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)


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

See study design(s) arrow-right

BID, twice daily.