Table 3.
Summary of adverse events from BREEZE-AD1, AD2, AD4, AD5, and AD7 phase III studies currently available on clinicaltrials.gov. (accessed on 2 November 2021).
| BREEZE-AD1 | BREEZE-AD2 | BREEZE-AD4 | BREEZE-AD5 | BREEZE-AD7 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Number of Patients | 125 | 123 | 249 | 123 | 123 | 244 | 92 | 184 | 93 | 145 | 146 | 111 | 109 | 108 |
| Baricitinib dosage | 4 mg | 2 mg | PBO | 4 mg | 2 mg | PBO | 4 mg + TCS |
2 mg + TCS |
PBO + TCS | 2 mg | PBO | 4 mg + TCS | 2 mg + TCS | PBO + TCS |
| TEAES | 73 (58.4%) | 71 (57.7%) | 135 (54.2%) | 66 (53.7%) | 71 (57.7%) |
137 (56%) | 50 (54.3%) |
69 (37.5%) |
29 (31.2%) |
18 (12.4%) | 20 (13.7%) | 64 (57.7%) | 61 (56%) | 41 (38%) |
| Nasopharingitis |
12 (9.6%) |
12 (9.8%) | 26 (10.4%) | 10 (8.1%) | 16 (13%) | 30 (12%) | 27 (29.3%) |
34 (18.5%) |
13 (14%) |
9 (6.1%) | 11 (7.5%) | 17 (15%) | 12(11%) | 13 (12%) |
| URIs | 4 (3.2%) | 3 (2.4%) | 6 (2.4%) | 4 (3.3%) | 5 (4.1%) |
5 (2%) |
10 (11%) |
10 (5.4%) |
2 (2.1%) |
11 (7.6%) | 9 (6.2%) | 3 (3%) |
8 (7%) | 2 (2%) |
| Herpes simplex | 9 (7.2%) | 4 (3.3%) | 3 (1.2%) | 5 (4.1%) | 7 (5.7%) | 11 (4.5%) | 5 (5.4%) |
5 (2.7%) |
4 (4.3%) |
nr | nr | 3 (3%) |
1 (1%) | 3 (3%) |
| Headache | 10 (8%) | 14 (11.4%) | 16 (6.4%) | 11 (8.9%) | 9 (7.3%) | 5 (2%) | 9 (9.8%) |
11 (6%) |
6 (6.5%) |
nr | nr | nr | nr | nr |
| CPK elevations | 4 (3.2%) | 1 (0.8%) | 2 (0.8%) | 7 (5.7%) | 1 (0.8%) | 1 (0.4%) | nr | nr | nr | nr | nr | 0 | 3 (3%) | 0 |
| SAE | 2 (1.6%) | 0 | 6 (2.4%) | 1 (0.8%) | 3 (2.4%) | 9 (3.7%) | 6 (6.5%) |
4 (2.2%) |
2 (2.2%) |
2 (1.4%) |
3 (2%) |
4 (4%) |
2 (2%) | 4 (4%) |
| MACE | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Malignant | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Results refer to W16. Abbreviations; PBO, placebo; TCS, topical corticosteroid; TEAE, treatment emergent adverse event; URIs, upper respiratory infections; CPK, creatine phosphokinase; SAE, serious adverse event; MACE, major adverse cardiovascular events; nr, not reported.