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Chan SMH, Cro S, Cornelius V, et al. Omalizumab for severe atopic dermatitis in 4- to 19-year-olds: the ADAPT RCT. Southampton (UK): National Institute for Health and Care Research; 2022 May. (Efficacy and Mechanism Evaluation, No. 9.5.)

Cover of Omalizumab for severe atopic dermatitis in 4- to 19-year-olds: the ADAPT RCT

Omalizumab for severe atopic dermatitis in 4- to 19-year-olds: the ADAPT RCT.

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Appendix 5Week 24 data on allergen-specific IgEs and skin prick tests

TABLE 36

Week 24 allergen-specific IgEs

Week 24 SpIgEsIgE level (kUA/l) by treatment arm
OmalizumabPlacebo
Cow’s milk
n 2928
Mean (SD)29.2 (39.9)14.3 (29.1)
Median (IQR)4.8 (0.3–40.1)1.4 (0.4–4.3)
Egg white
n 2928
Mean (SD)18.7 (29.5)22.9 (35.5)
Median (IQR)3.5 (0.9–22.8)3.5 (1.2–26.7)
Soya
n 2928
Mean (SD)8.5 (12.1)10.4 (22.5)
Median (IQR)4.0 (1.5–9.4)1.3 (0.8–7.0)
Wheat
n 2928
Mean (SD)11.5 (19.5)8.0 (16.1)
Median (IQR)4.1 (1.1–13.2)1.5 (0.8–6.6)
Peanut
n 2928
Mean (SD)30.5 (37.1)31.4 (37.0)
Median (IQR)15.0 (3.0–47.4)16.3 (2.3–59.7)
Brazil nut
n 2928
Mean (SD)9.0 (19.0)9.7 (22.6)
Median (IQR)2.8 (0.6–9.9)0.7 (0.2–4.5)
Hazelnut
n 2928
Mean (SD)61.2 (43.4)43.6 (38.3)
Median (IQR)85.4 (8.1–100.0)42.2 (1.3–76.8)
Almond
n 2928
Mean (SD)13.5 (14.7)8.5 (17.2)
Median (IQR)8.1 (2.8–22.0)1.6 (1.0–5.1)
Walnut
n 2928
Mean (SD)26.1 (36.4)15.8 (31.6)
Median (IQR)6.9 (1.1–43.1)1.1 (0.4–7.2)
Cashew
n 2928
Mean (SD)28.1 (35.0)7.0 (13.5)
Median (IQR)7.1 (2.4–65.5)1.3 (0.5–6.8)
Pistachio
n 2928
Mean (SD)34.1 (38.1)9.9 (14.6)
Median (IQR)17.0 (4.5–46.8)1.9 (1.0–15.4)
Pecan
n 2928
Mean (SD)12.6 (23.4)8.6 (21.9)
Median (IQR)0.9 (0.3–7.0)0.5 (0.3–1.7)
Macadamia
n 2928
Mean (SD)14.4 (20.6)6.5 (13.6)
Median (IQR)6.8 (1.2–16.1)1.5 (0.8–3.9)
Sesame
n 2928
Mean (SD)24.3 (27.9)14.3 (22.5)
Median (IQR)15.3 (3.5–37.8)5.4 (2.4–12.5)
Pine nut
n 2928
Mean (SD)5.3 (9.3)2.4 (4.5)
Median (IQR)1.3 (0.3–7.0)1.0 (0.3–1.8)
Cod
n 2928
Mean (SD)22.3 (36.8)14.7 (30.8)
Median (IQR)0.7 (0.2–32.3)0.8 (0.3–5.3)
Alternaria spp.
n 2928
Mean (SD)6.4 (11.7)10.7 (19.1)
Median (IQR)1.8 (0.8–4.6)3.2 (0.4–15.2)
House dust mite (Dermatophagoides pteronyssinus)
n 2928
Mean (SD)84.8 (31.5)73.6 (40.2)
Median (IQR)100.0 (91.1–100.0)100.0 (39.9–100.0)
House dust mite (Dermatophagoides farinae)
n 2928
Mean (SD)81.5 (33.4)71.0 (42.0)
Median (IQR)100.0 (83.8–100.0)100.0 (26.4–100.0)
Silver birch
n 2927
Mean (SD)56.4 (48.4)57.8 (45.8)
Median (IQR)100.0 (0.5–100.0)88.4 (1.9–100.0)
Timothy grass
n 2928
Mean (SD)46.4 (38.9)48.7 (39.7)
Median (IQR)43.2 (4.8–81.6)44.9 (8.8–92.3)
Cat dander
n 2928
Mean (SD)34.9 (42.8)40.5 (40.2)
Median (IQR)4.6 (0.5–85.8)30.2 (1.1–78.9)
Dog dander
n 2928
Mean (SD)37.1 (40.8)30.6 (37.2)
Median (IQR)10.3 (4.0–83.7)10.3 (2.8–56.7)
Rabbit
n 2927
Mean (SD)13.9 (23.8)4.9 (10.0)
Median (IQR)2.5 (0.4–13.0)0.9 (0.2–2.7)
Horse
n 2827
Mean (SD)18.6 (31.7)21.3 (32.6)
Median (IQR)0.9 (0.3–28.8)1.6 (0.5–43.9)
Shrimp
n 2826
Mean (SD)23.2 (35.9)26.2 (35.9)
Median (IQR)1.5 (0.7–37.5)7.0 (0.4–32.5)
IgE (kU/l)
n 29
Mean (SD)12,497.1 (12,115.3)11,747.5 (11,040.2)
Median (IQR)6521.0 (3836.0–17,164.0)9208.5 (3271.0–15,861.5)

Note

IgE levels of < 0.35 kU/l recorded as 0.35 kU/l and IgE levels of > 100 kU/l recorded as 100 kU/l.

