Table 6 Interventions in other remission induction studies
From: Interventions for renal vasculitis in adults. A systematic review
Study ID | Treatment | Control | Study outcomes |
|---|---|---|---|
Hu 2008 | MMF 2 G/d (1.5 G if weight < 50 kg) for 6 months Immunosuppression as for control group | Intravenous CPA for 6 months as 0.75-1.0 G/m2, modified depending on WCC nadir Iv MethylPrednisolone 0.5 G daily for three days both groups followed by oral prednisolone at 0.6-0.8 mg/kg/d for 4 weeks tapered by 5 mg/wk to 10 mg/d | 1. Remission rate at 6 months. Defined as no clinical signs of vasculitis, improved or stable renal function, no active urinary sediment and BVAS score 0. 2. Changes in renal function, side effects |
Jones 2008 (RITUXVAS) | Rituximab, 375 mg/m2 IV once a week for 4 weeks (i.e. 4 doses total), with 2 doses of cyclophosphamide 15 mg/kg, 2 weeks apart given with the 1st and 3rd rituximab dose. All patients received 1 g IV methylprednisolone, then same daily oral corticosteroid regimen. | CPA 15 mg/kg for 3-6 months (6-10 doses total) IV for remission induction. AZA for remission maintenance. All patients received 1 g IV methylprednisolone, then same daily oral corticosteroid regimen. | 1. Primary i) Sustained remission (BVAS = 0 at 6 months and sustained for 6 months). ii) Severe adverse events at 2 years. 2. Secondary a. Efficacy Response rate at 6 weeks (BVAS < 50% baseline) Remission at 6 months (BVAS = 0 for 2 months by 6 months) Time to remission (BVAS = 0) Relapses (all relapses and major/minor) BVAS area under the curve Change in GFR Change in SF-36 Change in VDI b. Safety Severe adverse events at 6 weeks and 6 months. All adverse events. Death. Prednisolone cumulative dose. CPA cumulative dose 3. Tertiary. Human anti-chimeric antibody testing Correlation of B cells with disease activity Change in ANCA and disease activity Histopathology predictors of outcome. |
Stone 2009 (RAVE) | rituximab (375 mg/m2) infusions once weekly for 4 weeks and cyclophosphamide (CPA) placebo daily for 3 to 6 months. Remission Maintenance: discontinue CPA placebo and start oral azathioprine (AZA) placebo daily until Month 18 Both groups: Iv MP 1-3 G then Prednisolone 1 mg/kg/d reduced to 40 mg month 1, tapered to discontinue at the end of month 6 | rituximab placebo infusions once weekly for 4 weeks and CPA daily for 3 to 6 months Remission Maintenance: discontinue CPA and start AZA daily until Month 18. Both groups: Iv MP 1-3 G then Prednisolone 1 mg/kg/d reduced to 40 mg month 1, tapered to discontinue at the end of month 6 | Primary outcome measures Complete remission during the first 6 months after randomisation Secondary outcome measures Adverse events |
Jayne 2000 | IVIg 0.4 G/kg/d for 5 days | Placebo (identical injections) | Primary outcome: treatment response. BVAS reduction of 50% between entry and 3 months Secondary outcomes: fall in BVAS, CRP and ANCA, relapse frequency between 3 and 12 months, reduction in immunosuppressive drug doses and adverse effect |
Furuta 1998 | Three 1 hour sessions of lymphocytapheresis on alternate days in each of three consecutive weeks. Immunosuppression as for control group | 1 G MP iv for 3 consecutive days in each of three consecutive weeks. BOTH GROUPS: Prednisolone 20 mg/day and CPA 50 mg/day. | 1. SCr 4 weeks post treatment 2. Mortality |
Stegmayr 1999 | Immunoadsorption: At least 2 plasma volumes were removed. Median of 6 sessions. Immunosuppression as for control group | 3 PE in first 5 days of at least 1 plasma volume. 4% Albumin as replacement. Median of six sessions. All patients received immunosuppression with pulse MP and oral or iv CPA 2 mg/kg/day. CPA continued for 8 weeks or longer if ANCA positive. | 1. CrCl and SCr 2. Responder (CrCl improved by at least 20 ml/min or patient could leave dialysis) 3. Adverse events 4. Dialysis 5. Death |