OBJECTIVE: Following induction of remission with rituximab in anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV) relapse rates are high, especially in patients with history of relapse. Relapses are associated with increased exposure to immunosuppressive medications, the accrual of damage and increased morbidity and mortality. The RITAZAREM trial compared the efficacy of repeat-dose rituximab to daily oral azathioprine for prevention of relapse in patients with relapsing AAV in whom remission was reinduced with rituximab. METHODS: RITAZAREM was an international randomised controlled, open-label, superiority trial that recruited 188 patients at the time of an AAV relapse from 29 centres in seven countries between April 2013 and November 2016. All patients received rituximab and glucocorticoids to reinduce remission. Patients achieving remission by 4 months were randomised to receive rituximab intravenously (1000 mg every 4 months, through month 20) (85 patients) or azathioprine (2 mg/kg/day, tapered after month 24) (85 patients) and followed for a minimum of 36 months. The primary outcome was time to disease relapse (either major or minor relapse). RESULTS: Rituximab was superior to azathioprine in preventing relapse: HR 0.41; 95% CI 0.27 to 0.61, p<0.001. 19/85 (22%) patients in the rituximab group and 31/85 (36%) in the azathioprine group experienced at least one serious adverse event during the treatment period. There were no differences in rates of hypogammaglobulinaemia or infection between groups. CONCLUSIONS: Following induction of remission with rituximab, fixed-interval, repeat-dose rituximab was superior to azathioprine for preventing disease relapse in patients with AAV with a prior history of relapse. TRIAL REGISTRATION NUMBER: NCT01697267; ClinicalTrials.gov identifier.
- MeSH
- ANCA-asociované vaskulitidy * farmakoterapie MeSH
- azathioprin * terapeutické užití MeSH
- cyklofosfamid terapeutické užití MeSH
- imunosupresiva terapeutické užití MeSH
- indukce remise MeSH
- lidé MeSH
- protilátky proti cytoplazmě neutrofilů MeSH
- recidiva MeSH
- rituximab terapeutické užití MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
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.
- MeSH
- ANCA-asociované vaskulitidy farmakoterapie patologie MeSH
- antirevmatika aplikace a dávkování MeSH
- dospělí MeSH
- glukokortikoidy aplikace a dávkování MeSH
- indukční chemoterapie MeSH
- kombinovaná farmakoterapie MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- prospektivní studie MeSH
- recidiva MeSH
- rituximab aplikace a dávkování MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- pozorovací studie MeSH
- práce podpořená grantem MeSH
- Research Support, N.I.H., Extramural MeSH
2nd edition 144 stran : ilustrace
Early detection of renal problems coupled with the appropriate therapeutic strategy can radically reduce the progressive nature of, and complications associated with, chronic kidney disease, and in many instances will result in the successful treatment of acute kidney injury. As many patients will not be seen by nephrologists, it is essential that all healthcare professionals, in hospitals and in the community, have an awareness of renal disease – the presenting signs, differential diagnoses, treatment strategies and approach to the management of complications. 'Fast Facts: Renal Disorders' is an easy-to-read, evidence-based guide to renal diseases and disorders for all doctors, nurses and medical students. It includes:• A clear explanation of proteinuria, hematuria, electrolyte imbalances and acid–base disorders• A concise summary of kidney function tests, imaging techniques and biopsy• Important questions for prompt diagnosis of acute kidney injury• Management options for chronic kidney disease and its complications• Practical guidance on the most common renal problems, including glomerulonephritis, systemic disease, UTIs and kidney stonesWritten by three specialists of international repute, 'Fast Facts: Renal Disorders' provides the key information required for the optimal care of renal patients. This fully updated second edition will help healthcare professionals assess, identify, treat and refer patients with renal problems appropriately. Directly applicable to the clinical setting, it is essential reading for all primary care providers, junior hospital doctors, specialist trainees, renal nurses and medical students.Contents:• Proteinuria, hematuria and renal investigations• Electrolyte disturbances and acid–base disorders• Acute kidney injury• Chronic kidney disease• Hypertension and diabetic nephropathy• Glomerulonephritis• Systemic disease• Inherited kidney disease• Urinary tract infection• Kidney stones• Urinary tract obstruction and tumors• Renal replacement therapy and transplantation
- MeSH
- nefrologie MeSH
- nemoci ledvin MeSH
- Publikační typ
- příručky MeSH
- NLK Obory
- nefrologie