Rinvoq Siv Rau Kev Qhia Tshiab: Kev Kho Mob Radiologically Negative Axial Spondyloarthritis (nr-axSpA)!

AbbVie (AbbVie) recently announced that it has submitted a new indication application for the oral JAK1 inhibitor Rinvoq (upadacitinib) rau US Food and Drug Administration (FDA) thiab European Medicines Agency (EMA): rau kev kho mob ntawm cov tshuaj uas tsis yog-steroidal anti-inflammatory cov neeg laus uas muaj active radiologically tsis zoo axial spondyloarthritis (nr-axSpA) nrog tsis txaus teb rau NSAIDs, Lub hom phiaj cov cim qhia ntawm o.

Daim ntawv thov qhia tshiab yog ua raws li cov ntaub ntawv los ntawm Theem 3 SELECT-AXIS 2 (Study 2) kev sim tshuaj. Qhov kev sim tshuaj ntsuam xyuas qhov ua tau zoo thiab kev nyab xeeb ntawm Rinvoq hauv cov neeg laus nrog nr-axSpA. Cov txiaj ntsig tau pom tias Rinvoq tau ntsib thawj qhov kawg thiab qhov tseem ceeb tshaj plaws thib ob qhov kawg. Piv nrog rau cov placebo, Rinvoq 15 mg ib hnub ib hnub txo cov tsos mob thiab cov tsos mob ntawm nr-axSpA, nrog rau mob nraub qaum thiab mob, thaum tseem txhim kho lub cev thiab kev ua haujlwm ntawm cov kab mob hauv cov neeg mob.

Hauv kev sim tshuaj ntsuam xyuas tau piav qhia saum toj no, cov ntaub ntawv kev nyab xeeb tau pom rau Rinvoq hauv cov neeg mob nrog AS thiab nr-axSpA feem ntau ua raws li Rinvoq paub txog kev nyab xeeb profile. Tsis muaj kev pheej hmoo kev nyab xeeb tshiab raug txheeb xyuas.

& quot; Axial spondyloarthritis (axSpA) yog ib qho kab mob inflammatory uas cuam tshuam rau tus txha nraub qaum uas tuaj yeem raug kev txom nyem los ntawm kev mob debilitating thiab txo lawv lub neej zoo. AbbVie tau cog lus los ua haujlwm nrog FDA thiab EMA ua Rinvoq kev kho mob rau cov neeg mob uas muaj cov mob no."

Rinvoq' cov khoom siv tshuaj nquag yog, ib qho kev xaiv qhov ncauj thiab thim rov qab JAK1 inhibitor pom thiab tsim los ntawm AbbVie uas tau 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 tam sim no, nyob rau hauv EU, Rinvoq 15mg tau pom zoo rau 4 qhov qhia: (1) rau kev kho mob ntawm cov neeg laus cov neeg mob uas muaj mob rheumatoid mob caj dab (RA); (2) rau kev kho mob psoriatic mob caj dab (PsA) cov neeg laus; (3) rau kev kho mob ntawm active ankylosing spondylitis (AS) nyob rau hauv cov neeg laus; (4) rau kev kho mob ntawm nruab nrab mus rau mob atopic dermatitis (AD) rau cov neeg laus thiab cov tub ntxhais hluas hnub nyoog 12 xyoos thiab laus dua. Nyob rau hauv European Union, Rinvoq 30mg tau pom zoo rau 1 qhov taw qhia: rau kev kho mob ntawm cov neeg laus cov neeg mob uas muaj mob nruab nrab mus rau AD.

Hauv Tebchaws Meskas, Rinvoq 15mg tau pom zoo rau 2 qhov qhia: rau kev kho mob ntawm cov neeg laus uas muaj mob nruab nrab mus rau RA, thiab cov neeg laus uas muaj PsA nquag.

Tam sim no, Rinvoq kho mob rheumatoid mob caj dab (RA), atopic dermatitis (AD), psoriatic mob caj dab (PsA), axial spondyloarthritis (axSpA), Crohn' s kab mob (CD), ulcerative Phase 3 kev sim tshuaj rau colitis (UC). ), giant cell arteritis (GCA), thiab Takayasu arteritis tseem muaj.