Table 2.
Patient-reported outcomes of flares, skin symptoms, sleep, quality of life, and work and activity impairment
| Outcome | Baseline (n = 698) | Month 12 (n = 483)a | Month 30–36 (n = 425)a |
|---|---|---|---|
| Percent of patients reporting no flares in the past 4 weeks, (PMM range)b | 3.0 | 43.5 (41.4–43.5) | 45.9 (42.6–45.9) |
|
Non-itch skin symptoms NRS score, (PMM range)b,c | |||
| Skin pain | 5.9 ± 2.5 | 1.7 ± 2.2 (1.3–3.1) | 1.5 ± 2.0 (1.0–3.1) |
| Hot/burning skin | 5.2 ± 2.9 | 1.5 ± 2.1 (1.1–2.8) | 1.2 ± 1.9 (0.8–2.7) |
| Skin sensitivity | 5.5 ± 2.9 | 1.5 ± 2.2 (1.1–2.9) | 1.2 ± 1.9 (0.8–2.8) |
| Percent of patients reporting sleep problems in the past week, (PMM range)b | 77.5 | 14.1 (14.1–16.2) | 13.4 (12.7–15.1) |
| Percent of patients reporting no trouble falling/staying asleep in the past week, (PMM range)b,d | 15.3 | 77.6 (56.2–82.2) | 81.6 (52.9–82.2) |
| DLQIe | |||
| Total score, (PMM range)b | 14.4 ± 7.3 | 3.5 ± 4.9 (2.7–7.5) | 3.2 ± 4.8 (2.2–8.1) |
| Percent of patients achieving a clinically meaningful change, (PMM range)b | – | 82.6 (65.0–85.4) | 84.9 (61.7–87.7) |
| Percent of patients reporting no effect of AD on the patient’s life, (PMM range)b | 1.1 | 46.2 (32.1–58.4) | 52.5 (32.1–66.8) |
| WPAI:AD, (PMM range)a,f | |||
| Percent total work impairment | 40.3 ± 28.1 | 9.6 ± 17.9 (7.0–24.0) | 8.6 ± 17.1 (5.2–22.9) |
| Percent activity impairment | 45.6 ± 28.4 | 10.8 ± 19.5 (8.3–24.0) | 9.4 ± 17.7 (6.5–23.5) |
Data are presented as % of patients or mean ± standard deviation unless otherwise indicated
AD atopic dermatitis, ADCT Atopic Dermatitis Control Tool, DLQI Dermatology Life Quality Index, NRS numerical rating scale, PMM pattern-mixture model, WPAI:AD Work Productivity and Activity Impairment Questionnaire specific for Atopic Dermatitis
aP < 0.001 vs. baseline
bPMM range is imputed based on n = 698 for follow-up
cScore range is 0–10, with 10 = worst score
dBased on item 4 of the ADCT
eTotal score ranges from 0 to 30, with higher scores indicating a greater impact; a change of ≥ 4 points in total score is clinically meaningful, and scores of 0–1 are interpreted as no effect of AD on a patient’s life
fEvaluated among patients who were employed full or part time or were self-employed and worked more than 0 h during the previous 7 days: n = 494, 322, and 278 for baseline, month-12, and long-term timepoints, respectively