From: Interventions for renal vasculitis in adults. A systematic review
Study ID | Treatment | Control | Study Outcomes |
---|---|---|---|
Hiemstra 2009 (IMPROVE) | Mycophenolate mofetil 2 G/d for 42 months | azathioprine 2 mg/kg/d for 42 months | 1. Time to first relapse 2. relapse rate 3. Rate of side-effects and intolerance 4. cumulative doses (AZA, CS, MMF), 5. AUC for BVAS, SF-36 or VDI 6. Evolution of titres of ANCA and CRP |
Pagnoux 2008 | All patients received identical remission induction therapy. Pulse MP 15 mg/kg for 3 days. Oral prednisolone 1 mg/kg/d for 3 weeks, tapered to 12.5 mg at 6 months. Pulse CPA 0.6 G/m2, 3 doses at 2 week intervals then every 3 weeks until remission, 3 further consolidation doses at 3 week intervals. Azathioprine 2 mg/kg/d Maintenance therapy continued for 12 months then withdrawn over 3 months. Trimethoprim-sulfamethoxazole 320/1600 daily recommended for WG patients for additional 2 years. | Methotrexate 0.3 mg/kg/week, increasing every week by 2.5 mg to 25 mg/week. Folinic Acid 25 mg or Folic Acid 5 mg given 48 hours after Methotrexate. Maintenance therapy continued for 12 months then withdrawn over 3 months. Trimethoprim-sulfamethoxazole 1600/320 daily recommended for WG patients for additional 2 years. | Primary end point: 1. adverse reaction causing death or leading to discontinuation of the study drug. Secondary end points: 2. any adverse event, 3. severe adverse event, 4. relapse, 5. relapse free survival, 6. event free survival, 7. quality of life. |
WGET 2005 | Etanercept 25 mg twice weekly by subcutaneous injection Immunosuppression as for control group. | Twice weekly placebo injection Severe disease: Cyclophosphamide 2 mg/kg/d. Replaced with methotrexate if in remission at 3 to 6 months. Limited disease: Methotrexate 0.25 mg/kg/week to maximum of 25 mg/week. 12 months after remission, MTX dose cut by 2.5 mg each month. Prednisolone was given to patients with severe and limited disease starting at 0.5 to 1.0 mg/kg/d. Tapered to 0 mg at 6 months if no relapse. Patients in remission with creatinine > 2 mg/dl received Azathioprine 2 mg/kg/d, decreased after 12 months in remission by 25 mg each month. | 1. Sustained remission. BVAS/WG score 0 for at least 6 months. 2. Number and rate of flares during treatment, percentage of patients with sustained low level of disease activity (BVAS/WG < 3 for at least 6 months), percentage of patients with a remission, cumulative area under the curve for the BVAS/WG, adverse events, quality of life. |
Metzler 2007 | Leflunomide. Loading dose of 100 mg/d for 3 days, followed by 20 mg/d from day 4 to end of week 4. Then increased to 30 mg/d thereafter. Prednisolone as per methotrexate group. | Methotrexate: 7.5 mg/week weeks 1 to 4. 15 mg/week for weeks 5 to 8. 20 mg/week after week 8. Prednisolone allowed at a dose of 10 mg/d or less. In the absence of disease activity, the dose was tapered by 2.5 mg/month to 5 mg, then by 1 mg/month. | 1. Number of major and minor relapses. 2. Disease Extent Index (DEI), BVAS, patient self assessment of quality of life (SF-36), cANCA titre, ESR, CRP. |
Stegeman 1996 | Co-trimoxazole 960 mg twice daily | Placebo | 1. Death 2. Remission |
Jayne 2003 | CPA 1.5 mg/kg/d from remission. Switched to AZA 1.5 mg/kg/d 12 months after study entry. Immunosuppression as for control group. | After remission induction, AZA 2 mg/kg/d with Prednisolone 10 mg/d. BOTH GROUPS: Remission induction with oral CPA 2 mg/kg/d and prednisolone 1 mg/kg/d tapered to 0.25 mg/kg/d by 12 weeks. From 12 months both groups received AZA 1.5 mg/kg/d and prednisolone 7.5 mg/d. | 1. Relapse by 18 months 2. Side effects including leucopenia and infections |