AbbVie's Qhov Ncauj JAK 1 Tus Xov Xwm Raug Rinvoq Xa Daim Ntawv Thov Kev Pom Zoo Tshiab Hauv Tebchaws Meskas thiab Tebchaws Europe Los Kho Psoriatic Mob Pob Txha (PsA)!

AbbVie nyuam qhuav tshaj tawm tias nws tau xa daim ntawv thov tshiab rau kev tiv thaiv kab mob hauv lub qhov ncauj Rinvoq (upadacitinib, 15 mg ib hnub ib zaug) rau Asmeskas Chaw Tswj Xyuas Khoom Noj thiab Tshuaj (FDA) thiab European Tshuaj Noj Tshuaj (EMA) Qhov no tshuaj yog kev xaiv thiab thim rov qab JAK inhibitor rau kev kho mob ntawm cov neeg mob cov neeg laus nrog mob psoriatic mob caj dab (PsA).

Michael Severino, MD, Tus Lwm Thawj Coj thiab Thawj Tswj Hwm ntawm AbbVie, tau hais tias:" Psoriatic mob caj dab yog cov kab mob ua rau mob uas ua rau ntau qhov chaw mob, suav nrog pob qij txha thiab tawv nqaij, ua rau mob txhua hnub, qaug zog thiab txhav. Peb cia siab tias kuv yuav ua haujlwm nrog cov neeg tswj hwm kev cia siab thiab vam tias yuav coj Rinvoq rau cov neeg mob uas muaj cov kab mob no sai li sai tau."

Daim ntawv thov kev qhia tshiab no yog saib raws li cov ntaub ntawv los ntawm ob qhov Kev Tshawb Nrhiav Kab Mob III, SELECT-PsA-1 (NCT 03104400) thiab SELECT-PsA-2 txoj kev kawm (NCT 03104374). Ob txoj kev tshawb fawb no tau cuv npe ntau dua 2000 cov neeg mob uas muaj lub siab PsA. Cov txiaj ntsig tau pom tias hauv ob qho kev tshawb fawb, Rinvoq tau mus txog qhov kawg ntawm ACR 20 cov lus teb piv rau cov placebo. Tsis tas li ntawd, qhov 15 mg koob tshuaj Rinvoq thiab adalimumab qhia pom tias tsis muaj qhov tsis zoo nyob hauv kev teb rau ACR 20 ntawm lub lis piam 12 ntawm kev kho mob. Cov neeg mob uas tau txais Rinvoq kuj tseem muaj kev txhim kho ntau dua hauv kev ua haujlwm ntawm lub cev (HAQ-DI) thiab cov tsos mob ntawm daim tawv nqaij (PASI 75), thiab ntau feem pua ​​ntawm cov neeg mob tau ua tiav cov haujlwm qis tshaj plaws. Ntawm cov neeg mob PsA, kev nyab xeeb ntawm Rinvoq yog ua tau raws li cov txiaj ntsig tau hais dhau los theem III mob rheumatoid caj dab kuaj mob, thiab tsis muaj kev tiv thaiv kev pheej hmoo loj tshiab tau pom.

—SELECT-PsA-1: yog cov neeg ua ntau yam, sib xws, muab ob tog dig muag, cov pab pawg sib tw, cov tshuaj muaj txiaj ntsig zoo thiab cov tshuaj placebo tswj theem III kawm hauv 1705 cov neeg mob hloov kho tsawg kawg ib qho kab mob tiv thaiv kab mob rheumatic (DMARD) Ua nyob rau hauv cov neeg laus cov neeg mob uas tsis muaj kev tiv thaiv PsA, qhov ua tau zoo thiab kev nyab xeeb ntawm ob koob tshuaj Rinvoq (15 mg thiab 30 mg ib hnub ib zaug) ntsig txog cov placebo thiab adalimumab tau raug ntsuas. Hauv txoj kev tshawb no, cov neeg mob tau raug xaiv los txais Rinvoq 15 mg, Rinvoq 30 mg, adalimumab (40 mg, txhua lwm lub lim tiam [EOW]), thiab placebo. Lub ntsiab lus xaus yog qhov sib piv ntawm cov neeg mob uas tau ua tiav ACR 20 cov lus teb hauv lub lis piam 12 ntawm ob koob tshuaj Rinvoq kho pawg piv nrog cov placebo pab pawg. Thib ob cov ntsiab lus kawg muaj xws li: kev hloov pauv ntawm Cov Kev Ntsuas Cov Lus Nug Kev Noj Qab Haus Huv Kev Noj Qab Zib (HAQ-DI) cov qhab nia los ntawm lub hauv paus ntawm lub limtiam 12, qhov feem pua ​​ntawm cov neeg mob uas ua tiav PASI 75 (thaj tsam ntawm qhov pom kev zoo txhim kho los ntawm {{18 }}%) thaum lub lim tiam 16, thiab tus kab mob qis tshaj plaws ntawm lub lim tiam 24 Qhov feem ntawm cov neeg mob uas muaj kev ua haujlwm (MDA).

