Table 2 Safety through week 24
Patients with events, n (%) | Part A (weeks 0–12) | Parts A and B (weeks 0–24) | ||||||
|---|---|---|---|---|---|---|---|---|
PBO, n = 39 | SLK 60-mg NI, n = 41 | SLK 60-mg WI, n = 41 | SLK 120-mg WI, n = 43 | ADA ref, n = 42 | SLK 60 mg, n = 82 | SLK 120 mg, n = 97 | ADA ref, n = 47 | |
Any TEAE | 15 (38.5) | 12 (29.3) | 14 (34.1) | 17 (39.5) | 15 (35.7) | 37 (45.1) | 57 (58.8) | 22 (46.8) |
Any serious TEAE | 0 | 0 | 1 (2.4)a | 0 | 0 | 1 (1.2)a | 4 (4.1)a | 0 |
Any TEAE leading to treatment discontinuation | 0 | 0 | 0 | 1 (2.3)b | 0 | 0 | 6 (6.2)b | 0 |
Fatal TEAE | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Most frequent TEAEsc | ||||||||
Nasopharyngitis | 1 (2.6) | 0 | 1 (2.4) | 0 | 3 (7.1) | 5 (6.1) | 5 (5.2) | 4 (8.5) |
URTI | 1 (2.6) | 3 (7.3) | 2 (4.9) | 1 (2.3) | 1 (2.4) | 5 (6.1) | 4 (4.1) | 2 (4.3) |
Injection-site erythema | 0 | 0 | 2 (4.9) | 3 (7.0) | 1 (2.4) | 3 (3.7) | 3 (3.1) | 1 (2.1) |
Headache | 0 | 0 | 1 (2.4) | 2 (4.7) | 1 (2.4) | 2 (2.4) | 4 (4.1) | 1 (2.1) |
AEs of special interest | ||||||||
IBD | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Diarrhea | 0 | 0 | 1 (2.4) | 0 | 1 (2.4) | 1 (1.2) | 2 (2.1) | 1 (2.1) |
Candidiasis | 0 | 1 (2.4) | 1 (2.4) | 0 | 0 | 2 (2.4) | 2 (2.1) | 0 |
Oral candidiasis | 0 | 1 (2.4) | 1 (2.4) | 0 | 0 | 2 (2.4) | 2 (2.1) | 0 |
Other AEs of interest | ||||||||
Serious hypersensitivity | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Serious infection | 0 | 0 | 1 (2.4) | 0 | 0 | 1 (1.2)a | 1 (1.0)a | 0 |
MACE | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Liver ALT/AST >3× ULN | 0 | 0 | 0 | 0 | 1 (2.4) | 0 | 0 | 0 |
Depression (or suicidal ideation) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
SIB | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