TABLE 37

Week 24 SPT reactivity by treatment arm

SPTWheal (mm) by treatment arm
OmalizumabPlacebo
Positive control
n 2324
Mean (SD)6.7 (4.9)6.8 (3.5)
Median (IQR)6.0 (4.0–7.0)6.0 (4.0–9.0)
Negative control
n 2224
Mean (SD)0.0 (0.0)0.0 (0.0)
Median (IQR)0.0 (0.0–0.0)0.0 (0.0–0.0)
Cow’s milk (fresh)
n 2224
Mean (SD)3.5 (5.4)2.5 (3.6)
Median (IQR)0.0 (0.0–5.0)0.0 (0.0–5.0)
Cow’s milk (extract)
n 2124
Mean (SD)1.0 (2.1)1.1 (1.7)
Median (IQR)0.0 (0.0–0.0)0.0 (0.0–2.5)
Egg white
n 2224
Mean (SD)1.9 (3.2)7.3 (7.6)
Median (IQR)0.0 (0.0–3.0)6.0 (0.0–10.0)
Egg white (raw)
n 2222
Mean (SD)2.9 (5.7)13.9 (13.5)
Median (IQR)0.0 (0.0–4.0)12.0 (0.0–20.0)
Soya
n 2224
Mean (SD)0.4 (1.2)1.7 (2.6)
Median (IQR)0.0 (0.0–0.0)0.0 (0.0–3.5)
Wheat
n 2224
Mean (SD)0.8 (1.9)1.2 (1.8)
Median (IQR)0.0 (0.0–0.0)0.0 (0.0–2.5)
Peanut
n 2224
Mean (SD)3.3 (5.7)6.9 (6.2)
Median (IQR)0.0 (0.0–4.0)6.5 (0.0–10.5)
Brazil nut
n 2224
Mean (SD)1.9 (5.1)3.4 (6.0)
Median (IQR)0.0 (0.0–0.0)1.0 (0.0–4.0)
Hazelnut
n 2224
Mean (SD)1.9 (3.7)4.2 (5.9)
Median (IQR)0.0 (0.0–3.0)2.5 (0.0–6.5)
Almond
n 2224
Mean (SD)0.8 (2.6)2.0 (3.0)
Median (IQR)0.0 (0.0–0.0)0.0 (0.0–4.0)
Walnut
n 2224
Mean (SD)0.9 (2.6)2.6 (4.5)
Median (IQR)0.0 (0.0–0.0)0.0 (0.0–3.5)
Cashew
n 2224
Mean (SD)4.2 (5.7)2.6 (5.8)
Median (IQR)0.0 (0.0–10.0)0.0 (0.0–2.0)
Pistachio
n 2224
Mean (SD)3.1 (3.6)3.2 (4.6)
Median (IQR)1.0 (0.0–7.0)0.0 (0.0–5.5)
Pecan
n 2224
Mean (SD)1.1 (2.7)1.5 (3.1)
Median (IQR)0.0 (0.0–0.0)0.0 (0.0–2.0)
Macadamia
n 2224
Mean (SD)1.7 (3.7)1.3 (2.2)
Median (IQR)0.0 (0.0–1.0)0.0 (0.0–2.0)
Sesame
n 2224
Mean (SD)0.7 (2.2)1.7 (4.3)
Median (IQR)0.0 (0.0–0.0)0.0 (0.0–1.5)
Pine nut
n 2224
Mean (SD)0.0 (0.0)0.7 (1.5)
Median (IQR)0.0 (0.0–0.0)0.0 (0.0–0.5)
Cod
n 2224
Mean (SD)2.4 (6.0)1.9 (3.4)
Median (IQR)0.0 (0.0–0.0)0.0 (0.0–3.0)
Alternaria ssp.
n 2324
Mean (SD)1.0 (2.4)3.4 (5.7))
Median (IQR)0.0 (0.0–0.0)1.5 (0.0–4.0)
House dust mite (Dermatophagoides pteronyssinus)
n 2324
Mean (SD)3.1 (2.9)6.4 (3.9)
Median (IQR)3.0 (0.0–5.0)7.5 (3.5–10.0)
House dust mite (Dermatophagoides farinae)
n 2324
Mean (SD)3.1 (2.9)6.6 (4.6)
Median (IQR)3.0 (0.0–5.0)6.5 (3.0–10.5)
Birch pollen
n 2324
Mean (SD)1.9 (3.4)4.5 (3.6)
Median (IQR)0.0 (0.0–3.0)4.0 (2.0–7.5)
Timothy grass pollen
n 2224
Mean (SD)2.0 (3.0)4.8 (3.9)
Median (IQR)0.0 (0.0–3.0)5.0 (0.5–8.0)
Cat
n 2224
Mean (SD)1.6 (2.6)5.3 (6.8)
Median (IQR)0.0 (0.0–4.0)2.0 (0.0–10.5)
Dog
n 2224
Mean (SD)1.3 (2.5)2.8 (3.8)
Median (IQR)0.0 (0.0–1.0)1.5 (0.0–3.5)
Rabbit
n 2224
Mean (SD)0.7 (1.4)1.1 (2.3)
Median (IQR)0.0 (0.0–0.0)0.0 (0.0–1.0)
Horse
n 2224
Mean (SD)1.3 (2.8)1.5 (2.9)
Median (IQR)0.0 (0.0–1.0)0.0 (0.0–1.5)
Shrimp
n 2222
Mean (SD)0.2 (0.9)1.3 (2.1)
Median (IQR)0.0 (0.0–0.0)0.0 (0.0–2.0)
Copyright © Queen’s Printer and Controller of HMSO 2022. This work was produced by Chan et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health and Care Research, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.
Bookshelf ID: NBK580988
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