Use of Birmingham Vasculitis Activity Score and Birmingham Vasculitis Activity Score for Wegener’s granulomatosis in clinical trials
| Trial | Details | Intervention | Outcome | BVAS at entry | Disease assessment scores used |
|---|---|---|---|---|---|
| AASV, antineutrophil cytoplasmic antibody-associated systemic vasculitis; Aza, azathioprine; BVAS, Birmingham Vasculitis Activity Score; BVAS/WG, Birmingham Vasculitis Activity Score for Wegener’s granulomatosis; CR, complete remission; Cryo, cryoglobulinaemia; CS, corticosteroids; CSS, Churg–Strauss syndrome; CYC, cyclophosphamide; DEI, Disease Extent Index; DSG, deoxyspergualin; FFS, Five Factor score; iv Ig, intravenous immunoglobulin; LN, lupus nephritis; MMF, mycophenolate mofetil; MPA, microscopical polyangiitis; MTX, methotrexate; PP, plasmapheresis; PR, partial remission; RCT, randomised controlled trial; RV, rheumatoid arthritis vasculitis; SF-36, Short Form 36; SLEDAI, Systemic Lupus Erythematosus Disease Activity Index; SNVDI, Systemic Necrotising Vasculitis Damage Index; VDI, Vasculitis Damage Index; WG, Wegener’s granulomatosis. | |||||
| Keogh et al,322006 | Prospective, open-label,10 WG | Rituximab for refractory vasculitis | CR at 3 months 100% | Median 6 | BVAS/WG, SF-36 |
| WGET,33 2005 | Double-blind RCT, 180 WG | Standard treatment+etanercept v placebo for remission maintenance | No major difference in sustained remission rates (69.7% v 75.3%) | Mean 6.5 and 7.5 | BVAS/WG, VDI, SF-36 |
| De Groot et al,22 2005 | RCT, 100 new onset AASV | MTX v CYC for remission induction | Remission 6 months, MTX 89.8%, CYC 93.5% | Median 15 | BVAS 1+2, DEI, VDI |
| Benenson et al,23 2005 | Open-label, 4 WG,2 LN | High dose intravenous Aza in refractory WG or LN | 2 CR, 2 PR (LN),2 no response | Range 2–14 | BVAS, SLEDAI |
| Joy et al,31 2005 | Prospective, open-label,12 AASV | MMF for relapsing or persistent disease | Reduction in BVAS at 24 and 52 weeks | Mean 9.1 | BVAS 1+2 |
| Booth et al,272004 | Prospective, open-label,32 AASV | Addition of infliximab for remission induction in new and persistent disease | Remission 88% | Mean 12.3 | BVAS 1+2 |
| Metzler et al,28 2004 | Prospective, open-label,20 WG | Leflunomide for remission maintenance | 1 major and 8 minor relapses; median follow-up 1.75 years | Median 0 | DEI, BVAS, SF-36 |
| Danieli et al,242004 | Non-randomised, prospective, historic controls, 18 CSS | Addition of iv Ig+PP v standard treatment alone in new CSS | Remission 12 months, iv Ig 100%, control 44% | Range 13–31 | BVAS, FFS, Rankin score, SNVDI |
| Jayne et al,252003 | RCT, 155 new-onset AASV | Aza v CYC for remission maintenance | Relapse 18 months, Aza 15.5%, CYC 13.7% | Mean 18 | BVAS 1+2, DEI, VDI, SF-36 |
| Birck et al,302003 | Prospective, open–label, 19 WG,1 MPA | DSG in refractory disease | 6 CR and 8 PR after 6 months | Range 3–25 | BVAS, VDI, SF-36 |
| Bartolucci et al,29 2002 | Prospective, open-label,7 WG, 2 RV, 1 Cryo | Infliximab+CS for refractory vasculitis | 5 CR and 5 PR after 6 months | Mean 9.1 | BVAS |
| Stone et al,202001 | Prospective, open-label,20 WG | Standard treatment+etanercept for relapsing and persistent disease | 80% achieved BVAS/WG at some point | Mean BVAS/WG 3.6 | BVAS/WG |
| Jayne et al,262000 | Double-blind, placebo-controlled, 34 AASV | Standard treatment+iv Ig v placebo for persistent disease | Therapeutic response at 3 months, iv Ig 82.4%; placebo 35.3% | Mean 6.1 and 5.4 | BVAS |