Why carry out this study?
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Little is known about possible differences in treatment efficacy between adults with adult-onset or childhood-onset atopic dermatitis (AD). |
Dupilumab, a fully human monoclonal antibody, inhibits the signaling of both interleukin (IL)-4 and IL-13, which are key drivers of type 2-mediated inflammation, a molecular signature common to AD across age groups and clinical phenotypes. |
We hypothesize that dupilumab treatment responses in adults with moderate-to-severe AD would be similar, regardless of age of AD-onset. |
What has been learned from this study?
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Our findings show that dupilumab is efficacious in adults with moderate-to-severe AD regardless of age of AD-onset; despite possible endophenotypic differences linked to age of onset and differences in AD duration at baseline, dupilumab showed similar improvements in AD signs, symptoms, and quality of life (QoL) in adults during 16 weeks of treatment. |
These findings support targeting of both IL-4 and IL-13 as an effective treatment strategy for AD across all ages of onset. |
Digital Features
Introduction
Methods
Assessments
Statistical Analysis
Results
Patient Demographics and Medical History
Placebo (N = 460) | Dupilumab 300 mg q2w (N = 457) | |
---|---|---|
Age, mean (SD), years | 38.4 (14.0) | 38.3 (14.4) |
Duration of AD, mean (SD), years | 28.8 (14.4) | 27.9 (15.2) |
Self-reported AD age of onset, n (%) | ||
< 5 years | 249 (54.1) | 239 (52.3) |
5 to < 10 years | 67 (14.6) | 61 (13.3) |
10 to < 20 years | 60 (13.0) | 63 (13.8) |
20 to < 30 years | 28 (6.1) | 38 (8.3) |
30 to < 40 years | 21 (4.6) | 21 (4.6) |
≥ 40 years | 30 (6.5) | 32 (7.0) |
Unsure | 4 (0.9) | 3 (0.7) |
Missing | 1 (0.2) | 0 |
Age of AD onset (self-reported) | 0–4 years | 5–9 years | 10–19 years | ≥ 20 years | ||||
---|---|---|---|---|---|---|---|---|
Placebo (N = 249) | Dupilumab 300 mg q2w (N = 239) | Placebo (N = 67) | Dupilumab 300 mg q2w (N = 61) | Placebo (N = 60) | Dupilumab 300 mg q2w (N = 63) | Placebo (N = 79) | Dupilumab 300 mg q2w (N = 91) | |
Age, mean (SD), years | 35.1 (12.59) | 36.1 (13.10) | 36.8 (11.84) | 34.1 (12.05) | 35.9 (13.71) | 35.3 (13.26) | 51.8 (12.6) | 49.4 (14.54) |
Sex, male, n (%) | 133 (53.4) | 132 (55.2) | 31 (46.3) | 38 (62.3) | 37 (61.7) | 36 (57.1) | 48 (60.8) | 59 (64.8) |
Race, n (%) | ||||||||
White | 172 (69.1) | 178 (74.5) | 35 (52.2) | 37 (60.7) | 31 (51.7) | 34 (54.0) | 61 (77.2) | 69 (75.8) |
Black | 14 (5.6) | 10 (4.2) | 9 (13.4) | 2 (3.3) | 7 (11.7) | 4 (6.3) | 5 (6.3) | 7 (7.7) |
Asian | 51 (20.5) | 42 (17.6) | 19 (28.4) | 21 (34.4) | 22 (36.7) | 20 (31.7) | 13 (16.5) | 14 (15.4) |
Duration of AD, mean (SD), years | 34 (12.66) | 34.9 (13.10) | 30.6 (11.99) | 27.7 (12.21) | 22.8 (14.06) | 21.1 (14.59) | 15.7 (11.95) | 14.2 (10.47) |
EASI score (0–72), mean (SD) | 34.7 (14.22) | 34.2 (14.12) | 32.7 (12.95) | 33.3 (11.29) | 33.0 (15.76) | 29.6 (12.06) | 33.4 (14.46) | 29.1 (12.53) |
IGA score (0–4), mean (SD) | 3.5 (0.50) | 3.5 (0.50) | 3.5 (0.50) | 3.6 (0.50) | 3.4 (0.50) | 3.4 (0.49) | 3.5 (0.50) | 3.4 (0.49) |
BSA (0–100), mean (SD) | 57.5 (23.20) | 56.3 (22.84) | 54.9 (22.05) | 55.8 (20.48) | 52.2 (25.02) | 50.9 (21.58) | 53.5 (22.69) | 47.6 (21.23) |
