Table 1.
Baseline patient demographics and disease characteristics
| Baseline study characteristics | BREEZE-AD1 | BREEZE-AD2 | BREEZE-AD7 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo. N = 249 |
Baricitinib 1 mg N = 127 |
Baricitinib 2 mg N = 123 |
Baricitinib 4 mg N = 125 |
Placebo N = 244 | Baricitinib 1 mg N = 125 |
Baricitinib 2 mg N = 123 |
Baricitinib 4 mg N = 123 |
Placebo + TCS N = 109 |
Baricitinib 2 mg + TCS N = 109 |
Baricitinib 4 mg + TCS N = 111 |
|
| Age (years) | 35 (12.6) | 36 (12.4) | 35 (13.7) | 37 (12.9) | 35 (13.0) | 33 (10.0) | 36 (13.2) | 34 (14.1) | 34 (13.2) | 34 (12.8) | 34 (11.4) |
| Female, n (%) | 101 (40.6) | 49 (38.6) | 41 (33.3) | 42 (33.6) | 90 (36.9) | 45 (36.0) | 58 (47.2) | 41 (33.3) | 38 (34.9) | 39 (35.8) | 36 (32.4) |
| Race, n (%) | |||||||||||
| Caucasian | 147 (59.5) | 74 (58.3) | 75 (61.0) | 70 (56.5) | 169 (69.3) | 85 (68.0) | 85 (69.1) | 82 (66.7) | 46 (42.2) | 50 (45.9) | 54 (48.6) |
| Asian | 73 (29.6) | 40 (31.5) | 35 (28.5) | 41 (33.1) | 72 (29.5) | 36 (28.8) | 37 (30.1) | 38 (30.9) | 57 (52.3) | 57 (52.3) | 54 (48.6) |
| Duration since AD diagnosis (years) | 26 (15.5) | 27 (14.9) | 25 (14.6) | 25 (14.9) | 25 (13.9) | 24 (12.7) | 24 (13.8) | 23 (14.8) | 22.0 (12.2) | 24.6 (14.8) | 25.5 (13.2) |
| Weight (kg) | 73 (15.7) | 74 (17.2) | 75 (17.7) | 74 (17.2) | 72 (15.5) | 75 (16.6) | 72 (14.7) | 73 (14.9) | 73 (15.8) | 72 (15.5) | 73 (17.8) |
| Body mass index (kg/m) | 25 (4.5) | 25 (4.6) | 25 (5.1) | 25 (4.3) | 25 (4.3) | 26 (5.2) | 25 (5.0) | 25 (4.2) | 26 (4.6) | 25 (4.7) | 25 (5.1) |
| Geographic region, n (%) | |||||||||||
| Europea | 135 (54.2) | 67 (52.8) | 67 (54.5) | 68 (54.4) | 111 (45.5) | 57 (45.6) | 56 (45.5) | 56 (45.5) | 38 (34.9) | 38 (34.9) | 39 (35.1) |
| Japan | 45 (18.1) | 23 (18.1) | 21 (17.1) | 22 (17.6) | 45 (18.4) | 22 (17.6) | 22 (17.9) | 23 (18.7) | 21 (19.3) | 20 (18.3) | 22 (19.8) |
| Otherb | 69 (27.7) | 37 (29.1) | 35 (28.5) | 35 (28.0) | 88 (36.1) | 46 (36.8) | 45 (36.6) | 44 (35.8) | 50 (45.9) | 51 (46.8) | 50 (45.0) |
| vIGA-ADc score of 4, n (%) | 105 (42.2) | 53 (41.7) | 52 (42.3) | 51 (40.8) | 121 (49.6) | 63 (50.8) | 62 (50.4) | 63 (51.2) | 48 (44.4) | 50 (45.9) | 50 (45.0) |
| EASId | 32 (13.0) | 29 (11.8) | 31 (11.7) | 32 (12.7) | 33 (12.8) | 33 (12.7) | 35 (16.0) | 33 (12.7) | 29 (12.3) | 29 (11.9) | 31 (12.6) |
| SCORADe | 68 (14.0) | 66 (14.4) | 68 (13.0) | 68 (12.9) | 68 (12.7) | 67 (12.9) | 69 (13.3) | 68 (13.6) | 66.6 (13.8) | 66.8 (14.0) | 68.3 (13.2) |
| Body surface area affected | 53 (23.1) | 47 (21.2) | 50 (22.1) | 52 (21.8) | 52 (21.7) | 55 (21.9) | 55 (26.1) | 54 (21.5) | 48.1 (24.4) | 50.6 (21.6) | 52.1 (23.3) |
| Itch NRSf | 6.7 (2.0) | 6.1 (2.1) | 6.4 (2.2) | 6.5 (2.0) | 6.8 (2.2) | 6.4 (2.2) | 6.6 (2.2) | 6.6 (2.2) | 7.4 (1.7) | 7.0 (2.1) | 7.0 (2.0) |
| Skin pain NRSg | 6.1 (2.5) | 5.5 (2.4) | 5.7 (2.6) | 5.7 (2.4) | 6.2 (2.5) | 5.7 (2.7) | 6.2 (2.5) | 6.0 (2.6) | 6.8 (2.3) | 6.3 (2.5) | 6.0 (2.5) |
