Kone Aksjeopsjoner 2010

Dagens aksjemarked Nyheter amp Analyse Realtid etter timer Pre-Market Nyheter Flash Sitat Sammendrag Sitat Interaktive diagrammer Standardinnstilling Vær oppmerksom på at når du har valgt ditt valg, gjelder det for alle fremtidige besøk på NASDAQ. Hvis du, når som helst, er interessert i å gå tilbake til standardinnstillingene, velg Standardinnstilling ovenfor. Hvis du har spørsmål eller støter på problemer ved å endre standardinnstillingene, vennligst send epost til isfeedbacknasdaq. Vennligst bekreft ditt valg: Du har valgt å endre standardinnstillingen for Quote Search. Dette vil nå være din standardmålside, med mindre du endrer konfigurasjonen din igjen, eller du sletter informasjonskapslene dine. Er du sikker på at du vil endre innstillingene dine Vi har en tjeneste å spørre Vennligst deaktiver annonseblokkeren din (eller oppdater innstillingene dine for å sikre at javascript og informasjonskapsler er aktivert), slik at vi kan fortsette å gi deg de førsteklasses markedsnyheter og data du har kommet til å forvente fra oss. Kingtone Wirelessinfo Solution Holding Ltd Amerikanske Depositary Shares Quote Sammendrag Data Real-Time Etter Timer Pre-Market News Flash Sitat Sammendrag Sitat Interactive Charts Standard Innstilling Vær oppmerksom på at når du har valgt ditt valg, vil det gjelde for alle fremtidige besøk på NASDAQ. Hvis du, når som helst, er interessert i å gå tilbake til standardinnstillingene, velg Standardinnstilling ovenfor. Hvis du har spørsmål eller støter på problemer ved å endre standardinnstillingene, vennligst send epost til isfeedbacknasdaq. Vennligst bekreft ditt valg: Du har valgt å endre standardinnstillingen for Quote Search. Dette vil nå være din standardmålside, med mindre du endrer konfigurasjonen din igjen, eller du sletter informasjonskapslene dine. Er du sikker på at du vil endre innstillingene dine Vi har en tjeneste å spørre Vennligst deaktiver annonseblokkeren din (eller oppdater innstillingene dine for å sikre at javascript og informasjonskapsler er aktivert), slik at vi kan fortsette å gi deg de førsteklasses markedsnyheter og data du har kommet til å forvente fra oss. Rituximab versus cyklofosfamid i ANCA-assosiert nyreflekkulære sykdommer Bakgrunnsyklofosfamid-induksjonsregimer for antineutrofilt cytoplasmatisk antistoff (ANCA) assosiert vaskulitt er effektive hos 70 til 90 pasienter, men de er forbundet med høye dødsfall og bivirkninger. Behandling med rituximab har ført til remisjonshastigheter på 80 til 90 blant pasienter med ildfast ANCA-assosiert vaskulitt og kan være tryggere enn cyklofosfamidregimer. Vi sammenlignet rituximab med cyklofosfamid som induksjonsbehandling i ANCA-assosiert vaskulitt. Vi ga tilfeldigvis i et 3: 1-forhold 44 pasienter med nylig diagnostisert ANCA-assosiert vaskulitt og nyreinnblanding til et standard glukokortikoid regime, pluss enten rituximab i en dose på 375 mg per kvadratmeter kroppsareal per uke i 4 uker , med to intravenøse cyklofosfamidpulser (33 pasienter, rituximab-gruppen) eller intravenøs cyklofosfamid i 3 til 6 måneder etterfulgt av azathioprin (11 pasienter, kontrollgruppen). Primær endepoeng var vedvarende remisjonshastigheter etter 12 måneder og alvorlige bivirkninger. Medianalderen var 68 år, og den glomerulære filtreringshastigheten (GFR) var 18 ml per minutt pr. 1,73 m 2 kroppsoverflate. Totalt 25 pasienter i rituximab-gruppen (76) og 9 pasienter i kontrollgruppen (82) hadde en vedvarende remisjon (P0.68). Alvorlige bivirkninger forekom hos 14 pasienter i rituximab-gruppen (42) og 4 pasienter i kontrollgruppen (36) (P0.77). Seks av de 33 pasientene i rituximab-gruppen (18) og 2 av de 11 pasientene i kontrollgruppen (18) døde (P1.00). Medianøkningen i GFR mellom 0 og 12 måneder var 19 ml per minutt i rituximab-gruppen og 15 ml per minutt i kontrollgruppen (P0,14). Konklusjoner