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OTEZLA 30 mg twice daily
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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
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