Introduction
Methods
Study Design and Treatment
Patients
QoL Assessments
Minimal Clinically Important Difference
CDLQI and DLQI Severity Bands
Statistics
Results
Patient Disposition and Characteristics
Patient demographics and characteristics | Ages 2–15 years | Ages ≥ 16 years | ||
---|---|---|---|---|
Vehicle (n = 412) | Crisaborole ointment (n = 815) | Vehicle (n = 94) | Crisaborole ointment (n = 201) | |
Sex, % | ||||
Male | 47.6 | 46.9 | 30.9 | 33.8 |
Female | 52.4 | 53.1 | 69.1 | 66.2 |
Ethnicity, % | ||||
Hispanic or Latino | 21.4 | 20.9 | 13.8 | 14.9 |
Not Hispanic or Latino | 78.6 | 79.1 | 86.2 | 85.1 |
Race, % | ||||
American Indian or Alaskan Native | 0.7 | 1.0 | 2.1 | 1.5 |
Asian | 4.4 | 4.8 | 9.6 | 6.5 |
Black or African American | 26.2 | 27.4 | 33.0 | 30.8 |
Hawaiian or other Pacific Islander | 1.7 | 0.7 | 1.1 | 0.5 |
White | 61.9 | 61.7 | 54.3 | 56.7 |
Other | 5.1 | 4.4 | 0.0 | 4.0 |
Severity of pruritus scale, n (%) | ||||
0—none | 14 (3.9) | 31 (4.3) | 5 (6.0) | 4 (2.3) |
1—mild | 102 (28.5) | 185 (25.4) | 17 (20.5) | 44 (25.0) |
2—moderate | 137 (38.3) | 253 (34.8) | 30 (36.1) | 78 (44.3) |
3—severe | 105 (29.3) | 258 (35.5) | 31 (37.3) | 50 (28.4) |
CDLQI | ||||
n | 403 | 797 | – | – |
Mean (SD) | 9.0 (6.02) | 9.3 (5.99) | – | – |
DLQI | ||||
n | – | – | 92 | 192 |
Mean (SD) | – | – | 9.3 (6.55) | 9.7 (6.29) |
DFI (parents/caregivers/families of patients ages 2–17 years) | ||||
n | 431 | 862 | – | – |
Mean (SD) | 7.8 (6.17) | 8.1 (6.61) | – | – |
Overall QoL Assessment and MCID at Day 29
Severity Bands for CDLQI and DLQI
CDLQI, DLQI, and DFI: Question Level Analysis
Question | Treatment | Patients per response, % | P valuea,b | |||
---|---|---|---|---|---|---|
Not at all | Only a little | Quite a lot | Very much | |||
Itching/scratching, painful/sore
|
Vehicle
|
13.5
|
48.9
|
24.9
|
12.7
|
< 0.001
|
Crisaborole ointment
|
18.6
|
57.9
|
17.1
|
6.4
| ||
Embarrassed/self-conscious
|
Vehicle
|
61.0
|
23.8
|
10.5
|
4.7
|
0.011
|
Crisaborole ointment
|
68.2
|
21.2
|
7.7
|
2.9
| ||
Affected friendships | Vehicle | 90.1 | 6.1 | 2.2 | 1.7 | 0.241 |
Crisaborole ointment | 92.0 | 6.6 | 0.8 | 0.7 | ||
Affected clothing | Vehicle | 61.3 | 24.6 | 8.8 | 5.2 | 0.210 |
Crisaborole ointment | 64.2 | 25.6 | 6.7 | 3.6 | ||
Playing
|
Vehicle
|
62.4
|
26.8
|
6.6
|
4.1
|
0.010
|
Crisaborole ointment
|
69.5
|
23.8
|
4.5
|
2.2
| ||
Sports | Vehicle | 74.0 | 16.0 | 5.2 | 4.7 | 0.205 |
Crisaborole ointment | 77.6 | 13.9 | 3.8 | 4.7 | ||
School time | Vehicle | 75.0 | 15.9 | 6.9 | 2.2 | 0.155 |
Crisaborole ointment | 79.1 | 16.1 | 3.1 | 1.7 | ||
Holiday time
|
Vehicle
|
61.2
|
25.9
|
5.8
|
7.2
|
0.039
|
Crisaborole ointment
|
69.9
|
22.7
|
6.0
|
1.3
| ||
Teasing/bullying | Vehicle | 82.8 | 11.9 | 3.6 | 1.7 | 0.210 |
Crisaborole ointment | 85.5 | 11.2 | 1.8 | 1.4 | ||
Child sleep
|
Vehicle
|
42.3
|
34.5