Et rituximab-basert regime var ikke overlegen standard intravenøs cyklofosfamid for alvorlig ANCA-assosiert vaskulitt. Vedvarende bivirkninger var høy i begge grupper, og rituximab-baserte diett var ikke forbundet med reduksjoner i tidlig alvorlige bivirkninger. (Finansiert av Cambridge University Hospitals National Health Service Foundation Trust og F. HoffmannLa Roche Current Controlled Trials-nummer, ISRCTN28528813.) Medier i denne artikkelen Figur 1 Tilfeldighet og inkludering i analysen ved 12 måneder. I kontrollgruppen døde en andre pasient om 20 måneder. Figur 2 Kumulativ forekomst av remisjon og kumulativ andel av pasienter med alvorlig bivirkning. Panel A viser tiden for remisjon. Remisjonstid var tiden da en Birmingham Vasculitis Aktivitetspoeng på 0 ble registrert først. Data for pasienter som døde ble sensurert ved dødsfallet. Panel B viser tiden til den første alvorlige bivirkningen. Artikkel Aktivitet Antineutrofilt cytoplasmatisk antistoff (ANCA) assosiert vaskulitt, inkludert Wegeners granulomatose og mikroskopisk polyangiitt, ​​er et multisystem autoimmunt syndrom karakterisert ved vaskulitt som hovedsakelig påvirker mikroskopiske kar og sirkulerende autoantistoffer mot neutrofile cytoplasmatiske antigener. Nyrene involverer seg hos 70 av de berørte pasientene, og manifesteres som raskt progressiv glomerulonephritis med pauci-immune nekrotiserende, crescentisk glomerulonephritis på biopsi. Den nåværende standarden for omsorg for ANCA-assosiert vaskulitt er cyklofosfamid med høydose glukokortikoider 1-4 slike regime er effektive hos 70 til 90 pasienter. Imidlertid er cyklofosfamid forbundet med leukopeni, alvorlige infeksjoner, kreft og ovariesvikt. 5 Dødelighet på 1 år overstiger 15 infeksjoner, og aktiv vaskulitt er de overordnede årsakene til tidlig død. Den delvise effekten og alvorlige toksisiteten av slike regime indikerer et behov for bedre induksjonsbehandling i ANCA-assosiert vaskulitt. Rituximab er et B-celledepterende anti-CD20 monoklonalt antistoff som er godkjent av Det europeiske legemiddelkontoret og US Food and Drug Administration for behandling av ikke-Hodgkins lymfom 6 og reumatoid artritt. 7-10 I ANCA-assosiert vaskulitt korrelerer B-celleaktivering og nivåer av B-celleaktiveringsfaktor med sykdomsaktivitet. 11,12 CD20-positive, B-celleriktede, follikkellignende områder som inneholder autoreaktive minne B-celler med affinitet for ANCA-antigenet, proteinase 3, finnes i Wegeners granulomer. 13,14 ANCA er implicert i patogenesen av ANCA-assosiert vaskulitt. Videre undertrykker cyklofosfamid aktivering, proliferasjon og differensiering av autoreaktive B-celler. 16 Disse funnene av en patogen rolle av B-celler og ANCA i ANCA-assosiert vaskulitt gir støtte til bruken av en B-celletilpasset terapi. Vedvarende tilbakemeldinger er rapportert hos 80 til 90 pasienter med ildfast ANCA-assosiert vaskulitt som ble behandlet med rituximab. 17-23 Vi gjennomførte en randomisert studie av rituximab versus cyklofosfamid i ANCA-assosiert vaskulitt (RITUXVAS). Formålet med forsøket var å vurdere behandlingsresponsen og graden av tilknyttede alvorlige bivirkninger ved et rituximabbasert regime sammenlignet med et cyklofosfamidbasert regime som induksjonsterapi hos pasienter med nylig diagnostisert, alvorlig ANCA-assosiert vaskulitt, i Håpet at et rituximab-basert regime kan være mer effektivt og tryggere. En relatert artikkel om Rituximab i ANCA-Associated Vasculitis (RAVE) studie (ClinicalTrials. gov nummer, NCT00104299), som sammenlignet rituximab med standard cytotoksisk terapi for induksjon av fullstendig remisjon med 6 måneder hos pasienter med alvorlig ANCA-assosiert vaskulitt, er rapportert andre steder i dette nummeret av Journal. 