Rinvoq tau pom zoo los ntawm European Union rau qhov kev qhia plaub: kev kho AD cov laus thiab cov hluas!

AbbVie tsis ntev los no tshaj tawm tias European Commission (EC) tau pom zoo qhov qhia tshiab rau Rinvoq (upadacitinib): rau kev kho mob ntawm mob hnyav rau mob hnyav atopic dermatitis (AD) cov neeg laus thiab cov neeg muaj hnub nyoog 12 xyoos thiab 12 xyoos uas tsim nyog rau kev kho mob. Saum cov neeg mob hluas. Hais txog kev siv tshuaj, hauv cov neeg mob laus, qhov pom zoo koob tshuaj Rinvoq yog 15 mg lossis 30 mg hais lus ib hnub ib zaug; hauv cov tub ntxhais hluas (hnub nyoog 12-17 xyoos) thiab cov neeg mob laus hnub nyoog 65 xyoos thiab laus dua, qhov pom zoo koob tshuaj Rinvoq yog 15 mg ib zaug ib hnub. Rinvoq tuaj yeem siv nrog lossis tsis muaj tshuaj pleev corticosteroids (TCS).

Qhov kev pom zoo no yog qhov cim thib plaub uas Rinvoq tau pom zoo hauv EU. Nyob rau tib lub sijhawm, Rinvoq kuj tseem yog thawj JAK inhibitor pom zoo los ntawm EU rau kev kho mob ntawm cov neeg laus laus thiab cov hluas (≥12 xyoos).

Rinvoq yog qhov ncauj, ib zaug ib hnub, xaiv thiab thim rov qab JAK inhibitor. Hauv European Union, yav dhau los Rinvoq tau pom zoo rau 3 qhov qhia: (1) Rau kev kho mob ntawm mob rheumatoid mob caj dab mus rau qhov tsis txaus lossis tsis mob siab rau ib lossis ntau yam kab mob-kho tshuaj tiv thaiv rheumatic (DMARD) (RA) cov neeg laus; (2) rau kev kho mob ntawm cov neeg laus nrog mob psoriatic mob caj dab (PsA) uas tsis txaus lossis tsis kam ua rau ib lossis ntau DMARDs; (3) rau kev kho mob ntawm cov neeg uas muaj lus teb tsis txaus rau cov kev kho mob pom zoo Cov neeg laus uas muaj mob ankylosing spondylitis (AS). Ntawm cov kev qhia no, qhov pom zoo koob tshuaj Rinvoq yog 15 mg.

Hauv Tebchaws Meskas, Rinvoq tsuas yog pom zoo rau kev kho mob ntawm mob hnyav rau mob rheumatoid mob caj dab (RA) cov neeg laus uas tsis txaus lossis ua tsis tau siab rau methotrexate (MTX). Qhov koob tshuaj pom zoo rau qhov ntsuas no yog 15 mg. Tam sim no, Rinvoq' daim ntawv thov ntxiv rau kev kho mob PsA, AS, thiab AD tab tom raug tshuaj xyuas los ntawm Asmeskas FDA.

Kev pom zoo ntawm EU yog ua raws cov ntaub ntawv txhawb nqa ntawm ib ntawm AD loj tshaj plaws hauv ntiaj teb theem 3 cov phiaj xwm sau npe. Txoj haujlwm suav nrog 3 qhov kev tshawb fawb tseem ceeb thoob ntiaj teb (Ntsuas Up 1, Ntsuas Up 2, AD Up), rau npe ntau dua 2500 tus neeg mob nrog mob hnyav rau qhov mob hnyav atopic dermatitis (AD), thiab tshuaj xyuas Rinvoq raws li kev kho mob ib txwm muaj (ntsuas qhov ua tau zoo thiab nyab xeeb ntawm Up 1) , Ntsuas 2) thiab ua ke cov tshuaj corticosteroids (AD Up) txheeb ze rau cov placebo. Hauv tag nrho 3 qhov kev tshawb fawb, qhov tseem ceeb tshaj plaws yog: nyob rau lub lim tiam thib 16 ntawm kev kho mob, thaj chaw muaj kab mob thiab qhov ntsuas hnyav tau zoo dua los ntawm tsawg kawg 75% (EASI75), thiab qhov kev tshuaj xyuas kab mob atopic dermatitis' kev tshuaj xyuas tag nrho ( vIGA-AD) tus qhab nia yog 0 /1 (cov tawv nqaij raug tshem tawm tag lossis yuav luag raug tshem tawm tag nrho).

