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The OTEZLA® international website

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NO LABEL-REQUIRED LABORATORY PRESCREENING OR ONGOING MONITORING DURING TREATMENT1

Marked laboratory abnormalities were generally infrequent and transient across exposure periods2,3
 
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 ULN0.20.11.1
AST >3x ULN0.70.21.5
Bilirubin >1.8x ULN mmol/L0.20.20.6
Total cholesterol >7.8 mmol/Lb2.10.82.4
Hemoglobin A1C >9%0.50.51.0
Hematology
Lymphocytes <0.8 x 109/L mmol/L3.01.13.7
Neutrophils <1.0 x 109/L0.00.00.3
  • No clinically meaningful effects on laboratory parameters were reported during short-or long-term treatment2,3

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.

References:

  1. OTEZLA Summary of Product Characteristics. Stockley Park, Uxbridge, UK: Celgene Europe, Ltd; 2017.
  2. Papp K, Sobell JM, Shah K, et al. Safety and Tolerability of Apremilast Up to 182 Weeks: Pooled Analyses From Phase 3 Clinical Trials. Presented at: the 74th Annual Meeting of the American Academy of Dermatology; March 4-8, 2016; Washington, DC.
  3. Data on file, Celgene Corporation.
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