I-Actemra ibonakala iphumelela kumuntu omdala kanye nesifo samathambo esifubeni
I-Actemra (tocilizumab) i -antibody monoclonal , eyakhiwe nguGenentech (ilungu leqembu le-Roche) yokwelashwa kwesifo samathambo .
Usebenza kanjani i-Actemra?
Umgomo wokwelapha we-Actemra ukuvimbela izimpendulo zokuvuvukala. Lokhu kwenza ngokuvimbela i-interleukin-6. I-Actemra empeleni ivimbela i-interleukin-6 receptor, ngaleyo ndlela ivimbele i-interleukin-6.
Lesi yisidakamizwa sokuqala ukwenza lokhu, okwenza kube indlela entsha yokwelapha ye-RA. I-Classifieds njenge- cytokine , i-interleukin-6 iyaziwa ukuthi idlala indima emaphendulweni omzimba nokuvuvukala.
Ukusebenza kwe-Actemra kuZilingo Zomtholampilo
Uhlelo olubanzi lwezokuthuthukiswa kwemitholampilo lwezinyathelo ezi-5 zeSigaba III lwenzelwe ukuhlola i-Actemra. Ucwaningo lwesine seluqedile futhi lubikwe ukuhlangabezana nemiphelo yabo yokugcina (imigomo). Isivivinyo sesihlanu, okuthiwa i-LITHE (Tocilizumab Safety kanye nokuvimbela ukulimala okuhlangene kwezakhiwo), kuyilingo lezinyanga ezimbili oluqhubekayo. Idatha yokuqala yonyaka wokuqala kulindeleke ku-LITHE ngo-2008.
Izivivinyo ze-Phase III ze-Actemra ziyaziwa ngokuthi: I-OPTION (Tocilizumab Trial Trial in Methotrexate Abaphenduli Abangenele), TOWARD (Tocilizumab ekuhlanganiseni ne-Traditional DMARD Therapy), I-RADIATE (Ucwaningo ngo-Actemra Ukuqaphela Ukusebenza Ngemva kokuhluleka Kwe-Anti-TNF), AMBITION (Actemra ngokuhambisana ne-Methotrexate Trial Investigative Investigative In Monotherapy), ne-LITHE.
I-Actemra eSifundweni se-OPTION
Esifundweni se-OPTION, kubikwa ngo-March 22, 2008, umagazini we -Lancet , iziguli ezingu-622 ezinomqondo ohambelana nesifo samathambo e-rheumatoid ezikhuthele kakhulu zazingenakulinganiswa ukuthola i-8 mg / kg Actemra, 4 mg / kg Actemra, noma i-placebo phakathi kwamasonto amane. I-Methotrexate yaqhutshwa emasithweni angaphambi kokufunda (10-25 mg / ngesonto).
Imiphumela yokufundwa ibonise ukuthi ngeviki 24, kuneziguli eziningi ezithola i-Actemra eyafinyelela ku-ACR20 kunelase-placebo. Kulabo abathintekayo, iziguli ezingu-59% eziqenjini lika-8 mg / kg ngokumelene no-48% eqenjini le-4 mg / kg ngokumelene no-26% eqenjini le-placebo lithole i-ACR20. Imigomo ye-ACR20 ifaka ukuthuthukiswa kwezingu-20% eziningana zamathenda nesibindi; ngaphezulu noma okulingana nokuthuthukiswa okungu-20% okungenani oku-3 kwezingu-5 ezilandelayo:
- Ukuhlolwa kwezifo zesifo
- Ukuhlolwa kwesineke kwezifo
- Iprotheyini esebenzayo e-C
- Ubuhlungu
- Umbuzo Wokuhlola Ezempilo
Esinye isifundo esanyatheliswa kuyi -Lancet ngo-March 22, 2008, saphetha ngokuthi i-Actemra iphinde iphumelele kubantwana abane- arthritis yezingane ezihlelekile -isimo esivame ukuluphatha.
I-Actemra inikezwa kanjani?
