PROVEN SAFETY PROFILE IN ADULTS WITH ACTIVE PSORIATIC ARTHRITIS1
The most common adverse reactions (≥ 5%) during weeks 0–16 were diarrhea (16.7%), nausea (15.3%), and headache (10.5%), which were mostly mild to moderate in intensity. Incidences of these adverse events were higher in females than in males.
For the most common adverse events:
- Most were mild to moderate in severity
- More than half occurred within the first 15 days, and more than half resolved within the first 30 days
- The most common adverse reactions leading to discontinuation were nausea (2.2%), diarrhea (2.2%), and headache (1.5%)
The long-term safety profile of OTEZLA, for up to 52 weeks of treatment, was comparable to that observed with OTEZLA for up to 16 weeks of treatment.1
PALACE 1–3: INCIDENCE OF ADVERSE
REACTIONS THROUGH WEEK 16
Treatment-emergent adverse events ≥ 1% in any
treatment
group (incidence in
OTEZLA exceeded placebo) during weeks 0–16 (Phase 3 pooled
data)1
| Patients as initially treated at week 0 | ||
|
Placebo (n=495) n (%) |
OTEZLA 30 mg BID (n=497) n (%) |
|
| System organ class preferred term | ||
| Cardiac disorders | ||
| Palpitations | 1 (0.2) | 5 (1.0) |
| Gastrointestinal disorders | ||
| Diarrhea* | 14 (2.8) | 83 (16.7) |
| Nausea* | 22 (4.4) | 76 (15.3) |
| Vomiting* | 4 (0.8) | 19 (3.8) |
| Abdominal pain upper | 1 (0.2) | 13 (2.6) |
| Abdominal pain | 8 (1.6) | 13 (2.6) |
| Dyspepsia | 6 (1.2) | 11 (2.2) |
| Frequent bowel movements | 0 (0.0) | 8 (1.6) |
| Gastroesophageal reflux disease | 1 (0.2) | 7 (1.4) |
| Flatulence | 1 (0.2) | 7 (1.4) |
| General disorders and administrative site conditions | ||
| Fatigue | 5 (1.0) | 9 (1.8) |
| Infections and infestations | ||
| Upper respiratory tract infection | 12 (2.4) | 21 (4.2) |
| Nasopharyngitis | 9 (1.8) | 14 (2.8) |
| Influenza | 1 (0.2) | 5 (1.0) |
| Investigations | ||
| Weight decreased | 2 (0.4) | 7 (1.4) |
| Nervous system disorders | ||
| Headache* | 20 (4.0) | 52 (10.5) |
| Dizziness | 6 (1.2) | 11 (2.2) |
| Migraine | 0 (0.0) | 9 (1.8) |
| Respiratory, thoracic, and mediastinal disorders | ||
| Cough | 2 (0.4) | 8 (1.6) |
* One patient experienced a serious adverse drug reaction of nausea and vomiting in OTEZLA 30 mg BID; 1 patient treated with OTEZLA 20 mg BID experienced a serious adverse drug reaction of diarrhea. One patient treated with OTEZLA 30 mg BID experienced a serious adverse drug reaction of headache.1
More than half of the most commonly reported adverse drug reactions (diarrhea, nausea, and headache) occurred in the first 15 days of exposure and more than half of these resolved within the first 30 days.1
BID, twice daily.