Rinvoq (upadacitinib) Phase 3 Clinical Success: Txhim kho cov tsos mob thiab cov tsos mob ntawm tus kab mob!

AbbVie tsis ntev los no tau tshaj tawm cov txiaj ntsig zoo tshaj plaws ntawm thawj txoj kev tshawb fawb (Study 1) nyob rau theem 3 SELECT-AXIS 2 kev soj ntsuam kev sim ntawm cov tshuaj tiv thaiv kab mob Rinvoq (upadacitinib). Txoj kev tshawb no (Study 1) tau ua nyob rau hauv cov neeg mob uas nquag ankylosing spondylitis (AS) uas tau txais cov lus teb tsis txaus rau cov kab mob lom-hloov tshuaj tiv thaiv rheumatic (bDMARD). Cov txiaj ntsig tau pom tias Rinvoq tau mus txog qhov kawg ntawm qhov kawg thiab tag nrho cov ntsiab lus thib ob ntawm ASAS40 ntawm 14 lub lis piam ntawm kev kho mob.

Rinvoq yog qhov ncauj, ib zaug ib hnub, xaiv thiab thim rov qab JAK inhibitor tsim los kho ntau yam kab mob tiv thaiv kab mob sib kis. Yav dhau los, AbbVie tau ua txoj kev tshawb fawb SELECT-AXIS 1, uas yog ib theem 2/3 txoj kev tshawb fawb hauv cov neeg laus nrog AS. Cov neeg mob cuv npe tsis tau txais kev kho mob bDMARD yav dhau los lossis cov tshuaj uas tsis yog steroidal anti-inflammatory (NSAID). Tsis txaus teb los yog intolerance. Cov txiaj ntsig ntawm txoj kev tshawb no tau siv los txhawb European Commission (EC) kev pom zoo ntawm Rinvoq rau kev kho mob ntawm cov kab mob ankylosing spondylitis (AS) qhia thaum Lub Ib Hlis 2021.

Cov txiaj ntsig ntawm Kev Tshawb Fawb 1 txoj kev tshawb fawb luam tawm lub sijhawm no qhia tau hais tias piv nrog cov pab pawg placebo, qhov feem pua ​​​​ntawm cov neeg mob hauv pab pawg kho mob Rinvoq uas ua tiav ASAS40 (40% kev txhim kho raws li kev soj ntsuam los ntawm International Spondyl Arthritis Society) cov lus teb ntawm lub lim tiam 14 tau nce siab dua. (45% vs 18%; p< 0.0001).="" tsis="" tas="" li="" ntawd,="" nyob="" rau="" lub="" lim="" tiam="" 14,="" cov="" tsos="" mob="" thiab="" cov="" tsos="" mob="" ntawm="" as="" (xws="" li="" mob="" nraub="" qaum="" thiab="" o)="" hauv="" pab="" pawg="" kho="" mob="" rinvoq="" tau="" txo="" qis,="" thiab="" kev="" ua="" haujlwm="" ntawm="" lub="" cev="" thiab="" kev="" ua="" haujlwm="" ntawm="" cov="" kab="" mob="" kuj="" tau="" txhim="" kho.="" piv="" nrog="" rau="" cov="" placebo="" pab="" pawg,="" qhov="" feem="" ntau="" ntawm="" cov="" neeg="" mob="" hauv="" pab="" pawg="" kho="" mob="" rinvoq="" tau="" ua="" tiav="" cov="" qhab="" nia="" ntawm="" tus="" kab="" mob="" ankylosing="" spondylitis="" (asdas)="" nrog="" cov="" kab="" mob="" tsawg="" (44%="" vs="">

SELECT-AXIS 2 test (Study 1).

Piv nrog rau cov placebo pab pawg, cov neeg mob hauv pab pawg kho mob Rinvoq tau pom qhov kev txhim kho tseem ceeb hauv kev sib nqus resonance imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) cov qhab nia (s txha nraub qaum) (qhov nruab nrab hloov ntawm qhov pib: -3.95 vs -) 0.04). Nyob rau lub lim tiam 14, piv nrog cov placebo pab pawg, cov neeg mob hauv pab pawg kho mob Rinvoq tau ntsib qhov poob qis dua qhov nruab nrab ntawm tus neeg mob' s Kev Ntsuas Tag Nrho Cov Mob Rov Qab los ntawm qhov pib (-3.00 vs -1.47). Tsis tas li ntawd, siv Bath Ankylosing Spondylitis Function Index (BASFI) los ntsuas qhov nruab nrab ntawm qhov kev hloov pauv los ntawm kev ntsuam xyuas hauv paus, piv nrog cov placebo pab pawg, kev txhim kho lub cev ua haujlwm ntawm pab pawg kho mob Rinvoq tau ntau dua (raws li: -2.26 thiab -1.09) . Piv nrog rau cov placebo pab pawg, p-tus nqi ntawm tag nrho cov qhab nia thib ob kawg yog<>

