Table. Adverse Event Profiles for Roflumilast and Vehicle Groups in INTEGUMENT-1 and INTEGUMENT-2a.
| Event | No. of patients (%) | |||
|---|---|---|---|---|
| INTEGUMENT-1 | INTEGUMENT-2 | |||
| Roflumilast cream, 0.15% (n = 433) | Vehicle cream (n = 221) | Roflumilast cream, 0.15% (n = 452) | Vehicle cream (n = 230) | |
| Patients with any TEAE | 92 (21.2) | 35 (15.8) | 102 (22.6) | 30 (13.0) |
| Patients with any treatment-related TEAEb | 27 (6.2) | 4 (1.8) | 26 (5.8) | 8 (3.5) |
| Patients with any serious TEAEc | 4 (0.9) | 0 | 4 (0.9) | 0 |
| Patients with any TEAE leading to discontinuation | 6 (1.4) | 3 (1.4) | 8 (1.8) | 2 (0.9) |
| Most common TEAEs by preferred term, ≥1% in any group | ||||
| Headache | 10 (2.3) | 3 (1.4) | 16 (3.5) | 1 (0.4) |
| Nausea | 8 (1.8) | 2 (0.9) | 9 (2.0) | 0 |
| Application-site pain | 9 (2.1) | 1 (0.5) | 4 (0.9) | 2 (0.9) |
| Nasopharyngitis | 8 (1.8) | 2 (0.9) | 0 | 1 (0.4) |
| COVID-19 | 4 (0.9) | 5 (2.3) | 4 (0.9) | 3 (1.3) |
| Diarrhea | 6 (1.4) | 0 | 7 (1.5) | 2 (0.9) |
| Vomiting | 5 (1.2) | 0 | 8 (1.8) | 2 (0.9) |
| Upper respiratory tract infection | 0 | 1 (0.5) | 5 (1.1) | 1 (0.4) |
Abbreviations: INTEGUMENT, Interventional Trial Evaluating Roflumilast Cream for the Treatment of Atopic Dermatitis; TEAE, treatment-emergent adverse event.
Adverse events are for the safety population, defined as all patients who were enrolled and received at least 1 confirmed dose of trial medication.
Investigators reviewed each event and assessed its relationship to the investigational product. A treatment-related TEAE is defined as any TEAE that is assessed by the investigator as likely, probably, or possibly related to study treatment.
In INTEGUMENT-1, serious adverse events were depression (unlikely related to the investigational product), diverticulitis (unrelated to the investigational product), pulmonary embolism (unrelated to the investigational product), and suicidal ideation (unrelated to the investigational product). In INTEGUMENT-2, serious adverse events were cutaneous nerve entrapment (unrelated to the investigational product), general physical health deterioration (possibly related to the investigational product), progression of atopic dermatitis that was disproportionately greater than the natural history of atopic dermatitis (probably related to the investigational product), and staphylococcal scalded skin syndrome (unlikely related to the investigational product).