I-MS Ukwelashwa Okusha Kwamanje Okuvunyelwe Ukubuyiselwa Kwe-MS kanye ne-Primary-Progressive MS
I-antioclonal anti-ocrevus (ocrelizumab) i-FDA-evunyelwe ukwelapha ama- MS amabili okuqhubekayo okuphambili nokuphindaphinda izinhlobo ze-MS. Lokhu kuphumelela okukhulu kwe-MS, njengoba okwamanje akukho minye imithi yokwelapha abantu abanezifo eziphambili eziqhubekayo.
Kuyini i-Ocrevus?
I-Ocrevus (ocrelizumab) isilwane esiphikisayo se-monoclonal esinobuciko esivumelana nomuntu obizwa nge-CD20, esezulwini kwamaseli B (uhlobo lomzimba wesistimu omzimba).
Ngokubophezela ku-CD20, inani lamaseli e-B liyancipha emzimbeni wegazi lomuntu.
Njengoba amangqamuzana e-B enza indima ekulahlekelweni kwe-myelin kanye nokulimala kwe-multiple sclerosis, okuvezwa ukuthi lawa maseli B athile aboniswe ukunciphisa umsebenzi we-MS wesifo. Lokhu kuthiwa, ngoba i-Ocrevus kuphela amathekithi e-target B, amanye amaseli angaphansi kwesimiso somzimba sokuzivikela (njengama-T cells) ahlala engaqinile, asize ukugcina umzimba womzimba.
Ama-Ocrevus ku-Phase III Trials MS
I-Ocrevus ihlolwe ngezivivinyo ezintathu zesigaba III sokuphatha kokubili ukubuyisela kabusha i-MS kanye ne-MS eyinhloko eqhubekayo. Ezilingo ezimbili, i-Ocrevus yayiqhathaniswa noRebif ngokuphatha abantu nge-MS ebuyela kabusha. Njengoba okwamanje ayikho imithi evunyelwe i-FDA ye-primary-progress MS, i-Ocrevus iqhathaniswa ne-placebo kulolu cwaningo.
Isikhumbuzo esincane-ngenkathi isigaba sesibili sesivivinyo sihlola ukuphepha nokuzuza kwezidakamizwa, izivivinyo zesigaba III zikhulu futhi ziqhathanise nezidakamizwa kuze kube sezingeni lokunakekelwa kwezidakamizwa.
Ukwelapha Ukuphinda Ubuyele MS Nge-Ocrevus
Esivivinyweni sesigaba sesi-III sabantu abane-MS, abaphathi abangaphezu kuka-1600 babenomsebenzi wokuthola ukumiswa kwe-Ocrevus njalo ezinyangeni eziyisithupha noma i- Rebif (i-interferon beta-1a) kathathu ngesonto ngamasonto angu-96 (cishe eminyakeni emibili). I-rebif iyinjojo engaphansi, okusho ukuthi inikezwa ngaphansi kwesikhumba ngenaliti encane.
Imiphumela yabonisa ukuthi izinga lokuphindaphinda ngonyaka kwaba ngamaphesenti angama-46 kuya kwangu-47 aphansi kulabo ababambiqhaza abathola i-Ocrevus kunelabo ababambiqhaza abathola i-Rebif. Ngaphezu kwalokho, ukuqhubekela phambili kokukhubazeka kwabahlanganyeli kwalinganiswa kokubili amasonto angu-12 namaviki angu-24 besebenzisa i- EDSS .
Kuzo zombili ozimele isikhathi, abahlanganyeli abathola i-Ocrevus babe nokuthuthuka okuphansi kokukhubazeka kunabo abamukela i-Rebif.
Futhi, kunezilonda ezingamaphesenti angu-94 kuya kwangu-95 ezingaphansi kwe- gadolinium-enhancing lesi- MRI eqenjini le-Ocrevus kuneqembu leRebif.
Imiphumela emibi kulezi zivivinyo ezimbili zihlanganisa:
- Ukusabela okuhlobene nokumnika amandla eqoqweni le-Ocrevus (okungaphezu kwezingxenye ezingaphezu kwesithathu kwabahlanganyeli): njengokushona, ukuqhuma, noma ukuchithwa
- Izifo ezinzima zenzeke ngamaphesenti angu-1.3 alabo abaseqembu le-Ocrevus namaphesenti angu-2.9 eqenjini leRebif
- Ukukhula okusha okwejwayelekile kwezicubu (okubizwa ngokuthi ama-neoplasms) kwenzeke ngamaphesenti angu-0.5 alabo abaseqembu le-Ocrevus namaphesenti angu-0.2 eqenjini leRebif.