Cov ntaub ntawv kev nyab xeeb hauv txoj kev tshawb no yog ua raws li SELECT-AXIS 1 sim, cov kev tshawb fawb theem 3 yav dhau los rau lwm cov kev qhia, thiab paub txog kev nyab xeeb profile ntawm Rinvoq, thiab tsis muaj kev pheej hmoo kev nyab xeeb tshiab tau pom. Tag nrho cov txiaj ntsig ntawm SELECT-AXIS-2 mus sib hais yuav raug tshaj tawm ntawm cov rooj sib tham kho mob yav tom ntej thiab luam tawm hauv cov ntawv txheeb xyuas cov phooj ywg.

Michael Severino, MD, tus lwm thawj coj thiab tus thawj tswj hwm ntawm AbbVie, tau hais tias:" Ankylosing spondylitis (AS) yog ib qho kab mob debilitating uas tuaj yeem ua rau mob hnyav, txhav, txwv tsis pub txav mus los, thiab kev puas tsuaj tas mus li, cuam tshuam rau tus neeg mob lub neej niaj hnub. Lub neej. AbbVie tau cog lus los txhim kho qib kev saib xyuas rau cov neeg mob rheumatic. Peb tau txais kev txhawb nqa los ntawm cov txiaj ntsig no, uas qhia tau tias Rinvoq tuaj yeem txhim kho cov tsos mob thiab cov tsos mob ntawm tus kab mob hauv cov neeg mob uas nquag nquag AS uas tau txais cov lus teb tsis txaus rau kev kho mob bDMARD, thiab lwm yam kab mob kev ua ub no."

Ankylosing spondylitis (AS) yog ib qho mob ntev, muaj kev loj hlob, kab mob inflammatory uas pib thaum ntxov laus thiab ua rau mob thiab txhav hauv qaum. Cov tshuaj nquag ntawm Rinvoq yog upadacitinib, uas yog ib qho kev xaiv ntawm qhov ncauj thiab thim rov qab JAK1 inhibitor nrhiav thiab tsim los ntawm AbbVie. Nws raug tsim los kho ntau yam kab mob tiv thaiv kab mob sib kis. JAK1 yog kinase uas ua lub luag haujlwm tseem ceeb hauv pathophysiology ntawm ntau yam kab mob inflammatory.

Txog rau tam sim no, nyob rau hauv European Union, Rinvoq 15mg tau pom zoo rau 4 qhov kev qhia: (1) rau kev kho mob ntawm cov mob nruab nrab mus rau mob rheumatoid mob caj dab (RA) cov neeg laus; (2) rau kev kho mob psoriatic mob caj dab (PsA) rau cov neeg laus; (3) rau kev kho mob ntawm cov neeg laus cov neeg mob uas muaj active ankylosing spondylitis (AS); (4) rau kev kho mob ntawm cov neeg laus uas muaj mob nruab nrab mus rau mob atopic dermatitis (AD) thiab cov neeg hluas hnub nyoog 12 xyoos thiab laus dua. Hauv European Union, Rinvoq 30mg tau pom zoo rau 1 qhov taw qhia: nws yog siv los kho cov neeg laus uas muaj hnub nyoog qis dua rau AD hnub nyoog qis dua 65 xyoos.

Hauv Tebchaws Meskas, Rinvoq 15mg tsuas yog pom zoo rau 1 qhov taw qhia: nws yog siv los kho cov neeg laus uas muaj mob rheumatoid mob caj dab (RA).

Tam sim no, Rinvoq kho ulcerative colitis (UC), rheumatoid mob caj dab (RA), psoriatic mob caj dab (PsA), atopic dermatitis (AD), axial spondyloarthritis (axSpA), Crohn Theem 3 kev tshawb fawb ntawm En' (CD) thiab giant cell arteritis (GCA) tab tom ua.