Table II.
Primary effectiveness outcomes of 16 weeks’ treatment with upadacitinib in 47 patients with atopic dermatitis
| Baseline | Week 4 | Week 8 | Week 16 | p-valuea | |
|---|---|---|---|---|---|
| Total cohort | n=47 | n=47 | n=42 | n=38 | – |
| Patients who discontinued treatment, n (%) | 0 (0) | 5 (10.6) | 4 (8.5) | 5 (10.6) | – |
| Concomitant immunosuppressive therapy, n (%) | 32 (68.1) | 13 (27.7) | 4 (9.5)b | 2 (5.3)c | – |
| Primary endpoints, mean (95% CI) | |||||
| EASI score | 16.6 (13.6–19.6) | 7.5 (5.7–9.3) | 5.8 (4.5–7.1) | 5.7 (4.2–7.2) | <0.001 |
| Weekly average NRS-pruritus | 7.0 (6.4–7.6) | 3.9 (3.1–4.7) | 4.4 (3.7–5.1) | 3.7 (2.9–4.5) | <0.001 |
| DLQI score | 11.2 (9.6–12.8) | 7.1 (5.5–8.7) | 6.2 (4.9–7.5) | 5.8 (4.2–7.5) | <0.001 |
| POEM score | 19.9 (18.4–21.5) | 11.4 (9.8–13.1) | 11.1 (9.5–12.8) | 11.5 (9.7–13.2) | <0.001 |
| Responder subgroups | – | ||||
| Dup-NR | n=23 | n=23 | n=21 | n=20 | |
| Dup-R/naïve | n=24 | n=24 | n=21 | n=18 | |
| Bari-NR | n=14 | n=14 | n=14 | n=13 | |
| Bari-R/naïve | n=33 | n=33 | n=28 | n=25 | |
| Patients who discontinued treatment, n (%) | – | ||||
| Dup-NR | 0 (0) | 2 (8.7) | 1 (4.8) | 2 (10.0) | |
| Dup-R/naïve | 0 (0) | 3 (12.5) | 3 (14.3) | 3 (16.7) | |
| Bari-NR | 0 (0) | 0 (0) | 1 (7.1) | 1 (7.7) | |
| Bari-R/naïve | 0 (0) | 5 (15.2) | 3 (10.7) | 4 (16.0) | |
| Primary endpoints, mean (95% CI) | |||||
| EASI score | |||||
| Dup-NR | 17.3 (13.8–20.8) | 8.0 (5.9–10.1) | 5.8 (4.6–7.1) | 6.5 (4.0–8.9) | 0.938 |
| Dup-R/naïve | 15.8 (10.8–20.9) | 7.1 (4.3–10.0) | 5.7 (3.4–8.0) | 4.8 (3.3–6.3) | |
| Bari-NR | 15.7 (11.9–19.5) | 5.9 (4.1–7.7) | 7.7 (5.3–10.1) | 6.0 (4.0–8.1) | 0.187 |
| Bari-R/naïve | 16.9 (13.0–20.9) | 8.2 (5.8–10.6) | 4.7 (3.4–6.1) | 5.5 (3.5–7.5) | |
| Weekly average NRS-pruritus | |||||
| Dup-NR | 7.0 (6.0–7.9) | 4.4 (3.3–5.4) | 4.2 (3.4–5.1) | 3.7 (2.7–4.7) | 0.311 |
| Dup-R/naïve | 7.0 (6.2–7.8) | 3.5 (2.4–4.7) | 4.5 (3.4–5.7) | 3.7 (2.5–5.0) | |
| Bari-NR | 7.2 (6.2–8.2) | 4.6 (3.3–5.8) | 4.7 (3.2–6.1) | 4.3 (3.2–5.5) | 0.443 |
| Bari-R/naïve | 6.9 (6.1–7.7) | 3.7 (2.7–4.7) | 4.3 (3.5–5.1) | 3.4 (2.3–4.4) | |
| DLQI score | |||||
| Dup-NR | 11.3 (9.0–13.6) | 7.4 (5.5–9.4) | 5.5 (4.0–7.0) | 6.4 (3.7–9.1) | 0.601 |
| Dup-R/naïve | 11.1 (8.9–13.3) | 6.9 (4.3–9.4) | 6.9 (4.8–9.0) | 5.2 (3.6–6.8) | |
| Bari-NR | 10.3 (8.0–12.6) | 8.4 (5.0–11.8) | 6.3 (3.7–8.9) | 5.8 (3.2–8.3) | 0.541 |
| Bari-R/naïve | 11.6 (9.6–13.6) | 6.6 (4.9–8.4) | 6.2 (4.7–7.6) | 5.9 (3.7–8.0) | |
| POEM score | |||||
| Dup-NR | 19.4 (17.1–21.7) | 10.9 (8.6–13.2) | 10.5 (9.0–12.1) | 10.6 (8.2–12.9) | 0.970 |
| Dup-R/naïve | 20.5 (18.3–22.6) | 11.9 (9.5–14.3) | 11.7 (8.8–14.6) | 12.4 (10.0–14.9) | |
| Bari-NR | 20.7 (18.1–23.3) | 13.4 (10.8–16.1) | 12.1 (9.3–14.8) | 11.7 (8.9–14.2) | 0.679 |
| Bari-R/naïve | 19.6 (17.7–21.5) | 10.6 (8.6–12.5) | 10.7 (8.7–12.7) | 11.3 (9.2–14.3) | |
a
p-values based on overall likelihood ratio tests for time. – Not measured.
Data after multiple imputation.
AD: atopic dermatitis; 95% CI; 95% confidence interval; dup: dupilumab; bari: baricitinib; NR: non-responders; R/naïve: responders/naïve patients; EASI: Eczema Area and Severity Index; IGA: Investigator Global Assessment; NRS: numerical rating scale; DLQI: Dermatology Life Quality Index; POEM: Patient-Oriented Eczema Measure; ADCT: Atopic Dermatitis Control Tool; PGADS: Patient Global Assessment of Disease Status.