closedosingdownloadefficacymoasafetytable-checktable-cross

The OTEZLA® international website

This site is intended for healthcare professionals outside the U.S.

NO LABEL-REQUIRED LABORATORY PRESCREENING OR ONGOING MONITORING DURING TREATMENT1

Marked laboratory abnormalities were generally infrequent and transient across exposure periods2,a
 
OTEZLA 30 mg twice daily
Selected laboratory abnormalitiesWeeks 0 to <52
(N = 721) n (%)
Weeks > 52 to ≤104
(N = 520) n (%)
Weeks > 104 to ≤156
(N = 443) n (%)
Weeks > 156 to ≤208
(N = 401) n (%)
Alanine aminotransferase >3x ULN9/713 (1.3)2/518 (0.4)2/442 (0.5)1/401 (0.2)
Creatine > 1.7x ULN1/713 (0.1)0/518 (0.0)0/442 (0.0)1/401 (0.2)
Leukocytes <1.5, 109/L0/713 (0.0)0/517 (0.0)0/442 (0.0)0/401 (0.0)
Neutrophilis <1, 109/L2/713 (0.3)3/517 (0.0)2/442 (0.5)2/401 (0.5)
Platelets <75, 109/L0/713 (0.0)0/517 (0.0)1/441 (0.2)0/399 (0.0)
Hemoglobin, male <10.5 g/dL; females <8.5 g/dL5/713 (0.7)4/517 (0.8)5/442 (1.1)5/401 (1.2)

aRepresents the number of patients with ≥1 occurrence of the abnormality at any time point/number of patients with ≥1 post-baseline value.

bIncludes all patients who received apremilast during the exposure interval relative to the start of apremilast administration.

Discontinuation rates were generally low2,3

  • Discontinuation of treatment due to any adverse reaction was 4.6% for patients taking OTEZLA vs 1.2% for placebo by Week 16
  • Discontinuation due to adverse reactions occurred at a lower rate over time: 1.6% in year 3, 2.5% in year 2, and 7.8% in year 1

References:

  1. OTEZLA Summary of Product Characteristics. Stockley Park, Uxbridge, UK: Celgene Europe, Ltd; 2017.
  2. Mease PJ, Gladman DD, Gomez-Reino JJ, et al. Consistent safety profile with up to 4 years of apremilast treatment: analysis of data from 1,493 subjects with psoriatic arthritis in 3 large, phase III, long-term studies. Presented at: the 2017 ACR/ARHP Annual Meeting; November 3-8, 2017; San Diego, CA.
  3. Data on file, Celgene Corporation.
You are leaving the OTEZLA® (apremilast) website
Do you wish to leave this site?
OTEZLA International Websites
OTEZLA is approved in 51 Countries
  • United States

  • Canada

  • Australia

  • Israel

  • Switzerland

  • New Zealand

  • Austria

  • Belgium

  • Bulgaria

  • Croatia

  • Republic of Cyprus

  • Czech Republic

  • Denmark

  • Estonia

  • Finland

  • France

  • Germany

  • Greece

  • Hungary

  • Ireland

  • Italy

  • Latvia

  • Lithuania

  • Luxembourg

  • Malta

  • Netherlands

  • Poland

  • Portugal

  • Romania

  • Slovakia

  • Slovenia

  • Spain

  • Sweden

  • United Kingdom

  • Norway

  • Iceland

  • Liechtenstein

  • Russia

  • Japan

  • Hong Kong

  • Singapore

  • Kuwait

  • Taiwan

  • UAE

  • Korea

  • Thailand

  • Lebanon

  • Qatar

  • Argentina

  • Mexico

  • Brazil