Background/Purpose:
Rituximab (RTX) is non-inferior to cyclophosphamide (CYC) followed by azathioprine (AZA) for remission-induction in severe ANCA associated vasculitis (AAV) but details of outcomes among patients with renal involvement have not been reported. We present the long-term outcomes of patients who had renal involvement at baseline in the RAVE trial.
Methods:
Patients with renal involvement defined by a Birmingham Vasculitis Activity Score/Wegener’s Granulomatosis (BVAS/WG) renal item score ≥ 3 at baseline were included. Glomerular filtration rate was estimated (e-GFR) by Cockcroft-Gault formula. Complete remission (CR) was defined by BVAS/WG = 0, off prednisone; Renal flare by renal BVAS/WG ≥ 3. Remission rates, slopes of eGFR and renal flares were compared between treatment groups.
Results:
102 of the 197 (52%) patients had renal involvement at entry (GPA: 68; MPA: 34; PR3-ANCA: 58; MPO-ANCA: 44; new diagnosis: 58; relapsing disease: 44). The mean age was 55 years, 52% were males. 51 patients each received RTX or CYC/AZA. Except for lower mean baseline e-GFR in the RTX group (53 ml/min vs 69ml/min p=0.01), there were no clinical differences between the treatment groups. 60.8 % patients treated with RTX and 62.7 % patients treated with CYC/AZA achieved CR by 6 months, and 74.5 % and 76.5% at any time on the originally assigned treatment, respectively. Median times to CR were similar in both groups. The mean e-GFR increased in parallel in the two groups during the 18 months. The number of renal flares did not differ between the two groups at 6, 12, or 18 months. When stratified by ANCA or AAV type or new vs relapsing disease, there were no differences in remission rates or slopes of e-GFR increase at 18 months. Four MPA patients treated with RTX without maintenance therapy had a total of 5 renal flares by month 18 vs none treated with CYC/AZA (p=0.04).
Conclusion:
A single course of RTX is as effective as 18 months of therapy with CYC/AZA for induction and maintenance of remission in patients with AAV with renal disease. MPA patients treated with RTX and no maintenance therapy may be more likely to experience a renal flare following B cell reconstitution.
Disclosure:
D. Geetha,
Genentech and Biogen IDEC Inc.,
9;
F. Fervenza,
Genentech and Biogen IDEC Inc.,
2.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/the-efficacy-of-rituximab-vs-cyclophosphamide-for-treatment-of-renal-disease-in-anca-associated-vasculitis-the-rave-trial-geetha-d-fervenza-fc-for-the-rave-itn-research-group/