Cov ntaub ntawv tau qhia tias qhov kev tshawb nrhiav tau mus txog qhov kawg: thaum lub lim tiam 12, 71% thiab 79% ntawm cov neeg mob hauv 15 mg thiab 30 mg pawg ua tiav ACR 20 cov lus teb, feem, thiab 36% hauv cov pawg tso npe (p< 0.="" 0001).="" thaum="" piv="" nrog="" adalimumab,="" ob="" koob="" tshuaj="" ntawm="" rinvoq="" tau="" tiav="" qhov="" tsis-qhov="" ua="" tsis="" tau="" zoo="" hauv="" acr="" 20="" cov="" lus="" teb="" ntawm="" lub="" sijhawm="" 12="" ntawm="" lub="" lim="" tiam="" ntawm="" kev="" kho="" mob,="" thiab="" tsuas="" yog="" lub="" sijhawm="" ntawm="" 30="" mg="" pom="" zoo="" dua.="" hais="" txog="" acr="" 50="" cov="" lus="" teb="" ntawm="" lub="" sijhawm="" 12="" th="" ntawm="" kev="" kho="" mob,="" 15="" mg="" pawg,="" 30="" mg="" pab="" pawg,="" thiab="" pawg="" placebo="" yog="" 38%,="" 52%,="" thiab="" 13%,="" feem="" (nominal="">< 0.="" 0001).="" hais="" txog="" acr="" 75="" tus="" lej="" teb="" ntawm="" 12="" th="" lub="" lim="" tiam="" ntawm="" kev="" kho,="" 16%,="" 25%,="" thiab="" 2%="" hauv="" lub="" {{3}="" }="" mg="" pab="" pawg,="" 30="" mg="" pab="" pawg,="" thiab="" pawg="" placebo="" (npe="" hauv="">< 0.="">

Raws li kev ntsuas ntawm HAQ-DI tus qhab nia, lub cev ua haujlwm ntawm cov neeg mob uas tau txais Rinvoq kuj tseem zoo dua qub nyob rau lub limtiam 12: cov qhab-nees HAQ-DI ntawm cov neeg mob hauv 15 mg thiab 30 mg Rinvoq kho pawg hloov pauv los ntawm cov hauv paus los ntawm -0. 42 thiab -0. 47, feem. Cov pab pawg hloov pauv yog -0. 14 (p< 0.="" 0001).="" lub="" lim="" tiam="" 16,="" rinvoq="" kuj="" pom="" tias="" kev="" txhim="" kho="" cov="" tsos="" mob="" ntawm="" daim="" tawv="" nqaij.="" ntawm="" cov="" neeg="" mob="" tau="" txais="" 15="" mg="" thiab="" 30="" mg="" koob="" tshuaj="" rinvoq,="" 63%="" thiab="" 62%="" ntawm="" cov="" neeg="" mob="" tau="" pasi="" 75,="" feem,="" thiab="" {{19}="" }%="" ntawm="" cov="" placebo="">< 0.="" 0001).="" qhov="" feem="" ntawm="" cov="" neeg="" mob="" uas="" ua="" tiav="" mda="" ntawm="" lub="" sijhawm="" ntawm="" 24="" th="" ntawm="" kev="" kho="" mob="" yog="" 37%="" thiab="" 45%="" hauv="" 15="" mg="" thiab="" 30="" mg="" rinvoq="" kho="" pawg="" ,="" raws="" li,="" thiab="" 12%="" hauv="" cov="" pawg="" tso="">< 0.="" 0001).="" tom="" qab="" 24="" lub="" lis="" piam="" ntawm="" kev="" kho="" mob,="" 15="" mg="" thiab="" 30="" mg="" ntawm="" rinvoq="" ua="" rau="" muaj="" kev="" cuam="" tshuam="" loj="" heev="" ntawm="" radiological="" piv="" nrog="" cov="" placebo="">< 0.="" 01,="" ntsuas="" los="" ntawm="" kev="" hloov="" pauv="" los="" ntawm="" lub="" hauv="" paus="" nrog="" psa="" sharp="" van="" der="" heijde="" qhab-nees).="" kev="" tsuj="" ntawm="" kev="" sib="" koom="" ua="" ke="" yog="" qhov="" tseem="" ceeb="" rau="" cov="" neeg="" mob="" psoriatic="" mob="" caj="" dab="" vim="" nws="" cuam="" tshuam="" rau="" lub="" cev="" ua="" haujlwm="" thiab="" kev="" tsis="" taus.="" hauv="" txoj="" kev="" tshawb="" no,="" rinvoq'="" kev="" nyab="" xeeb="" zoo="" ib="" yam="" li="" cov="" ntawv="" ceeb="" toom="" dhau="" los,="" thiab="" tsis="" muaj="" kev="" pheej="" hmoo="" pom="" kev="" nyab="" xeeb="">

