The OTEZLA® international website
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The OTEZLA® international website
This site is intended for healthcare professionals outside the U.S.
|
Placebo-controlled period
|
Cumulative exposure
|
||
|---|---|---|---|
| Weeks 0 to 16 (n = 418) |
Weeks 0 to 16 (n = 832) |
Weeks 0 to 156a (n = 1,184) |
|
| Placebo | OTEZLA (30 mg BID) |
OTEZLA (30 mg BID) |
|
| Adverse Reactions | |||
| Diarrhea | 28 (6.7) | 148 (17.8) | 221 (18.7) |
| Nausea | 28 (6.7) | 148 (17.8) | 221 (18.7) |
| Upper respiratory tract infection |
27 (6.5) | 70 (8.4) | 227 (19.2) |
| Nasopharyngitis | 29 (6.9) | 61 (7.3) | 196 (16.6) |
| Tension headache | 14 (3.3) | 61 (7.3) | 115 (9.7) |
| Headache | 14 (3.3) | 48 (5.8) | 86 (7.3) |
aPooled data from ESTEEM 1 and ESTEEM 2. Includes all patients who received OTEZLA regardless of when OTEZLA exposure started. OTEZLA exposure is based on each patient’s total exposure to OTEZLA, defined as the time interval between the date of the first dose and the date of the last dose, inclusive.
Discontinuation of treatment due to any adverse reaction was 5.4%
for patients taking OTEZLA vs 3.8% for placebo at week 161
BID, twice daily; ESTEEM, Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis.
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