24 Studiedesign og pasienter Studien var en åpen, to-gruppe, parallell design, randomisert studie med 44 pasienter fra åtte sentre i Europa og Australia. Alle pasientene ga skriftlig informert samtykke. Inkludering i studien krevde en ny diagnose av ANCA-assosiert vaskulitt, 25,26 ANCA positivitet og nyreintegrasjon, som påvist ved nekrotiserende glomerulonephritis på biopsi eller røde cellekaster eller hematuri (30 røde celler per høykraftfelt) ved urinanalyse . Prøveprotokollen er tilgjengelig med hele teksten til denne artikkelen på NEJM. org og på vasculitis. org. Tilfeldiggjørelse ble utført ved bruk av en dataminimeringsalgoritme for å opprettholde skjuling av studiegruppeoppgaver fra etterforskerne. Denne algoritmen ble stratifisert i henhold til pasientens alder, diagnose og nyrefunksjon i baseline (se detaljer i tilleggsvedlegget tilgjengelig på NEJM. org). Et 3: 1 forhold for tilfeldig oppgave ble brukt i lys av vår omfattende tidligere erfaring med kontrollregime 2 og et større behov for å karakterisere sikkerheten til rituximab. Forsøket ble sponset av Cambridge University Hospitals National Health Service Foundation Trust. F. HoffmannLa Roche ga rituximab og et forskningsbidrag som bidro til prøvekostnadene. Forsøket, som ble designet av første og forrige forfattere og rettsstyringskomitéen, mottok etisk godkjenning fra etikkkomiteen til hvert deltakende senter og ble utført i henhold til EUs kliniske forsøksdirektiv (direktiv 2001 EU20EC), 27 (EudraCT-nummer , 2005-003610-15). Regulatorisk godkjenning ble innhentet fra de nasjonale regulerende myndighetene i hvert land. Dataene ble holdt av etterforskerne på Addenbrookes Hospital. Alle forfatterne bestemte seg for å sende manuskriptet for publisering. Behandlinger Før innskrivning ble pasienter tillatt å gjennomgå plasmautveksling eller til å motta maksimalt 2 g intravenøs metylprednisolon, i henhold til lokal praksis for behandling av alvorlig sykdom. Etter randomisering fikk de to gruppene intravenøs metylprednisolon (i en dose på 1 g) og samme orale glukokortikoidbehandling (1 mg per kilo per dag i utgangspunktet, med en reduksjon til 5 mg per dag ved slutten av 6 måneder). Pasienter i rituximab-gruppen fikk rituximab (MabThera, Roche) i en dose på 375 mg per kvadratmeter per uke i 4 sammenhengende uker, og intravenøst ​​cyklofosfamid i en dose på 15 mg per kilo med den første og tredje rituximab-infusjonen disse pasientene ikke motta azathioprin for å opprettholde remisjon. For pasienter i rituximab-gruppen som hadde progressiv sykdom i løpet av de første 6 månedene, var en tredje dose intravenøs cyklofosfamid (i en dose på 15 mg per kilo) tillatt. Pasienter i kontrollgruppen mottok et validert regime av intravenøst ​​cyklofosfamid i 3 til 6 måneder, etterfulgt av azatioprin (se tilleggsvedlegget). 2,3 Ytterligere behandling med rituximab eller cyklofosfamid ble tillatt i tilfeller av tilbakefall. Relapses som oppstod før minst 6 måneder vedvarende remisjon ble ansett som feil i forhold til primær effekt slutpunkt. Vurderinger Evalueringer ble utført på 0, 1,5, 3, 6, 9 og 12 måneder og på tidspunktet for et tilbakefall (tilleggsvedlegg). Remission ble definert som et fravær av klinisk sykdomsaktivitet, som indikert ved en Birmingham Vasculitis Activity Score (BVAS) 28 av 0 som ble opprettholdt i 2 måneder (scorer fra 0 til 63, med høyere score som indikerer mer aktiv sykdom). Vedvarende remisjon ble definert som et fravær av sykdomsaktivitet (BVAS på 0) i minst 6 måneder. Tilbakeslag ble definert som tilbakefall eller nytt utseende av noen sykdomsaktivitet, som reflektert av BVAS, som skyldtes aktiv vaskulitt (tilleggsvedlegg). Progressiv sykdom ble definert som enten persistensen av hematuri og proteinuri, med fravær av forbedring i glomerulær filtreringshastighet (GFR), 29 eller fortsettelse av en stor nonrenal gjenstand, som angitt av BVAS, ved 6 uker. Resultatene ble bedømt av tre etterforskere og av en uavhengig assessor som ikke var oppmerksom på