Rituximab Versus Cyclophosphamide for ANCA-Associated Vasculitis with Renal Involvement
Year: 2014
Type: article
Abstract: Rituximab (RTX) is non-inferior to cyclophosphamide (CYC) followed by azathioprine (AZA) for remission-induction in severe ANCA-associated vasculitis (AAV), but renal outcomes are unknown. This is a post hoc analysis of patients enrolled in the Rituximab for ANCA-Associated Vasculitis (RAVE) Trial who had renal involvement (biopsy proven pauci-immune GN, red blood cell casts in the urine, and/or a rise in serum creatinine concentration attributed to vasculitis). Remission-induction regimens were RTX at 375 mg/m(2) × 4 or CYC at 2 mg/kg/d. CYC was replaced by AZA (2 mg/kg/d) after 3-6 months. Both groups received glucocorticoids. Complete remission (CR) was defined as Birmingham Vasculitis Activity Score/Wegener's Granulomatosis (BVAS/WG)=0 off prednisone. Fifty-two percent (102 of 197) of the patients had renal involvement at entry. Of these patients, 51 were randomized to RTX, and 51 to CYC/AZA. Mean eGFR was lower in the RTX group (41 versus 50 ml/min per 1.73 m(2); P=0.05); 61% and 75% of patients treated with RTX and 63% and 76% of patients treated with CYC/AZA achieved CR by 6 and 18 months, respectively. No differences in remission rates or increases in eGFR at 18 months were evident when analysis was stratified by ANCA type, AAV diagnosis (granulomatosis with polyangiitis versus microscopic polyangiitis), or new diagnosis (versus relapsing disease) at entry. There were no differences between treatment groups in relapses at 6, 12, or 18 months. No differences in adverse events were observed. In conclusion, patients with AAV and renal involvement respond similarly to remission induction with RTX plus glucocorticoids or CYC plus glucocorticoids.
Institutions: Johns Hopkins University, Mayo Clinic, Massachusetts General Hospital, University of Pennsylvania, Hospital for Special Surgery, Cleveland Clinic, University Medical Center Groningen, Duke University, University of Alabama, University of Alabama at Birmingham, UAB Medicine, National Institute of Allergy and Infectious Diseases, Immune Tolerance Network, Rho (United States), Genentech
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
Funders: Arthritis Foundation, Georgia Clinical and Translational Science Alliance, National Institutes of Health, Genentech, National Institute of Allergy and Infectious Diseases, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Center for Research Resources, National Center for Advancing Translational Sciences
Awards: G115515487, G1201304535, G1830311252, G1843845992, G219020131, Institute for Clinical and Translational Research (UL1), Translational Research in Systemic Vasculitis, Immune tolerance network: liver transplantation, Mayo Clinic Center for Clinical and Translational Science (CCaTS), Development of an ANCA-Vasculitis Index of Damage (AVID), General Clinical Research Center, G4814970433, G5029114750, General Clinical Research Center, Boston University Clinical and Translational Science Award (CTSA) Program UL1, G6823653762, Clinical and Translational Science Collaborative of Cleveland, Mayo Clinic Center for Translational Science Activities
OpenAlex ID: W2163003110
