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NO LABEL-REQUIRED LABORATORY PRESCREENING BEFORE OR PERIODIC TESTING DURING TREATMENT1

Marked laboratory abnormalities were generally infrequent and transient across exposure periods2,a-c
 
OTEZLA 30 mg twice daily
Selected laboratory abnormalities Weeks 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 ULN 9/713 (1.3) 2/518 (0.4) 2/442 (0.5) 1/401 (0.2)
Creatine > 1.7x ULN 1/713 (0.1) 0/518 (0.0) 0/442 (0.0) 1/401 (0.2)
Leukocytes <1.5, 109/L 0/713 (0.0) 0/517 (0.0) 0/442 (0.0) 0/401 (0.0)
Neutrophilis <1, 109/L 2/713 (0.3) 3/517 (0.0) 2/442 (0.5) 2/401 (0.5)
Platelets <75, 109/L 0/713 (0.0) 0/517 (0.0) 1/441 (0.2) 0/399 (0.0)
Hemoglobin, male <10.5 g/dL; females <8.5 g/dL 5/713 (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.

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

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

PALACE 1-3 pooled analysis.

ULN, upper limit of normal.

 

Discontinuation rates were generally low2-4

  • 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: 7.8% in year 1, 2.5% in year 2, and 1.6% in year 3

References:

  1. OTEZLA Summary of Product Characteristics. Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, The Netherlands; 2020.
  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, Amgen Inc.
  4. Kavanaugh A, Gladman DD, Edwards CJ, et al. Long-term experience with apremilast in patients with psoriatic arthritis: 5-year results from a PALACE 1–3 pooled analysis. Arthritis Res Ther. 2019;21(1):118.
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