Cov txiaj ntsig tau pom tias hauv txhua theem 3 kev tshawb fawb, ob koob tshuaj ntawm Rinvoq tau mus txog txhua qhov kawg thiab theem ob: piv nrog cov placebo pab pawg, cov neeg mob hauv Rinvoq pawg kho mob tau kho nyob rau lub lim tiam 16 thiab lwm lub sijhawm (p< 0.001).="" muaj="" kev="" txhim="" kho="" sai="" thiab="" tseem="" ceeb="" hauv="" kev="" tshem="" tawm="" kev="" puas="" tsuaj="" thiab="">

Cov ntaub ntawv muaj txiaj ntsig tshwj xeeb: (1) Feem coob ntawm cov neeg mob tau mus txog EASI 75 hauv lub lim tiam 16: Rinvoq 15mg pab pawg (MU1: 70%; MU2: 60%; AU: 65%), Rinvoq 30 mg pawg (MU1: 80%); MU2: 73%; AU: 77%), pab pawg placebo (MU1: 16%; MU2: 13%; AU: 26%). (2) Feem coob ntawm cov neeg mob mus txog vIGA AD 0/1 hauv lub lim tiam 16: hauv Rinvoq 15 mg pab pawg (MU1: 48%; MU2: 39%; 40: 31%), pawg Rinvoq 30 mg (MU1: 62%); MU2: 52%; AU: 59%), pab pawg placebo (MU1: 8%; MU2: 5%; AU: 11%). (3) Thaum lub lim tiam 16, feem coob ntawm cov neeg mob tau ua tiav kev kho mob tseem ceeb txo qhov mob pruritus (NRS txhim kho qhov mob hnyav tshaj plaws ≥4): Rinvoq 15mg pab pawg (MU1: 52%; MU2: 42%; AU: 52%) ) thiab RINVOQ 30mg pawg (MU1: 60%; MU2: 60%; AU: 64%), pab pawg placebo (MU1: 12%; MU2: 9%; AU: 15%). (4) Sib piv nrog cov pab pawg placebo, cov neeg mob hauv ob-koob tshuaj kho mob Rinvoq pom kev kho mob tseem ceeb txo qhov khaus (qhov hnyav tshaj khaus NRS txhim kho ≥ 4) thiab tshem tawm cov tawv nqaij (EASI) thaum ntxov li thawj lub lim tiam thiab lub lim tiam thib ob , feem. 75).

(5) Rau cov neeg mob uas tau txais koob tshuaj Rinvoq, cov txiaj ntsig ntawm lub lim tiam 16 txuas ntxiv mus kom txog thaum lub lim tiam 52.

Hais txog kev nyab xeeb, feem ntau tshaj tawm cov kev tsis zoo (%5%) hauv Rinvoq 15mg pab pawg thiab 30mg pab pawg yog cov kab mob ua pa sab saud (25.4%), pob txuv (15.1%), herpes simplex (8.4%), mob taub hau (6.3) %) thiab ntshav Creatine phosphokinase (CPK, 5.5%) nce. Qhov tshwm sim tsis zoo tshaj plaws feem ntau yog kis mob hnyav (& lt; 1.0%).

Cov txheej txheem tshuaj Upadacitinib

Atopic dermatitis (AD) yog ib qho tshwm sim, mob ntev, rov tshwm sim, thiab kab mob ntawm daim tawv nqaij, tshwm sim los ntawm kev rov ua dua ntawm khaus thiab khawb, ua rau tawg, tawv nqaij, thiab tawv nqaij exudative. Nws tau kwv yees tias ntau npaum li 25% ntawm cov menyuam thiab 10% ntawm cov neeg laus yuav raug cuam tshuam los ntawm AD ntawm qee kis hauv lawv lub neej. 20% -46% ntawm cov neeg laus AD cov neeg mob yuav muaj mob hnyav mus rau mob hnyav. Cov tsos mob ntawm tus kab mob yuav ua rau lub cev, lub paj hlwb thiab nyiaj txiag tseem ceeb rau tus neeg mob.

Cov khoom siv tshuaj muaj zog ntawm Rinvoq yogupadacitinib, uas yog qhov ncauj xaiv thiab thim rov qab JAK1 inhibitor pom thiab tsim los ntawm AbbVie. Nws tau tsim los kho ntau yam kab mob tiv thaiv kab mob. JAK1 yog kinase uas ua lub luag haujlwm tseem ceeb hauv cov kab mob pathology ntawm ntau yam kab mob sib kis.

Tam sim no, Rinvoq kho tus kab mob ulcerative (UC), mob caj dab rheumatoid (RA), mob caj dab psoriatic (PsA), axial spondyloarthritis (axSpA), Crohn's disease (CD), atopic Phase III kev tshawb fawb soj ntsuam ntawm kev sib deev dermatitis (AD) thiab cov kab mob loj heev ntawm tes ( GCA) tab tom ua.

Kev lag luam zoo heev txog Rinvoq' kev cia siab rau kev lag luam. UBS cov kws tshuaj ntsuam yav dhau los kwv yees tias Rinvoq thiab AbbVie' lwm yam monoclonal antibody anti-inflammatory tshuaj Skyrizi yuav muaj qhov muag siab tshaj ntawm 11 txhiab nyiaj daus las Asmeskas las. Ob yam khoom tshiab no yuav tuaj yeem ua rau poob ntawm kev muag khoom los ntawm kev cuam tshuam ntawm biosimilars ntawm AbbVie' cov khoom lag luam tseem ceeb Humira (Humira, adalimumab).