Table 6

Interventions in other remission induction studies

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


Walters et al. BMC Nephrology 2010 11:12   doi:10.1186/1471-2369-11-12

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