studiegruppens oppgaver. De primære resultatene var vedvarende remisjon og frekvenser av alvorlige bivirkninger 27 på 12 måneder. Dødsfall og ondartede forhold som oppstod etter 12 måneder ble også registrert. Sekundære effektendepunkter var tid til ettergivelse, endring i BVAS mellom 0 og 3 måneder, endring i GFR, prednisolondosis, score på medisinsk utfallsstudie 36-Item Short Form (SF-36) spørreskjema, 30 og score på Vaskulittskaderindeks (score for dette indeksområdet fra 0 til 64, med høyere score som indikerer mer alvorlig skade) 31 mellom 0 og 12 måneder. Sekundære sikkerhetsendepunkter var alvorlige bivirkninger, infeksjoner og død. Statistisk analyse Vi forventet en vedvarende remisjon på 95 blant pasienter i rituximab-gruppen. 19 Blant pasienter i kontrollgruppen, forventet vi en remisjonsrate på 80 og en vedvarende remisjon på 65 på grunn av tidlige tilbakefall. Vi anslår at med 44 pasienter som gjennomgår randomisering, ville studien ha en statistisk effekt på mer enn 80, på et tosidig alfa nivå på 0,05. Den minste forskjellen i risikoen for at forsøket vår ble registrert var en 33 økning (95 konfidensintervall CI, 4 til 63) i frekvensen av vedvarende remisjon, tilsvarende et risikofaktor på 1,5. Denne forskjellen ble ansett som klinisk viktig. Analyser ble utført på grunnlag av en intensjonsbehandling. Alle analysene inkluderte 44 pasienter. Manglende laboratoriedata (for eksempel GFR) for pasienter som døde, ble beregnet ved bruk av den siste verdien-fremførte metode for å gi et konservativt estimat av effekter. Resultatene uttrykkes som verdier og prosenter for kategoriske variabler og medianer og interkvartile intervall for kontinuerlige variabler (gjennomsnittsverdier er gitt i tilleggsvedlegget). Proportjoner ble sammenlignet med bruken av chi-kvadratprøven. Bivirkninger er uttrykt som forekomst. Tids-til-hendelsesanalyser ble utført ved bruk av log-rank-testen. Analyse av kovarians ble brukt til å vurdere endringen i GFR. 32 P-verdier på mindre enn 0,05 ble vurdert å indikere statistisk signifikans. Alle statistiske tester var tosidige. Alle analyser ble utført ved bruk av Stata-programvare, versjon 10. Mellom juni 2006 og juni 2007 ble totalt 44 pasienter innmeldt i studien (33 i rituximab-gruppen og 11 i kontrollgruppen). Ingen pasienter ble tapt for oppfølging. Seks pasienter i rituximab-gruppen og 1 pasient i kontrollgruppen hadde dødd med 12 måneder (Figur 1 Figur 1 Randomisering og inkludering i analysen ved 12 måneder. I kontrollgruppen døde en andre pasient ved 20 måneder.). En ytterligere pasient i kontrollgruppen døde om 19 måneder. Karakteristikkene til pasientene er vist i Tabell 1 Tabell 1 Demografiske og kliniske egenskaper hos pasientene ved forsøk. Medianalderen ved studietilgang var 68 år. Bruk av plasmautveksling var balansert mellom gruppene (tabell 1). To pasienter i rituximab-gruppen fikk en tredje dose cyklofosfamid: en ble klassifisert som en behandlingssvikt den andre, som hadde et svar på rituximabregimet og mottok den tredje cyklofosfamiddosen i strid med protokollen, ble klassifisert som en vellykket behandling . Primærutbytte Vedvarende remisjon Oppstått avgift oppsto hos 25 av 33 pasienter i rituximab-gruppen (76) og 9 av 11 pasienter i kontrollgruppen (82). Den absolutte forskjellen i vedvarende remisjon med rituximab sammenlignet med cyklofosfamid var 6 prosentpoeng (95 CI, 33 til 21 P0,68). Seks pasienter i rituximab-gruppen og 1 pasient i kontrollgruppen døde innen de første 12 månedene. Blant pasientene som overlevde, hadde 93 av pasientene i rituximab-gruppen og 90 av pasientene i kontrollgruppen vedvarende remisjon (P0.80). I tillegg til de 7 pasientene som døde, hadde 3 pasienter ikke opprettholdt remisjon: 1 pasient i rituximab-gruppen som fikk rituximab-retreatment for ufullstendig remisjon etter 5 måneder (som senere førte til