Table 1 Adverse events: select subgroups from weeks 0 to 24
| One TNF inhibitor or non-TNF inhibitor naïve | More than one TNF inhibitor or non-TNF inhibitor naïve | |||||
|---|---|---|---|---|---|---|
| Events | Placebo (n = 69) | Baricitinib 2 mg (n = 61) | Baricitinib 4 mg (n = 63) | Placebo (n = 30) | Baricitinib 2 mg (n = 33) | Baricitinib 4 mg (n = 33) |
| SAEsa | 4 (6) | 1 (2) | 4 (6) | 1 (3) | 0 | 4 (12) |
| Serious infections | 2 (3) | 0 | 0 | 0 | 0 | 2 (6) |
| TEAEs | 42 (61) | 39 (64) | 46 (73) | 21 (70) | 23 (70) | 24 (73) |
| Infections | 19 (28) | 21 (34) | 23 (37) | 9 (30) | 15 (45) | 8 (24) |
| Death | 0 | 0 | 0 | 0 | 0 | 0 |
| Less than three prior bDMARDs | Three or more prior bDMARDs | |||||
|---|---|---|---|---|---|---|
| Placebo (n = 129) | Baricitinib 2 mg (n = 124) | Baricitinib 4 mg (n = 132) | Placebo (n = 47) | Baricitinib 2 mg (n = 50) | Baricitinib 4 mg (n = 45) | |
| SAEsa | 9 (7) | 3 (2) | 11 (8) | 4 (9) | 4 (8) | 7 (16) |
| Serious infections | 4 (3) | 1 (<1) | 4 (3) | 1 (2) | 3 (6) | 2 (4) |
| TEAEs | 79 (61) | 81 (65) | 98 (74) | 33 (70) | 42 (84) | 39 (87) |
| Infections | 38 (29) | 47 (38) | 49 (37) | 17 (36) | 29 (58) | 21 (47) |
| Deathb | 0 | 0 | 0 | 0 | 0 | 1 (2) |
Data displayed as n (%) of patients up to the time of rescue.
SAE: serious adverse event; TEAE: treatment-emergent adverse event.
a
SAEs reported using conventional ICH definitions.
b
One death occurred in association with basilar artery thrombosis in a 76-year-old patient with pre-existing diabetes mellitus.