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 end | 20 (61%) | 7 (64%) | |
| Patients with one or more relapse | 7 (21%) | 2 (18%) | 1.16 (0.28 to 4.80) |
| PR3-ANCA positive patients | 3 of 20 (15%) | 1 of 5 (20%) | |
| MPO-ANCA positive patients | 4 of 13 (31%) | 1 of 6 (17%) | |
| Patients with a major relapse | 1 (3%) | 2 (18%) | |
| Patients with more than one relapse | 4† (12%) | 0 | |
| Recovery from eGFR<15 mL/min/1.73 m2 | 7 of 13§ (54%) | 2 of 6*§ (33%) | |
| ESRD | 2‡ (6%) | 0 | 1.11 (0.12 to 9.77) |
| Death | 6 (18%) | 3 (27%) | 0.66 (0.20 to 2.22) |
| Composite of death, ESRD and relapse | 14 (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.