Table 1

Outcomes at trial end

Rituximab group (n=33)Control group (n=11)RR (95% CI)
Sustained remission for 6 months*25 (76%)9 (82%)
Remission maintained until trial end20 (61%)7 (64%)
Patients with one or more relapse7 (21%)2 (18%)1.16 (0.28 to 4.80)
 PR3-ANCA positive patients3 of 20 (15%)1 of 5 (20%)
 MPO-ANCA positive patients4 of 13 (31%)1 of 6 (17%)
Patients with a major relapse1 (3%)2 (18%)
Patients with more than one relapse4† (12%)0
Recovery from eGFR<15 mL/min/1.73 m27 of 13§ (54%)2 of 6*§ (33%)
ESRD2‡ (6%)01.11 (0.12 to 9.77)
Death6 (18%)3 (27%)0.66 (0.20 to 2.22)
Composite of death, ESRD and relapse14 (42%)4 (36%)1.16 (0.48 to 2.80)
  • Relative risk and CI were calculated by adding one to each cell when there were no events in the control group. End-stage renal disease was defined as dialysis for ≥6 weeks without recovery.

  • *Patients that achieved sustained remission after induction regimen met the previously reported sustained remission end point.1

  • †All second relapses were minor.

  • ‡One rituximab patient remained dialysis dependent since entry and one developed ESRD after a major renal relapse.

  • §Of those that were alive and had recovered renal function to above eGFR 15 mL/min/m2 at 24 months, initial plasma exchange was administered to four of seven rituximab patients and one of two cyclophosphamide patients.

  • ANCA, antineutrophil cytoplasm antibody; PR3, proteinase 3; MPO, myeloperoxidase; eGFR, estimated glomerular filtration rate; ESRD, end-stage renal disease; RR, relative risk of the rituximab group compared with the control group.