I-Actemra ibonakala isebenzayo kubantu abadala kunye nabantwana abasempilweni ye-rheumatoid arthritis
I-Actemra (tocilizumab) yintsholongwane ye- monoclonal , eyenziwe nguGenentech (ilungu leqela laseRoche) kunyango lwe- rheumatoid arthritis .
Umsebenzi we-Actemra usebenza njani?
Injongo yokwelapha ye-Actemra kukukhusela iimpendulo ezivuthayo. Yenza oku ngokukhusela i-interleukin-6. U-Actemra uyayinqanda ukufumana i-interleukin-6 receptor, ngaloo ndlela uvimbele i-interleukin-6.
Le yilisiyilisi sokuqala ukwenza oku, okwenza indlela entsha yokwelapha ye-RA. Ukuchongwa njenge- cytokine , i-interleukin-6 yaziwa ngokuba negalelo kwimpendulo yomzimba kunye nokuvuvukala.
Umsebenzi we-Actemra kwiimvavanyo zeZliniki
Iprogram ephuhlisayo yokuphuhliswa kweeklinikhi zezilingo ezi-5 zeSigaba III zenzelwe ukuhlola i-Actemra. Izifundo ezine sele zigqityiwe kwaye zibikwe zidibanisa iziphelo zazo eziphambili (iinjongo). Icandelo lesihlanu, elibizwa ngokuba yi-LITHE (i-Tocilizumab Safety kunye noKhuselo lweZakhiwo eziManyeneyo), luvavanyo lweminyaka emi-2 oluqhubekayo. Idatha yokuqala yonyaka wokuqala kulindeleke ukuba i-LITHE ngo-2008.
Izilingo ezi-5 zeSigaba III ze-Actemra ziyaziwa ngokuthi: I-OPTION (i-Tocilizumab Trial Trial in Methotrexate Abaphenduli abangenelisekile), UKUBHALA (i-Tocilizumab ekudibaniseni neNyango ye-DMARD Treaty), I-RADIATE (uphando nge-Actemra Ukuqulunqwa kobuchule emva kokusilela kwe-Anti-TNF), AMBITION (Actemra ngokuchasene ne-Methotrexate Uvavanyo loPhando oluPhupha kabini kwi-Monotherapy), kunye ne-LITHE.
Actemra kwi-OPTION Study
KUSIFUNDO lwe-OPTION, oluchazwe ngo-Matshi 22, 2008, umcimbi we -Lancet , izigulane ezingama-622 ezinokulinganisela ukuya kwi-arthritis enokusebenza ngokuthe ngcipheko zange-random ukufumana u-8 mg / kg Actemra, 4 mg / kg Actemra, okanye indawo ye-placebo phakathi kweveki ezine. I-Methotrexate yaqhutyelwa kwi-do-pre-study dosages (10-25 mg / iveki).
Iziphumo zophando zibonisa ukuba ngeveki-24, kwakukho izigulane ezininzi ezifumana u-Actemra oye wafikelela kwi-ACR20 kunezo kwi-placebo. Kwabathathi-nxaxheba be-study, 59% yezigulane kwiqela le-8 mg / kg ngokumalunga ne-48% kwiqela le-4 mg / kg ngokumalunga no-26% kwiqela le-placebo liphumelele kwi-ACR20. Iimfuno ze-ACR20 ziquka ukuphuculwa kwe-20% kwinani lamathenda kunye nesibindi; elikhulu kunokuba lilingane nokuphucula u-20% ubuncinane kwi-3 yezi-5 ezilandelayo:
- Uvavanyo lwezonyango zezifo
- Uvavanyo lokunyamezela izifo
- Iprotheyini esebenzayo yeC
- Ubuhlungu
- Umbuzo woPhando lwezeMpilo
Olunye uphando olupapashwe kwi -Lancet ngo-Matshi 22, 2008, luphetha ngokuthi uMthetho we-Actemra uphinde usebenze kubantwana abane -arthritis ye-childhood system
I-Actemra inikezelwa njani?
