Table 2.
Safety
| Characteristics, n (%) | SLE (n=38) |
| Any adverse events (AEs) | 19 (50.0%) |
| AEs led to drug discontinuation | 8 (21.05%) |
| Non-flare AEs which led to drug discontinuation | 4 (10.53%) |
| Serious AEs | 2 (5.26%) |
| Non-flare serious AEs* | 1 (2.63%) |
| Flare | 7 (18.42%) |
| Major flares | 3 (7.89%) |
| Mild-to-moderate flares | 4 (10.53%) |
| Nausea or vomiting | 1 (2.63%) |
| Diarrhoea | 1 (2.63%) |
| Cutaneous pruritus | 1 (2.63%) |
| Asymptomatic pyuria† | 5 (13.16%) |
| Infections | 4 (10.53%) |
| Upper respiratory tract infection | 2 (5.26%) |
| Fungal pneumonia* | 1 (2.63%) |
| Lower urinary tract infection | 1 (2.63%) |
| Death | 0 |
| Diabetic ketoacidosis | 0 |
| Hypoglycaemia | 0 |
*The patient with fungal pneumonia was also accounted for the serious AE.
†Pyuria was defined as white blood cell count >15/HP in urine analysis and patients were symptom-free. Of which, three were patients without LN and the other two were patients with LN. All without evidence of SLE/LN disease flares.
LN, lupus nephritis; SLE, systemic lupus erythematosus.