Uvavanyo olutsha olutsha olusandulwayo lwe-MS lokuLawula kwakhona kunye ne-Primary Progressive MS
I-anticlonal antibody Ocrevus (ocrelizumab) ivunyiwe yi-FDA yokuphatha ii- MS eziphambili kunye nokuphindaphinda iintlobo ze-MS. Oku kuqhutywe phambili kwe-MS, njengokuba okwangoku akukho nanye imishanguzo yokuphatha abantu abanezifo eziphambili.
Yintoni i-Ocrevus?
I-Ocrevus (ocrelizumab) yintsholongwane engumntu oyimvelo ebophelela kwi-molecule ebizwa ngokuba yi-CD20, elele phezu kwamaseli e-B (uhlobo lwesistim ye-immune system).
Ngokuzibophelela kwiCD20, inani leeseli ze-B liyancipha kwigazi lomntu.
Ekubeni iiseli ze-B zidlala indima kwi-myelin ukulahleka kunye nokulimala kwi-multiple sclerosis, ukugqithiswa kwezi zisele ze-B ziboniswe ukunciphisa umsebenzi we-MS. Oko kuthethwa, kuba i-Ocrevus iithagethi ze-B kuphela, ezinye iiseli ezisistim somzimba (njengama-T cells) zihlala zizinzile, zinceda ukugcina umzimba womntu.
I-Ocrevus kwiSigaba III seMvavanyo MS
I-Ocrevus yahlolwa kwiimvavanyo ezintathu zesigaba III zokunyanga kokubili ukubuyisela i-MS kunye ne-MS ephambili. Kwizilingo ezimbini, i-Ocrevus yayifaniswa noRebif ngokuphatha abantu ngokubuyisela-MS. Ekubeni okwangoku akukho nonyango evunyiweyo ye-FDA ye-MS ephambili, i-Ocrevus ibinganiswa ne-placebo kweso silingo.
Isikhumbuzo esincinci-ngelixa iimeko zesigaba II zihlola ukhuseleko kunye nenzuzo yesilwayo, izilingo zesigaba III zikhulu kwaye ziqhathanise izilwanyana kumgangatho wonyango.
Ukunyanga Ukubuyiselwa kwe-MS kunye ne-Ocrevus
Kwizilingo ezimbini zesigaba III zabantu ababuyiselwayo kwi-MS, abathathi-nxaxheba abangaphezu kwe-1600 babenomsebenzi wokufumana ukunyuswa kwe-Ocrevus rhoqo emva kweenyanga ezintandathu okanye iRebif (i-interferon beta-1a) kathathu ngeveki kwiiveki ezingama-96 (phantse iminyaka emibini). I-Rebif yintsimbi engaphantsi komzimba, oku kuthetha ukuba kunikwa phantsi kwesikhumba ngesaliti esincinci.
Iziphumo zityhila ukuba izinga lokuphindaphinda ngonyaka lilingama-46 ukuya kuma-47 ekhulwini kumatriki athathe i-Ocrevus kunabathathi-nxaxheba abafumana uRebf. Ukongezelela, ukunyuka kobuthathaka kwabathathi-nxaxheba kwalinganiselwa kwiiveki ezili-12 kunye neeveki ezingama-24 zisebenzisa i- EDSS .
Kuzo zombini izihlandlo zexesha, abathathi-nxaxheba abafumene i-Ocrevus babenenkqubela phambili yokukhubazeka kunabo bafumana iRebif.
Kwakhona, kukho ama-94 ukuya kuma-95 kweepesenti ezingaphantsi kwezilwanyana ezixhasayo kwi-MRI kwiqela le-Ocrevus kuneqela leRebif.
Iziphumo ezimbi kwezi zilingo zimbini zibandakanya:
- Ukuphendula okuxhomekeke kumngcipheko kwiqela le-Ocrevus (kwisithuba esincinane kwisithathu sabathathi-nxaxheba): njengokukhawuleza, ukuxubha, okanye utywala
- Izifo ezithintekayo zenzeke kwi-1.3 ekhulwini labo beqela le-Ocrevus kunye nama-2.9 ekhulwini kwiqela leRebif
- Ukukhula okuqhelekileyo, okubizwa ngokuba ngama-neoplasms) kwenzeke kwi-0.5 ekhulwini yabase-Ocrevus kunye ne-0.2 ekhulwini kwiqela leRebif.
