Table 3. TEAEs Through Week 16 for All Patients Receiving 1 Dose or More of Study Drug.
| TEAE | Patients, No. (%) | |
|---|---|---|
| Dupilumab, 300 mg (n = 331) | Upadacitinib, 30 mg (n = 342) | |
| AE | 215 (65.0) | 249 (72.8) |
| AE with reasonable possibility of being drug-relateda | 122 (36.9) | 153 (44.7) |
| Severe AE | 14 (4.2) | 25 (7.3) |
| SAE | 4 (1.2) | 10 (2.9) |
| SAE with reasonable possibility of being drug relateda | 2 (0.6) | 4 (1.2) |
| AE leading to discontinuation of study drug | 4 (1.2) | 7 (2.0) |
| AE leading to deathb | 0 | 1 (0.3) |
| AEs of special interest | ||
| Serious infections | 2 (0.6) | 4 (1.1) |
| Opportunistic infection, excluding tuberculosis and herpes zosterc | 0 | 1 (0.3) |
| Herpes zoster | 3 (0.9) | 7 (2.0) |
| Active tuberculosis | 0 | 0 |
| Nonmelanoma skin cancerd | 1 (0.3) | 0 |
| Malignant neoplasm, excluding NMSC | 0 | 0 |
| Lymphoma | 0 | 0 |
| Hepatic disordere | 4 (1.2) | 10 (2.9) |
| Adjudicated gastrointestinal perforations | 0 | 0 |
| Anemia | 1 (0.3) | 7 (2.0) |
| Neutropenia | 2 (0.6) | 6 (1.8) |
| Lymphopenia | 0 | 2 (0.6) |
| Creatine phosphokinase elevation | 10 (3.0) | 23 (6.7) |
| Renal dysfunction | 1 (0.3) | 1 (0.3) |
| Adjudicated major adverse cardiovascular events | 0 | 0 |
| Adjudicated venous thromboembolic events | 0 | 0 |
| TEAEs reported by ≥5% in either treatment group | ||
| Acnef | 9 (2.7) | 55 (16.1) |
| Dermatitis atopic | 29 (8.8) | 24 (7.0) |
| Upper respiratory tract infection | 13 (3.9) | 22 (6.4) |
| Blood CPK level increased | 10 (3.0) | 23 (6.7) |
| Nasopharyngitis | 22 (6.6) | 20 (5.8) |
| Headache | 21 (6.0) | 14 (4.1) |
| Conjunctivitis | 29 (8.8) | 5 (1.5) |
Abbreviations: AE, adverse event; CPK, creatine phosphokinase; NMSC, nonmelanoma skin cancer; SAE, serious AE; TB, tuberculosis; TEAE, treatment-emergent adverse event.
a
As assessed by investigator.
b
A 40-year-old woman who had bronchopneumonia associated with influenza A was found deceased at home on study day 70.
c
All opportunistic infections were eczema herpeticum.
d
Keratoacanthoma, no reasonable possibility of association with study drug according to the investigator.
e
Hepatic disorders: most were elevated transaminase levels.
f
Most acne events consisted primarily of inflammatory papules, pustules, and comedones, involving the face. All events were nonserious. None led to treatment discontinuation.