full remisjon) og 2 pasienter, 1 i hver behandling gruppe, som hadde tilbakefall innen 6 måneder etter at remisjon var oppnådd. Blant de 9 pasientene som var avhengig av dialyse ved studietilgang, hadde 6 av de 8 pasientene i rituximab-gruppen opprettholdt remisjon (5 av dem som ikke lenger behøvde dialyse), og 1 pasient i kontrollgruppen døde kort tid etter studietilgang. Median tid til remisjon var 90 dager (interkvartile rekkevidde, 79 til 112) i rituximab-gruppen og 94 dager (interkvartileområde, 91 til 100) i kontrollgruppen (P0.87) (Figur 2A Figur 2 Kumulativ forekomst av remisjon og Kumulativ andel pasienter med alvorlig uønsket hendelse. Panel A viser tidspunktet for remisjon. Remisjonstid var tiden da en Birmingham Vasculitis Aktivitetspoeng på 0 ble registrert først. Data for pasienter som døde ble sensurert ved dødsfallet. B viser tiden til den første alvorlige bivirkningen.). Bivirkninger Totalt 31 alvorlige bivirkninger forekom hos 14 av de 33 pasientene i rituximab-gruppen (42) og 12 alvorlige bivirkninger forekom hos 4 av de 11 pasientene i kontrollgruppen (36) (Tabell 2 Tabell 2 Bivirkninger. ). Incidensrater for alvorlige bivirkninger var 1,00 per pasientår i rituximab-gruppen (95 CI, 0,69 til 1,44) og 1,10 per pasientår i kontrollgruppen (95 CI, 0,61 til 1,99 P0,77) (figur 2B). Totalt 19 infeksjoner oppstod hos 12 av de 33 pasientene i rituximab-gruppen (36), og 7 infeksjoner forekom hos 3 av de 11 pasientene i kontrollgruppen (27) (forekomstfrekvens, 0,66 per pasientår i rituximab-gruppen og 0,60 per pasientår i kontrollgruppen). Antibiotisk profylakse ble brukt hos 22 av de 33 pasientene i rituximab-gruppen (67) og hos 8 av de 11 pasientene i kontrollgruppen (73). Pneumocystis lungebetennelse utviklet seg ikke hos noen av pasientene. Seks av de 33 pasientene i rituximab-gruppen (18) og 2 av de 11 pasientene i kontrollgruppen (18) døde (P1.00). Median tid til døden var 81 dager (område, 22 til 330 i rituximabgruppen og 2 til 601 i kontrollgruppen). Medianalderen ved døden var 76 år (rekkevidde, 63 til 84 i rituximab-gruppen og 76 til 82 i kontrollgruppen), og GFR ved studietilgang hos pasienter som døde var 9 ml per minutt (område, 0 til 29 i rituximab-gruppen og 0 til 9 i kontrollgruppen). Årsakene til døden var infeksjoner (hos 3 pasienter i rituximab-gruppen og hos 1 pasient i kontrollgruppen), kardiovaskulær sykdom (hos 1 pasient i rituximab-gruppen og hos 1 pasient i kontrollgruppen) og komplikasjoner av sluttstadiet Nyresvikt (hos 2 pasienter i rituximab-gruppen). Alvorlige og alvorlige bivirkninger og død var vanlige blant de 9 pasientene som var avhengig av dialyse ved studietilgang: 3 pasienter (33) døde, 6 pasienter (67) hadde minst en alvorlig bivirkning, og 7 pasienter (78) hadde på minst en alvorlig uønsket hendelse. Sekundært utfall Laboratoriedata og sykdomsaktivitet B-celleutarmning (definert som lt210 6 celler per liter) skjedde hos 82 av pasientene i rituximab-gruppen etter 6 uker, og ble opprettholdt hos 75 av pasientene i denne gruppen etter 12 måneder. Til sammen 64 av pasientene i kontrollgruppen hadde også B-celleutarmning på et tidspunkt under studien. Doser av prednisolon ble redusert i begge grupper i henhold til protokoll 96 av pasienter i rituximab-gruppen og 89 av pasientene i kontrollgruppen fikk 5 mg per dag med 9 måneder. På 12 måneder var de medianvektjusterte dosene prednisolon 0,071 mg per kilo per dag (interkvartilintervall, 0,062 til 0,082) i rituximabgruppen og 0,082 mg per kilo per dag (interkvartileområde, 0,071 til 0,093) i kontrollgruppen (P0.78) (Figur 3A Figur 3 Endringer i Prednisolon Dose og Birmingham Vasculitis Aktivitetspoeng (BVAS), ifølge studiegruppe. Panel A viser endringer i de vektjusterte dosene prednisolon, og Panel B viser endringer i BVAS under 12 måneders oppfølging av pasienter i rituximab - og kontrollgruppene. Sirklene