—— SIS-PSA 2: Ntau lub chaw, xaiv ib pawg, ob qhov muag tsis pom kev, ib pawg ob tog sib luag, cov chaw kawm tshuaj uas tau tshawb pom muaj nyob rau hauv cov neeg mob PsA uas muaj cov lus teb tsis txaus rau tsawg kawg ib yam tshuaj lom neeg mob hloov kho rheumatic ( bDMARD), Lub hom phiaj yog txhawm rau ntsuas qhov ua tau zoo thiab kev nyab xeeb ntawm Rinvoq txheeb ze rau cov placebo. Hauv txoj kev tshawb no, cov neeg mob tau raug xaiv los txais Rinvoq 15 mg, Rinvoq 30 mg, thiab cov placebo. Lub lim tiam 2 4, lawv tau txais qhov ncauj Rinvoq 15 mg lossis Rinvoq 30 mg.

Qhov pib xaus ntawm txoj kev tshawb no yog qhov feem pua ​​ntawm cov neeg mob uas ua tiav ACR 20 kev zam txim tom qab 12 lub lis piam ntawm kev kho mob. Thib ob cov ntsiab lus kawg suav nrog kev hloov pauv ntawm Cov Kev Ntsuas Cov Lus Nug Kev Noj Qab Nyob Zoo (HAQ-DI) los ntawm cov hauv paus, qhov sib piv ntawm cov neeg mob uas ua tiav ACR 50 thiab ACR 70 ntawm lub lis piam 12, thiab Qhov feem ntawm PASI 75 tau mus txog ntawm lub lis piam 16 thiab qhov sib piv ntawm cov neeg mob uas tau mus txog qhov tsawg tshaj plaws ntawm kev ua haujlwm kabmob (MDA) ntawm lub limtiam 24. Qhov kev sim tseem tab tom ua mus ntxiv thiab kev nthuav dav mus ntev ntev tseem tseem qhov muag tsis pom kev los mus ntsuas qhov kev nyab xeeb ntev, kev tiv taus, thiab kev ua tau zoo ntawm 2 ib zaug-txhua hnub noj tshuaj (15 mg thiab 30 mg ) ntawm Rinvoq hauv cov neeg mob uas tau ua tiav cov tshuaj placebo.

Cov txiaj ntsig tau pom tias ob qho tshuaj ntawm Rinvoq (15 mg thiab 30 mg ib hnub ib zaug) tau mus txog qhov kawg ntawm ACR 20 kev zam nyob rau lub limtiam 12 piv rau cov placebo. Ib qho ntxiv, ob qho tshuaj tiv thaiv ntawm Rinvoq qhia tau muaj kev cuam tshuam zoo ntau dua ntawm txhua qhov kev ua tiav theem nrab piv rau cov placebo.

