AbbVie JAK inhibitor nyob rau hauv kev kho mob ntawm ulcerative colitis theem 3 kev soj ntsuam thaum kawg tau mus txog

AbbVie tshaj tawm txog cov txiaj ntsig zoo ntawm kev tiv thaiv tshuaj tiv thaiv Rinvoq (upadacitinib) hauv kev kho mob ntawm ulcerative colitis (UC) theem III induction kawm (U-ACHIEVE). Txoj kev tshawb no tau ua rau cov neeg mob laus uas muaj mob me ntsis mus rau mob hnyav UC. Cov txiaj ntsig tau pom tias txoj kev tshawb no tau mus txog qhov pib qhov kawg thiab txhua qhov kev txom nyem: piv rau cov placebo, Rinvoq (45mg, ib hnub ib zaug) kev kho mob zoo dua qub tau kho cov chaw kuaj mob, endoscopic, thiab keeb kwm ntawm UC cov neeg mob.

U-ACHIEVE yog qhov kev ua ntu zus, tsis muaj kev cuam tshuam ntawm theem IIb / III multicenter, muaj kev sib tw, ob qhov muag tsis pom, qhov chaw kawm tshuaj ntsuam xyuas los ntsuas qhov ua haujlwm tau zoo thiab kev nyab xeeb ntawm Rinvoq hauv kev ntxias thiab kev saib xyuas ntawm kev noj haus nruab nrab mus rau UC. Cov txiaj ntsig ntawm kev kawm qib IIb Nws tau tshaj tawm thaum Lub Kaum Hlis 2018. Lub hom phiaj ntawm txoj kev kawm qib III yog kom ntsuas qhov ua tau zoo thiab kev nyab xeeb ntawm Rinvoq (45mg, ib zaug ib hnub) thiab cov placebo.

Lub hauv paus ntsiab lus tseem ceeb yog kev kho mob kho mob (raws li daim ntawv Adapted Mayo Score) nyob rau 8 lub lim tiam ntawm kev kho mob. Cov chaw xaus thib ob suav nrog hauv cov lus teb kho mob (tau sib haum Mayo Cov qhab nia poob qis los ntawm points2 cov ntsiab lus thiab ≥30% los ntawm lub hauv paus, thiab lub qhov quav tawm ntawm cov khoom tawg tau [RBS] ≥1 lossis meej RBS≤1), txhim kho kev txhim kho (sab hauv qhov nruab nrab Endoscopy qhab nia ≤ 1) thiab kev txhim kho histological endoscopic mucosal txhim kho (kev ua kom tiav cov qhab nia 0 lossis 1, Geboes qhab nia ≤ 3.1).

Cov ntaub ntawv sau tseg tau qhia tias thaum lub asthiv thib 8 ntawm kev kho, piv nrog pab pawg placebo, qhov feem ntau ntawm cov neeg mob hauv pawg Rinvoq tau ua tiav kev kho mob (26% vs 5%; p< 0.001).="" cov="" ntaub="" ntawv="" sib="" tw="" ua="" tiav="" pom="" tau="" hais="" tias="" thaum="" lub="" asthiv="" thib="" 8="" ntawm="" kev="" kho="" mob,="" piv="" nrog="" cov="" pab="" pawg="" placebo,="" qhov="" feem="" ntau="" ntawm="" cov="" neeg="" mob="" hauv="" rinvoq="" pawg="" tau="" ua="" tiav="" kev="" txhim="" kho="" endoscopic="" (36%="" vs="" 7%;="">< 0.001)="" thiab="" ua="" tiav="" histological="" endoscopy="" mucosal="" txhim="" kho="" (30%="" vs="" 7%;="">< 0.001)="" thiab="" cov="" lus="" teb="" soj="" ntsuam="" (73%="" vs="" 27%;="">< 0.001).="" tsis="" tas="" li="" ntawd,="" nyob="" rau="" lub="" lim="" tiam="" thib="" ob="" ntawm="" kev="" kho="" mob,="" piv="" nrog="" pab="" pawg="" placebo,="" qhov="" feem="" ntau="" ntawm="" cov="" neeg="" mob="" hauv="" rinvoq="" pawg="" tau="" ntsib="" cov="" lus="" teb="" soj="" ntsuam="" (60%="" vs="" 27%;=""><>

Hauv qhov kev tshawb fawb no, kev nyab xeeb ntawm Rinvoq tau zoo nrog cov txiaj ntsig kev nyab xeeb ntawm txhua qhov taw qhia hauv cov kev tshawb fawb dhau los, thiab tsis muaj kev tiv thaiv kev nyab xeeb tshiab. Lub sijhawm kawm 8 lub lim tiam, cov kev pom muaj tshwm sim ntau tshaj plaws (AE) pom nyob hauv pawg Rinvoq yog pob txuv, nce ntshav creatine phosphokinase, thiab nasopharyngitis. Qhov kev nce rau hauv cov ntshav creatine phosphokinase tsis loj thiab tsis ua rau kev kawm tsis ua haujlwm. Cov neeg mob uas tau tsim cov ntshav creatine phosphokinase feem ntau yog asymptomatic thiab tsis muaj mob ntawm rhabdomyolysis tau tshaj tawm.

Cov kev mob hnyav tshwm sim (SAE) tshwm sim hauv 2.5% ntawm cov neeg mob hauv Rinvoq pawg thiab 5.8% hauv cov placebo pawg. Cov kab mob hnyav tsis tshua tau qhia tawm (1.6% hauv pawg Rinvoq thiab 1.3% hauv pawg placebo). Tsis muaj neeg tuag, plab zom mov perforation, hlav hlav, hlav cov hlab plawv loj lossis cov teeb meem loj hauv lub plawv.

Rinvoq yog qhov ncauj ntawm kev xaiv thiab thim xim JAK1 inhibitor, nrhiav thiab tsim los ntawm AbbVie, rau kev kho mob ntawm ntau yam kab mob tiv thaiv kab mob sib kis. JAK1 yog kinase uas ua lub luag haujlwm tseem ceeb hauv pathophysiology ntawm cov kabmob sib kis.

Tam sim no, Rinvoq (upadacitinib) Tau txais kev pom zoo nyob hauv Tebchaws Meskas thiab European Union los kho cov neeg mob cov neeg laus uas muaj mob tsis txaus mus txog qhov mob caj dab (RA). Hauv kev qhia txog RA, kev pom zoo koob tshuaj Rinvoq yog 15 mg. Tam sim no, AbbVie tab tom txhim kho Rinvoq los kho ntau yam mob tiv thaiv kab mob. Cov neeg nyob rau Ntu 3 kev sim kho mob muaj xws li: atopic dermatitis, mob rheumatoid kev mob caj dab, mob caj dab, mob leeg txha hlaws tawm, mob leeg nkees, mob leeg, ulcerative mob plab, mob hlab ntsha hlwb loj, mob caj pas aortic.

Kev lag luam muaj txiaj ntsig zoo txog Rinvoq' s lag luam pom tom ntej. EvaluatePharma, lub koom haum kev tshawb fawb txog kev lag luam tshuaj, yav dhau los tshaj tawm tsab ntawv tshaj tawm hais tias Rinvoq' s muag thoob ntiaj teb xyoo 2024 yuav txog 2.57 txhiab daus las Asmeskas, ua lub ntiaj teb' s thib tsib zoo tshaj plaws tshuaj tiv thaiv kev mob rheumatic.