Ukwelapha i-MS Primary Progressive nge-Ocrevus
Esivivinyweni sesigaba sesi-III se-Ocrevus kwi -MS eyinhloko eqhubekayo (i-PPMS), abahlanganyeli abangaphezu kuka-700 bathola i-Ocrevus noma ukukhishwa kwe-placebo njalo ezinyangeni ezingu-6 okungenani amasonto angu-120.
Imiphumela yabonisa ukuthi emasontweni angu-12, kunciphise okungamaphesenti angama-24 ekuthuthukisweni kokukhubazeka kwabahlanganyeli abathola i-Ocrevus, ngokuphambene nalabo abathola ukukhishwa kwe-placebo.
Emasontweni angu-24, ukuqhubeka kokukhubazeka okuqinisekisiwe kunciphise amaphesenti angu-25 kulabo ababambiqhaza abathatha u-Ocrevus.
I-Ocrevus nayo itholakale ukunciphisa isikhathi esathatha ukuba abahlanganyeli bahambe ngamamitha angu-25 ngamaphesenti angaba ngu-30 uma kuqhathaniswa nokwehliswa kwe-placebo.
Ebuchosheni be-MRI, ngemva kwamasonto angu-120, kunamaphesenti angu-3.4 ngaphansi kwenani eliphelele lama-T2-hyperintense lesi-brain lesions eqenjini le-Ocrevus elibhekene nezilonda ezingamaphesenti angu-7,4 eqenjini le-placebo.
Ngokuphathelene nemiphumela emibi, iqembu le-Ocrevus linemiphumela ehlobene nokutheleleka kwe-infusion, izifo ezingaphezulu zokuphefumula, kanye nezifo zomlomo we-herpes . Ukuphendula okuhlobene nokwehlisa ukumfutho (njengokushaywa, ukushaywa, ukuhlwitha, nokuphunga komphimbo) kwakuvame kakhulu ngemva kokumnika ukuqala futhi kuthuthukiswe ngamanani alandelayo.
Izifo ezinzima zenzeke ngamaphesenti angu-6.2 weqembu le-Ocrevus kanye namaphesenti angu-5.9 weqembu le-placebo-elifanayo emaqenjini womabili. Abacwaningi bachaza ngokucophelela ukuthi ukutheleleka okukhulu kangakanani-isifo esasibulalayo, esasongela ukuphila, sidinga ukunakekelwa esibhedlela, siphumelele ekukhubazekeni, noma kudingekile ukungenelela kwezokwelapha (njengama-antibiotiki emithi) ukuvimbela ukufa noma ukukhubazeka.
Kuyathakazelisa ukuphawula ukuthi kunezinhlayiya ezingaphezulu eqenjini le-Ocrevus (njengomdlavuza wesifuba wesikhumba) kuneqembu le-placebo. Akucaci ukuthi kungani lokhu kuyilokho futhi kuvumela uphenyo oluqhubekayo.
Izwi elivela
I-Ocrevus (ocrelizumab) imithi yokuqala evunyiwe i-FDA yokwelapha i-MS eyinhloko eqhubekayo, echaphazela cishe amaphesenti angu-10 kuya kwangu-15 abantu abane-MS, ngakho lokhu kuyathandeka kakhulu futhi kuyathemba. Yiqiniso, kuyathakazelisa kakhulu kulabo abanezinhlobo zokuvuselela ze-MS, njengabantu abaningi abaye baqhubeka nokuthuthukisa ukubuyela emuva naphezu kwamanje okwelashwa kwe-MS. I-Ocrevus manje ibanika yona enye inketho.
Konke lokhu kushiwo, kubalulekile ukukhumbula ukuthi ukukhetha ukwelashwa okulungile kwe-MS kuyinkqubo encane futhi eyodwa. Ngaphezu kwalokho, imiphumela yezilingo ezintathu ku-Ocrevus azibikezeli ukuthi uzosabela kanjani kumuthi.
> Imithombo:
> Hauser SL et al. I-Ocrelizumab ngokumelene ne-Interferon Beta-1a ekubuyiseni kabusha izifo eziningi ze-sclerosis. N Engl J Med . 2016 Dec 21.
> Montalban X et al. I-ocrelizumab ngokumelene ne-placebo e-primary sclerosis multiple sclerosis. N Engl J Med. 2016 Dec 21.
> I-Sorensen PS, i-Blinkenberg M. Indima engaba khona ye-ocrelizumab ekwelapheni kwe-multiple sclerosis: ubufakazi obukhona namathemba esizayo. I-Ther Adv Neurol Disord . 2016 Jan; 9 (1): 44-52.