AE during the 24-week placebo-controlled and 52-week apremilast-exposure periods. Placebo-controlled period includes data through Week 16 for patients initially receiving placebo who escaped, and data through Week 24 for all other patients. Apremilast-exposure period includes all apremilast-exposure data, regardless of when the apremilast exposure started (weeks 0, 16, or 24).
| Characteristics | Weeks 0 to 24 | Weeks 0 to 52 | |||
|---|---|---|---|---|---|
| Apremilast | Apremilast | ||||
| Placebo, n =168 | 20 mg BID, n = 168 | 30 mg BID, n = 168 | 20 mg BID, n = 245 | 30 mg BID, n = 245 | |
| Patients, n (%) | |||||
| ≥ 1 AE | 81 (48.2) | 101 (60.1) | 103 (61.3) | 164 (66.9) | 174 (71.0) |
| Any serious AE | 7 (4.2) | 8 (4.8) | 9 (5.4) | 14 (5.7) | 19 (7.8) |
| Any severe AE | 6 (3.6) | 8 (4.8) | 11 (6.5) | 15 (6.1) | 15 (6.1) |
| AE leading to drug withdrawal | 8 (4.8) | 10 (6.0) | 12 (7.1) | 16 (6.5) | 23 (9.4) |
| Death | 0 (0.0) | 1 (0.6)* | 0 (0.0) | 1 (0.4) | 0 (0.0) |
| Frequent AE, ≥ 5% in any treatment group, n (%) | |||||
| Diarrhea | 4 (2.4) | 19 (11.3) | 32 (19.0) | 27 (11.0) | 47 (19.2) |
| Nausea | 11 (6.5) | 16 (9.5) | 31 (18.5) | 24 (9.8) | 35 (14.3) |
| Headache | 8 (4.8) | 17 (10.1) | 18 (10.7) | 22 (9.0) | 24 (9.8) |
| URTI | 6 (3.6) | 10 (6.0) | 7 (4.2) | 19 (7.8) | 14 (5.7) |
| Nasopharyngitis | 5 (3.0) | 6 (3.6) | 8 (4.8) | 17 (6.9) | 16 (6.5) |
| Select laboratory assessments | |||||
| Marked abnormalities, n/m (%)§ | |||||
| ALT > 150 U/l | 0/167 (0.0) | 0/166 (0.0) | 2/168 (1.2) | 0/243 (0.0) | 2/245 (0.8) |
| Creatinine, male > 156, female > 126 μmol/l | 0/167 (0.0) | 1/166 (0.6) | 0/168 (0.0) | 1/243 (0.4) | 0/245 (0.0) |
| Hemoglobin, male: decrease > 2.0 and value < 10.5 g/dl; female: decrease | |||||
| > 2.0 and value < 10.0 g/dl | 0/167 (0.0) | 0/166 (0.0) | 1/168 (0.6) | 0/243 (0.0) | 2/245 (0.8) |
| Leukocytes < 2.0, 109/l | 0/167 (0.0) | 0/166 (0.0) | 0/168 (0.0) | 0/243 (0.0) | 0/245 (0.0) |
| Neutrophils < 0.75, 109/l | 0/167 (0.0) | 0/166 (0.0) | 0/168 (0.0) | 0/243 (0.0) | 0/245 (0.0) |
| Platelets < 75, 109/l | 0/166 (0.0) | 0/166 (0.0) | 0/168 (0.0) | 0/243 (0.0) | 0/245 (0.0) |
| Select laboratory shifts from normal to > upper limit of normal, n/m (%)§ | |||||
| ALT, U/l | 20/150 (13.3) | 12/146 (8.2) | 12/155 (7.7) | 29/215 (13.5) | 28/222 (12.6) |
| Creatinine, μmol/l | 3/159 (1.9) | 7/151 (4.6) | 10/158 (6.3) | 14/222 (6.3) | 16/228 (7.0) |
| Select laboratory shifts from normal to < lower limit of normal, n/m (%)§ | |||||
| Leukocytes, 109/l | 1/155 (0.6) | 4/155 (2.6) | 2/159 (1.3) | 5/227 (2.2) | 6/232 (2.6) |
| Neutrophils, 109/l | 2/146 (1.4) | 2/145 (1.4) | 5/151 (3.3) | 3/213 (1.4) | 8/221 (3.6) |
| Platelets, 109/l | 0/146 (0.0) | 0/142 (0.0) | 1/151 (0.7) | 1/208 (0.5) | 1/221 (0.5) |
| Hemoglobin, g/dl | 8/148 (5.4) | 7/149 (4.7) | 14/153 (9.2) | 22/220 (10.0) | 26/224 (11.6) |
↵* Multiorgan failure considered by investigator to be unrelated to study medication.
↵§ Represents patients with ≥ 1 occurrence of the abnormality (n)/patients with a baseline value of normal and ≥ 1 post-baseline value for criteria requiring baseline or with ≥ 1 post-baseline value for criteria requiring baseline (m). AE: adverse event; URTI: upper respiratory tract infection; ALT: alanine transaminase.