IN THE PIVOTAL RAVE TRIAL, RITUXAN + GCC INDUCED COMPLETE REMISSION FROM GPA AND MPA, WITH STEROID USE TAPERED TO 0 MG


Primary end point of noninferiority was complete remission (defined as BVAS/GPA of 0 and prednisone dose of 0 mg) at 6 months[1,2]

  • Tertiary end points were complete remission at 12 and 18 months[1]
    • There was no statistically significant difference between the 2 arms[3]
    • No adjustments for multiplicity were made[4]
  • Rituxan arm received Rituxan IV (375 mg/m2/wk) x 4. CYC followed by AZA arm received CYC oral (2 mg/kg daily)[1]
    • All patients received 1-3 IV pulses of methylprednisolone (1000 mg each), followed by daily oral prednisone taper (N=197)

Complete remission rates at 6, 12, and 18 months[1,2,3]
Complete remission is defined as BVAS/GPA*=0,
prednisone dose of 0 mg

AZA, azathioprine; CYC, cyclophosphamide; GCC, glucocorticoids; GPA, granulomatosis with polyangiitis; MPA, microscopic polyangiitis.
*The BVAS/GPA is a validated tool that quantifies disease activity based on evidence of active disease in 8 organ systems, an “other” category, and a physician's global assessment. Disease features are scored only if they are attributed to active vasculitis, as opposed to damage.[5]

RAVE Trial: secondary end point

RAVE Trial secondary end point: Duration of complete remission by treatment group[3]

AZA, azathioprine; CYC, cyclophosphamide.
Complete remission is defined as BVAS/GPA=0 and prednisone dose of 0 mg.

  • Among the patients in the Rituxan induction-only group who achieved complete remission, 24/76 (32%) had a relapse before the 18-month time point, with a mean (± SD) time to relapse of 176 ± 91.2 days[3]
  • Among the patients in the CYC/AZA induction + maintenance group who achieved complete remission, 20/70 (29%) had a relapse before 18 months, with a mean time to relapse of 142 ± 99.2 days[3]
  • No multiplicity adjustments were made[4]