Actemra ikuwoneka yothandiza kwa akuluakulu ndi ana a nyamakazi ya nyamakazi
Actemra (tocilizumab) ndi anti-monoclonal antibody , yotengedwa ndi Genentech (membala wa gulu la Roche) kuti athetse matenda a nyamakazi .
Kodi Actemra Amagwira Ntchito Motani?
Cholinga cha chithandizo cha Actemra ndicho kupeŵa mayankho opweteka. Zimatero poletsa interleukin-6. Actemra kwenikweni imaletsa interleukin-6 receptor, motero imaletsa interleukin-6.
Ichi ndi mankhwala oyambirira kuchita izi, kupanga njira yatsopano yothandizira RA. Kutchuka monga cytokine , interleukin-6 imadziwika kuti imathandiza kwambiri pa mayankho okhudzana ndi kuteteza thupi komanso kutentha.
Zochita za Actemra mu Zilinga Zoyamwitsa
Pulogalamu yaikulu ya chitukuko cha zachipatala ya mayesero asanu a Gawo III anagwiritsidwa ntchito kuti ayeseko Actemra. Maphunziro anayi adatsirizidwa ndipo atsimikizika kukwaniritsa mapeto awo (zolinga). Mlandu wachisanu, wotchedwa LITHE (Tocilizumab Security ndi Prevention of Structural Joint Damage), ndi zaka 2 zomwe zikuyesedwa. Deta yoyamba yoyamba ikuyembekezeredwa ku LITHE mu 2008.
Mayesero 5 a Gawo III a Actemra amadziwika kuti: OPTION (Tocilizumab Trialal Trial in Methotrexate Osafuna Kuyankha), TOWARD (Tocilizumab mu Mgwirizano ndi DMARD Therapy), KUKHALA ZOKHUDZA (Kafukufuku pa Actemra Potsimikiza Kuchita Zotsatira za Kulephera kwa TNF Kulephera), AMBITION (Actemra kutsutsana ndi Mayankho Ofufuza Opunduka Awiri Omwe Amapezeka mu Monotherapy), ndi LITHE.
Actemra mu Phunziro la OPTION
Mu phunziro la OPTION, lipoti la March 22, 2008, la Lancet , odwala 622 omwe anali ndi nyamakazi yambiri yapamwamba kuti ayambe kugwiritsidwa ntchito mwakayakaya kuti athe kulandira 8 mg / kg Actemra, 4 mg / kg Actemra, kapena placebo mkati mwa masabata onse 4. Methotrexate inapitilizidwa pa mayesero oyamba omwe amaphunzira (10-25 mg / sabata).
Zotsatira za Phunziro zasonyeza kuti pamlungu 24, panali odwala ochulukirapo omwe amalandira Actemra omwe anafika ku ACR20 kusiyana ndi omwe ali pa placebo. Pa ophunzirawo, 59% odwala pa gulu la 8 mg / kg motsutsana ndi 48% pa gulu la 4 mg / kg poyerekeza ndi 26% mu gulu la placebo lapeza ACR20. Zolinga za ACR20 zimaphatikizapo kukonzanso kwa 20% mu ziwalo zingapo zosautsa ndi zotupa; wamkulu kuposa kapena wofanana ndi 20% kusintha kwa osachepera 3 mwa zisanu zotsatirazi:
- Dokotala wofufuza za matenda
- Kuleza mtima kwa matenda
- Puloteni wothandizira
- Ululu
- Lipoti la Kuyeza Zaumoyo
Kafukufuku wina wofalitsidwa ku The Lancet pa March 22, 2008, anapeza kuti Actemra imathandizanso ana omwe ali ndi matenda a nyamakazi - omwe nthawi zambiri amavutika.
Kodi Actemra Wapatsidwa Motani?
Actemra imaperekedwa mwachangu (kupyolera mu IV). Mu phunziro la OPTION, lapatsidwa milungu iwiri iliyonse.
Zotsatira Zotsatira Zomwe Zili ndi Actemra
Malinga ndi wolemba mankhwala osokoneza bongo dzina lake Roche, "Chidziwitso chonse chachitetezo chomwe chikupezeka pa kafukufuku padziko lonse wa Actemra n'chogwirizana ndipo Actemra nthawi zambiri imalekerera. Zochitika zovuta kwambiri zomwe zachitika mu Actemra zofufuza zachipatala zikuphatikizapo matenda akuluakulu ndi machitidwe a hypersensitivity (allergic) anaphylaxis.
Zochitika zovuta kwambiri zomwe zimachitika m'maphunziro azachipatala zinali zapamwamba zowonjezera matenda, nasopharyngitis, mutu, matenda oopsa. Kuwonjezeka kwa chiwindi cha ntchito ya chiwindi (ALT ndi AST) kunawoneka mwa odwala ena. Kuwonjezeka kumeneku kunali kawirikawiri komanso kochepetsedwa, popanda kuvulala kapena kupweteka kwa chiwindi. "
Kodi N'chiyani Chimawadetsa nkhaŵa Anthu Ena Otsutsa a Actemra?
Otsutsa ena mwa mayesero a zachipatala omwe amachititsa Actemra amakhulupirira kuti ndi ochepa adaphunzira poyerekezera Actemra ndi placebo. Zoonadi, otsutsawo akuti ndizomveka kuganiza kuti Actemra angakhale bwino kuposa china chilichonse, koma zowonjezereka zitha kupindula poyerekeza Actemra ndi mankhwala ochiritsidwa.
Kodi Actemra FDA-Yavomerezedwa Ndipo Ipezeka?
Mu November 2007, Roche analembera biologics license application (BLA) ku US Food and Drug Administration (FDA) pofuna kuyanjidwa kwa Actemra kuchepetsa zizindikiro ndi zizindikiro kwa akuluakulu omwe ali ndi nyamakazi yovuta kwambiri. Pa July 29, 2008, Komiti Yowonongeka ya Arthritis ya FDA inavomereza 10-1 kuti ipereke chilolezo cha Actemra, koma FDA inapempha zambiri kuchokera ku Roche musanapereke chivomerezo chomaliza.
Pa January 8, 2010, Actemra inavomerezedwa ndi FDA kwa odwala akuluakulu a nyamakazi odwala nyamakazi odwala matenda oopsa kwambiri, omwe alephera imodzi kapena angapo a TNF.
Zotsatira:
Zotsatira za kupopera pakati pa interleukin-6 ndi tocilizumab odwala omwe ali ndi matenda a nyamakazi (OPTION study): mayesero awiri omwe amachititsa kuti awonongeke. Smolen et al. Lancet. March 22, 2008.
http://www.thelancet.com/journals/lancet/article/PIIS0140673608604535/bambo
Kuchita bwino ndi chitetezo cha tocilizumab kwa odwala omwe ali ndi vuto la mwana wodwala matenda odwala matendawa: njira yowonongeka, yosaoneka bwino, yowonongeka, yomwe imachotsedwa. Yokota et al. Lancet. March 22, 2008.
http://www.thelancet.com/journals/lancet/article/PIIS0140673608604547/bambo
Roche Amapereka Chilolezo cha FDA Chivomerezo cha Actemra cha Chithandizo cha Matenda a Nyamakazi. November 21, 2007. Roche Media News.
http://www.roche.com/med-cor-2007-11-21