Disease outcomes | Rituximab group | Comparison group | P value |
n (% of all patients) | n (% of all patients) | ||
Disease control | 8 (20) | 9 (17) | 0.8 |
Partial disease control | 27 (67.5) | 11 (20.8) | <0.01* |
Flare-up† | 5 (12.5) | 33 (62.3) | <0.01* |
Prednisolone increased to >0.5 mg/kg/day | 5 (12.5) | NA | NA |
Steroid pulse therapy | 3 (7.5) | 30 (56.6) | <0.01* |
Hospitalisation for SLE flare-up | 3 (7.5) | 33 (62.3) | |
SLEDAI-2K increase to >12 points | 1 (2.5) | NA | NA |
New CYC, AZA or MTX | 0 (0) | NA | NA |
Expired post-RTX | 0 (0) | 4 (7) | 0.13 |
End-stage renal disease | 0 (0) | 6 (11.3) | 0.04* |
Adverse effects of RTX | |||
Allergic reactions | 2 (5) | NA | NA |
Infection (UTI, AGE) | 2 (5) | NA | NA |
Hypogammaglobulinaemia needing IVIG | 1 (2.5) | NA | NA |
Viral hepatitis | 0 | NA | NA |
*p<0.05.
†Flare-up refers to events occurring after the initial rituximab dose in the rituximab-treated group and post-SLE diagnosis in the comparison group.
AGE, acute gastroenteritis; AZA, azathioprine; CYC, cyclophosphamide; IVIG, intravenous immunoglobulin; MTX, methotrexate; NA, not applicable; RTX, rituximab; SLEDAI-2K, Systemic Lupus Erythematosus Disease Activity Index 2000; UTI, urinary tract infection.