Njira yatsopano yovomerezeka ya MS yokonzanso ndi MS yopambana
Ocrevus antioclonal (ocrelizumab) ndi FDA -vomerezedwa kuti athetse MS komanso njira zowonjezera za MS. Izi ndizochitika zazikulu za MS, popeza pakalipano palibe mankhwala ena ochiza anthu omwe ali ndi matenda opambana.
Kodi Ocrevus Ndi Chiyani?
Ocrevus (ocrelizumab) ndi wodwala wotchedwa monoclonal antibody amene amamanga molekyu yotchedwa CD20, yomwe ili pamwamba pa maselo a B (mtundu wa chitetezo cha chitetezo cha mthupi).
Mwa kumangiriza ku CD20, chiwerengero cha maselo a B chimachepa m'magazi a munthu.
Popeza maselo a B amachititsa kuti myelin iwonongeke komanso kuwonongeka kwa multiple sclerosis, kuwononga maselo ena a B akuwonetsetsa kuchepetsa matenda a MS. Izi zikunenedwa, chifukwa Ocrevus amalowetsa maselo a B, maselo ena omwe ali m'kati mwa chitetezo cha mthupi (ngati maselo T) amakhalabe olimba, kuthandiza kuti chitetezo cha munthu chitetezeke.
Ocrevus mu Mayesero a Phase III MS
Ocrevus anafufuzidwa mu mayesero atatu omwe anagwiritsidwa ntchito pochiza onse awiri kachiwiri ndi MS komanso chipambano cha MS. Mu mayesero awiri, Ocrevus amafanizidwa ndi Rebif chifukwa chochiza anthu ndi MS kubwezeretsanso. Popeza pakalipano palibe mankhwala ovomerezedwa ndi FDA kwa MS apamwamba, Ocrevus amafanizidwa ndi placebo mu mayesero.
Kukumbutsa pang'ono - pamene mayesero a Gawo II akuyang'ana chitetezo ndi phindu la mankhwala, gawo lachitatu lazitsulo ndi lalikulu ndipo limayerekezera mankhwala ndi mlingo wa chisamaliro cha mankhwala.
Kuchiza Kubwezeretsa MS Ndi Ocrevus
Pakati pa mayesero awiri a anthu omwe ali ndi kachilombo ka HIV, anthu oposa 1600 analandira mpata wokwanira kuti amulandire kupatsirana kwa Ocrevus miyezi isanu ndi umodzi kapena Rebif (interferon beta-1a) katatu mlungu uliwonse kwa milungu 96 (pafupifupi zaka ziwiri). Rebif ndi jekeseni yapansi, kutanthauza kuti imaperekedwa pansi pa khungu ndi singano yopyapyala.
Zotsatira zawonetsa kuti chaka chilichonse anthu ambiri omwe adalandira ocrevus anali 46 mpaka 47 peresenti kusiyana ndi omwe adalandira Rebif. Kuonjezera apo, kupita patsogolo kwa kulemala kwa ophunzirawo kunayesedwa pa masabata khumi ndi awiri ndi makumi awiri ndi awiri pogwiritsa ntchito EDSS .
Mu mafelemu onse awiri, omwe adalandira Ocrevus anali ndi zocheperapo zochepa kusiyana ndi omwe adalandira Rebif.
Komanso, panali 94 mpaka 95 peresenti zochepa zowonjezera gadolinium- enhaning lesions pa MRI mu gulu la Ocrevus kuposa gulu la Rebif.
Zotsatira zovuta m'mayesero awiriwa ndi awa:
- Zomwe zimakhudzana ndi kulowetsedwa mu gulu la Ocrevus (mu gawo limodzi mwa magawo atatu mwa ophunzirawo): monga kutukumuka, kuthamanga, kapena chitsulo
- Matenda akuluakulu anachitika mu 1.3 peresenti ya anthu omwe ali mu gulu la Ocrevus ndi 2,9 peresenti mu gulu la Rebif
- Zatsopano, zosaoneka bwino (zotchedwa neoplasms) zinachitika mu 0,5 peresenti ya omwe ali gulu la Ocrevus ndi 0.2 peresenti mu gulu la Rebif.
