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    CANVASC2011 Meeting FVSG EUVAS

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    The document summarizes the history and activities of the French Vasculitis Study Group (FVSG) network and the European Vasculitis Study Group (EUVAS). The FVSG was founded in 1980 and has conducted numerous clinical trials that helped establish treatment protocols for ANCA-associated vasculitis. It maintains a large patient registry and provides educational resources. EUVAS was formed in 1985 and has received major grants enabling large multicenter trials. Both networks have played major roles in international collaborations and establishing treatment guidelines.

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    CANVASC2011 Meeting FVSG EUVAS

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    popescu daniela
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    The document summarizes the history and activities of the French Vasculitis Study Group (FVSG) network and the European Vasculitis Study Group (EUVAS). The FVSG was founded in 1980 and has conducted numerous clinical trials that helped establish treatment protocols for ANCA-associated vasculitis. It maintains a large patient registry and provides educational resources. EUVAS was formed in 1985 and has received major grants enabling large multicenter trials. Both networks have played major roles in international collaborations and establishing treatment guidelines.

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    CANVASC2011-meeting-FVSG-EUVAS

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    The document summarizes the history and activities of the French Vasculitis Study Group (FVSG) network and the European Vasculitis Study Group (EUVAS). The FVSG was founded in 1980 and has conducted numerous clinical trials that helped establish treatment protocols for ANCA-associated vasculitis. It maintains a large patient registry and provides educational resources. EUVAS was formed in 1985 and has received major grants enabling large multicenter trials. Both networks have played major roles in international collaborations and establishing treatment guidelines.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    30 views32 pages

    CANVASC2011 Meeting FVSG EUVAS

    Uploaded by

    popescu daniela
    The document summarizes the history and activities of the French Vasculitis Study Group (FVSG) network and the European Vasculitis Study Group (EUVAS). The FVSG was founded in 1980 and has conducted numerous clinical trials that helped establish treatment protocols for ANCA-associated vasculitis. It maintains a large patient registry and provides educational resources. EUVAS was formed in 1985 and has received major grants enabling large multicenter trials. Both networks have played major roles in international collaborations and establishing treatment guidelines.

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    The European and

    French networks
    Christian Pagnoux, MD, MSc, MPH
    Mount Sinai Hospital, Toronto, Canada
    Cochin Hospital, Paris, France
    French Vasculitis Study Group
    • December 1980: L. Guillevin

    – no research, no real interest for rare diseases


    – no REB, no Helsinky or Huriet
    – Research funded by health social insurance
    FVSG network
    • Core group

    • 66 millions
    vs 35 millions
    FVSG network
    • Core group

    • 66 millions in 675,000 km²

    vs 35 millions in 10,000,000 km²


    FVSG network
    • Core group

    • 66 millions in 675,000 km²

    vs 35 millions in 10,000,000 km²


    • Any center/MD in France (+ Belgium) > 60/600
    • Only 1 REB
    FVSG database
    16 TA 724 GPA 120 BRD
    21 GCA 368 MPA 10 PACNS
    2,742 patients 479 CSS 50 BEHC
    512 PAN 92 CRYO 4 TAO
    7 KD 25 HSP 315 NC
    GFEV international connections
    International collaborations
    • Pagnoux C, Hogan SL, Chin H, Jennette JC, Falk RJ, Guillevin L, Nachman PH.
    Predictors of treatment resistance and relapse in antineutrophil cytoplasmic antibody-
    associated small-vessel vasculitis: comparison of two independent cohorts. Arthritis
    Rheum 2008;58:2908-18.

    • Hauser T, Mahr A, Metzler C, Coste J, Sommerstein R, Gross WL, Guillevin L,


    Hellmich B. The leucotriene receptor antagonist montelukast and the risk of Churg-
    Strauss syndrome: a case-crossover study. Thorax 2008;63:677-82.

    • Lidar M, Lipschitz N, Langevitz P, Barzilai O, Ram M, Porat-Katz BS, Pagnoux C,


    Guilpain P, Sinico RA, Radice A, Bizzaro N, Damoiseaux J, Tervaert JW, Martin J,
    Guillevin L, Bombardieri S, Shoenfeld Y. Infectious serologies and autoantibodies in
    Wegener's granulomatosis and other vasculitides: novel associations disclosed using
    the Rad BioPlex 2200. Ann N Y Acad Sci 2009;1173:649-57
    1980 Cyclophosphamide
    1991
    CS + PE vs
    PAN MPA
    CSS CS + PE + oral CYC
    Guillevin, J Rheumatol 1991; 18: 567

    But NO stratification according to


    Disease
    Severity
    HBV status

    Relapses
    No difference in survival 9,4% without CYC
    vs 38,5% with CYC
    at 10 years
    SURVIVAL IN 278 PAN, MPA, CSS PATIENTS

    NS

    Gayraud et al, Arthritis Rheum 2001;44:666-75


    The Five Factor Score

    • Proteinuria >1 g/day


    • Creatinine level >140 µmol/l
    • Specific GI involvement
    • Specific cardiomyopathy
    • Specific CNS involvement

