US FDA pom zoo qhia tshiab ntawm JAK1 inhibitor Rinvoq: kev kho mob ntawm cov neeg laus thiab cov hluas!

AbbVie tshaj tawm hnub no tias US Food and Drug Administration (FDA) tau pom zoo Rinvoq (upadacitinib) rau kev kho mob ntawm cov menyuam yaus ≥12 xyoo uas muaj refractory nruab nrab - txog - mob hnyav atopic dermatitis (AD) thiab cov neeg laus. Cov tshuaj no tau qhia tshwj xeeb rau: cov neeg laus thiab cov menyuam yaus uas muaj mob nruab nrab mus rau AD uas tsis tau teb rau cov kev kho mob ua ntej thiab cov uas tswj tsis tau zoo nrog lwm cov tshuaj noj los yog txhaj tshuaj (nrog rau cov tshuaj biologics), lossis cov uas tsis pom zoo rau lwm cov tshuaj noj los yog txhaj tshuaj. (≥12 xyoo) cov neeg mob. Hais txog kev siv tshuaj, Rinvoq 15mg, ib hnub ib zaug, tuaj yeem siv rau cov neeg laus hnyav ≥ 40 kg thiab menyuam yaus 12 xyoos thiab laus dua. Hauv cov neeg laus thiab cov menyuam yaus hnub nyoog qis dua 65 xyoos uas tsis tau ua tiav cov lus teb txaus, cov koob tshuaj yuav raug nce mus rau 30 mg ib hnub ib zaug.

Hauv European Union, Rinvoq tau pom zoo thaum Lub Yim Hli 2021 rau kev kho mob ntawm cov neeg laus nrog nruab nrab ntawm - txog - mob hnyav AD thiab menyuam yaus (≥12 xyoo) cov neeg mob tsim nyog rau kev kho mob. Nyob rau hauv cov nqe lus ntawm cov tshuaj, nyob rau hauv cov neeg laus, qhov pom zoo koob tshuaj ntawm Rinvoq yog 15mg los yog 30mg, hais lus ib hnub ib zaug; Hauv cov tub ntxhais hluas (12 - 17 xyoo) thiab cov neeg laus laus 65 xyoo thiab laus dua, qhov pom zoo koob tshuaj Rinvoq yog 15mg, hais lus ib hnub ib zaug. Rinvoq tuaj yeem siv ua ke nrog lossis tsis muaj tshuaj pleev corticosteroids (TCS).

Rinvoq yog qhov ncauj, ib zaug - txhua hnub, xaiv, thim rov qab JAK inhibitor pom zoo hauv EU rau 4 qhov qhia (rheumatoid mob caj dab [RA], psoriatic mob caj dab [PsA], tonic spondylitis [AS], atopic dermatitis [AD]), 3 cov lus qhia ( RA, PsA) tau pom zoo hauv Tebchaws Meskas. Rinvoq 15mg koob tshuaj yog tsim nyog rau kev kho mob ntawm tag nrho cov saum toj no qhia, thaum Rinvoq 30mg tsuas yog haum rau kev kho mob ntawm AD.

AD Ntiaj Teb Ntiaj Teb Phase 3 Kev Sau Npe Cov Ntaub Ntawv

Qhov kev pom zoo ntawm AD yog raws li cov ntaub ntawv txhawb nqa los ntawm ib qho ntawm qhov loj tshaj plaws AD thoob ntiaj teb Phase 3 rau npe ua haujlwm. Qhov kev zov me nyuam suav nrog 3 qhov kev tshawb fawb thoob ntiaj teb (Measure Up 1, Measure Up 2, AD Up) tso npe ntau dua 2500 cov neeg mob uas muaj mob nruab nrab - txog - mob hnyav atopic dermatitis (AD) ntsuas Rinvoq raws li kev kho mob monotherapy (Measure Up 2, AD Up). Kev ua tau zoo thiab kev nyab xeeb ntawm Up 1, Measure Up 2) thiab ua ke cov tshuaj corticosteroids (AD Up) piv rau cov placebo. Thoob plaws tag nrho 3 kev tshawb fawb, co - thawj qhov kawg yog tsawg kawg yog 75 % Kev txhim kho nyob rau hauv Eczema Area thiab Severity Index (EASI75) thiab Validated Investigator's Ntiaj Teb Kev Ntsuam Xyuas rau Atopic Dermatitis (vIGA - AD) tau qhab nia ntawm 0 ntawm lub lim tiam 16 ntawm kev kho mob /1 (ua tiav lossis yuav luag tiav tshem tawm ntawm qhov txhab).

Cov txiaj ntsig tau pom tias hauv txhua qhov kev tshawb fawb Theem 3, ob koob tshuaj ntawm Rinvoq tau ntsib tag nrho cov ntsiab lus tseem ceeb thiab theem nrab: piv nrog cov placebo, cov neeg mob hauv Rinvoq - kho pab pawg ntawm lub lim tiam 16 thiab lwm lub sijhawm cov ntsiab lus (p<{{3} }.001)="" muaj="" kev="" txhim="" kho="" sai="" thiab="" tseem="" ceeb="" hauv="" qhov="" txhab="" tshem="" tawm="" thiab="">

Rinvoq' cov khoom siv tshuaj nquag yogupadacitinib, ib qho kev xaiv ntawm qhov ncauj thiab thim rov qab JAK1 inhibitor pom thiab tsim los ntawm AbbVie uas tau tsim los kho ntau lub cev tiv thaiv kab mob - kho cov kab mob sib kis. JAK1 yog kinase uas ua lub luag haujlwm tseem ceeb hauv pathophysiology ntawm ntau yam kab mob inflammatory.