Novartis Remibrutinib Yeej Teriflunomide Hauv Theem III Rov Qab Mob MS Sim, Txo Kev Rov Qab Mob Los Ntawm Kwv Yees Li Ib Feem Peb
Novartis thaum Lub Kaum Hli Ntuj hnub tim 23 tau nthuav tawm cov txiaj ntsig zoo los ntawm qhov kev sim theem III REMODEL-1 thiab REMODEL-2 tseem ceeb uas qhia tias nws cov tshuaj BTK inhibitor remibrutinib uas noj tau ua rau muaj kev tswj hwm zoo dua qub thiab kev ncua sijhawm tseem ceeb hauv kev mob nkeeg piv rau teriflunomide hauv kev rov qab mob ntau yam sclerosis (RMS), tsis muaj teeb meem kev nyab xeeb ntawm daim siab. Cov txiaj ntsig tau nthuav tawm hauv kev sib tham lig ntawm MSToronto2026, Lub Rooj Sib Tham Sib Koom Tes ACTRIMS-ECTRIMS thib 10, thiab luam tawm tib lub sijhawm hauv The Lancet.
Ob qhov kev sim zoo sib xws tau xaiv kwv yees li 2,000 tus neeg mob thoob ntiaj teb 1:1 rau remibrutinib lossis teriflunomide. Ntawm qhov kawg tseem ceeb, tus nqi rov qab mob txhua xyoo, remibrutinib tau tshaj tawm 0.073 piv rau 0.112 hauv REMODEL-1 (35.2 feem pua txo qis) thiab 0.080 piv rau 0.116 hauv REMODEL-2 (31.2 feem pua), txhais tau tias kwv yees li ib qho kev rov qab mob txhua 13 xyoos. Qhov kev pheej hmoo ntawm kev nce qib ntawm kev tsis taus rau lub hlis tau poob qis 29.2 feem pua, thiab ntau dua 92 feem pua ntawm cov neeg mob remibrutinib tseem tsis tau nce qib dhau 24 lub hlis. Ntawm qhov kev ntsuas NEDA-3 sib xyaw ntawm tsis muaj pov thawj ntawm kev ua haujlwm ntawm tus kab mob, 55.0 feem pua ntawm cov neeg mob remibrutinib tau tsim nyog piv rau 32.1 feem pua ntawm teriflunomide. Cov txiaj ntsig MRI kuj nyiam remibrutinib, nrog rau kev ua haujlwm ntawm cov qhov txhab T2 txhua xyoo txo qis 65 thiab 70 feem pua hauv ob qhov kev sim thiab cov qhov txhab T1 uas ua rau gadolinium nce ntxiv los ntawm 66 feem pua.
Kev nyab xeeb yog qhov kev tshawb pom tseem ceeb. Tsis muaj teeb meem kev nyab xeeb ntawm daim siab thiab tsis muaj cov ntaub ntawv ntawm Hy txoj cai, uas tau tshaj tawm hauv lwm cov kev pab cuam BTK inhibitor theem kawg. Kev nce siab ntawm cov enzyme siab tshaj peb zaug ntawm qhov txwv siab tshaj plaws ntawm qhov ib txwm muaj tshwm sim hauv 2.0 feem pua ntawm cov neeg mob remibrutinib piv rau 7.4 feem pua ntawm teriflunomide, thiab kev tsum tsis ua vim muaj cov xwm txheej tsis zoo yuav luag 50 feem pua tsawg dua (3.1 piv rau 5.8 feem pua). Ob tus neeg tuag hauv pawg remibrutinib tau raug soj ntsuam los ntawm cov kws tshawb fawb tias tsis muaj feem cuam tshuam nrog kev kho mob. Heinz Wiendl, xibfwb ntawm kev kho mob hlwb ntawm University of Freiburg, tau hais tias cov kev tshawb pom kev ua tau zoo, ua ke nrog cov ntaub ntawv kev nyab xeeb zoo, qhia tias remibrutinib tuaj yeem xa cov kev xaiv tseem ceeb, sib txawv rau cov neeg uas muaj MS rov qab. Tsis zoo li kev kho mob B-cell uas tau pom zoo, remibrutinib ua haujlwm yam tsis muaj kev puas tsuaj ntawm B-cell ntev.
Multiple sclerosis yog ib yam kab mob o ntawm lub paj hlwb uas cuam tshuam rau yuav luag 3 lab tus tib neeg thoob ntiaj teb, thiab MS rov qab los yog nws hom mob feem ntau. Remibrutinib twb tau pom zoo siv lub npe lag luam Rhapsido rau ob hom mob pob khaus ntev. Novartis tau hais tias nws npaj yuav nrhiav kev pom zoo los ntawm cov koom haum tswj hwm rau qhov cim RMS thoob ntiaj teb.
[txuas: https://www.novartis.com/us-en/news/media-releases/novartis-remibrutinib-delivered-comprehensive-disease-control-phase-iii-rms-trials-proven-robust-safety-profile|Novartis tshaj tawm xov xwm]
Qhov chaw: GSM · Tebchaws Meskas (Qhov kev tshaj tawm lus Askiv · Qhov kev tshaj tawm lus Suav qub)
Duab: 多发性硬化患者的脑部MRI影像（资料图）。Favaretto 等摄，CC BY 4.0，经 Wikimedia Commons。 / A brain MRI showing multiple sclerosis lesions (file photo). Image by Favaretto et al., CC BY 4.0, via Wikimedia Commons.
