Table 2.
Adverse events in patients who applied 1.5% ruxolitinib cream at any time during the 52-week study perioda
| n, % | Vehicle to 1.5% ruxolitinib cream (n = 22) | 1.5% ruxolitinib cream (n = 92) |
Total 1.5% ruxolitinib cream (n = 114) |
|---|---|---|---|
| Patients with TEAE | 17 (77.3) | 43 (46.7) | 60 (52.6) |
| Most common TEAEb | |||
| Upper respiratory tract infection | 3 (13.6) | 15 (16.3) | 18 (15.8) |
| Nasopharyngitis | 2 (9.1) | 7 (7.6) | 9 (7.9) |
| Influenza | 2 (9.1) | 5 (5.4) | 7 (6.1) |
| Headache | 2 (9.1) | 3 (3.3) | 5 (4.4) |
| Pharyngitis | 0 | 5 (5.4) | 5 (4.4) |
| Rhinitis | 2 (9.1) | 2 (2.2) | 4 (3.5) |
| Streptococcal pharyngitis | 1 (4.5) | 2 (2.2) | 3 (2.6) |
| Cough | 0 | 2 (2.2) | 2 (1.8) |
| Acne | 0 | 2 (2.2) | 2 (1.8) |
| Neutropenia | 2 (9.1) | 0 | 2 (1.8) |
| Sinusitis | 1 (4.5) | 1 (1.1) | 2 (1.8) |
| Patients with application site reactions | 1 (4.5) | 1 (1.1) | 2 (1.8) |
| Application site painc | 0 | 1 (1.1) | 1 (0.9) |
| Application site pustules | 1 (4.5) | 0 | 1 (0.9) |
| Patients with treatment-related AEd | 2 (9.1) | 3 (3.3) | 5 (4.4) |
| Patients who discontinued due to a TEAE | 0 | 0 | 0 |
| Patients with serious TEAE | 0 | 0 | 0 |
AE adverse event, TEAE treatment-emergent adverse event
aFor patients who switched from vehicle after week 8, the period was 44 weeks
bOccurring in ≥ 2% in patients applying 1.5% ruxolitinib cream at any point in the study
cIncludes application site burning, stinging, and pain after application
dNo treatment-related AE occurred in more than one patient in any group