Actemra inoratidzika kubudirira kwevakuru uye vechidiki rheumatoid arthritis
Actemra (tocilizumab) inonzi monoclonal antibody , yakagadzirwa naGenentech (nhengo yeboka raRoche) pakurapa rheumatoid arthritis .
Sei Actemra Inoshanda?
Chinangwa chokurapa chaCentemra ndechekudzivirira kupindura kwekupisa. Inoita izvi nekudzivirira interleukin-6. Actemra inhibits the interleukin-6 receptor, nekudzivirira interleukin-6.
Iyi ndiyo mishonga yekuita izvi, zvichiita kuti ive nzira itsva yekurapa yeRA. Yakasarudzwa se cytokine , interleukin-6 inozivikanwa kuti inobatsira mukudzivirira mafungiro uye kupisa.
Actemra Performance mu Clinical Trials
Purogiramu yakakura yekliniki yekukuridzira yemayero mashanu eGlasi III yakagadzirirwa kuongorora Actemra. Zvidzidzo zvina zvakapedzwa uye zvichinzi zvinosangana nemagumo avo ekupedzisira (zvinangwa). Chiyero chechishanu, chinonzi LITHE (Tocilizumab Security uye Prevention of Structural Joint Damage), inotora makore maviri ari kuitika iye zvino. Yokutanga yemakore ekutanga data inotarisirwa kuLITHE muna 2008.
Dambudziko reChitatu III reCamemra rinozivikanwa sekuti: KUNYANYA (Tocilizumab Pivotal Trial mu Methotrexate Vasingakwanisi Vagadziri), TOWARD (Tocilizumab Mukusanganiswa neMadzitateguru eDMARD Therapy), RADIATE (Tsvakurudzo pamusoro peChitemra Kugadzirisa Efficacy mushure mekusagadzikana kweTan-TNF), AMBITION (Actemra kupikisa Methotrexate Double-Blind Investigative Trial In Monotherapy), uye LITHE.
Actemra mune OPTION Study
Muchiitiko cheUCHIDZIDZWA, chakataurwa mumusi waMarch 22, 2008, weLancet , 622 varwere vane muongorori kuti varatidze zvakanyanya rheumatoid arthritis vakashandurwa kuti vagamuchire 8 mg / kg Actemra, 4 mg / kg Actemra, kana placebo mukati mavhiki mana. Methotrexate yakaramba ichiendeswa mberi kwekudzidza zvidzidzo (10-25 mg / vhiki).
Zvidzidzo zvekudzidza zvakaratidza kuti pavhiki 24, pakanga pane vamwe varwere vachiwana Actemra avo vakawana ACR20 kupfuura avo vari panzvimbobo. Pakati pevatori vechidzidzo, 59% yevarwere mu 8 mg / kg boka vs. 48% muboka 4 mg / kg vs. 26% muboka re placebo rakawana ACR20. Zvirongwa zve ACR20 zvinosanganisira kuwedzera kwe20% mune dzimwe nhengo dzetete uye dzakaputika; yakakura kudarika kana yakaenzana nekugadziriswa kwe20% mune zvinenge zvitatu zve 5 zvinotevera:
- Chiremba anoongorora chirwere
- Mwoyo murefu wezvirwere
- C-reactive protein
- Pain
- Kuongorora Kuongorora Utano
Chimwe chidzidzo chakabudiswa muThe Lancet musi waMarch 22, 2008, chakagumisa kuti Actemra inoshandawo kune vana vane chirongwa chevana chirwere cheArthritis - chirwere chinowanzooma kubata.
Sei Actemra Inopiwa?
Actemra inopiwa intravenously (kuburikidza ne IV). Muchiitiko cheUCHOKWADI, chakapiwa mavhiki mana.
Migumisiro Yechikamu Yakavhiringidzwa na Actemra
Maererano nemudzvinyiriri weRechmaker Roche, "Zvose zvakachengetedzwa zvekuchengetedzwa kwakaonekwa mune zvidzidzo zvepasi rose zveMitemra hazvigadziriki uye Actemra inowanzochengetedzwa zvakanaka. Zviitiko zvakakomba zvakashata zvakataurwa muCentemra zvidzidzo zvekliniki pasi rose zvinosanganisira zvirwere zvakakomba uye hypersensitivity (allergic) zvinosanganisira mashoma mashoma anaphylaxis.
Zviitiko zvinowanzovhiringidza zvakanyanya zvinotaurwa mumakiriniki epurogiramu zvakanga zviri kumusoro kuputika kwetachiona zvirwere, nasopharyngitis, musoro wemusoro, hypertension. Kuwedzera kwechiropa chekuita mabasa (ALT neAST) kwakaonekwa kune vamwe varwere. Iko kuwedzerwa kwaive kazhinji kwakanyorova uye kuchinjwa, pasina kukuvadzwa kwehupenzi kana chimwe chezvinhu zvakaonekwa pachiropa chinoshanda. "
Chii Chinoshungurudza Vamwe Vatsoropodzi veCentemra?
Vatsoropodzi vevamwe makiriniki ekuedzwa anosanganisira Actemra vasingatendi zvakakwana zvakadzidziswa nekuenzanisa Actemra ne placebo. Chaizvoizvo, vatsoropodzi vakati zvine musoro kufunga kuti Actemra angave ari nani kupfuura chinhu, asi ruzivo rwakanyanya ruzivo rwunogona kuwanikwa kuburikidza nekuenzanisa Actemra nekugadzirwa kwemishonga.
Is Actemra FDA-Yakagamuchirwa uye Inowanikwa Here?
MunaNovember 2007, Roche akatumira biologics license application (BLA) kuU.S. Food and Drug Administration (FDA) achida kubvumirwa kuti Actemra kuderedze zviratidzo nezviratidzo kune vanhu vakuru vane muongorori wekurwisa rheumatoid arthritis. Musi waJuly 29, 2008, Arthritis Advisory Komiti yeDFA yakasarudza 10-1 kuti ikurudzire kubvumirwa kwe Actemra, asi FDA yakakumbira mamwe mashoko kubva kuRoche isati yapa chibvumirano chekupedzisira.
Musi waJanuary 8, 2010, Actemra yakagamuchirwa neRDA yevanhu vakuru vepachirwere vemahara arthritis vane chirwere chenguva yakaoma kurwara zvakanyanya, avo vakakundikana imwe kana kuti akawanda TNF blockers.
Sources:
Migumisiro ye interleukin-6 receptor inhibition ine tocilizumab kune varwere vane rheumatoid arthritis (OPTION study): aviri-blind, placebo-controlled, test randomized. Smolen et al. The Lancet. March 22, 2008.
http://www.thelancet.com/journals/lancet/article/PIIS0140673608604535/abstract
Kubudirira uye kuchengeteka kweturirizumab kune varwere vane systemic-inotanga vana vechidiki idiopathic arthritis: randomized, double-blind, placebo-controlled, withdrawal phase III muedzo. Yokota et al. The Lancet. March 22, 2008.
http://www.thelancet.com/journals/lancet/article/PIIS0140673608604547/abstract
Roche Inotumira Chibvumirano cheDefA Chibvumirano cheMutemo weMutemo weChirongwa cheRheumatoid Arthritis. November 21, 2007. Roche Media News.
http://www.roche.com/med-cor-2007-11-21