|
13.5
|
9.7
|
0.001
|
Crisaborole ointment
|
51.4
|
33.0
|
9.3
|
6.2
| ||
Burden of treatment
|
Vehicle
|
49.7
|
34.5
|
11.0
|
4.7
|
0.001
|
Crisaborole ointment
|
60.2
|
29.2
|
7.4
|
3.3
|
Question | Treatment | Patients per response, % | P valuea,b | |||
---|---|---|---|---|---|---|
Not at all | Only a little | Quite a lot | Very much | |||
Itching/scratching, painful/sore
|
Vehicle
|
8.3
|
65.5
|
16.7
|
9.5
|
0.001
|
Crisaborole ointment
|
27.1
|
56.4
|
12.2
|
4.3
| ||
Embarrassed/self-conscious
|
Vehicle
|
47.6
|
25.0
|
11.9
|
15.5
|
0.024
|
Crisaborole ointment
|
56.9
|
31.4
|
6.9
|
4.8
| ||
Shopping, home, yard activities | Vehicle | 81.0 | 13.1 | 2.4 | 3.6 | 0.391 |
Crisaborole ointment | 75.5 | 19.7 | 3.7 | 1.1 | ||
Influenced clothes worn | Vehicle | 47.6 | 25.0 | 9.5 | 17.9 | 0.063 |
Crisaborole ointment | 55.9 | 27.1 | 11.2 | 5.9 | ||
Affected social/leisure activity | Vehicle | 70.2 | 17.9 | 6.0 | 6.0 | 0.366 |
Crisaborole ointment | 73.9 | 20.7 | 3.7 | 1.6 | ||
Affected sports participation | Vehicle | 79.8 | 16.7 | 0.0 | 3.6 | 0.556 |
Crisaborole ointment | 83.0 | 12.2 | 3.7 | 1.1 | ||
Affected work/studying | Vehicle | 70.2 | 23.8 | 3.6 | 2.4 | 0.193 |
Crisaborole ointment | 78.7 | 13.8 | 1.6 | 5.9 | ||
Affected relationships | Vehicle | 75.0 | 21.4 | 1.2 | 2.4 | 0.263 |
Crisaborole ointment | 80.9 | 17.0 | 1.1 | 1.1 | ||
Sexual difficulties
|
Vehicle
|
86.9
|
10.7
|
0.0
|
2.4
|
0.017
|
Crisaborole ointment
|
95.2
|
3.2
|
0.5
|
1.1
| ||
Burden of treatment | Vehicle | 67.9 | 27.4 | 2.4 | 2.4 | 0.164 |
Crisaborole ointment | 59.6 | 31.4 | 9.0 | 0.0 |
Question | Treatment | Patients per response, % | P valuea,b | |||
---|---|---|---|---|---|---|
Not at all | Only a little | Quite a lot | Very much | |||
Housework | Vehicle | 61.5 | 29.6 | 6.0 | 2.9 | 0.555 |
Crisaborole ointment | 63.6 | 27.4 | 5.7 | 3.3 | ||
Food | Vehicle | 73.8 | 18.8 | 4.7 | 2.6 | 0.142 |
Crisaborole ointment | 77.5 | 17.2 | 3.5 | 1.8 | ||
Sleep
|
Vehicle
|
56.8
|
27.6
|
8.4
|
7.1
|
0.015
|
Crisaborole ointment
|
64.2
|
22.8
|
8.5
|
4.5
| ||
Leisure | Vehicle | 66.2 | 23.8 | 5.8 | 4.2 | 0.281 |
Crisaborole ointment | 68.7 | 24.2 | 3.8 | 3.3 | ||
Time shopping
|
Vehicle
|
78.3
|
18.6
|
1.8
|
1.3
|
0.026
|
Crisaborole ointment
|
83.7
|
13.7
|
1.6
|
1.1
| ||
Expenditure | Vehicle | 63.4 | 29.3 | 5.0 | 2.4 | 0.042 |
Crisaborole ointment | 69.9 | 23.4 | 5.0 | 2.0 | ||
Tiredness
|
Vehicle
|
60.2
|
27.7
|
7.3
|
4.7
|
0.019
|
Crisaborole ointment
|
67.2
|
22.9
|
6.2
|
3.7
| ||
Emotional distress | Vehicle | 58.6 | 29.8 | 8.9 | 2.6 | 0.191 |
Crisaborole ointment | 63.1 | 25.9 | 7.3 | 3.7 | ||
Relationships | Vehicle | 76.7 | 17.8 | 4.5 | 1.0 | 0.117 |
Crisaborole ointment | 80.8 | 14.4 | 3.3 | 1.6 | ||
Burden of treatment | Vehicle | 46.5 | 36.0 | 13.4 | 4.2 | 0.201 |
Crisaborole ointment | 49.0 | 37.8 | 9.0 | 4.3 |