PROVEN SAFETY PROFILE IN ADULTS WITH MODERATE-TO-SEVERE PLAQUE PSORIASIS1
Most common adverse reactions (≥ 5%) during weeks 0–16 were diarrhea (17.8%), nausea (16.6%), upper respiratory tract infection (8.4%), tension headache (7.3%), and headache (5.8%), which were mostly mild in intensity. Incidences of these adverse events were higher in females than males.*
For the most common adverse events:1
- Most were mild in intensity
- Most occurred within the first 2 weeks, and nearly half resolved within 2 weeks of onset
- The most common adverse reactions leading to discontinuation were nausea, diarrhea, psoriasis, headache, and vomiting
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
* The particular incidence rates were 29.7% for females experiencing nausea (vs. 9.9% for males), 24.0% for diarrhea (vs. 14.6% for males), 7.9% for vomiting (vs. 1.6% for males), and 11.5% for tension headache (vs. 5.2% for males).1
ESTEEM 1 & 2: INCIDENCE OF ADVERSE
REACTIONS THROUGH WEEK 161
Treatment-emergent adverse events ≥ 2% in any
treatment
group (incidence in
OTEZLA exceeded placebo) during weeks 0–16 (Phase 3 pooled
data)
Patients as initially treated at week 0 | ||
Placebo (n=418) n (%) |
OTEZLA 30 mg BID (n=832) n (%) |
|
System organ class preferred term | ||
Gastrointestinal disorders | ||
Diarrhea | 28 (6.7) | 148 (17.8) |
Nausea | 28 (6.7) | 138 (16.6) |
Vomiting | 7 (1.7) | 31 (3.7) |
Dyspepsia | 4 (1.0) | 25 (3.0) |
Abdominal discomfort | 6 (1.4) | 18 (2.2) |
Frequent bowel movements | 1 (0.2) | 17 (2.0) |
Abdominal pain | 6 (1.4) | 17 (2.0) |
Abdominal pain upper | 4 (1.0) | 18 (2.2) |
Infections and infestations | ||
Upper respiratory tract infection | 27 (6.5) | 70 (8.4) |
Nasopharyngitis | 29 (6.9) | 61 (7.3) |
Sinusitis | 6 (1.4) | 18 (2.2) |
Nervous system disorders | ||
Tension headache | 14 (3.3) | 61 (7.3) |
Headache | 14 (3.3) | 48 (5.8) |
Migraine | 4 (1.0) | 17 (2.0) |
General disorders and administration site conditions | ||
Fatigue | 6 (1.4) | 25 (3.1) |
Metabolism and nutrition disorders | ||
Decreased appetite | 4 (1.0) | 23 (2.8) |
Musculoskeletal and connective tissue disorders | ||
Back pain | 4 (1.0) | 20 (2.4) |
Psychiatric disorders | ||
Insomnia | 4 (1.0) | 20 (2.4) |
Many of the most common adverse reactions, including diarrhea, nausea, tension headache, and headache, began within the first two weeks of treatment, and nearly half of these adverse reactions resolved within 2 weeks of onset.1
BID, twice daily.