Cov ntaub ntawv tshwj xeeb yog: (1) Lub sijhawm 1 2 th lub lim tiam ntawm kev kho, {{2}}% thiab {{3}}% ntawm cov neeg mob hauv 1 5 - mg thiab 3 0-mg Rinvoq kho pawg tau ua tiav ACR {{6}} kev zam txim, feem, thiab {{{{{54 }}}% hauv qhov tso pawg (p< 0.000="" 1).="" (2)="" thaum="" lub="" sijhawm="" kho="" mob="" 2="" ntawm="" lub="" lim="" tiam="" kho,="" 3="" 2%="" thiab="" 2="" 8%="" ntawm="" cov="" neeg="" mob="" hauv="" lub="" {{0="" }}="" 5="" -="" mg="" thiab="" 3="" 0-mg="" rinvoq="" kho="" pawg="" tau="" ua="" tiav="" acr="" {{1="" 6}}="" kev="" zam="" txim,="" feem,="" thiab="" {{1="" 7}}%="" hauv="" cov="" pab="" pawg="" placebo="">< 0.000="" 1).="" (3)="" thaum="" lub="" sijhawm="" kho="" mob="" 1="" lub="" lim="" tiam="" ntawm="" kev="" kho="" mob,="" 9%="" thiab="" 1="" 7%="" ntawm="" cov="" neeg="" mob="" hauv="" lub="" {{0}="" }="" 5="" -="" mg="" thiab="" 3="" 0-mg="" rinvoq="" kho="" pawg="" tau="" ua="" tiav="" acr="" {{2="" 6}}="" kev="" zam="" txim,="" feem,="" thiab="" 0.="" 5%="" hauv="" cov="" placebo="" pawg="" (="">< 0.000="" 1).="" (4)="" thaum="" lub="" sijhawm="" kho="" ntawm="" 1="" 2="" ntawm="" lub="" lim="" tiam="" ntawm="" kev="" kho="" mob,="" lub="" cev="" ua="" haujlwm="" (kev="" tshuaj="" xyuas="" haq-di)="" ntawm="" cov="" neeg="" mob="" kho="" nrog="" rinvoq="" tau="" zoo="" dua.="" (5)="" rinvoq-kho="" cov="" neeg="" mob="" tau="" txhim="" kho="" hauv="" cov="" tsos="" mob="" ntawm="" daim="" tawv="" nqaij.="" hauv="" kev="" kho="" mob="" 1="" 6="" lub="" lis="" piam="" ntawm="" kev="" kho,="" {{1="" 7}}="" 2%="" thiab="" {{2}%="" ntawm="" cov="" neeg="" mob="" hauv="" lub="" {{="" 0}}="" 5="" -="" thiab="" 3="" 0-mg="" rinvoq="" kho="" pawg="" ua="" tiav="" pasi="" 7="" 5="" kev="" zam="" txim,="" feem,="" thiab="" 1="" 6%="" hauv="" cov="" pab="" pawg="" placebo="">< 0.000="" 1).="" (6)="" lub="" lim="" tiam="" ntawm="" kev="" kho="" mob,="" 2="" 5%="" thiab="" 2="" 9%="" ntawm="" cov="" neeg="" mob="" hauv="" lub="" {{0}="" }="" 5="" -="" thiab="" 3="" 0-mg="" rinvoq="" kho="" pawg="" ua="" tiav="" mda,="" ntsig="" txog,="" thiab="" 3%="" hauv="" cov="" placebo="" pawg="">< 0.000="" 1).="" (7)="" hauv="" txoj="" kev="" tshawb="" no,="" rinvoq&#="" 3="" 9;="" kev="" nyab="" xeeb="" yog="" zoo="" ib="" yam="" nrog="" cov="" kev="" tshawb="" fawb="" yav="" dhau="" los,="" thiab="" tsis="" muaj="" kev="" pheej="" hmoo="" pom="" kev="" nyab="" xeeb="">

Cov tshuaj nquag ua haujlwm ntawm Rinvoq yog upadacitinib, uas yog qhov ncauj xaiv thiab thim rov qab JAK 1 inhibitor nrhiav thiab tsim los ntawm AbbVie. Nws tab tom raug kho los kho ob peb yam kab mob tiv thaiv kab mob. JAK 1 yog cov kinase uas yog lub luag haujlwm tseem ceeb hauv pathophysiology ntawm ntau yam kabmob kho.

Thaum Lub Yim Hli 2019, Rinvoq tau txais lub ntiaj teb' s thawj cov pob rau kev kho mob me ntsis mus rau mob rheumatoid mob caj dab (RA) cov laus uas tsis txaus los yog tsis teb rau methotrexate (MTX). Thaum Lub Kaum Ob Hlis 2019, Rinvoq tau pom zoo los ntawm European Union rau kev kho mob ntawm cov neeg laus uas muaj kev tiv thaiv luv luv mus rau RA uas tsis muaj kev saib xyuas lossis tsis txaus siab rau ib lossis ntau hom kabmob-hloov kho kev ua kom tsis haum tshuaj (DMARD). Hauv RA, kev pom zoo koob tshuaj Rinvoq yog 15 mg.

Tam sim no, Rinvoq kho tus mob psoriatic mob caj dab (PsA), RA, axial spondyloarthritis (axSpA), Crohn' s kab mob (CD), atopic dermatitis (AD), ulcerative colitis (UC), Phaub III soj ntsuam kev tshawb fawb ntawm mob leeg ntshav tes (GCA) txuas ntxiv.

Kev lag luam muaj txiaj ntsig zoo txog Rinvoq' s lag luam pom tom ntej. Lub chaw muag tshuaj tshawb xyuas kev lag luam EvaluatePharma yav dhau los tshaj tawm tsab ntawv tshaj tawm hais tias Rinvoq' s kev muag khoom thoob ntiaj teb hauv 2024 yuav mus txog 2. ntiaj teb' s 5 qhov zoo tshaj plaws-muag tshuaj tiv thaiv rheumatic.