    Guillevin et al. Medicine 1996;75:17-28


    SURVIVAL IN 278 PAN, MPA, CSS PATIENTS

    p = 0.004

    Gayraud et al, Arthritis Rheum 2001;44:666-75


    CHUSPAN
    PAN or MPA & CSS – FFS=0
    1994 CS alone
    2005
    (6 CYC pulse vs AZA)
    2-phases open label trials
    CSS #72 p. Ribi et al, Arthritis Rheum 2008;58:586-94
    PAN-MPA #124p. Ribi et al, Arthritis Rheum 2010;62:1186-97

    CHUSPAN
    1994 PAN or MPA & CSS – FFS ≥1
    2005 CS + 6 vs 12 CYC pulses
    Open label randomized trials
    PAN-MPA #65 p. Guillevin et al, Arthritis Care Res 2003;49:93-100
    CSS #48 p. Cohen et al, Arthritis Care Res 2007;57:686-93
    CHUSPAN PAN MP

    Guillevin et al, Arthritis Care Res 2003;49:93-100


    1989
    CYC routes in PAN MPA
    1997 CS + oral CYC vs
    CS + IV CYC
    Gayraud, Br J Rheumatol 1997; 36: 1290

    Wegener’s granulomatosis
    1990
    1997 CS + IV vs oral CYC

    Guillevin, Arthritis Rheum 1997, 40: 2187


    End of full dose CYC Rx Survival

    End of CYC
    Open label RCT
    66%
    – > design over 5 yrs
    – 66 p/arm needed 57%
    – Interim at half-time 3 yrs
    – 50 WG enrolled
    – Remission at M6 NS
    IV CYC 88.9%
    oral CYC 78.3% (NS)

    – Relapses (mean f/u 30 mo)


    IV CYC 59.2%
    oral CYC 13% (P = 0.02)

    Cumulative relapse rates


    – AEs
    IV CYC 40.7% 59%
    oral CYC 69.6% (P<0.05)
    – Cumulative CYC dose
    IV CYC 27.8 g
    oral CYC 43.9 g (P<0.01) P = 0.02
    13%

    Guillevin et al, Arthritis Rheum 1997;62:1186-97


    WG & MPA: MAINTENANCE

    WEGENT
    • > design for AE
    • 159  126 p. (WG 75%)
    • AE requiring drug withdrawal
    7 AZA vs 12 MTX (P = 0.21)
    • 1 death in the MTX
    • Relapses
    23 AZA vs 21 MTX (P = 0.71)
    73% after discontinuation

    Pagnoux et al, N Engl J Med 2008;359:2790-803.


    Ongoing FVSG trials/studies
    • CHUSPAN 2
    – CSS, MPA or PAN with FFS = 0
    – 60/120 included
    – Double blinded study

    • MAINRITSAN
    – RTX 500 mg/6 months vs AZA for maintenance

    • COVAC’
    – PACNS cohort
    French recommendations
    Educational program and
    annual meetings
    • Annual national meetings
    – 80 to 120 attendees since 1990
    – No way to skip 1 year…

    • Website
    – vascularites.org
    – 80 to 150 visitors per day
    EUVAS
    EUVAS
    • Unofficial group since 1985
    – Denmark + Netherlands
    EUVAS
    • Unofficial group since 1985
    – Denmark + Netherlands
    • EC/BCR ANCA study in 1989
    – 7  14 centers in Europe
    EUVAS
    • Unofficial group since 1985
    – Denmark + Netherlands
    • EC/BCR ANCA study in 1989
    – 7  14 centers in Europe
    • BIOMED1 grant 1994  ECSYSVASTRIAL
    – 3 clinical trials: CYCAZAREM, NORAM, MEPEX
    EUVAS
    • Unofficial group since 1985
    – Denmark + Netherlands
    • EC/BCR ANCA study in 1989
    – 7  14 centers in Europe
    • BIOMED1 grant 1994  ECSYSVASTRIAL
    – 3 clinical trials: CYCAZAREM, NORAM, MEPEX
    • BIOMED2 grant 1999  AVERT
    – CYCLOPS, IMPROVE, REMAIN

    • EUVAS
    EUVAS
    • Pharmaceutical industry funded trials
    – MYCYC, RITUXVAS, (ABAVAS)
    EUVAS

    • NO multicentric cohort or longitudinal


    database
    – UKVAS

    • Long-term follow-up of trial patients


    EUVAS international connections
    EUVAS / EULAR
    • Hellmich et al. EULAR recommendations for conducting clinical
    studies and/or clinical trials in systemic vasculitis: focus on anti-
    neutrophil cytoplasm antibody-associated vasculitis. Ann Rheum
    Dis. 2007;66:605-17

    • Mukhtyar et al. EULAR recommendations for the management of


    primary small and medium vessel vasculitis. Ann Rheum Dis.
    2009;68:310-7
    • Mukhtyar et al. EULAR recommendations for the management of
    large vessel vasculitis. Ann Rheum Dis 2009;68:318-23

    • Basu et al. EULAR points to consider in the development of


    classification and diagnostic criteria in systemic vasculitis. Ann
    Rheum Dis 2010;69:1744-50
    EUVAS
    • MAJOR international EU trials
    • MAJOR funding
    • MAJOR playerS (including « fellows »)
    • MAJOR « expert » (only) meetings

    • Successful network

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