angir utjevningsmidler. De horisontale linjene i boksene representerer medianene, de nedre og øvre grensene av boksene representerer 25 og 75 prosentene, og I-barene representerer 5. og 95. prosentiler.). Remisjon (BVAS på 0 i 2 måneder) skjedde hos 30 av de 33 pasientene i rituximab-gruppen (91) og 10 av de 11 pasientene i kontrollgruppen (91). Median BVAS reduserte fra 19 (interkvartile rekkevidde, 14 til 24) ved studietilgang til 0 (interkvartilområde, 0 til 1,5) ved 3 måneder i rituximabgruppen og fra 18 (interkvartilområde, 12 til 25) ved studietilgang til 0 (interkvartilområde, 0 til 0) ved 3 måneder i kontrollgruppen (figur 3B). I rituximab-gruppen økte den mediane estimerte GFR fra 20 ml per minutt per 1,73 m 2 kroppsoverflate (interkvartilområde, 5 til 44) ved studietilgang til 39 ml pr. Minutt pr. 1,73 m 2 (interkvartilområde, 20 til 45) ved 12 måneder. I kontrollgruppen økte den estimerte GFR fra 12 ml per minutt per 1,73 m 2 (interkvartilområde, 9 til 33) ved studietilgang til 27 ml per minutt pr. 1,73 m 2 (interkvartilområde, 12 til 47) ved 12 måneder. (P0.14 for sammenligning av medianer.) Gjennomsnittlig endring i estimert GFR var 5 ml per minutt større i rituximab-gruppen enn i kontrollgruppen (95 CI, 9 til 19 P0,49). Myeloperoksidase og proteinase 3-farging av nyre-biopsiprøver for ANCA-binding viste reduksjoner i begge grupper, med negative resultater hos alle pasienter i rituximab-gruppen og hos 8 av 10 pasienter i kontrollgruppen (80). Ved 12 måneders oppfølging hadde 4 av 27 pasienter i rituximab-gruppen (15) og 1 av 10 pasienter i kontrollgruppen (10) hatt tilbakefall (P0.70). Livskvalitet og sykdomsskader Medianendringen i poengsummen på vasculittskaderindeksen var ikke vesentlig forskjellig mellom de to behandlingsgruppene, poengsummet endret seg med 2 poeng (interkvartilområde, 0 til 3) i rituximabgruppen og med 1 punkt (interkvartil område, 0 til 2) i kontrollgruppen (P0.38). Endringen i poengsummen på den fysiske komponenten til SF-36 varierte heller ikke vesentlig mellom de to gruppene (P0.36). Kontrollgruppen hadde et vesentlig bedre utfall enn rituximabgruppen med hensyn til endringen i poengsummen på den mentale komponenten i SF-36 (P0.04), men denne forskjellen ble regnskapsført av to innflytelsesrike avvikere i rituximab-gruppen. Censurering av data for disse to pasientene eliminert det betydelige resultatet (P0.32). Diskusjon Det er et viktig ufullstendig behov for sikrere og mer effektive behandlinger hos pasienter med ANCA-assosiert vaskulitt, spesielt de som har størst risiko for behandlingstoksisitet og død, som eldre pasienter og personer med alvorlig nedsatt nyrefunksjon. Vi undersøkte effekten og sikkerheten til et rituximab-basert regime sammenlignet med et konvensjonelt cyklofosfamid-regime som remisjon-induksjonsbehandling for ANCA-assosiert nyrevasculitt. Det rituximabbaserte diett var ikke overlegen i forhold til det konvensjonelle syklofosfamidregimet. Begge behandlingsgruppene hadde høye grad av vedvarende remisjon med høye nivåer av alvorlige bivirkninger. Bivirkninger for bivirkninger var ikke overlegen i rituximab-gruppen. I begge grupper hadde mer enn 90 overlevende opprettholdt remisjon. Disse prisene er lik de som er rapportert i tidligere studier. Vår prøveversjon var ublinde. Nyrene involvert var imidlertid den dominerende manifestasjonen av sykdom, og vi brukte objektive målinger (for eksempel kreatininnivåer) for å vurdere nyrefunksjonen. Videre var det ikke noe tegn på bias med hensyn til samtidig behandling, og overholdelse av kortikosteroidreduksjonsprotokollen var god. I tillegg var det uavhengig vurdering av utfall. Bare 2 av 27 overlevende i rituximab-gruppen hadde ikke en vedvarende remisjon. Høydose glukokortikoider og to doser syklofosfamid bidro til de første responsene, men var sannsynligvis ikke tilstrekkelig til å ta hensyn til den vedvarende sykdomskontrollen som ble observert hos de fleste pasienter i rituximab-gruppen. Ukontrollerte studier har vist en effekt på 80 til 90 med rituximabbehandling i ildfast ANCA-assosiert vaskulitt denne frekvensen var vedvarende i 12 måneder i gjennomsnitt. 