Weekly peak pruritus NRS (0–10), mean (SD) | 7.5 (1.67) | 7.6 (1.69) | 7.4 (2.02) | 7.3 (1.73) | 7.2 (1.78) | 7.1 (1.68) | 7.6 (1.98) | 7.2 (1.98) |
SCORAD score (0–103), mean (SD) | 69.5 (14.12) | 69.2 (13.64) | 67.2 (13.72) | 67.8 (11.31) | 66.4 (16.04) | 63.7 (13.45) | 69.0 (14.50) | 63.5 (14.51) |
o-SCORAD (0–83), mean (SD) | 56.5 (12.11) | 56.2 (11.83) | 54.4 (11.96) | 55.0 (10.19) | 54.8 (13.56) | 52.2 (10.89) | 55.8 (12.04) | 51.6 (11.93) |
SCORAD VAS Itch (0–10), mean (SD) | 7.5 (1.83) | 7.6 (1.91) | 7.8 (1.78) | 7.7 (1.91) | 7.0 (2.22) | 6.9 (2.20) | 7.6 (2.11) | 7.0 (2.43) |
SCORAD VAS Sleep (0–10), mean (SD) | 5.6 (3.11) | 5.5 (3.11) | 5.1 (3.30) | 5.5 (3.11) | 4.7 (3.45) | 4.6 (3.27) | 5.6 (3.49) | 4.9 (3.35) |
POEM score (0–28), mean (SD) | 21.1 (5.69) | 21.4 (5.32) | 21.1 (5.27) | 20.6 (5.53) | 19.6 (5.66) | 18.0 (6.38) | 19.7 (7.17) | 19.0 (6.91) |
DLQI score (0–30), mean (SD) | 15.6 (7.24) | 15.3 (6.79) | 15.6 (7.07) | 15.5 (7.11) | 14.1 (7.46) | 13.7 (7.82) | 13.9 (8.27) | 13.5 (7.79) |
Age of AD onset (self-reported) | 0–4 years | 5–9 years | 10–19 years | ≥ 20 years | ||||
---|---|---|---|---|---|---|---|---|
Placebo (N = 249) | Dupilumab 300 mg q2w (N = 243) | Placebo (N = 66) | Dupilumab 300 mg q2w (N = 63) | Placebo (N = 60) | Dupilumab 300 mg q2w (N = 63) | Placebo (N = 78) | Dupilumab 300 mg q2w (N = 93) | |
Family history of atopic/allergic conditions, n (%) | ||||||||
AD | 99 (39.8) | 125 (51.4) | 30 (45.5) | 29 (46.0) | 24 (40.0) | 22 (34.9) | 25 (32.1) | 29 (31.2) |
Asthma | 72 (28.9) | 78 (32.1) | 24 (36.4) | 15 (23.8) | 12 (20.0) | 12 (19.0) | 22 (28.2) | 18 (19.4) |
Allergic rhinitis | 75 (30.1) | 58 (23.9) | 17 (25.8) | 15 (23.8) | 18 (30.0) | 13 (20.6) | 8 (10.3) | 16 (17.2) |
Other allergies | 55 (22.1) | 63 (25.9) | 18 (27.3) | 16 (25.4) | 11 (18.3) | 9 (14.3) | 8 (10.3) | 12 (12.9) |
Food allergy | 54 (21.7) | 52 (21.4) | 14 (21.2) | 7 (11.1) | 5 (8.3) | 4 (6.3) | 4 (5.1) | 13 (14.0) |
Allergic conjunctivitis | 34 (13.7) | 30 (12.3) | 10 (15.2) | 6 (9.5) | 5 (8.3) | 3 (4.8) | 4 (5.1) | 6 (6.5) |
Hives | 24 (9.6) | 25 (10.3) | 11 (16.7) | 7 (11.1) | 4 (6.7) | 6 (9.5) | 2 (2.6) | 5 (5.4) |
Chronic rhinosinusitis | 11 (4.4) | 14 (5.8) | 3 (4.5) | 2 (3.2) | 2 (3.3) | 2 (3.2) | 2 (2.6) | 2 (2.2) |
Nasal polyps | 9 (3.6) | 5 (2.1) | 2 (3.0) | 0 | 0 | 1 (1.6) | 1 (1.3) | 2 (2.2) |
Eosinophilic esophagitis | 1 (0.4) | 2 (0.8) | 1 (1.5) | 0 | 0 | 0 | 0 | 1 (1.1) |
Patient history of atopic/allergic conditions other than AD, n (%) | ||||||||
Asthma | 117 (47.0) | 132 (54.3) | 18 (27.3) | 22 (34.9) | 13 (21.7) | 15 (23.8) | 18 (23.1) | 29 (31.2) |
Allergic rhinitis | 131 (52.6) | 143 (58.8) | 30 (45.5) | 32 (50.8) | 22 (36.7) | 26 (41.3) | 29 (37.2) | 25 (26.9) |
Other allergies | 172 (69.1) | 174 (71.6) | 39 (59.1) | 36 (57.1) | 31 (51.7) | 33 (52.4) | 37 (47.4) | 44 (47.3) |
Food allergy | 121 (48.6) | 117 (48.1) | 19 (28.8) | 20 (31.7) | 14 (23.3) | 15 (23.8) | 16 (20.5) | 20 (21.5) |
Allergic conjunctivitis | 76 (30.5) | 87 (35.8) | 18 (27.3) | 13 (20.6) | 10 (16.7) | 11 (17.5) | 14 (17.9) | 11 (11.8) |
Hives | 38 (15.3) | 52 (21.4) | 8 (12.1) | 8 (12.7) | 5 (8.3) | 8 (12.7) | 9 (11.5) | 4 (4.3) |
Chronic rhinosinusitis | 14 (5.6) | 13 (5.3) | 1 (1.5) | 2 (3.2) | 2 (3.3) | 4 (6.3) | 4 (5.1) | 6 (6.5) |
Atopic keratoconjunctivitis | 13 (5.2) | 16 (6.6) | 0 | 1 (1.6) | 0 | 3 (4.8) | 2 (2.6) | 1 (1.1) |