Adverse events reported during the 12-week study of Japanese patients with rheumatoid arthritis treated with baricitinib or placebo. Values are n (%).
| Events | Placebo, n = 49 | Baricitinib QD | |||
|---|---|---|---|---|---|
| 1 mg, n = 24 | 2 mg, n = 24 | 4 mg, n = 24 | 8 mg, n = 24 | ||
| TEAE | 26 (53) | 11 (46) | 12 (50) | 13 (54) | 18 (75) |
| SAE* | 1 (2) | 0 | 1 (4) | 0 | 1 (4) |
| TEAE leading to discontinuation from the study** | 1 (2) | 1 (4) | 0 | 0 | 0 |
| TEAE related to infections*** | 11 (22) | 6 (25) | 4 (17) | 7 (29) | 5 (21) |
| Common adverse events† | |||||
| Nasopharyngitis | 6 (12) | 2 (8) | 2 (8) | 2 (8) | 2 (8) |
| Abnormal hepatic function ‡ | 0 | 0 | 3 (13) | 0 | 3 (13) |
| Blood creatine phosphokinase increased | 2 (4) | 0 | 0 | 2 (8) | 3 (13) |
| Abnormal liver function test ‡ | 0 | 1 (4) | 0 | 2 (8) | 2 (8) |
| Hypercholesterolemia | 0 | 0 | 0 | 1 (4) | 3 (13) |
| Pharyngitis | 1 (2) | 1 (4) | 1 (4) | 0 | 2 (8) |
| Hyperlipidemia | 1 (2) | 1 (4) | 1 (4) | 0 | 1 (4) |
| Lymphopenia | 1 (2) | 0 | 1 (4) | 1 (4) | 1 (4) |
↵* Placebo group: cholecystitis; 2-mg baricitinib group: acute pancreatitis; 8-mg baricitinib group: cataract.
↵** Placebo group: pollakiuria; 1-mg baricitinib group: herpes simplex.
↵*** TEAE reported for the system organ class of infections and infestations.
↵† Reported by at least 4 patients.
↵‡ For these cases, all reports were mild or moderate and recovered. QD: once daily; TEAE: treatment-emergent adverse event; SAE: serious adverse event.