecia areata, rheumatoid arthritis) n (%)	4 (1.8)
Diabetes mellitus n (%)	18 (8.3)
Carcinomas (larynx, bladder, vulvar, colon, prostate) n (%)	8 (3.7)
Previous systemic therapies
Yes n (%)	740 (91.5)
No n (%)	69 (8.5)
Corticosteroids n (%)	685 (92.6)§
Cyclosporin n (%)	452 (61.1)§
Methotrexate n (%)	92 (12.4)§
Azathioprine n (%)	67 (9.0)
Multiple systemic treatment n (%)	451 (60.9)

*Sum does not always match the total due to missing data.

^§Sum does not match the total due to multiple concomitant features.

Table 2. Treatment response.

	Overall study population	Standard dose schedule	Dose spacing or withdrawal for satisfactory response	P value*
Baseline
Number of patients	818	654	164
EASI (mean ± SD)	26.7 (8.6)	26.5 (8.43)	27.41 (9.21)	0.251
DLQI (mean ± SD)	19.6 (5.7)	19.38 (5.67)	20.28 (5.87)	0.081
itch-NRS (mean ± SD)	8.0 (1.6)	8.04 (1.62)	8.10 (1.67)	0.649
Week 4
Number of patients	818	654	164
EASI (mean ± SD)	8.2 (6.0)	8.56 (6.41)	7.15 (4.69)	0.011
DLQI (mean ± SD)	6.3 (5.0)	6.69 (5.26)	5.06 (4.01)	0.0003
itch-NRS (mean ± SD)	3.5 (2.2)	3.67 (2.29)	3.04 (2.00)	0.002
Week 16
Number of patients	818	654	164
EASI (mean ± SD)	4.6 (5.3)	4.99 (5.98)	3.58(2.98)	0.004
DLQI (mean ± SD)	3.5 (4.6)	3.92 (4.98)	2.59 (3.24)	0.0018
itch-NRS (mean ± SD)	2.3 (2.2)	2.59 (2.36)	1.68 (1.67)	<0.0001
Week 36
Number of patients	499	356	143
EASI (mean ± SD)	2.9 (3.6)	3.27 (4.11)	2.39 (2.53)	0.022
DLQI (mean ± SD)	2.4 (3.3)	2.77 (3.73)	1.80 (2.25)	0.0053
itch-NRS (mean ± SD)	1.8 (1.9)	2.04 (2.03)	1.37 (1.91)	0.0007
Week 48
Number of patients	428	300	128
EASI (mean ± SD)	2.6 (3.9)	3.28 (4.86)	1.61 (1.87)	0.0002
DLQI (mean ± SD)	1.9 (3.0)	2.42 (3.58)	1.36 (1.83)	0.0023
itch-NRS (mean ± SD)	1.5 (1.8)	1.81 (2.07)	1.05 (1.82)	0.0003
Week 96
Number of patients	354	246	108
EASI (mean ± SD)	2.2 (3.5)	2.63 (4.07)	1.74 (2.62)	0.054
DLQI (mean ± SD)	1.9 (3.2)	2.29 (3.67)	1.47 (2.45)	0.052
NRS-itch (mean ± SD)	1.4 (1.8)	1.76 (2.08)	0.94 (1.43)	0.0007
Week 140
Number of patients	288	212	76
EASI (mean ± SD)	2.3 (4.2)	3.16 (5.36)	1.33 (1.99)	0.012
DLQI (mean ± SD)	2.0 (3.9)	2.72 (4.76)	1.23 (2.57)	0.028
NRS-itch (mean ± SD)	1.1 (1.9)	1.49 (2.39)	0.69 (1.15)	0.016

*t-test for the comparison between standard schedule and dose spacing/withdrawal for satisfactory response groups. Bold: statistically significant.

Dupilumab efficacy at specified time points considering either the overall study population or its subgrouping into standard dose schedule and dose spacing/withdrawal for satisfactory treatment response.

Figure 1. Trends in mean EASI score over time during treatment with dupilumab, highlighting statistically significant difference between standard schedule and dose spacing or withdrawal due to remission groups.

Table 3. Clinical features of the study population and of its subgrouping into standard schedule, dose spacing and withdrawal for satisfactory response.

	Standard schedule	Dose spacing or withdrawal for satisfactory response	P value*	Dose spacing	Withdrawal for satisfactory response	P value°
Total number of patients§	654	164		97	67
Age at treatment initiation (mean ± SD)	44.7 (0.9)	51.4 (21.0)	0.0004	45.8 (18.2)	59.6 (22.3)	<0.0001
Age at onset (mean ± SD)	23.9 (26.5)	31.5 (27.9)	0.0018	25.2 (24.5)	40.7 (30.2)	0.0004
Early onset (0–18 y) n(%)	288 (57.3)	70 (42.7)	0.005	49 (50.5)	21 (31.3)	0.003
Adult onset (19–65 y) n(%)	163 (32.4)	73 (44.5)		42 (43.3)	31 (46.3)
Very late onset (>65 y) n(%)	52 (10.3)	21 (12.8)		6 (6.2)	15 (22.4)
Disease duration (mean ± SD)	20.4 (15.7)	19.9 (16.5)	0.783	20.7 (15.2)	18.9 (18.3)	0.476
Disease phenotype
Flexural	466 (91.4)	139 (84.8)	0.003	89 (91.7)	50 (74.6)	0.008
Erythrodermic	17 (3.3)	3 (1.8)		2 (2.1)	1 (1.5)
Prurigo nodularis	19 (3.7)	18 (11.0)		4 (4.1)	14 (20.9)
Nummular eczema	8 (1.6)	4 (2.4)		2 (2.1)	2 (3.0)
Atopic comorbidities
Yes n(%)	238 (45.7)	93 (56.7)	0.014	64 (66.0)	29(43.3)	0.004
No n(%)	283 (54.3)	71 (43.3)		33 (34.0)	38 (56.7)
Total IgE
IgE ≥ 100 n(%)	108 (49.5)	40 (59.7)	0.186	27 (62.8)	13 (54.2)	0.490
IgE < 100 n(%)	106 (50.5)	27 (40.3)		16 (37.2)	11 (45.8)
Baseline EASI (mean ± SD)	26.5 (8.49	27.4 (9.2)	0.251	26.7 (9.9)	28.3 (8.1)	0.286
Baseline DLQI (mean ± SD)	19.4 (5.7)	20.3 (5.9)	0.081	19. 9 (6.1)	20.7 (5.5)	0.431
Baseline NRS-itch (mean ± SD)	8.0 (1.6)	8.1 (1.7)	0.649	7.9 (1.9)	8.3 (1.3)	0.215

^§ Sum does not always match the total due to missing data.

*p value for the comparison between the standard schedule and the dose spacing/withdrawal for satisfactory response groups.

^°p value for the comparison between the dose spacing versus the withdrawal for satisfactory response subgrouping.

Bold: statistically significant.

Data availability statement

Enquiries related to the data generated or analyzed during this study can be directed to the corresponding author.