Table I.
Baseline patient characteristics
| Study cohort (n = 235)a | Light skin type (n = 156, 66.4%) | Dark skin type (n = 68, 28.9%) | P value | |
|---|---|---|---|---|
| Sex—no. (%): Male/Female | 139 (59.1)/96 (40.9) | 93 (59.6)/63 (40.4) | 40 (58.8)/28 (41.2) | .91 |
| Age, median (IQR)—years | 26.0 (14.0-45.0) | 29.0 (17.3-48.0) | 19.5 (13.0-32.3) | <.001 |
| Age of onset AD, median (IQR)—years1 | 0 (0-3) | 0 (0-3) | 0 (0-4) | .92 |
| EASI, median (IQR)2 | 17.0 (9.175-27.325) | 14.9 (7.6-25.8) | 20.1 (10.8-30.6) | .009 |
| NRS pruritus past 24h, median (IQR)3 | 7 (6-8) | 7 (6-8) | 7 (4-9) | .38 |
| POEM, median (IQR)4 | 21 (16-24) | 21 (16-24) | 20 (13-24) | .67 |
| DLQI, mean ± SD5 | 14.1 ± 7.0 | 13.8 ± 6.9 | 14.8 ± 7.2 | .32 |
| Patients per treatment group—no. (%) | ||||
| Dupilumab | 168 (71.5) | 121 (77.6) | 42 (61.8) | |
| Methotrexate | 65 (27.7) | 37 (23.7) | 22 (32.4) | |
| Ciclosporin | 26 (11.1) | 19 (12.2) | 7 (10.3) | |
| BMI—median (IQR)b | 24.7 (22.6-27.8) | 24.7 (22.6-27.3) | 24.8 (21.8-30.1) | .63 |
| Educational statusc,6 | .28 | |||
| ISCED 0-2: Early childhood, primary and lower secondary education | 57 (24.3) | 38 (24.4) | 14 (20.6) | |
| ISCED 3-5: Upper secondary to short cycle tertiary education | 103 (43.8) | 73 (46.8) | 27 (39.7) | |
| ISCED 6-8: Bachelor’s, Master’s, Doctoral or equivalent level | 64 (27.2) | 40 (25.6) | 21 (30.8) | |
| Ethnicity—no. (%)7 | <.001 | |||
| White (Europe, Russia, Middle East, North Africa, USA, Canada, Australia) | 159 (67.7) | 147 (94.2) | 4 (5.9) | |
| Black African, Afro-Caribbean | 18 (7.7) | 0 (0) | 17 (25.0) | |
| Asian-Chinese | 5 (2.1) | 0 (0) | 5 (7.4) | |
| South-Asian (India, Pakistan, Sri Lanka, Nepal, Bhutan, Bangladesh) | 23 (9.8) | 4 (2.6) | 18 (26.5) | |
| Asian-other (Korea, China north of Huai River) | 8 (3.4) | 0 (0) | 7 (10.3) | |
| Hispanic or Latino | 1 (0.4) | 1 (0.6) | 0 (0) | |
| Mixed | 19 (8.1) | 4 (2.6)d | 15 (22.0)e | |
| Other | 1 (0.4) | 0 (0) | 1 (1.5) | |
| Fitzpatrick skin type—no. (%)6 | <.001 | |||
| I/II | 17 (7.2)/87 (37.0) | 17 (10.9)/87 (55.8) | 0 (0)/0 (0) | |
| III/IV | 52 (22.1)/29 (12.3) | 52 (33.3)/0 (0) | 0 (0)/29 (42.6) | |
| V/VI | 29 (12.3)/10 (4.3) | 0 (0)/0 (0) | 29 (42.6)/10 (14.7) | |
| Fitzpatrick skin type—median (IQR) | 3 (2-4) | 2 (2-3) | 5 (4-5) | <.001 |
| Morphological phenotypes—no. (%) | ||||
| Flexural eczema8 | 169 (71.9) | 113 (72.4) | 49 (72.0) | .96 |
| Non-flexural eczema8 | 173 (73.6) | 116 (74.4) | 51 (75.0) | .31 |
| Palmar hyperlinearity9 | 64 (27.2) | 45 (28.8) | 18 (26.5) | .29 |
| Pompholyx10 | 13 (5.5) | 10 (6.4) | 3 (4.4) | .84 |
| Discoïd (syn. nummular) eczema11 | 7 (3.0) | 4 (2.6) | 3 (4.4) | .41 |
| Prurigo nodularis12 | 14 (6.0) | 6 (3.8) | 7 (10.3) | .13 |
| Follicular eczema13 | 19 (8.0) | 4 (2.6) | 15 (22.1) | <.001 |
| Keratosis pilaris14 | 12 (5.1) | 5 (3.2) | 7 (10.3) | .09 |
| Erythroderma15 | 14 (6.0) | 9 (5.8) | 3 (4.4) | .58 |
| Ichthyosis vulgaris16 | 11 (4.7) | 6 (3.8) | 5 (7.4) | .34 |
| Infraorbital Dennie-Morgan skin folds17 | 13 (9.8) | 10 (10.5) | 3 (7.9) | .53 |
