Table 2.
Safety at week 24
| <50 years | ≥50 and <65 years | ≥65 years | ||||
| Placebo (n=254) |
Baricitinib 4 mg (n=259) | Placebo (n=349) |
Baricitinib 4 mg (n=319) | Placebo (n=113) | Baricitinib 4 mg (n=136) | |
| Patients with ≥1 adverse event | 212 (83.5) | 229 (88.4) | 326 (93.4) | 296 (92.8) | 111 (98.2) | 135 (99.3) |
| Discontinuation from study due to adverse event or death* | 6 (2.4) | 6 (2.3) | 14 (4.0) | 18 (5.6) | 7 (6.2) | 12 (8.8) |
| Discontinuation from study for any reason | 21 (8.3) | 14 (5.4) | 31 (8.9) | 28 (8.8) | 19 (6.8) | 17 (12.5) |
| Death† | 0 | 0 | 2 (0.6) | 1 (0.3) | 0 | 1 (0.7) |
| Serious adverse event‡ | 10 (3.9) | 8 (3.1) | 11 (3.2) | 15 (4.7) | 12 (10.6) | 12 (8.8) |
| Serious infections | 4 (1.6) | 3 (1.2) | 5 (1.4) | 2 (0.6) | 2 (1.8) | 4 (2.9) |
| Cardiac disorders | 1 (0.4) | 0 | 1 (0.3) | 2 (0.6) | 2 (1.8) | 2 (1.5) |
| Patients with ≥1 infection | 89 (35.0) | 99 (38.2) | 86 (24.6) | 125 (39.2) | 38 (33.6) | 48 (35.3) |
| Herpes zoster | 0 | 2 (0.8) | 2 (0.6) | 5 (1.6) | 0 | 3 (2.2) |
Data presented as n (%).
*A listing of the adverse events that led to discontinuation and a listing of serious adverse events can be found in online supplementary material.
†Deaths in placebo ≥50 and <65 years due to subarachnoid haemorrhage and renal failure, baricitinib 4 mg ≥50 and <65 years due to circulatory failure, and in baricitinib 4 mg ≥65 years due to pneumonia.
‡Any serious adverse event based on the MedDRA dictionary system organ class.