OBJECTIVES: Evaluation of rituximab and glucocorticoids as therapy to induce remission after relapse in ANCA-associated vasculitis (AAV) in a prospective observational cohort of patients enrolled into the induction phase of the RITAZAREM trial. METHODS: Patients relapsing with granulomatosis with polyangiitis or microscopic polyangiitis were prospectively enrolled and received remission-induction therapy with rituximab (4×375 mg/m2) and a higher or lower dose glucocorticoid regimen, depending on physician choice: reducing from either 1 mg/kg/day or 0.5 mg/kg/day to 10 mg/day by 4 months. Patients in this cohort achieving remission were subsequently randomised to receive one of two regimens to prevent relapse. RESULTS: 188 patients were studied: 95/188 (51%) men, median age 59 years (range 19-89), prior disease duration 5.0 years (range 0.4-34.5). 149/188 (79%) had previously received cyclophosphamide and 67/188 (36%) rituximab. 119/188 (63%) of relapses had at least one major disease activity item, and 54/188 (29%) received the higher dose glucocorticoid regimen. 171/188 (90%) patients achieved remission by 4 months. Only six patients (3.2% of the study population) did not achieve disease control at month 4. Four patients died in the induction phase due to pneumonia (2), cerebrovascular accident (1), and active vasculitis (1). 41 severe adverse events occurred in 27 patients, including 13 severe infections. CONCLUSIONS: This large prospective cohort of patients with relapsing AAV treated with rituximab in conjunction with glucocorticoids demonstrated a high level of efficacy for the reinduction of remission in patients with AAV who have relapsed, with a similar safety profile to previous studies.

Cambridge Clinical Trials Unit Cambridge University Hospitals NHS Foundation Trust Cambridge UK

Cambridge University Hospitals NHS Foundation Trust Cambridge UK

Canberra Hospital Canberra Australian Capital Territory Australia

Cedars Sinai Medical Center Los Angeles California USA

Chiba University Chiba Japan

Cleveland Clinic Foundation Cleveland Ohio USA

Department of Nephrology Charles University Prague Czech Republic

Department of Renal Medicine Karolinska University Hospital and Karolinska Institute Stockholm Sweden

Division of Rheumatology University of Pennsylvania Perelman School of Medicine Philadelphia Pennsylvania USA

Division of Rheumatology VA Boston Healthcare System West Roxbury Massachusetts USA

Dudley Group NHS Foundation Trust Dudley West Midlands UK

East Kent Hospitals University NHS Foundation Trust Canterbury Kent UK

HSS New York New York USA

Imperial College London London UK

Ipswich Hospital NHS Trust Ipswich UK

Kyorin University School of Medicine Tokyo Japan

Kyoto University Kyoto Japan

Mayo Clinic Rochester Minnesota USA

McMaster University Hamilton Ontario Canada

Mount Sinai Hospital University of Toronto Toronto Ontario Canada

NIHR Leeds Musculoskeletal Biomedical Research Unit Leeds Teaching Hospitals Trust Leeds UK

Nottingham University Hospitals NHS Trust Nottingham Nottingham UK

Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Science University of Oxford Oxford UK

Okayama Universty Hospital Okayama Japan

Perelman School of Medicine at the University of Pennsylvania Philadelphia Pennsylvania USA

Rheumatology Nottingham University Hospital Nottingham UK

Royal Adelaide Hospital Adelaide South Australia Australia

Royal Brisbane and Women's Hospital Herston Queensland Australia

South Tees Hospitals NHS Foundation Trust Middlesbrough Middlesbrough UK

University Hospitals of Leicester NHS Trust Leicester Leicester UK

University of Birmingham Birmingham UK

University of Cambridge Cambridge UK

University of Leicester Leicester UK

University of Michigan Ann Arbor Michigan USA

University of Miyazaki Miyazaki Japan

University of North Carolina Chapel Hill North Carolina USA

University of Pennsylvania Perelman School of Medicine Philadelphia Pennsylvania USA

University of Pennsylvania Philadelphia Pennsylvania USA

University of Pittsburg Pittsburg Pennsylvania USA

University of Toronto Toronto Ontario Canada

University of Utah Vasculitis Center Salt Lake City Utah USA

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Ann Rheum Dis. 2023 Jan;82(1):e23. doi: 10.1136/annrheumdis-2020-219312. PubMed

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Ann Rheum Dis. 2023 Jan;82(1):e24. doi: 10.1136/annrheumdis-2020-219329. PubMed

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