Use of systemic therapies in adults with atopic dermatitis: 12-month results from the European prospective observational study in patients eligible for systemic therapy for atopic dermatitis (EUROSTAD)

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© 2022 Sanofi. Published with license by Taylor & Francis Group, LLC.

Figure 1. Patient enrollment in EUROSTAD by country.

Table 1. Baseline demographics and disease characteristics.

	n = 308
Age, years	37.2 (13.8)
Male sex, n (%)	175 (56.8)
Weight, kg	73.3 (17.7)
Height, cm	171.9 (9.3)
Duration of AD, years	25.4 (15.6)
EASI, mean (SD), N1	16.2 (10.9), 281
IGA score, mean (SD), N1	3.1 (0.8), 266
0 – Clear, n (%)	2 (0.8)
1 – Almost clear, n (%)	8 (3.0)
2 – Mild disease, n (%)	29 (10.9)
3 – Moderate disease, n (%)	143 (53.8)
4 – Severe disease, n (%)	84 (31.6)
Peak Pruritus NRS score, mean (SD), N1	5.5 (2.5), 290
DLQI, mean (SD), N1	11.8 (6.9), 272
POEM, mean (SD), N1	17.0 (7.2), 279
HADS-anxiety, mean (SD), N1	8.3 (3.7), 271
HADS-depression, mean (SD), N1	8.6 (4.7), 271
EQ-5D-3L VAS score, mean (SD), N1	65.9 (21.4), 270
Sleep VAS score, mean (SD), N1	49.8 (31.6), 272

Values are means (SD) unless otherwise specified.

AD: atopic dermatitis; DLQI: Dermatology Life Quality Index; EASI: Eczema Area and Severity Index; EQ-5D-3L: 5-dimension EuroQoL 3-level scale; HADS: Hospital Anxiety and Depression Scale; IGA: Investigator’s Global Assessment; N1: number of patients with available data; NRS: Numerical Rating Scale; POEM: Patient-Oriented Eczema Measure; SD: standard deviation; VAS: visual analog scale.

Table 2. Systemic treatment at enrollment and during 12-month follow-up.

n (%)	Enrollment N = 286	Use during 12-month follow-up N = 288
Cyclosporine	112 (39.2)	126 (42.7)
Dupilumab	56 (19.6)	104 (35.3)
Methotrexate	66 (23.1)	83 (28.1)
Systemic steroids
Oral corticosteroid	40 (14.0)	75 (25.4)
Injectable corticosteroid	11 (3.8)	18 (6.1)
Azathioprine	16 (5.6)	20 (6.8)
Mycophenolate	8 (2.8)	10 (3.4)
Hydroxyquinoline	1 (0.3)	1 (0.3)
Other systemic drugs	5 (1.7)	7 (2.4)
Drug combinations during study	N = 286
Cyclosporine/dupilumab	14 (4.8)
Cyclosporine/methotrexate	5 (1.8)
Dupilumab/methotrexate	12 (4.7)
Cyclosporine/dupilumab/methotrexate	3 (1.04)

Percentages of each systemic treatment are calculated over the number of patients reporting any systemic treatments. Multiple start reasons of treatment are allowed per each medication.

Figure 2. Treatment duration: Kaplan–Meier analysis of time to treatment discontinuation. Values underneath the graphs show patients with available measurements at each visit. Month 0 is the therapy start time. The X-axis represents the time (month) since the start of therapy.

Table 3. Most common reasons for initiating or discontinuing systemic therapy.

	Cyclosporine	Dupilumab	Methotrexate	Oral corticosteroid	Injectable corticosteroid
Initiation reason, n (%)	n = 126	n = 104	n = 83	n = 75	n = 18
Exacerbation	80 (63.5)	66 (63.5)	29 (35.0)	59 (79.73)	13 (72.2)
Maintenance	21 (16.7)	13 (12.5)	31 (37.5)	18 (24.32)	3 (16.7)
Use on an as-needed basis	0	1 (1.0)	0	2 (2.7)	2 (11.1)
Used for induction	29 (23.0)	27 (26.0)	28 (33.7)	0	2 (11.1)
Unable to taper TCS	7 (5.6)	0	3 (3.6)	0	0
Missing	0	0	0	1	0
Reasons for stopping, n (%)	n = 97 (77.0)	n = 23 (22.1)	n = 53 (63.9)	n = 65 (86.7)	n = 17 (94.4)
Lack of efficacy	31	6	19	11	3
Low compliance	2	1	0	0	0
Adverse events	16	7	14	3	1
Patient decision	12	3	8	0	2
Disease well controlled	39	4	11	50	10
Labelling in the country limits the use to a certain period of time	2	0	0	4	0
Issue with reimbursement	1	1	0	0	0
Contraindication with another concomitant therapy	3	0	2	1	0
Other	6	2	3	3	1
Number of therapy changes, mean (SD)	1.2 (1.07)	0.8 (0.72)	1.2 (1.17)	2.2 (1.95)	2.0 (1.41)
Number of changes due to lack of efficacy of prior treatment, mean (SD)	0.2 (0.43)	0.1 (0.23)	0.3 (0.57)	0.1 (0.36)	0.3 (0.75)

Table shows number of patients discontinuing from treatment by reason. A patient could have multiple instances of discontinuation from the same or different drugs. They could also select multiple reasons for discontinuation from a drug.

SD: standard deviation; TCS: topical corticosteroid.

Table 4. Change in EASI and IGA score over time from the start of EUROSTAD.

Disease activity	Baseline	Month 3	Month 6	Month 9	Month 12
EASI global score
Number of patients	273	204	163	131	114
Mean (SD)	16.1 (10.7)	9.0 (9.4)	8.2 (8.8)	9.1 (9.5)	8.3 (9.1)
IGA, n (%)
Number of patients	259	192	160	130	114
0 – Clear	2 (0.8)	5 (2.6)	11 (6.9)	9 (6.9)	14 (12.3)
1 – Almost clear	8 (3.1)	49 (25.5)	39 (24.4)	35 (26.9)	24 (21.1)
2 – Mild erythema/infiltration	29 (11.2)	56 (29.2)	45 (28.1)	36 (27.7)	38 (33.3)
3 – Moderate erythema/infiltration	140 (54.1)	58 (30.2)	49 (30.6)	37 (28.5)	29 (25.4)
4 – Severe erythema/infiltration	80 (30.9)	24 (12.5)	16 (10.0)	13 (10.0)	9 (7.9)

Patients who completed follow-up visits within a (±) 1-month window are included in the summaries.

EASI: Eczema Area and Severity Index; IGA: Investigator’s Global Assessment.