| Infra-auricular fissure(s)18 | 14 (10.5) | 11 (11.6) | 3 (7.9) | .29 |
| Skin infection19 | 17 (7.2) | 11 (7.1) | 4 (5.9) | .95 |
| Allergic co-morbidities—no. (%) | ||||
| Asthmaf,7 | 128 (54.5) | 87 (55.8) | 41 (60.3) | .68 |
| Allergic rhinoconjunctivitisf,7 | 129 (54.9) | 92 (59.0) | 37 (54.4) | .69 |
| Atopic eye diseasef,20 | 18 (7.7) | 13 (8.3) | 5 (7.4) | .53 |
| Eosinophilic esophagitisf,20 | 2 (0.8) | 1 (0.6) | 1 (1.5) | .86 |
| Allergic contact dermatitisg | 97 (41.3) | 74 (47.4) | 21 (30.9) | .026 |
| Food allergy | 118 (50.2)h/93 (39.6)i | 76 (48.7)h/63 (40.4)i | 42 (61.8)h/30 (44.1)i | .18/.14 |
| Family history of AD and allergic diseasesj,21- no. (%) | 140 (59.6) | 98 (62.8) | 42 (61.8) | .84 |
| Previous use of systemic therapies for AD—no. (%)5 | 190 (80.9) | 134 (85.9) | 50 (73.5) | .052 |
| Ciclosporin | 127 (54.0) | 89 (57.1) | 35 (51.5) | .57 |
| Azathioprine | 38 (16.2) | 29 (18.6) | 6 (8.8) | .14 |
| Methotrexate | 96 (40.9) | 64 (41.0) | 28 (41.2) | .80 |
| Mycophenolic acid/mycophenolate mofetil | 30 (12.8) | 19 (12.2) | 10 (4.7) | .71 |
| Systemic corticosteroids | 99 (42.1) | 76 (48.7) | 23 (33.8) | .09 |
| Dupilumabk | 2 (0.9) | 0 (0) | 1 (1.5) | .26 |
| Other medicationl | 2 (0.9) | 2 (1.3) | 0 (0) | .52 |
| Investigational medication | 14 (6.0) | 11 (7.1) | 3 (4.4) | .60 |
| Previous use of phototherapy—no. (%) | 122 (51.9) | 92 (59.0) | 27 (39.7) | .008 |
| Concomitant immunomodulating therapy—no. (%) | 37 (15.7) | 24 (15.4) | 13 (19.1) | .49 |
| Systemic corticosteroidsm/Othern | 30 (12.8)/7 (3.0) | 20 (12.8)/4 (2.6) | 10 (14.7)/3 (4.4) | .70/.47 |
AD, Atopic dermatitis; BMI, body mass index; DLQI, Dermatology Life Quality Index; EASI, Eczema Area Severity Index; IQR, interquartile range; ISCED, International Standard Classification of Education; No., number; NRS, Numerical Rating Scale; POEM, Patient-Oriented Eczema Measure; SD, standard deviation.
Significant P values displayed in bold. Missing data: 1n = 15, 2n = 5, 3n = 33, 4n = 14, 5n = 16, 6n = 11, 7n = 1, 8n = 51-57, 9n = 25, 10n = 59, 11n = 62,12n = 59, 13n = 64, 14n = 22, 15n = 20, 16n = 58, 17n = 53, analysis of NL data, 18n = 56, analysis of NL data, 19n = 16, 20n = 2, 21n = 10.
aAD based on the U.K. Working Party’s Diagnostic Criteria: n = 133 (NL), n = 102 (UK), bExcluding patients <18 years, c<18 years: ISCED of parents, fphysician-diagnosed, gpositive patch test; never tested (n = 24), tested negative (n = 15), unknown (n = 12) or missing (n = 87), hpatient-reported, ipatient-reported food allergy was confirmed by a physician diagnosis; patient-reported food allergy (n = 131), jfirst degree family member with at least one of the following allergic diseases: AD, asthma, allergic rhinoconjunctivitis, atopic eye disease or other, kopen-label extension study, ldimethyl fumarate (n = 1), rituximab (n = 1), mpredniso(lo)ne, nciclosporin (n = 3), long-term clarithromycin (n = 1), methotrexate (n = 1), mycophenolate mofetil (n = 1), ciclosporin and dupilumab concomitantly (n = 1).