Safety data
| Events, N (%) | PKS and OLLI (N=220) | Events, N (%) | DBW Placebo (N=81) | DBW Baricitinib (N=82) | |
|---|---|---|---|---|---|
| Discontinuations due to AEs | 2 (0.9) | 2 (2.5) | 1 (1.2) | ||
| TEAEs | 126 (57.3) | 38 (46.9) | 54 (65.9) | ||
| most common TEAEs | Nasopharyngitis | 19 (8.6) | URTI | 1 (1.2) | 9 (11.0) |
| Headache | 14 (6.4) | Headache | 3 (3.7) | 9 (11.0) | |
| Arthralgia | 12 (5.5) | Nasopharyngitis | 3 (3.7) | 6 (7.3) | |
| URTI | 11 (5.0) | Arthralgia | 3 (3.7) | 6 (7.3) | |
| Nausea | 11 (5.0) | Oropharyngeal pain | 1 (1.2) | 5 (6.1) | |
| SAEs | 6 (2.7) | 3 (3.7) | 4 (4.9) | ||
| All reported SAEs | Arthralgia | 1 (0.5) | COVID-19 | 0 | 1 (1.2) |
| Joint Destruction | 1 (0.5) | Gastroenteritis | 0 | 1 (1.2) | |
| Joint Effusion | 1 (0.5) | Headache | 0 | 1 (1.2) | |
| JIA | 1 (0.5) | Pulmonary Embolism | 0 | 1 (1.2) | |
| Musculoskeletal Chest Pain | 1 (0.5) | Bronchospasm | 1 (1.2) | 0 | |
| Decreased Appetite | 1 (0.5) | JIA | 1 (1.2) | 0 | |
| Suicide Attempt | 1 (1.2) | 0 | |||
| Potential opportunistic infections | 2 (0.9) | 1 (1.2) | 1 (1.2) | ||
| Herpes virus | 1 (0.5) | Herpes virus | 1 (1.2) | 0 | |
| Herpes zoster | 1 (0.5) | Candida | 0 | 1 (1.2) | |
URTI= Upper Respiratory Tract Infection