I-Actemra inikezwa kwangaphakathi (nge-IV). Kwisifundo se-OPTION, sanikwa iiveki ezi-4.
Iimpawu eziPhakathi ezinxulumene ne-Actemra
Ngokwe-drugmaker Roche, "Iprogram ekhuselekileyo yokhuseleko eyenziwa kwizifundo ze-Actemra iqhubekile kwaye i-Actemra ivame ukunyamezela. Iziganeko ezibi kakhulu ezichazwe kwi-Actemra zifundo zonyango jikelele zibandakanya izifo ezinzulu kunye nokuxhomekeka komntu (ukuguquka) okuquka ambalwa amacala anaphylaxis.
Iziganeko eziqhelekileyo eziqhelekileyo ezichazwe kwizifundo zeklinikhi zazikhuselekileyo ukusulela ukuphefumula, i-nasopharyngitis, intloko yesifo, uxinzelelo lwegazi. Ukwandiswa kwezilingo zomsebenzi wesibindi (i-ALT ne-AST) kubonwe kwezinye izigulane. Ezi zinyuka ngokuqhelekileyo zincinci kwaye ziguqulwa, kungabikho ukulimala kwe-hepatic okanye nayiphina impembelelo ekusebenzeni kwesibindi. "
Ziyintoni Ixhalaba Abanye Abagxeki be-Actemra?
Abagxeki bezinye izilingo ze-klinikhi ezibandakanya u-Actemra bakholelwa ukuba akunakwanele kuye kwafundwa ngokuthelekisa u-Actemra kwindawo ye-placebo. Okubalulekileyo, abagxeki bathi kunengqiqo ukucinga ukuba u-Actemra uza kuba ngcono kunanto, kodwa ulwazi olunolwazi luya kufumaneka ngokuthelekisa u-Actemra ukuya kwonyango olulisiweyo.
Ngaba i-Actemra FDA-Iyavunyelwa kwaye iyafumaneka?
NgoNovemba 2007, uRoche wathumela isicelo selayisenisi ye-biologics (BLA) kwi-US Food and Drug Administration (FDA) efuna ukuvunyelwa kuka-Actemra ukunciphisa impawu kunye neempawu kubantu abadala abanomlinganiselo ohambelana nesifo se-rheumatoid arthritis. NgoJulayi 29, 2008, iKomiti yeNgcebiso yeArthritis ye-FDA ivotele i-10-1 ukukhuthaza ukuvunyelwa kuka-Actemra, kodwa i-FDA yacela ulwazi olungakumbi kwiRoche ngaphambi kokuba linike imvume yokugqibela.
NgoJanuwari 8, 2010, i-Actemra ivunyiwe yi-FDA kwizigulane ze-rheumatoid arthritis ezixhasayo kwizifo ezikhutheleyo, eziye zahluleka omnye okanye ezininzi ze-TNF.
Imithombo:
Umphumo we-interleukin-6 receptor inhibition kunye ne -cilizumab kwizigulane ezine-arthritis ye-rheumatoid (ukufundwa kwe-OPTION): i-double blind-blind, i-placebo-elawulwayo. Smolen et al. Lancet. Matshi 22, 2008.
http://www.thelancet.com/journals/lancet/article/PIIS0140673608604535/abstract
Ukusebenza kunye nokukhuselwa kwe-toxiczumab kwizigulane ezine-systemic-up-juvenile idiopathic arthritis: i-random, i-double-blind, i-placebo-elawulwayo, isilingo sesigxina se-III. Yokota et al. Lancet. Matshi 22, 2008.
http://www.thelancet.com/journals/lancet/article/PIIS0140673608604547/abstract
URoche uhambisa isicelo se-FDA Ukuvunyelwa kwe-Actemra yoNyango lwe-Arthritis ye-Rheumatoid. NgoNovemba 21, 2007. I-Roche Media News.
http://www.roche.com/med-cor-2007-11-21