Kuchiza MS Wopambana Pakati pa Ocrevus
Mu gawo lachitatu la mayesero a Ocrevus mu MS (PPMS) oyambirira, anthu oposa 700 analandira Ocrevus kapena kulowetsedwa kwa placebo miyezi 6 iliyonse kwa masabata makumi awiri ndi awiri.
Zotsatira zinasonyeza kuti pamasabata khumi ndi awiri (24), kuchepa kwa 24% kunatsimikiziridwa kuti anthu omwe ali ndi vuto lolemala ndi omwe adalandira Ocrevus, mosiyana ndi omwe adalandira kulowetsedwa kwa placebo.
Pakadutsa milungu makumi awiri ndi awiri (24), kupititsa patsogolo kwaumphawi kunachepetsedwa 25 peresenti mwa ophunzira omwe anatenga Ocrevus.
Ocrevus inapezedwanso kuchepetsa nthawi yomwe amafunika kuti ophunzira aziyenda mamita 25 ndi pafupifupi 30 peresenti poyerekeza ndi kulowetsedwa kwa placebo.
Pa ubongo wa MRI, patadutsa masabata makumi awiri ndi awiri, peresenti ya 3.4 peresenti yocheperapo ya T2-hyperintense zilonda za ubongo mu gulu la Ocrevus motsutsana ndi 7.4 peresenti yambiri m'magulu a placebo.
Malingana ndi zotsatira zovuta, gulu la Ocrevus linali ndi zochitika zambiri zokhudzana ndi kulowetsedwa, matenda opatsirana opuma, komanso matendawo a herpes . Zomwe zimakhudzana ndi kulowetsedwa (monga kuthamanga, kuyabwa, kuthamanga, ndi kupweteka kwa khosi) zinali zowonjezereka pokhapokha kutsekedwa koyamba ndikukwera bwino ndi mayendedwe otsatira.
Matenda akuluakulu anachitika pa 6.2 peresenti ya gulu la Ocrevus ndipo 5,9 peresenti ya gulu la placebo-chimodzimodzi m'magulu awiriwa. Ofufuzawo anafotokoza mosamala kuti matenda aakulu anali-matenda omwe anali opha, owopsyeza moyo, amafunika kuwatsekera kuchipatala, amachititsa olemala, kapena amafuna thandizo lachipatala (monga mankhwala opha tizilombo) kuti ateteze imfa kapena kulemala.
Ndizosangalatsa kuzindikira kuti panali mazenera ambiri mu gulu la Ocrevus (monga khansa ya m'mawere ndi khungu) kusiyana ndi gulu la placebo. Sindikudziwa chifukwa chake izi ndizochititsa kuti kufufuzidweko kuchitike.
Mawu Ochokera
Ocrevus (ocrelizumab) ndi mankhwala oyamba omwe amavomerezedwa ndi FDA kuti athetse MS patsogolo, yomwe imakhudza pafupifupi 10 mpaka 15 peresenti ya anthu omwe ali ndi MS, kotero izi ndi zosangalatsa kwambiri. Inde, ndi zosangalatsa kwa iwo omwe ali ndi mitundu yatsopano ya MS, anthu ambiri apitilizabe kukhalanso ochira ngakhale kuti tsopano akuchiritsidwa ndi MS. Ocrevus tsopano akuwapatsa mwayi wina.
Zonsezi zikunenedwa, ndizofunika kukumbukira kuti kusankha chithandizo chabwino cha MS kwa inu ndi ndondomeko yosasinthasintha ndi yaumwini. Kuonjezera apo, zotsatira za mayesero atatu pa Ocrevus sizikuneneratu momwe mungayankhire mankhwala.
> Zotsatira:
> Hauser SL ndi al. Ocrelizumab motsutsana ndi Interferon Beta-1a pobwezeretsanso multiple sclerosis. N Engl J Med . 2016 Dec 21.
> Montalban X ndi al. Ocrelizumab motsutsana ndi placebo mu pulasitiki yopita patsogolo yambiri. N Engl J Med. 2016 Dec 21.
> Sorensen PS, Blinkenberg M. Cholinga cha ocrelizumab pochiza matenda osiyanasiyana: umboni weniweni komanso tsogolo labwino. Adv Adv Neurol Disord . 2016 Jan; 9 (1): 44-52.