Table 2

Disease outcomes and adverse effects of rituximab

Disease outcomesRituximab groupComparison groupP value
n (% of all patients)n (% of all patients)
Disease control8 (20)9 (17)0.8
Partial disease control27 (67.5)11 (20.8)<0.01*
Flare-up†5 (12.5)33 (62.3)<0.01*
 Prednisolone increased to >0.5 mg/kg/day5 (12.5)NANA
 Steroid pulse therapy3 (7.5)30 (56.6)<0.01*
 Hospitalisation for SLE flare-up3 (7.5)33 (62.3)
 SLEDAI-2K increase to >12 points1 (2.5)NANA
 New CYC, AZA or MTX0 (0)NANA
Expired post-RTX0 (0)4 (7)0.13
End-stage renal disease0 (0)6 (11.3)0.04*
Adverse effects of RTX
 Allergic reactions2 (5)NANA
 Infection (UTI, AGE)2 (5)NANA
 Hypogammaglobulinaemia needing IVIG1 (2.5)NANA
 Viral hepatitis0NANA
  • *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.