17-23 I denne studien var de vedvarende responsene hos pasienter i rituximabgruppen sannsynligvis tilskrives en langvarig effekt av tidlig behandling med rituximab. Vi vurderte imidlertid ikke varigheten av remisjon utover 12 måneder eller verdien av gjentatt administrasjon av rituximab for å opprettholde remisjon. Syklofosfamid er en anbefalt komponent av induksjonsterapi for ANCA-assosiert vaskulitt med større organs involvering 1,33, men bruken er komplisert av infeksjoner, kreft og infertilitet. 5,34 For å minimere cyclofosfamid toksisitet, har behandlingsregimer blitt optimalisert ved å bytte til et alternativt legemiddel for remisjon vedlikehold eller ved å bruke pulsadministrasjon reduserer begge tilnærmingene den kumulative eksponeringen for cyklofosfamid. 2,3 Bruken av rituximab gir mulighet til ytterligere å redusere eksponeringen for cyklofosfamid. Rituximab har ikke vært assosiert med en signifikant økning i smittsomme komplikasjoner ved bruk i kombinasjon med metotreksat til behandling av revmatoid artritt 9 eller med kjemoterapi for behandling av ikke-Hodgkins lymfom. 35 Videre resulterer bruken av rituximab, i motsetning til cyklofosfamid, sjelden i dyp leukopeni. I denne forsøket var imidlertid rituximabbasert regime ikke forbundet med lavere frekvenser av tidlig alvorlige bivirkninger enn det cyklofosfamidbaserte diett, og ingen sikkerhetsforskjell ble observert. Eldre alder og lavere GFR er sterke predikanter for død blant pasienter med ANCA-assosiert vaskulitt. 36 Hurtig progressiv glomerulonefrit er vanligst hos eldre pasienter. Tidligere studier har utelukket eldre pasienter. Vår inkludering av eldre pasienter, uten øvre aldersgrense, ga en mer nøyaktig refleksjon av populasjonen av pasienter med alvorlig sykdom. Dødeligheten var den samme i de to behandlingsgruppene og var i overensstemmelse med 18 dødsfall rapportert i en stor kohortstudie som involverte pasienter med ANCA-assosiert nyrevaskulitt, 36 samt dødsratene i andre forsøk som involverte pasienter med ANCA-assosiert nyrevaskulitt. 2-4 I denne forsøket ble 50 av dødsfallene tilskrives infeksjon, og de fleste dødsfall oppstod tidlig i behandlingen (før 3 måneder). Opptil 6 uker fra prøveinngang, fikk de to gruppene de samme glukokortikoid - og cyklofosfamidregimene. To initiale cyklofosfamidpulser ble gitt med rituximabregimet på grunn av inkludering av pasienter med raskt progressiv glomerulonefrit og mangel på erfaring med rituximab som primær terapi i slike pasienter. Dermed kan eventuelle fordeler ved rituximab ses ikke i den første perioden av sykdomsadministrasjon, men i langsiktig oppfølging, med unngått store kumulative doser av cyklofosfamid og vedlikeholdsimmunosuppresjon. Rituximab utøver sin effekt hovedsakelig gjennom B-celleutarmning. En del av cyclophosphamider terapeutisk effekt kan medieres gjennom kontroll av B-celle autoreaktivitet ved hjelp av B-celle suppresjon. 37 B-celledivert ANCA er implicert i patogenesen av vaskulitt, og ANCA negativitet etter induksjonsterapi er assosiert med redusert risiko for tilbakefall. 38 Denne studien gir støtte til en rolle som B-celler i patogenesen av ANCA-assosiert vaskulitt, siden B-celleutarmingen med rituximab var assosiert med en klinisk respons og alle pasienter i rituximab-gruppen ble ANCA-negative med 6 måneder. Graden av ANCA negativitet i denne forsøket var høyere enn det som ble observert med cyklofosfamidregimer i tidligere studier. 