PROVEN SAFETY PROFILE IN ADULTS WITH ORAL ULCERS ASSOCIATED WITH BEHÇET’S DISEASE1
RELIEF study: Treatment-emergent adverse events ≥ 5% in any treatment
group
(incidence in OTEZLA exceeded placebo ≥ 1%) during weeks 0–12
| Patients as initially treated at week 0 | ||
|
Placebo (n=103) n (%) |
OTEZLA 30 mg BID (n=104) n (%) |
|
| System organ class preferred term | ||
| Diarrhea* | 21 (20.4) | 43 (41.3) |
| Nausea* | 11 (10.7) | 20 (19.2) |
| Headache | 11 (10.7) | 15 (14.4) |
| Upper respiratory tract infection | 5 (4.9) | 12 (11.5) |
| Abdominal pain | 2 (1.9) | 9 (8.7) |
| Vomiting* | 2 (1.9) | 9 (8.7) |
| Back pain | 6 (5.8) | 8 (7.7) |
| Viral upper respiratory tract infection | 5 (4.9) | 7 (6.7) |
| Arthralgia | 3 (2.9) | 6 (5.8) |
* There were no serious adverse reactions of diarrhea, nausea, or vomiting.1
The long-term safety profile of OTEZLA treatment was comparable to that observed with OTEZLA during the placebo-controlled (12-week) study period.1
See study design(s) 
BID, twice daily.