Table 6.
Case-by-case assessment of reports concerning adverse events of clinical interest with baricitinib for COVID-19 management.
| Toxicity Areas | AE of Clinical Interest Reported with Baricitinib | No. Patients | No. Deaths | Proportion of Death | Seriousness | Mean Age | Sex | Weight (Kg) |
Concomitant Drugs Used for COVID-19 Management | Other Relevant Concomitant Medications Implicated in Specific AE of Clinical Interest |
|---|---|---|---|---|---|---|---|---|---|---|
| Cardiotoxicity | Hypotension (6) Bradycardia (2) Tachycardia (1) Ventricular extrasystoles (1) Atrial fibrillation (1) Ventricular tachycardia (1) |
8 | 6 | 75.0% | 100.0% | 61.9 ± 16.6 | 4 M–4 F | 94.7 ± 28.1 | 8 Remdesivir 8 Dexamethasone 1 COVID-19 convalescent plasma1 Methylprednisone |
- |
| Hepatotoxicity | Alanine aminotransferase increased (5) Aspartate aminotransferase increased (5) Liver function test increased (3) Drug-induced liver injury (1) Liver disorder (1) Transaminase increased (1) |
9 | 0 | 0.0% | 100.0% | 64.4 ± 12.8 | 4 M–5 F | 97.0 ± 37.4 | 8 Remdesivir 6 Dexamethasone 1 Enoxaparin |
1 Azithromycin 1 Ceftriaxone 1 Cefepime 1 Fluconazole |
| Infection | Septic shock (7) Sepsis (2) Infection (3) Pneumonia staphylococcal (4) Urinary tract infection (2) Candida infection (2) Pneumonia (2) Staphylococcal infection (2) Bacterial infection (2) Candida test positive (2) Other infections * |
25 | 8 | 32.0% | 100.0% | 59.4 ± 16.0 | 13 M–12 F | 102.5 ± 35.6 | 25 Remdesivir 21 Dexamethasone 5 Methylprednisone 2 Heparin 2 COVID-19 convalescent plasma1 Prednisone |
- |
| Nephrotoxicity | Acute kidney injury (11) Renal impairment (3) Renal failure (1) Renal disorder (1) |
16 | 9 | 56.3% | 100.0% | 62.1 ± 14.6 | 7 M–9 F | 94.9 ± 23.7 | 15 Remdesivir 14 Dexamethasone 2 Methylprednisone 1 Prednisone 1 Heparin |
3 Piperacillin-tazobactam 1 Vancomycin |
| Thromboembolic events | Deep vein thrombosis (4) Pulmonary embolism (4) Embolism (2) Vena Cava thrombosis (1) Thrombosis (1) Embolism venous (1) |
13 | 5 | 38.5% | 100.0% | 65.2 ± 16.4 | 6 M–6 F–1 NS | 102.2 ± 50.0 | 10 Remdesivir 6 Dexamethasone 2 Methylprednisone 2 Enoxaparin 2 Heparin |
- |
AE: adverse event; NS: not specified; * Other infections: Pneumonia pseudomonal, Pneumonia serratia, Pneumococcal infection, Escherichia urinary tract infection, Corynebacterium infection, Pseudomonas infection, Urinary tract infection pseudomonal, Urinary tract infection enterococcal, Klebsiella infection, Streptococcal infection, Stenotrophomonas test positive, Streptococcus test positive, Klebsiella test positive, Bacteraemia, and Pneumonia bacterial (one each).