Table I.
Baseline and patient characteristics
| Total cohort (n = 47) | Dup-R/naïve(n = 24) | Dup-NR(n = 23) | p - valuea | Bari-R/naïve(n = 33) | Bari-NR(n = 14) | p - valueb | |
|---|---|---|---|---|---|---|---|
| Male, n (%) | 31 (66.0) | 13 (54.2) | 18 (78.3) | 0.081 | 21 (63.6) | 10 (71.4) | 0.606 |
| Age (years), median (IQR) | 33.0 (26.0–43.0) | 37.0 (29.0–49.0) | 30.0 (25.0–42.0) | 0.337 | 37.0 (24.5–46.0) | 32.5 (29.8–42.8) | 0.681 |
| Age of onset ADc, n (%) | 0.548 | 0.008 | |||||
| Childhood | 41 (87.2) | 21 (87.5) | 20 (87.0) | 32 (97.0) | 9 (64.3) | ||
| Adolescence | 5 (10.6) | 3 (12.5) | 2 (8.7) | 1 (3.0) | 4 (28.6) | ||
| Adult | 1 (2.1) | 0 (0) | 1 (4.3) | 0 (0) | 1 (7.1) | ||
| Atopic disease at baseline, n (%) | 41 (87.2) | 23 (95.8) | 18 (78.3) | 0.071 | 28 (84.8) | 13 (92.9) | 0.452 |
| Allergic asthma | 28 (59.6) | 17 (70.8) | 11 (47.8) | 0.108 | 20 (60.6) | 8 (57.1) | 0.825 |
| Allergic rhinitis | 33 (70.2) | 20 (83.3) | 13 (56.5) | 0.045 | 22 (66.7) | 11 (78.6) | 0.414 |
| Allergic conjunctivitis | 32 (68.1) | 19 (79.2) | 13 (56.5) | 0.197 | 21 (63.6) | 11 (78.6) | 0.545 |
| Missing | 1 (2.1) | 0 (0) | 1 (4.3) | 1 (3.0) | 0 (0) | ||
| Food allergy | 19 (40.4) | 10 (41.7) | 9 (39.1) | 0.335 | 14 (42.4) | 5 (35.7) | 0.774 |
| Missing | 2 (4.3) | 0 (0) | 2 (8.7) | 1 (3.0) | 1 (7.1) | ||
| ≥ 2 atopic comorbidities | 33 (70.2) | 21 (87.5) | 12 (52.2) | 0.008 | 24 (72.7) | 9 (64.3) | 0.563 |
| History of conventional immunosuppressive drugs, n (%) | 47 (100) | ||||||
| Cyclosporine A | 43 (91.5) | 23 (95.8) | 20 (87.0) | 0.276 | 31 (93.9) | 12 (85.7) | 0.827 |
| Methotrexate | 20 (42.6) | 9 (37.5) | 11 (47.8) | 0.474 | 13 (39.4) | 7 (50.0) | 0.501 |
| Mycophenolate mofetil | 11 (23.4) | 5 (20.8) | 6 (26.1) | 0.671 | 8 (24.2) | 3 (21.4) | 0.835 |
| Oral tacrolimus | 3 (6.4) | 1 (4.2) | 2 (8.7) | 0.525 | 3 (9.1) | 0 (0) | 0.244 |
| Azathioprine | 2 (4.3) | 1 (4.2) | 1 (4.3) | 0.975 | 1 (3.0) | 1 (7.1) | 0.523 |
| History of ≥ 2 immunosuppressive drugs | 26 (55.3) | 13 (54.2) | 13 (56.5) | 0.871 | 19 (57.6) | 7 (50.0) | 0.870 |
| History of biological, n (%) | |||||||
| Dupilumab | 44 (93.6) | 21 (87.5) | 23 (100) | NA | 33 (100) | 11 (78.6) | 0.890 |
| Tralokinumab | 1 (2.1) | 0 (0) | 1 (43.5) | 0.302 | 1 (3.0) | 0 (0) | 0.510 |
| Reason of discontinuation dupilumab, n (%) | NA | NA | |||||
| Ineffectiveness | 13 (29.5) | 0 (0) | 13 (56.5) | 12 (36.4) | 1 (7.1) | ||
| Adverse events | 20 (45.5) | 20 (95.2) | 0 (0) | 14 (42.4) | 6 (42.9) | ||
| Ineffectiveness/AEs | 10 (22.7) | 0 (0) | 10 (43.5) | 6 (18.2) | 4 (28.6) | ||
| Patient wish* | 1 (2.3) | 1 (4.8) | 0 (0) | 1 (3.0) | 0 (0) | ||
| Reason of discontinuation tralokinumab, n (%) | |||||||
| Ineffectiveness | 1 (100) | 0 (0) | 1 (100) | NA | 1 (100) | 0 (0) | NA |
| History of JAK-inhibitor, n (%) | |||||||
| Baricitinib | 15 (29.4) | 7 (29.2) | 8 (34.8) | 0.680 | 1 (3.0) | 14 (100) | NA |
| Abrocitinib | 3 (6.4) | 2 (8.3) | 1 (4.3) | 0.576 | 1 (3.0) | 2 (14.3) | 0.149 |
| Reason of discontinuation baricitinib, n (%) | NA | NA | |||||
| Ineffectiveness | 13 (86.7) | 6 (85.7) | 7 (87.5) | 0 (0) | 13 (92.9) | ||
