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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 182a (N = 1,184), % |
|
| Placebo | OTEZLA (30 mg BID) | OTEZLA (30 mg BID) |
|
| Chemistry | |||
| ALT >3x ULN | 0.2 | 0.1 | 1.1 |
| AST >3x ULN | 0.7 | 0.2 | 1.5 |
| Bilirubin >1.8x ULN mmol/L | 0.2 | 0.2 | 0.6 |
| Total cholesterol >7.8 mmol/Lb | 2.1 | 0.8 | 2.4 |
| Hemoglobin A1C >9% | 0.5 | 0.5 | 1.0 |
| Hematology | |||
| Lymphocytes <0.8 x 109/L mmol/L | 3.0 | 1.1 | 3.7 |
| Neutrophils <1.0 x 109/L | 0.0 | 0.0 | 0.3 |
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.
bDid not have to be drawn when patient was fasting.
ALT, alanine aminotransferase; AST, aspartate aminotransferase; BID, twice daily; ULN, upper limit of normal.
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