Plasma Exchange and Glucocorticoids in Severe ANCA-Associated Vasculitis
Jazyk angličtina Země Spojené státy americké Médium print
Typ dokumentu hodnocení ekvivalence, časopisecké články, multicentrická studie, randomizované kontrolované studie, Research Support, N.I.H., Extramural, práce podpořená grantem
Grantová podpora
159662
CIHR - Canada
R01 FD003516
FDA HHS - United States
MR/N011775/1
Medical Research Council - United Kingdom
AOM11142
Ministère des Affaires Sociales et de la Santé - International
FDA R01 FD003516
U.S. Food and Drug Administration - International
APP1092957
National Health and Medical Research Council - International
U54 RR019497
NCRR NIH HHS - United States
211079
CIHR - Canada
APP1086192
National Health and Medical Research Council - International
631731
National Health and Medical Research Council - International
626939
National Health and Medical Research Council - International
U54 AR057319
NIAMS NIH HHS - United States
U54 AR0573319
NIAMS NIH HHS - United States
HTA 08/56/04
Health Technology Assessment Programme - International
PubMed
32053298
PubMed Central
PMC7325726
DOI
10.1056/nejmoa1803537
Knihovny.cz E-zdroje
- MeSH
- ANCA-asociované vaskulitidy komplikace farmakoterapie mortalita terapie MeSH
- aplikace orální MeSH
- chronické selhání ledvin epidemiologie etiologie prevence a kontrola MeSH
- cyklofosfamid terapeutické užití MeSH
- dospělí MeSH
- glukokortikoidy aplikace a dávkování škodlivé účinky MeSH
- imunosupresiva terapeutické užití MeSH
- incidence MeSH
- indukční chemoterapie MeSH
- kombinovaná terapie MeSH
- lidé středního věku MeSH
- lidé MeSH
- nemoci ledvin komplikace MeSH
- rituximab terapeutické užití MeSH
- senioři MeSH
- výměna plazmy * škodlivé účinky MeSH
- vztah mezi dávkou a účinkem léčiva MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- hodnocení ekvivalence MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Research Support, N.I.H., Extramural MeSH
- Názvy látek
- cyklofosfamid MeSH
- glukokortikoidy MeSH
- imunosupresiva MeSH
- rituximab MeSH
BACKGROUND: More effective and safer treatments are needed for antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. METHODS: We conducted a randomized trial with a 2-by-2 factorial design to evaluate the use of plasma exchange and two regimens of oral glucocorticoids in patients with severe ANCA-associated vasculitis (defined by an estimated glomerular filtration rate of <50 ml per minute per 1.73 m2 of body-surface area or diffuse pulmonary hemorrhage). Patients were randomly assigned to undergo plasma exchange (seven plasma exchanges within 14 days after randomization) or no plasma exchange (control group). Patients were also randomly assigned to follow either a standard-dose regimen or a reduced-dose regimen of oral glucocorticoids. Patients were followed for up to 7 years for the primary composite outcome of death from any cause or end-stage kidney disease (ESKD). RESULTS: Death from any cause or ESKD occurred in 100 of 352 patients (28.4%) in the plasma-exchange group and in 109 of 352 patients (31.0%) in the control group (hazard ratio, 0.86; 95% confidence interval [CI], 0.65 to 1.13; P = 0.27). The results were similar in subgroup analyses and in analyses of secondary outcomes. We also assessed the noninferiority of a reduced-dose regimen of glucocorticoids to a standard-dose regimen, using a noninferiority margin of 11 percentage points. Death from any cause or ESKD occurred in 92 of 330 patients (27.9%) in the reduced-dose group and in 83 of 325 patients (25.5%) in the standard-dose group (absolute risk difference, 2.3 percentage points; 90% CI, -3.4 to 8.0), which met the criterion for noninferiority. Serious infections at 1 year were less common in the reduced-dose group than in the standard-dose group (incidence rate ratio, 0.69; 95% CI, 0.52 to 0.93), but other secondary outcomes were similar in the two groups. CONCLUSIONS: Among patients with severe ANCA-associated vasculitis, the use of plasma exchange did not reduce the incidence of death or ESKD. A reduced-dose regimen of glucocorticoids was noninferior to a standard-dose regimen with respect to death or ESKD. (Funded by the U.K. National Institute for Health Research and others; PEXIVAS Current Controlled Trials number, ISRCTN07757494; ClinicalTrials.gov number, NCT00987389.).
Zobrazit více v PubMed
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