US FDA Pom Zoo AbbVie Qhov Kev Qhia Thib Ob Rau Qhov Ncauj JAK1 Inhibitor Rinvoq!

AbbVie tsis ntev los no tshaj tawm tias US Food and Drug Administration (FDA) tau pom zoo rau qhov ncauj JAK1 inhibitor Rinvoq (upadacitinib) rau kev kho mob ntawm ib lossis ntau dua qog nqaij hlav necrosis (TNF) Cov neeg laus cov neeg mob uas muaj mob psoriatic mob caj dab (PsA) uas tsis txaus lossis tsis txaus siab rau cov lus teb. Rinvoq tuaj yeem pab txhim kho kev sib koom tes, o, txhav, thiab qaug zog hauv cov neeg mob uas muaj PsA, thiab tiv thaiv kev puas tsuaj ntxiv.

Qhov kev pom zoo no yog qhov qhia thib ob uas Rinvoq tau pom zoo hauv Tebchaws Meskas. Nyob rau hauv 2019, Rinvoq tau pom zoo rau kev kho mob ntawm cov neeg laus cov neeg mob uas muaj mob rheumatoid mob caj dab (RA).

Michael Severino, Tus Lwm Thawj Coj thiab Thawj Tswj Hwm ntawm AbbVie, tau hais tias: "Qhov kev ua tau zoo ntawm Rinvoq hauv kev tshem tawm ntau qhov tshwm sim ntawm psoriatic mob caj dab tau pom zoo nyob rau hauv ob qhov loj ntev -cov kev tshawb fawb soj ntsuam. Qhov kev pom zoo tshiab no qhia txog peb lub hom phiaj yog kom muab ntau txoj kev kho mob los pab ntau tus neeg mob nrog cov kab mob rheumatic ua tiav kev tswj hwm kab mob. "

Rinvoq cov lus qhia tshiab rau kev kho mob ntawm PsA yog txhawb los ntawm cov ntaub ntawv los ntawm ob theem 3 kev tshawb fawb soj ntsuam SELECT-PsA-1 (NCT03104400) thiab SELECT-PsA-2 (NCT03104374). Ob qhov kev tshawb fawb no tau tso npe ntau dua 2000 tus neeg mob nrog PsA nquag.

SELECT-PsA 12 cov txiaj ntsig tshawb fawb

Cov txiaj ntsig tau pom tias hauv 2 txoj kev tshawb fawb, ntawm 12 lub lis piam ntawm kev kho mob, Rinvoq tau mus txog qhov kawg ntawm ACR20 cov lus teb: pawg Rinvoq 15mg koob tshuaj muaj qhov ntau dua ACR20 cov lus teb piv nrog cov placebo pawg (SELECT-PsA{ 1. Hauv kev tshawb fawb SESECT-PsA 1, ntawm 12 lub lis piam ntawm kev kho mob, 15mg koob ntawm Rinvoq thiab Humira (adalimumab) tau pom tias tsis muaj qhov tsis zoo hauv ACR20 cov lus teb.

Cov khoom xyaw tshuaj nquag ntawm Rinvoq yogupadacitinib, uas yog qhov ncauj xaiv thiab thim rov qab JAK1 inhibitor nrhiav thiab tsim los ntawm AbbVie. Nws tab tom tsim los kho ntau lub cev tiv thaiv kab mob - kho mob inflammatory kab mob. 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 qhia: (1) rau kev kho mob ntawm tus mob nruab nrab mus rau mob rheumatoid mob caj dab (RA) cov neeg laus; (2) rau kev kho mob psoriatic mob caj dab (PsA) cov neeg laus; (3) rau kev kho mob ntawm active ankylosing spondylitis (AS) cov neeg laus; (4) rau kev kho mob nruab nrab mus rau mob atopic dermatitis (AD) cov neeg laus thiab cov hluas cov neeg mob 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 nrog mob nruab nrab mus rau AD.

Hauv Tebchaws Meskas, Rinvoq 15mg tau pom zoo rau 2 qhov kev qhia: rau kev kho mob ntawm cov neeg laus cov neeg mob uas muaj mob nruab nrab mus rau mob hnyav 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 disease (CD), ulcerative Phase 3 kev sim tshuaj ntawm colitis (UC), loj heev cell arteritis (GCA). ), thiab aortic arteritis tseem muaj.