Table 2.
All-cause and treatment-emergent adverse eventsa
| Placebo n = 99 |
Abrocitinib 100 mg QD n = 173 |
Abrocitinib 200 mg QD n = 179 |
Dupilumab 300 mg Q2W n = 183 |
|
|---|---|---|---|---|
| Patients with AEs, n (%) | 55 (55.6) | 86 (49.7) | 118 (65.9) | 95 (51.9) |
| Patients with serious AEs, n (%) | 5 (5.1) | 5 (2.9) | 1 (0.6) | 2 (1.1) |
| Patients with severe AEs, n (%) | 2 (2.0) | 3 (1.7) | 3 (1.7) | 2 (1.1) |
| Discontinuations due to AEs, n (%) | 2 (2.0) | 2 (1.2) | 6 (3.4) | 5 (2.7) |
| Most common TEAEs, n (%) | ||||
| Nasopharyngitis | 7 (7.1) | 15 (8.7) | 13 (7.3) | 17 (9.3) |
| Headache | 6 (6.1) | 7 (4.0) | 11 (6.1) | 11 (6.0) |
| Nausea | 1 (1.0) | 7 (4.0) | 20 (11.2) | 4 (2.2) |
| Upper respiratory tract infection | 3 (3.0) | 7 (4.0) | 5 (2.8) | 7 (3.8) |
| Conjunctivitis | 2 (2.0) | 0 (0.0) | 3 (1.7) | 13 (7.1) |
| Blood creatine phosphokinase increased | 2 (2.0) | 5 (2.9) | 4 (2.2) | 2 (1.1) |
| Diarrhea | 1 (1.0) | 3 (1.7) | 4 (2.2) | 3 (1.6) |
AE adverse event, QD once daily, Q2W once every 2 weeks, TEAE treatment-emergent adverse event
aSubgroup with baseline IGA 4, or EASI > 21, or %BSA > 50 or failure or intolerance to prior systemic agents (excluding patients who took only corticosteroids).