| Adverse events | 1 (6.7) | 0 (0) | 1 (12.5) | 1 (100) | 0 (0) | ||
| Ineffectiveness/AEs | 1 (6.7) | 1 (14.2) | 0 (0) | 0 (0) | 1 (7.1) | 0.083 | |
| Reason of discontinuation abrocitinib, n (%) | 0.386 | ||||||
| Ineffectiveness | 1 (33.3) | 1 (50.0) | 0 (0) | 1 (100) | 0 (0) | ||
| Patient wish | 1 (33.3) | 0 (0) | 1 (100) | 0 (0) | 1 (50.0) | ||
| Pregnancy wish | 1 (33.3) | 1 (50.0) | 0 (0) | 0 (0) | 1 (50.0) | ||
| Immunosuppressive therapy at | 0.401 | 0.083 | |||||
| baseline, n (%) | 32 (68.1) | 15 (62.5) | 17 (73.9) | 25 (75.8) | 7 (50.0) | ||
| Cyclosporine A | 1 (2.1) | 1 (4.2) | 0 (0) | 1 (3.0) | 0 (0) | ||
| Methotrexate | 1 (2.1) | 0 (0) | 1 (4.3) | 0 (0) | 1 (7.1) | ||
| Prednisolone | 3 (6.4) | 3 (12.5) | 0 (0) | 2 (6.1) | 1 (7.1) | ||
| Hydrocortisone | 1 (2.1) | 1 (4.2) | 0 (0) | 1 (3.0) | 0 (0) | ||
| Dupilumab | 22 (46.8) | 9 (37.5) | 13 (56.5) | 21 (63.6) | 1 (7.1) | ||
| Tralokinumab | 1 (2.1) | 0 (0) | 1 (4.3) | 1 (3.0) | 0 (0) | ||
| Baricitinib | 5 (10.6) | 2 (8.3) | 3 (13.0) | 0 (0) | 5 (35.7) | ||
| EASI score, mean (SD) | 16.6 (10.4) | 15.8 (12.0) | 17.3 (8.5) | 0.630 | 16.4 (11.1) | 17.0 (7.0) | 0.869 |
| IGA score, n (%) | 0.111 | 0.546 | |||||
| Clear | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | ||
| Almost clear | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | ||
| Mild | 9 (19.1) | 6 (25.0) | 3 (13.0) | 8 (24.2) | 1 (7.1) | ||
| Moderate | 21 (44.7) | 13 (54.2) | 8 (34.8) | 14 (42.4) | 7 (50.0) | ||
| Severe | 15 (31.9) | 4 (16.7) | 11 (47.8) | 9 (27.3) | 6 (42.9) | ||
| Very severe | 2 (4.3) | 1 (4.2) | 1 (4.3) | 2 (6.1) | 0 (0) | ||
| NRS-pruritus, mean (SD) | 7.0 (2.1) | 7.0 (1.8) | 6.9 (2.4) | 0.924 | 6.9 (2.2) | 7.1 (1.9) | 0.773 |
| DLQI score, mean (SD) | 11.3 (5.5) | 11.0 (5.4) | 11.5 (5.5) | 0.784 | 11.6 (5.7) | 10.4 (4.6) | 0.500 |
| POEM score, mean (SD) | 19.9 (5.3) | 20.3 (5.2) | 19.5 (5.4) | 0.597 | 19.6 (5.5) | 20.8 (5.1) | 0.509 |
| ADCT score, mean (SD) | 12.5 (5.0) | 12.5 (4.4) | 12.5 (5.6) | 0.970 | 12.3 (5.1) | 12.9 (4.8) | 0.667 |
| PGADS, n (%) | 0.459 | 0.320 | |||||
| Poor | 12 (25.5) | 6 (25.0) | 6 (26.1) | 9 (27.3) | 3 (21.4) | ||
| Fair | 19 (40.4) | 9 (37.5) | 10 (43.5) | 14 (42.4) | 5 (35.7) | ||
| Good | 10 (21.3) | 7 (29.2) | 3 (13.0) | 6 (18.2) | 4 (38.6) | ||
| Very good | 6 (12.8) | 2 (8.3) | 4 (17.4) | 4 (12.1) | 2 (14.3) | ||
| Excellent | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
a
p-value calculated for differences between dupilumab non-responder(NR) vs. dupilumab responder(R)/naïve patients(naïve),
b
and baricitinib-NR vs. baricitinib-R/naïve.
c
Reference categories: childhood aged < 12 years, adolescence aged 12-17 years, adult ≥18 years.
Standard deviation (SD) was calculated by the standard error of the mean (SEM) multiplied by √n. AD: Atopic Dermatitis; EASI: Eczema Area and Severity Index; IGA: Investigator Global Assessment; NRS: Numeric Rating Scale; DLQI: Dermatology Life Quality Index; POEM: Patient-Oriented Eczema Measure; ADCT: Atopic Dermatitis Control Tool; PGADS: Patient Global Assessment of Disease Status; JAK: Janus Kinase; IQR: Interquartile Range. NA: Not Applicable.