2 Forstyrrelsen av andre B-cellefunksjoner, inkludert antigenpresentasjon og T-cellekostimulering, kan imidlertid også bidra til den terapeutiske mekanismen for rituximab. Til slutt fant vi at et rituximabbasert regime ikke var overlegen i forhold til en konvensjonell cyklofosfamidregim når den ble brukt som induksjonsbehandling hos pasienter med ANCA-assosiert nyrevaskulitt. Remissjonsratene var høye med begge regimene. Imidlertid var rituximabregimet ikke forbundet med en reduksjon i tidlig alvorlige bivirkninger, og begge regimene var assosiert med 18 dødelighet. Bruken av rituximab tillater redusert eksponering for cyklofosfamid og unngåelse av vedlikeholdsimmunosuppresjon. Det er behov for større forsøk for å bekrefte funnene våre, og det er viktig å avgjøre om de potensielle fordelene ved rituximab oversetter til forbedringer i effekt og sikkerhet på lang sikt. Støttet av Cambridge University Hospitals National Health Service Foundation Trust, et forskningsstipendium fra F. HoffmannLa Roche, som også ga rituximab for studien, en nyreforskerutdannet kjerneopplæring og nasjonalt opplæringsprogram pris fra canadisk institutt for helseforskning, tilskudd fra Kidney Foundation of Canada og Canadian Society of Nerology, og en klinisk stipendpris fra Alberta Heritage Foundation for medisinsk forskning (alle til Dr. M. Walsh). Dr. Jones rapporterer å motta forelesningsavgifter fra F. HoffmannLa Roche Dr. Jayne, konsulent - og forelesningsavgifter fra F. HoffmannLa Roche Dr. Cohen Tervaert, forelesningsavgifter og bokavgifter fra F. HoffmannLa Roche Dr. Tesar, reisehjelp fra F. HoffmannLa Roche Dr. Luqmani, konsulentkostnader fra Schering-Plough og F. HoffmannLa Roche, og reisesupport fra Wyeth, F. HoffmannLa Roche, Abbott og Dr. Savage, konsulentkostnader fra Biogen Idec og GlaxoSmithKline og en betalt sabbatical ved GlaxoSmithKline etter ferdigstillelse av denne studien. Addenbrookes Hospital har mottatt støttestøtte og forelesningsavgift fra F. HoffmannLa Roche for tjenester levert av Dr. Jayne. Universitetet i Birmingham har mottatt støtte fra Biovitrum og Talecris for tjenester levert av Dr. Savage. Ingen annen potensiell interessekonflikt som er relevant for denne artikkelen ble rapportert. Opplysningsskjema levert av forfatterne er tilgjengelig med fulltekst av denne artikkelen på NEJM. org. Vi takker National Institute for Health Research Cambridge Biomedical Research Center, Dr. Afzal Chaudhry av Addenbrookes Hospital for å utvikle prøvedatabasen, Drs. Annelies Berden og Ingeborg Bajema fra Leids universitets medisinske senter for histologisk gjennomgang av nyrefleksjonssymptomer, alle leger og sykepleiere som bidro til denne forsøket, spesielt Denise Brown fra Nuffield Orthopedic Center, Jo Gray og Wellcome Trust Clinical Research Facility i Birmingham, Frances Skilton fra Royal Adelaide Hospital, Karen Dahlsveen på Addenbrookes Hospital, og de primære og sekundære omsorgspersonene som henviste pasienter til denne forsøket. Kildeinformasjon Fra Vasculitis og Lupus Clinic, Renal Unit, Addenbrookes Hospital, Cambridge (RBJDWMWDRWJ), Institutt for revmatologi, Nuffield Orthopedic Center, Oxford (RL), og Institutt for nyreimmunobiologi, Immunitets - og infeksjonsskolen, College of Medical og Dental Sciences, University of Birmingham, Birmingham (MDMCOS), alle i Storbritannia, Divisjonen for klinisk og eksperimentell immunologi, Institutt for internmedisin, Maastricht University Medical Center, Maastricht, Nederland (JWCTPP) Immunologie-Zentrum Zrich og Universitetssykehus, Zürich, Sveits (TH) Nyrenheten, Royal Adelaide Hospital, Adelaide, Australia (CAP) Nephrologisk institutt i Lund, Universitetssykehuset i Skåne og Lunds Universitet, Lund (MS) og Institutt for nephrologi og transplantasjon i Malm, Universitetssykehuset i Skåne og Lunds Universitet, Malm (KW), både i Sverige og Det første fakultet for medisin, Ch arles universitet, praha, tsjekkia (vt). 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