TY - JOUR
T1 - Rituximab versus cyclophosphamide in ANCA-associated renal vasculitis
T2 - 2-year results of a randomised trial
AU - Jones, Rachel B
AU - Furuta, Shunsuke
AU - Tervaert, Jan Willem Cohen
AU - Hauser, Thomas
AU - Luqmani, Raashid
AU - Morgan, Matthew D
AU - Peh, Chen Au
AU - Savage, Caroline O
AU - Segelmark, Marten
AU - Tesar, Vladimir
AU - van Paassen, Pieter
AU - Walsh, Michael
AU - Westman, Kerstin
AU - Jayne, David Rw
AU - European Vasculitis Society (EUVAS)
N1 - Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
PY - 2015/6
Y1 - 2015/6
N2 - OBJECTIVES: The RITUXVAS trial reported similar remission induction rates and safety between rituximab and cyclophosphamide based regimens for antineutrophil cytoplasm antibody (ANCA)-associated vasculitis at 12 months; however, immunosuppression maintenance requirements and longer-term outcomes after rituximab in ANCA-associated renal vasculitis are unknown.METHODS: Forty-four patients with newly diagnosed ANCA-associated vasculitis and renal involvement were randomised, 3:1, to glucocorticoids plus either rituximab (375 mg/m(2)/week×4) with two intravenous cyclophosphamide pulses (n=33, rituximab group), or intravenous cyclophosphamide for 3-6 months followed by azathioprine (n=11, control group).RESULTS: The primary end point at 24 months was a composite of death, end-stage renal disease and relapse, which occurred in 14/33 in the rituximab group (42%) and 4/11 in the control group (36%) (p=1.00). After remission induction treatment all patients in the rituximab group achieved complete B cell depletion and during subsequent follow-up, 23/33 (70%) had B cell return. Relapses occurred in seven in the rituximab group (21%) and two in the control group (18%) (p=1.00). All relapses in the rituximab group occurred after B cell return.CONCLUSIONS: At 24 months, rates of the composite outcome of death, end-stage renal disease and relapse did not differ between groups. In the rituximab group, B cell return was associated with relapse.TRIAL REGISTRATION NUMBER: ISRCTN28528813.
AB - OBJECTIVES: The RITUXVAS trial reported similar remission induction rates and safety between rituximab and cyclophosphamide based regimens for antineutrophil cytoplasm antibody (ANCA)-associated vasculitis at 12 months; however, immunosuppression maintenance requirements and longer-term outcomes after rituximab in ANCA-associated renal vasculitis are unknown.METHODS: Forty-four patients with newly diagnosed ANCA-associated vasculitis and renal involvement were randomised, 3:1, to glucocorticoids plus either rituximab (375 mg/m(2)/week×4) with two intravenous cyclophosphamide pulses (n=33, rituximab group), or intravenous cyclophosphamide for 3-6 months followed by azathioprine (n=11, control group).RESULTS: The primary end point at 24 months was a composite of death, end-stage renal disease and relapse, which occurred in 14/33 in the rituximab group (42%) and 4/11 in the control group (36%) (p=1.00). After remission induction treatment all patients in the rituximab group achieved complete B cell depletion and during subsequent follow-up, 23/33 (70%) had B cell return. Relapses occurred in seven in the rituximab group (21%) and two in the control group (18%) (p=1.00). All relapses in the rituximab group occurred after B cell return.CONCLUSIONS: At 24 months, rates of the composite outcome of death, end-stage renal disease and relapse did not differ between groups. In the rituximab group, B cell return was associated with relapse.TRIAL REGISTRATION NUMBER: ISRCTN28528813.
KW - Aged
KW - Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
KW - Antibodies, Monoclonal, Murine-Derived
KW - Azathioprine
KW - B-Lymphocytes
KW - Cyclophosphamide
KW - Disease Progression
KW - Disease-Free Survival
KW - Drug Therapy, Combination
KW - Female
KW - Glucocorticoids
KW - Granulomatosis with Polyangiitis
KW - Humans
KW - Immunosuppressive Agents
KW - Kidney Failure, Chronic
KW - Lymphocyte Count
KW - Male
KW - Microscopic Polyangiitis
KW - Middle Aged
KW - Renal Insufficiency, Chronic
U2 - 10.1136/annrheumdis-2014-206404
DO - 10.1136/annrheumdis-2014-206404
M3 - Article
C2 - 25739829
SN - 0003-4967
VL - 74
SP - 1178
EP - 1182
JO - Annals of the Rheumatic Diseases
JF - Annals of the Rheumatic Diseases
IS - 6
ER -