Table II.
Primary and secondary outcomes on the effect of 16-week baricitinib treatment in 51 patients with atopic dermatitis
| Baseline (n = 51) | Week 4 (n = 51) | Week 8 (n = 48) | Week 16 (n = 36) | p-valuea | |
|---|---|---|---|---|---|
| Patients who discontinued treatment, n (%) | 0 (0) | 3 (5.9) | 12 (23.5) | 8 (15.6) | |
| Concomitant immunosuppressive therapy, n (%) | 28 (54.9) | 20 (39.2) | 4 (8.3) | 3 (8.3) | |
| Primary endpoints, mean (95% CI) | |||||
| EASI score | 18.3 (14.5–22.1) | 10.2 (8.0–12.4) | 9.7 (7.5–11.8) | 11.1 (7.8–14.4) | < 0.0001 |
| Weekly average NRS-pruritus | 6.6 (6.0–7.3) | 4.6 (3.9–5.4) | 4.9 (4.3–5.6) | 5.3 (4.5–6.2) | < 0.0001 |
| Weekly average NRS-pain | 4.2 (3.4–5.0) | 2.9 (2.1–3.6) | 2.7 (1.9–3.4) | 3.3 (2.3–4.2) | 0.001 |
| DLQI score | 12.0 (10.3–13.6) | 8.0 (6.4–9.7) | 7.2 (5.7–8.8) | 5.7 (4.4–7.0) | < 0.0001 |
| POEM score | 16.9 (15.4–18.3) | 13.8 (11.9–15.7) | 10.7 (9.1–12.3) | 12.6 (10.6–14.6) | < 0.0001 |
| Secondary endpoints, n (%), probability % (95% CI) | |||||
| EASI score≤7 | 10 (19.6), 8.4 (2.6–23.8) | 19 (37.3), 27.4 (11.9–51.2) | 20 (41.7), 31.5 (12.9–58.8) | 19 (52.8), 29.4 (13.1–53.5) | 0.023 |
| IGA score≤1 | 3.0 (5.9), 1.9 (3.2–10.7) | 9 (17.6), 8.7 (2.5–26.1) | 13 (27.1), 16.1 (0.5–43.3) | 13 (36.1), 22.2 (7.8–49.0) | 0.002 |
| NRS-pruritus≤4 | 7 (13.7), 5.9 (1.7–18.4) | 21 (41.2), 35.9 (18.3–58.3) | 17 (35.4), 23.9 (9.2–49.3) | 15 (41.7), 20.5 (8.8–40.9) | < 0.0001 |
| NRS-pain≤4 | 25 (49.0), 48.3 (27.1–70.1) | 37 (72.5), 83.3 (63.5–93.5) | 35 (72.9), 50.9 (29.8–71.7) | 26 (72.2), 78.6 (54.9–91.8) | 0.004 |
| DLQI score≤5 | 8 (15.7), 9.6 (3.3–24.5) | 19 (37.3), 31.9 (16.3–52.9) | 15 (31.3), 22.2 (8.3–47.3) | 19 (52.8), 31.4 (15.2–53.8) | 0.027 |
| POEM score≤7 | 3 (5.9), 1.1 (0.1–10.0) | 9 (17.6), 6.5 (1.3–26.9) | 9 (18.8), 6.6 (1.7–31.5) | 8 (22.2), 4.8 (0.8–24.5) | 0.076 |
| ADCT score<7 | 2 (3.9), 2.8 (2.9–22.3) | – | – | 18 (50.0), 33.0 (15.0–57.8) | 0.003 |
| PGADS score≥3 | 15 (29.4), 27.0 (12.7–48.4) | 27 (52.9), 52.9 (34.0–71.0) | 23 (47.9), 46.9 (27.4–67.4) | 25 (69.4), 70.0 (47.5–85.7) | 0.277 |
Data after multiple imputation.
a
p-values based on overall likelihood ratio tests for time.
AD: atopic dermatitis; CI; confidence interval; 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; –: not measured.