Table 3

AEs and laboratory abnormalities during the placebo-controlled phase (week 0–24) and apremilast-exposure phase (week 0–52)

 Week 0–24*Week 0–52†
ApremilastApremilast
Placebo
n=168
20 mg twice daily
n=170
30 mg twice daily
n=167
20 mg twice daily
n=241
30 mg twice daily
n=242
Overview of AEs, n (%)
 Any AE83 (49)100 (59)104 (62)160 (66)165 (68)
 Any serious AE9 (5)3 (2)6 (4)13 (5)10 (4)
 Any AE leading to drug withdrawal10 (6)13 (8)12 (7)22 (9)14 (6)
 Death0 (0)0 (0)0 (0)0 (0)0 (0)
AEs reported by ≥5% of patients in any treatment group, n (%)
 Diarrhoea3 (2)26 (15)26 (16)32 (13)33 (14)
 Nausea9 (5)19 (11)23 (14)24 (10)36 (15)
 Headache8 (5)16 (9)20 (12)26 (11)26 (11)
 URTI3 (2)11 (7)12 (7)21 (9)20 (8)
 Nasopharyngitis2 (1)7 (4)4 (2)12 (5)10 (4)
 Vomiting1 (0.6)5 (3)8 (5)8 (3)12 (5)
Serious AEs reported by ≥2 patients in any treatment group, n (%) 
 Acute pancreatitis2 (1)0 (0)0 (0)0 (0)0 (0)
 Psoriatic arthropathy2 (1)1 (0.6)1 (0.6)2 (0.8)1 (0.4)
Select laboratory assessments, n/m‡ (%) 
 ALT >150 U/L0/167 (0)0/168 (0)2/164 (1)2/238 (0.8)2/238 (0.8)
 Creatine (male >156, female >126 μmol/L)1/167 (0.6)0/168 (0)0/164 (0)1/238 (0.4)0/238 (0)
 Haemoglobin (male: decrease >2.0 and value <10.5 g/dL; female: decrease >2.0 and value <10.0 g/dL)0/165 (0)1/162 (0.6)0/161 (0)1/232 (0.4)3/236 (1)
 Leucocytes <2.0, 109/L0/165 (0)0/162 (0)1/161 (0.6)0/238 (0)2/238 (0.8)
 Neutrophils <0.75, 109/L1/164 (0.6)1/161 (0.6)0/161 (0)1/238 (0.4)0/238 (0)
 Platelets <75, 109/L0/165 (0)0/162 (0)0/161 (0)0/238 (0)0/238 (0)
  • *Placebo-controlled phase includes data through week 16 for patients initially receiving placebo who escaped, and data through week 24 for all other patients.

  • †Includes all patients who received ≥1 dose of apremilast regardless of when apremilast was started (week 0, week 16 or week 24).

  • ‡Represents patients with ≥1 occurrence of the abnormality (n)/patients with a baseline value and ≥1 postbaseline value for criteria requiring baseline or patients with ≥1 postbaseline value for criteria not requiring baseline (m). Individual abnormalities were infrequent and returned to baseline values with continuation of apremilast administration or were associated with a concurrent medical condition or medication.

  • AEs, adverse events; ALT, alanine aminotransferase; URTI, upper respiratory tract infection.