| ADSS item 1h | 2.0 (1.1) | 1.8 (1.0) | 1.9 (1.1) | 1.9 (1.0) | 1.9 (1.2) | 1.8 (1.1) | 1.9 (1.1) | 1.9 (1.1) | 2.3 (1.1) | 2.1 (1.1) | 2.1 (1.0) |
| ADSS item 2i | 3.4 (5.2) | 2.5 (3.4) | 2.3 (4.1) | 3.3 (5.2) | 1.8 (2.1) | 1.6 (1.8) | 2.1 (2.9) | 1.9 (2.5) | 1.8 (2.0) | 1.9 (2.3) | 1.8 (2.3) |
| ADSS item 3j | 2.2 (1.0) | 2.1 (0.9) | 2.3 (1.0) | 2.2 (0.9) | 2.2 (1.0) | 2.2 (1.0) | 2.2 (1.0) | 2.3 (0.9) | 2.5 (0.9) | 2.4 (1.0) | 2.4 (0.8) |
| POEMk | 21 (5.6) | 20 (5.6) | 21 (5.6) | 21 (5.6) | 21 (6.3) | 20 (6.5) | 21 (6.0) | 20 (6.3) | 20.9 (6.7) | 21.0 (6.3) | 21.4 (6.0) |
| DLQIl | 14 (7.4) | 13 (6.8) | 13 (7.7) | 14 (7.1) | 15 (8.1) | 15 (8.1) | 14 (7.7) | 14 (8.4) | 15.0 (7.9) | 15.0 (7.7) | 14.7 (7.9) |
Data are presented as the mean (SD) unless otherwise indicated. Data for race excludes patients who were not Caucasian or Asian
AD Atopic dermatitis, ADSS Atopic Dermatitis Sleep Scale, DLQI Dermatology Life Quality Index, EASI Eczema Area and Severity Index, N number of patients, n number of patients in a subgroup, NRS numeric rating scale, POEM Patient Oriented Eczema Measures, SCORAD SCORing Atopic Dermatitis, SD standard deviation, TCS topical corticosteroids, viGA-AD Validated Investigator Global Assessment for Atopic Dermatitis
aEurope: BREEZE-AD1: Czech Republic, Denmark, France, Germany, and Italy; BREEZE-AD2: Austria, Hungary, Poland, Spain, and Switzerland; BREEZE-AD7: Austria, Germany, Italy, Poland, and Spain
bOther: BREEZE-AD1: India, Mexico, Russia, and Taiwan; BREEZE-AD2: Argentina, Australia, Israel, and South Korea; BREEZE-AD7: Argentina, Australia, Japan, South Korea, and Taiwan
cvIGA-AD measures the investigator’s global assessment of disease severity based on a static 5-point scale from 0 (clear skin) to 4 (severe disease)
dEASI scores range from 0 to 72, with higher scores indicating greater severity
eSCORAD is a combined score of investigator-reported disease severity and affected body surface area and patient-reported symptoms of itch and sleep dysfunction; scores range from 0–103
fItch NRS, ranging from 0 (no itch) to 10 (worst itch imaginable)
gSkin Pain NRS, ranging from 0 (no pain) to 10 (worst pain)
hADSS item 1 assesses how difficult it was to fall asleep the previous night due to itch using a 5-point Likert-type scale with response options ranging from 0 = not at all to 4 = very difficult
iADSS item 2 assesses the frequency of nighttime awakenings due to itch the previous night on a scale of 0–29
jADSS item 3 assesses how difficult it was to get back to sleep the previous night due to itch using a 5-point Likert-type scale with response options ranging from 0 = not at all to 4 = very difficult
kPOEM is a composite measure of patient-reported symptoms, including the effect of symptoms on sleep and evaluates the frequency of symptoms (including itch) and the effect of atopic dermatitis on sleep on a scale of 0–28
lDLQI evaluates health-related quality of life on a scale of 0–30