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. 2024 Jan 9;41(3):1046–1061. doi: 10.1007/s12325-023-02753-1

Table 1.

Baseline demographics and clinical characteristics

Placebo + TCS (N = 62) Dupilumab 200/300 mg q4w + TCS (N = 63)
Baseline demographics
 Age, mean (SD), years 3.9 (1.2) 3.9 (1.3)
 Age group (years), n (%)
  6 months to < 2 years 3 (4.8) 6 (9.5)
  ≥ 2 years to 5 years 59 (95.2) 57 (90.5)
 Sex, male (%) 42 (67.7) 37 (58.7)
 Race, n (%)
  White 38 (61.3) 43 (68.3)
  Black/African American 15 (24.2) 12 (19.0)
  Other 9 (14.5) 8 (12.7)
 Ethnicity, n (%)
  Not Hispanic or Latino 56 (90.3) 52 (82.5)
  Hispanic or Latino 6 (9.7) 11 (17.5)
 Height (cm), mean (SD)a 101.2 (10.2) 99.8 (12.7)
 Weight (kg), mean (SD) 17.0 (3.7) 17.2 (4.5)
 Weight group (kg), n (%)
  5 to < 15 18 (29.0) 18 (28.6)
  15 to < 30 44 (71.0) 45 (71.4)
 BMI, mean (SD)b 16.3 (2.0) 17.2 (6.3)
 Country, n (%)
  Germany 2 (3.2) 4 (6.3)
  Poland 15 (24.2) 15 (23.8)
  UK 5 (8.1) 4 (6.3)
  USA 40 (64.5) 40 (63.5)
Clinical characteristics
 Age at disease onset, n (%)
  < 6 months 44 (71.0) 36 (57.1)
  ≥ 6 months 18 (29.0) 27 (42.9)
 Duration of AD, mean (SD; range), years 3.5 (1.3; 0–6) 3.3 (1.4; 0–6)
 Duration of AD, n (%)
  < 3 years 22 (35.5) 23 (36.5)
  ≥ 3 years 40 (64.5) 40 (63.5)
 EASI, mean (SD; range) 35.4 (12.0; 12–72) 38.8 (13.7; 18–72)
 SCORAD, mean (SD; range) 74.8 (10.8; 50–98) 76.7 (11.5; 50–98)
 BSA of AD, mean (SD; range) 58.9 (21.4; 14–100) 63.1 (21.1; 19–100)
 Weekly average of daily worst scratch/itch score, mean (SD; range) 7.6 (1.6; 2–10) 7.6 (1.4; 4–10)
 Caregiver Global Impression of Disease, n (%)
  Moderate 9 (14.5) 7 (11.1)
  Severe 31 (50.0) 31 (49.2)
  Very severe 22 (35.5) 25 (39.7)
 POEM, mean (SD; range) 23.4 (4.0; 9–28) 23.7 (3.9; 14–28)
 CDLQI, mean (SD; range)*c 17.8 (6.4; 5–28) 17.5 (5.5; 7–29)
 IDQOL, mean (SD; range)*d 17.4 (5.4; 5–28) 18.4 (5.1; 10–29)
 GISS, mean (SD; range) 10.1 (1.5; 7–12) 10.3 (1.5; 7–12)
 DFI, mean (SD; range) 17.4 (7.5; 3–29) 17.6 (6.0; 5–30)
 Weekly average of daily skin pain NRS score, mean (SD; range)e 7.1 (1.9; 2–10) 6.9 (1.9; 1–10)
 Weekly average of daily patient's sleep quality score, mean (SD; range)f 4.7 (2.0; 0–9) 4.9 (2.0; 0–9)
 Weekly average of daily caregiver's sleep quality score, mean (SD; range)g 4.8 (2.0; 0–9) 5.1 (2.0; 0–9)
 Patients with ≥ 1 concurrent allergic condition, n (%)
  Food allergy (self-reported) 46 (74.2) 42 (66.7)
  Allergic rhinitis 31 (50.0) 25 (39.7)
  Asthma 18 (29.0) 14 (22.2)
  Hives 16 (25.8) 15 (23.8)
  Allergic conjunctivitis 4 (6.5) 4 (6.4)
  Chronic rhinosinusitis 2 (3.2) 0
  Eosinophilic esophagitis 2 (3.2) 2 (3.2)
  Nasal polyps 0 0
 Other allergies 35 (56.5) 34 (54.0)
 Prior systemic medications for AD, n (%) 17 (27.4) 20 (31.8)
  Prior systemic corticosteroids 10 (16.1) 13 (20.6)
 Prior systemic non-steroidal immunosuppressants 10 (16.1) 12 (19.1)
  Cyclosporine 7 (11.3) 9 (14.3)
  Methotrexate 5 (8.1) 5 (7.9)
  Mycophenolate 2 (3.2) 2 (3.2)
  Azathioprine 1 (1.6) 1 (1.6)

AD atopic dermatitis, BMI body mass index, BSA body surface area, CDLQI Child Dermatology Life Quality Index, DFI Dermatitis Family Impact, EASI Eczema Area and Severity Index, EASI-75 75% decrease in EASI, GISS Global Individual Signs Score, IDQOL Infants' Dermatitis Quality of Life Index, IGA Investigator’s Global Assessment, LS least squares, NRS Numerical Rating Scale, POEM Patient-Oriented Eczema Measure, q4w every 4 weeks, SCORAD SCORing Atopic Dermatitis, SD standard deviation, TEAE treatment-emergent adverse event, TCS topical corticosteroids

*IDQOL for patients aged < 4 years; CDLQI for patients aged ≥ 4 years, aPlacebo group n = 61, dupilumab group n = 63. bPlacebo group n = 61, dupilumab group n = 63. cPlacebo group n = 32, dupilumab group n = 38. dPlacebo group n = 30, dupilumab group n = 25. ePlacebo group n = 61, dupilumab group n = 62. fPlacebo group n = 62, dupilumab group n = 62. gPlacebo group n = 62, dupilumab group n = 62