Table 3. Adverse Events.
| Adverse events | No. (%) | |||
|---|---|---|---|---|
| DERMIS-1 trial | DERMIS-2 trial | |||
| Roflumilast (n = 286) | Vehicle (n = 153) | Roflumilast (n = 290) | Vehicle (n = 152) | |
| Patients with any treatment-emergent adverse eventa | 72 (25.2) | 36 (23.5) | 75 (25.9) | 28 (18.4) |
| Patients with any treatment-related treatment-emergent adverse eventb | 7 (2.4) | 3 (2.0) | 16 (5.5) | 8 (5.3) |
| Patients with any serious adverse eventc | 2 (0.7) | 1 (0.7) | 0 | 1 (0.7) |
| Patients who discontinued study due to adverse event | 5 (1.7) | 2 (1.3) | 1 (0.3) | 2 (1.3) |
| Most common treatment-emergent adverse event (≥2% in any treatment group) | ||||
| Diarrhea | 10 (3.5) | 0 | 8 (2.8) | 0 |
| Headache | 3 (1.0) | 2 (1.3) | 11 (3.8) | 1 (0.7) |
| Hypertensiond | 5 (1.7) | 6 (3.9) | 4 (1.4) | 0 |
| Nasopharyngitis | 5 (1.7) | 3 (2.0) | 1 (0.3) | 1 (0.7) |
| Psoriasise | 0 | 3 (2.0) | 1 (0.3) | 0 |
A treatment-emergent adverse event is defined as an adverse event that emerges during treatment, having been absent pretreatment, or that worsens relative to the pretreatment state.
A treatment-related treatment-emergent adverse event was assessed by the principal investigator for each treatment-emergent adverse event. Adverse events with a relationship of possibly, probably, likely, or missing were considered treatment related.
A serious adverse event was any adverse event that, in the view of either the investigator or sponsor, resulted in death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. All serious adverse events were considered not related to study drug. Serious adverse events were concussion (DERMIS-1, roflumilast group), foot fracture (DERMIS-1, roflumilast group), deformity thorax (DERMIS-1, roflumilast group), pneumothorax (DERMIS-1, roflumilast group), plasma cell myeloma (DERMIS-1, vehicle group), and cervical radiculopathy (DERMIS-2, vehicle group).
Hypertension included synonymous terms (eg, blood pressure increased).
Progression of psoriasis that was out of proportion to the natural history of psoriasis.