Latest clinical data in AAV

Our current understanding of ANCA-associated vasculitis (AAV) is rapidly evolving. Read the key clinical research papers to find out more about treatment outcomes in AAV.

2010

RAVE

Rituximab (RTX) was found to be as effective as cyclophosphamide (CYC) for the induction and maintenance of remission, but remission rates remain variable

RAVE

Rituximab (RTX) was found to be as effective as cyclophosphamide (CYC) for the induction and maintenance of remission, but remission rates remain variable

  • Patient achievement and maintenance of full remission remains variable with current therapies

  • 1 in 3 patients fail to achieve remission at 6 months without use of GCs, and 1 in 2 fail to sustain remission at 12 months

  • Non-severe relapse is an under-recognised clinical problem; these patients suffer subsequent relapses resulting in high GC exposure

CYC, cyclophosphamide; GC, glucocorticoid; RTX, rituximab.
References 1. Stone JH, et al. N Engl J Med 2010;363(3):221–32 2. Specks U, et al. N Engl J Med 2013;369(5):417–27. 3. Miloslavsky EM, et al. Arthritis Rheum 2015;67(6):1629–36.

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2014

RITAZAREM

Preliminary results show that a reduced GC dose can be effective for reinducing remission in AAV, and RTX was superior to AZA at maintaining remission

MAINRITSAN 1

RTX is more effective than AZA for maintenance of remission, but GC use and relapse remain common

  • RTX was shown to be a more effective maintenance therapy than AZA for newly diagnosed AAV patients

  • Minor and major relapses occurred throughout the maintenance phase of treatment, by month 28; 17% of patients suffered a major relapse, increasing to 38% by month 60

  • GC use remained common amongst all patients throughout the 60-month follow-up period

AAV, ANCA-associated vasculitis; ANCA, antineutrophil cytoplasmic antibody; AZA, azathioprine; GC, glucocorticoid; RTX, rituximab.
References 1. Guillevin L, et al. N Engl J Med 2014;371(19):1771–80. 2. Terrier B, et al. Ann Rheum Dis 2018;77(8):1150–6. 3. Terrier B, et al. Ann Rheum Dis 2018;77(8): 1150–6. [Supplementary appendix]. 4. Guillevin L, et al. N Engl J Med 2014;371(19):1771–80. [Supplementary appendix]

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2018

PEXIVAS

Reducing the GC dose in severe AAV patients did not significantly impact the primary outcome of death or end-stage renal disease (ESRD) but did reduce the rate of infection (HR=0.69)

MAINRITSAN 2

Tailored and fixed-schedule RTX regimens are equally as effective at maintaining remission, but relapses still occur

  • Relapse rates were similar with tailored and fixed-schedule RTX treatment

  • The tailored regimen demonstrated that remission maintenance can be achieved with fewer RTX infusions

  • Further research is required to establish reliable laboratory tests that can predict the appearance of relapse

RTX, rituximab.
References 1. Charles P, et al.Ann Rheum Dis 2020;173(30):1143–9.

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2010

2014

2018

2019

2020

2019

MAINRITSAN 1

RTX is more effective than AZA for maintenance of remission, but GC use and relapse remain common

RITAZAREM

Preliminary results show that a reduced GC dose can be effective for reinducing remission in AAV, and RTX was superior to AZA at maintaining remission

  • Remission induction with a reduced GC dose should be considered clinically, as it was as effective as a typical GC dose regimen

  • Initial findings show RTX to be superior to AZA in reducing relapses

  • Relapses still occurred in both treatment groups. By 24 months, 13% of the RTX patients and 38% of the AZA patients experienced a relapse

AAV, ANCA-associated vasculitis; ANCA, anti-neutrophil cytoplasmic antibody; AZA, azathioprine; GC, glucocorticoid; RTX, rituximab.
References 1. Gopaluni S, et al. Trials 2017;18(1):112. doi: 10.1186/s13063-017-1857-z. 2. Smith RM, et al. Ann Rheum Dis 2020;79(9):1243–96. 3. Smith RM, et al. J Am Soc Nephrol 2019:30.

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2020

MAINRITSAN 2

Tailored and fixed-schedule RTX regimens are equally as effective at maintaining remission, but relapses still occur

PEXIVAS

Reducing the GC dose in severe AAV patients did not significantly impact the primary outcome of death or end-stage renal disease (ESRD) but did reduce the rate of infection (HR=0.69)

  • Risk of death or ESRD with reduced GC dose was non-inferior to standard GC dose

  • Reduced-dose regimen decreased the risk of serious infections (0.69; 95% CI, 0.52 to 0.93) without increasing the risk of other adverse events

  • The continued use of a standard-dose GC regimen, even in patients with severe AAV should be re-evaluated

  • Use of plasma exchange (PLEX) in this patient population provided no added benefit

AAV, ANCA-associated vasculitis; ANCA, anti-neutrophil cytoplasmic antibody; ESRD, end-stage renal disease; GC, glucocorticoid; HR, hazard ratio; PLEX, plasma exchange.
References 1. Walsh M, et al. N Engl J Med 2020;382(22)2169. doi: 10.1056/NEJMc2004843. 2. Walsh M, et al. N Engl J Med 2020;382(22)2169. doi: 10.1056/NEJMc2004843. [Supplementary appendix].

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2020

MAINRITSAN 3

Extended maintenance therapy leads to better clinical outcomes

MAINRITSAN 3

Extended maintenance therapy leads to better clinical outcomes

  • Relapse rates were reduced in patients receiving long-term RTX treatment compared to standard maintenance therapy

  • With standard maintenance therapy, relapse rates remain high. At month 28, 25% of patients experienced a relapse

  • There was no difference in the incidence of AEs with long-term treatment

AE, adverse event; RTX, rituximab.
References 1. Charles P, et al. Ann Intern Med 2020;173(30:179–87. 2. Terrier B, et al. Ann Rheum Dis 2018;77(8):1150–6.

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