I-Actemra inikezwa ngaphakathi (ngokusebenzisa i-IV). Esifundweni se-OPTION, sinikezwe njalo emavikini angu-4.
Imiphumela emibi ehlanganiswe ne-Actemra
Ngokusho komuthi wezidakamizwa uRoche, "Iphrofayli jikelele yokuphepha elandelwa kwizifundo zomhlaba jikelele ka-Actemra iyavumelana futhi i-Actemra ivame ukubekezelelana kahle. Izenzakalo ezimbi kakhulu ezibikwe ku-Actemra izifundo zomtholampilo zomhlaba zihlanganisa ukutheleleka okungathí sina nokuziphendulela kwe-hyperensitivity (i-allergenic) kuhlanganise namacala ambalwa i-anaphylaxis.
Izenzakalo ezivame kakhulu ezibikiwe ezifundweni zemitholampilo zaziphethwe ukutheleleka okuphezulu kokuphefumula, i-nasopharyngitis, ikhanda lokushisa, umfutho wegazi ophakeme. Ukwanda kwezivivinyo zokusebenza kwesibindi (ALT ne-AST) kubonakala kwezinye iziguli. Lokhu kwanda kwakunobumnene futhi kubuyiselwa emuva, kungekho ukulimala kwe-hepatic noma yimuphi umthelela owenziwe esibindi. "
Yini Okukhathazayo Abanye Abahlaziyi be-Actemra?
Abahlaziyi bezinye izivivinyo zemitholampilo ezibandakanya u-Actemra bakholwa ukuthi akwanele kuye kwafundwa ngokuqhathanisa Actemra ne placebo. Ngokuyinhloko, abagxeki bathi kunengqondo ukuthatha u-Actemra kungaba ngcono kunanoma yini, kodwa ulwazi oluwusizo luzozuzwa ngokuqhathanisa no-Actemra ekwenzeni imithi yokwelapha.
Ingabe i-Actemra FDA-Iyavunywa futhi iyatholakala?
NgoNovemba 2007, uRoche uthumele isicelo selayisensi ye-biologics (BLA) e-US Food and Drug Administration (FDA) efuna imvume yokuba u-Actemra anciphise izimpawu nezimpawu kubantu abadala abanomqondo olinganiselwe wokuthola isifo samathambo esibi kakhulu. Ngomhla ka-29 Julayi 2008, iKomidi Leziphakamiso ze-Arthritis ye-FDA livotele u-10-1 ukuphakamisa ukuvunyelwa kuka-Actemra, kodwa i-FDA yacela ulwazi oluthe xaxa kusuka eRoche ngaphambi kokuba lunikeze imvume yokugcina.
NgoJanuwari 8, 2010, i-Actemra yamukelwa yi-FDA kubantu abadala abanesifo samathambo e-rheumatoid ehambisana nesifo esibi kakhulu, abaye bahluleka ukuvimbela eyodwa noma ngaphezulu kwe-TNF.
Imithombo:
Imiphumela ye-interleukin-6 receptor inhibition ne-tocilizumab ezigulini ezine-arthritis ye-rheumatoid (Ucwaningo lwe-OPTION): isilingo esilawuliwe ngokuphindaphindiwe, esibekwe ngu-placebo. USolen et al. I-Lancet. Ngo-Mashi 22, 2008.
http://www.thelancet.com/journals/lancet/article/PIIS0140673608604535/abstract
Ukusebenza nokuphepha kwe-tocilizumab ezigulini ezine-arthritis e-systemic-initiation: i-trialbo-controlled-blind, i-doublebo blind, i-placebo-elawulwa yi-phase of withdrawal III. Yokota et al. I-Lancet. Ngo-Mashi 22, 2008.
http://www.thelancet.com/journals/lancet/article/PIIS0140673608604547/abstract
I-Roche ihambisa isicelo se-FDA Ukuvunyelwa kwe-Actemra ye-Treatment of Rheumatoid Arthritis. Novemba 21, 2007. I-Roche Media News.
http://www.roche.com/med-cor-2007-11-21