Treatment-emergent adverse events in detail
| Event, n (%) IR (95% CI) | Placebo controlled | Extended | All-Bari-SLE (N=1655) | |||
| Placebo (N=635) | Bari 2 mg (N=641) | Bari 4 mg (N=634) | Bari 2 mg (N=641) | Bari 4 mg (N=634) | ||
| TEAE in ≥4% of patients in All-Bari-SLE | ||||||
| Urinary tract infection | 64 (10.1) 13.1 (10.1, 16.7) | 76 (11.9) 15.6 (12.3, 19.5) | 67 (10.6) 13.9 (10.8, 17.6) | 91 (14.2) 11.0 (8.8, 13.5) | 90 (14.2) 10.8 (8.7, 13.2) | 208 (12.6) 10.1 (8.8, 11.5) |
| COVID-19 | 22 (3.5) 4.3 (2.7, 6.5) | 27 (4.2) 5.2 (3.4, 7.6) | 21 (3.3) 3.3 (2.6, 6.3) | 62 (9.7) 6.9 (5.3, 8.9) | 58 (9.1) 6.6 (5.0, 8.5) | 167 (10.1) 7.7 (6.6, 8.9) |
| Upper respiratory tract infection | 41 (6.5) 8.2 (5.9, 11.1) | 54 (8.4) 10.8 (8.1, 14.1) | 53 (8.4) 10.9 (8.2, 14.3) | 61 (9.5) 6.9 (5.3, 8.9) | 67 (10.6) 7.9 (6.1, 10.1) | 138 (8.3) 6.5 (5.4, 7.6) |
| Headache | 53 (8.3) 10.8 (8.1, 14.1) | 48 (7.5) 9.5 (7.0, 12.6) | 43 (6.8) 8.8 (6.4, 11.9) | 60 (9.4) 6.9 (5.2, 8.8) | 54 (8.5) 6.3 (4.7, 8.2) | 126 (7.6) 5.9 (4.9, 7.0) |
| Nasopharyngitis | 44 (6.9) 8.9 (6.5, 11.9) | 47 (7.3) 9.3 (6.8, 12.4) | 50 (7.9) 10.2 (7.5, 13.4) | 57 (8.9) 6.4 (4.9, 8.3) | 58 (9.1) 6.7 (5.1, 8.7) | 121 (7.3) 5.6 (4.6, 6.7) |
| Hypertension | 22 (3.5) 4.3 (2.7, 6.5) | 31 (4.8) 6.1 (4.1, 8.6) | 31 (4.9) 6.3 (4.3, 8.9) | 38 (5.9) 4.3 (3.0, 5.9) | 44 (6.9) 5.1 (3.7, 6.8) | 94 (5.7) 4.3 (3.5, 5.3) |
| Herpes zoster | 17 (2.7) 3.3 (1.9, 5.3) | 17 (2.7) 3.3 (1.9, 5.2) | 28 (4.4) 5.6 (3.7, 8.1) | 27 (4.2) 2.9 (1.9, 4.3) | 42 (6.6) 4.8 (3.5, 6.5) | 79 (4.8) 3.6 (2.8, 4.5) |
| Diarrhoea | 28 (4.4) 5.5 (3.7, 8.0) | 35 (5.5) 6.9 (4.8, 9.6) | 26 (4.1) 5.2 (3.4, 7.6) | 38 (5.9) 4.2 (3.0, 5.8) | 29 (4.6) 3.2 (2.2, 4.7) | 73 (4.4) 3.3 (2.6, 4.2) |
| Back pain | 14 (2.2) 2.7 (1.5, 4.6) | 14 (2.2) 2.7 (1.5, 4.5) | 28 (4.4) 5.6 (3.7, 8.1) | 20 (3.1) 2.2 (1.3, 3.4) | 38 (6.0) 4.3 (3.1, 5.9) | 67 (4.0) 3.0 (2.4, 3.9) |
| Permanent discontinuation because of AE≥0.4 IR, by system organ class | ||||||
| Infections and infestations | 7 (1.1) 1.3 (0.5, 2.8) | 11 (1.7) 2.1 (1.0, 3.7) | 14 (2.2) 2.7 (1.5, 4.6) | 14 (2.2) 1.5 (0.8, 2.5) | 18 (2.8) 2.0 (1.2, 3.1) | 26 (2.2) 1.6 (1.1, 2.2) |
| Musculoskeletal and connective tissue disorders | 3 (0.5) 0.6 (0.1, 1.7) | 5 (0.8) 0.9 (0.3, 2.2) | 7 (1.1) 1.4 (0.5, 2.8) | 6 (0.9) 0.6 (0.2, 1.4) | 10 (1.6) 0.7 (0.5, 2.0) | 18 (1.1) 0.8 (0.5, 1.2) |
| Blood and lymphatic system disorders | 6 (0.9) 1.2 (0.4, 2.5) | 8 (1.2) 1.5 (0.7, 3.0) | 6 (0.9) 1.2 (0.4, 2.5) | 9 (1.4) 1.0 (0.4, 1.8) | 8 (1.3) 0.9 (0.4, 1.7) | 18 (1.1) 0.8 (0.5, 1.2) |
| Renal and urinary disorders | 5 (0.8) 1.0 (0.3, 2.2) | 9 (1.4) 1.7 (0.8, 3.2) | 5 (0.8) 1.0 (0.3, 2.3) | 12 (1.9) 1.3 (0.7, 2.2) | 8 (1.3) 0.9 (0.4, 1.7) | 20 (1.2) 0.9 (0.5, 1.4) |
| Investigations | 5 (0.8) 1.0 (0.3, 2.2) | 4 (0.6) 0.8 (0.2, 1.9) | 6 (0.9) 1.2 (0.4, 2.5) | 7 (1.1) 0.7 (0.3, 1.5) | 6 (0.9) 0.7 (0.2, 1.4) | 14 (0.8) 0.6 (0.3, 1.0) |
| Nervous system disorders | 4 (0.6) 0.8 (0.2, 2.0) | 1 (0.2) 0.2 (0.0, 1.1) | 3 (0.5) 0.6 (0.1, 1.7) | 2 (0.3) 0.2 (0.0, 0.8) | 5 (0.8) 0.5 (0.2, 1.3) | 8 (0.5) 0.4 (0.2, 0.7) |
| Gastrointestinal disorders | 2 (0.3) 0.4 (0.0, 1.4) | 7 (1.1) 1.3 (0.5, 2.7) | 3 (0.5) 0.6 (0.1, 1.7) | 8 (1.2) 0.8 (0.4, 1.7) | 3 (0.5) 0.3 (0.1, 1.0) | 13 (0.8) 0.6 (0.3, 1.0) |
| Neoplasms, benign, malignant and unspecified | 1 (0.2) 0.2 (0.0, 1.1) | 2 (0.3) 0.4 (0.0, 1.4) | 3 (0.5) 0.6 (0.1, 1.7) | 4 (0.6) 0.4 (0.1, 1.1) | 3 (0.5) 0.3 (0.1, 1.0) | 10 (0.6) 0.4 (0.2, 0.8) |
AE, adverse events; bari, baricitinib; CI, confidence interval; IR, incidence rate; n, number of patients in the specified category; N, number of patients in the analysis set; SLE, systemic lupus erythematosus; TEAE, treatment-emergent adverse event.