Ukunyangwa kwe-MS-Progressive MS nge-Ocrevus
Kwi-III yesilingo se-Ocrevus kwi -MS ephambili (PPMS), abathathi-nxaxheba abangaphezu kwama-700 bafumana i-Ocrevus okanye i-placebo ukumnika zonke iinyanga ezintandathu kwiiveki ezili-120.
Iziphumo zityhila ukuba kwiiveki ezili-12, kukho ukuncipha kwepesenti ezingama-24 ekuqhubekeni kokukhubazeka kwabaqinisekileyo kubathathi-nxaxheba abafumana i-Ocrevus, ngokuchasene nalabo bafumana i-placebo ukumnika.
Kwiiveki ezingama-24, ukunyuswa kokukhubazeka okuqinisekisiweyo kwancitshiswe kuma-25 ekhulwini kubathathi-nxaxheba abathatha u-Ocrevus.
I-Ocrevus yafunyanwa kwakhona ukunciphisa ixesha elithatha ukuba abathathi-nxaxheba bahambe ngeenyawo ezingama-25 malunga neepesenti ezingama-30 xa kuthelekiswa ne-placebo ukumnika.
Kwiqondo le-MRI, emva kweiveki ezingama-120, bekukho iipesenti ezingama-3,4 ngaphantsi komthamo opheleleyo we-T2-hyperintense zilonda zengqondo kwiqela le-Ocrevus ngokumalunga ne-7.4 pesenti yezilonda ezingaphezulu kwiqela le-placebo.
Ngokwemiphumo emibi, iqela le-Ocrevus linempendulo enxulumene ne-infusion, izifo eziphezulu zokuphefumula, kunye nezifo zomlomo we-herpes . Impendulo ehambelana ne-infusion (efana nokuqhawula, ukubetha, ukuxubha kunye nokuphunga komqala) kwakuqhelekileyo emva kokunyuswa kwamanzi kunye nokuphuculwa ngamanani alandelayo.
Izifo ezithintekayo zenzeke kwi-6.2 yeepesenti yeqela le-Ocrevus kunye ne-5.9 ekhulwini yeqela le-placebo-elifanayo nakwamanye amaqela. Abaphandi bacacisa ngokucacileyo ukuba yintoni intsholongwane enkulu-intsholongwane eyayibhubhisa, isongela ubomi, yayidinga ukukhubazeka, kubangelwe ukukhubazeka, okanye ukufuna ukungenelela kwezonyango (njengama-antibiotitics angamaqhinga) ukukhusela ukufa okanye ukukhubazeka.
Kuyathakazelisa ukuqaphela ukuba kukho iiplastiki ezininzi kwiqela le-Ocrevus (njengomhlaza kunye nesifo somhlaza) kunokuba iqela le-placebo. Akucaci ukuba kutheni le nto yimeko kwaye iqinisekisa ukuba uphando olongezelelweyo.
ILizwi
I-Ocrevus (ocrelizumab) yiphilisi yokuqala evunyiweyo ye-FDA yokuphatha i-MS ephambili ephambili, echaphazela malunga nama-10 ukuya kwe-15 ekhulwini labantu abane-MS, ngoko oku kuvuyisayo kwaye kunethemba. Ngokuqinisekileyo, kuvuyisa kakhulu abo banokubuyiselwa kweentlobo ze-MS, abaninzi abantu baye baqhubeka nokuphuhliswa kwakhona nangona kunyango lwe-MS. I-Ocrevus ngoku ibonelela ngolunye uhlobo.
Oku kuthethwa konke, kubalulekile ukuba ukhumbule ukuba ukhetha unyango olungileyo lwe-MS kuwe yinkqubo enobuntu kunye neyodwa. Ukongezelela, iziphumo zezilingo ezintathu kwi-Ocrevus aziqapheli ukuba uzakuphendula njani amayeza.
> Imithombo:
> Hauser SL et al. I-Ocrelizumab ngokubhekiselele kwi-Interferon Beta-1a ekubuyiseleni i-multiple sclerosis. N Engl J Med . 2016 Dec 21.
> Montalban X et al. I-Ocrelizumab kunye ne-placebo kwi-primary sclerosis. N Engl J Med. 2016 Dec 21.
> I-Sorensen PS, Blinkenberg M. Inxaxheba enomsebenzi we-ocrelizumab kunyango lwe-sclerosis ezininzi: ubungqina obunje kunye nethemba elizayo. I-Adv Adv Neurol Disord . 2016 Jan; 9 (1): 44-52.