European Union Pom Zoo Xeljanz (tofacitinib): Kev Kho Mob Ntawm 2 Yam Me Me Ntawm Cov Menyuam Yaus Menyuam Yaus Mob Hlwb (JIA)!

Pfizer tsis ntev los no tshaj tawm tias European Commission (EC) tau pom zoo qhov ncauj JAK inhibitor Xeljanz (tofacitinib) rau siv rau menyuam yaus thiab tub ntxhais hluas ≥2 xyoos uas tsis muaj lus teb txaus rau cov kab mob yav dhau los hloov kho tshuaj antirheumatic (DMARD). Active polyarticular juvenile idiopathic arthritis (pcJIA) thiab cov hluas psoriatic mob caj dab (PsA). Kev pom zoo suav nrog 2 hom tshuaj ntawm Xeljanz, ib qho yog ntsiav tshuaj thiab lwm qhov yog kev daws qhov ncauj, tswj hwm raws li lub cev hnyav.

Nws tsim nyog hais tias Xeljanz yog thawj zaug thiab tsuas yog JAK inhibitor pom zoo rau kev kho mob polyarticular JIA thiab PSA menyuam yaus hauv Europe. Cov tshuaj tau pom zoo rau 4 qhov qhia hauv EU thiab yog txhua yam JAK inhibitors. Qhov feem ntau muaj xws li: (1) Cov neeg laus uas muaj mob hnyav rau mob rheumatoid mob caj dab (RA); (2) Cov neeg laus uas mob psoriatic mob caj dab (PsA); (3) kev ua haujlwm nruab nrab mus rau mob hnyav Cov neeg laus uas muaj tus kab mob plab (UC); (3) Cov neeg mob uas muaj mob polyarticular menyuam yaus idiopathic mob caj dab (pcJIA) thiab menyuam yaus PsA hnub nyoog 2 xyoos thiab laus dua.

Ib qho ntxiv, European Commission (EC) tseem tau pom zoo Xeljanz txuas ntxiv-tso 11mg ib zaug ib hnub rau kev kho mob rau cov neeg laus uas muaj PsA nquag uas tsis txaus lossis tsis txaus siab rau methotrexate (MTX) lossis lwm yam DMARDs. Qhov kev kho ib hnub ib hnub no yog lwm txoj hauv kev pom zoo tam sim no Xeljanz 5mg ob zaug-ib hnub kho PsA.

Hauv Tebchaws Meskas, Xeljanz tau pom zoo thaum lub Cuaj Hli 2020. Nws yog thawj zaug thiab tsuas yog JAK inhibitor pom zoo rau kev kho mob pcJIA. Kev pom zoo suav nrog 2 hom tshuaj ntawm Xeljanz, ib qho yog ntsiav tshuaj thiab lwm qhov yog qhov ncauj Qhov kev daws teeb meem raug tswj hwm raws li lub cev hnyav.

Ana Paula Carvalho, Tus Thawj Kav Tebchaws hauv cheeb tsam ntawm Pfizer Kev Tsim Kho Kev Lag Luam Thoob Ntiaj Teb ntawm Kev Ua Phem thiab Kev Tiv Thaiv Kab Mob, hais tias: "Ntau tus neeg mob nrog polyarticular cov menyuam yaus mob caj dab idiopathic mob caj dab (pcJIA) thiab menyuam yaus psoriatic mob caj dab (PsA) xav tau kev txhaj tshuaj thaum kho. Lossis kev tso ntshav, qhov no yog qhov nyuaj rau cov menyuam no thiab lawv cov neeg saib xyuas. Raws li Pfizer txuas ntxiv mus rau kev tshawb fawb tshawb fawb thiab nkag siab txog Xeljanz thiab lwm yam tshuaj, peb zoo siab muab cov kev xaiv tshiab no hauv European Union. Xeljanz twb tau nyob hauv ntau qhov chaw thoob ntiaj teb Kev Tshawb Fawb tau ua hauv ntau dua 50 qhov kev sim tshuaj hauv cov phiaj xwm kho mob."

JIA yog kab mob ua rau mob tsis paub txog keeb kwm, txhais tias yog mob caj dab uas pib ua ntej hnub nyoog 16 xyoos thiab kav ntev li 6 lub lis piam. Polyarticular JIA thiab PSA menyuam yaus yog cov subtypes ntawm JIA. JIA subtype ntau yam tshwj xeeb yog mob caj dab ntawm 5 lossis ntau dua pob qij txha, uas cuam tshuam rau pob qij txha me me ntawm txhais tes thiab taw, thiab cov pob qij txha loj xws li hauv caug, lub duav, thiab pob taws. Cov neeg mob uas muaj menyuam yaus PsA subtypes muaj cov tsos mob sib koom thiab ua pob tawv nqaij. Nws tau kwv yees tias JIA cuam tshuam txog kwv yees li 60,000 tus menyuam yaus hauv Tebchaws Europe.

Cov neeg laus PsA yog tus kab mob ua rau lub cev tsis muaj zog tiv thaiv kab mob uas tuaj yeem suav nrog kev mob ntawm cov pob qij txha ib puag ncig, cov leeg, lossis tawv nqaij. PsA tuaj yeem suav nrog ntau yam tsos mob xws li mob sib koom thiab txhav, o ntawm cov ntiv taw thiab/lossis ntiv tes, thiab txo qis ntawm cov lus tsa suab.

Kev pom zoo ntawm pcJIA thiab cov tub ntxhais hluas PsA qhia yog ua raws cov txiaj ntsig ntawm theem tseem ceeb 3 kev tshawb fawb soj ntsuam hauv cov neeg mob pcJIA thiab lwm yam JIA subtypes (suav nrog cov menyuam yaus PsA). Txoj kev tshawb no suav nrog 2 lub sijhawm kho: daim ntawv qhib 18-lub lim tiam, lub sijhawm ua haujlwm (suav nrog 225 tus neeg mob), tom qab ntawd 26-lub lim tiam ob-qhov muag tsis pom, tswj cov tshuaj placebo, tsis siv neeg, ncua sijhawm (suav nrog 173 tus neeg mob), thiab tag nrho cov voj voog Rau 44 lub lis piam. Txoj kev tshawb no tshuaj xyuas qhov ua tau zoo thiab nyab xeeb ntawm Xeljanz ua 5 mg ntsiav tshuaj lossis raws li 1 mg/mL kev daws qhov ncauj (daws qhov ncauj rau cov neeg mob lub cev hnyav< 40="" kg)="" ob="" zaug="" ib="" hnub,="" nrog="" rau="" tus="" neeg="" mob="" nyiam="">

Cov txiaj ntsig tau pom tias txoj kev tshawb fawb mus txog qhov kawg qhov kawg: ntawm cov neeg mob uas ua tiav JIA ACR30 kev zam txim thaum kawg ntawm lub sijhawm ua thawj coj, nyob rau lub lim tiam 44, piv nrog cov pab pawg placebo (55%, n/N=47/85), pawg Xeljanz (31 %, n/N=27/88) Kev faib ua feem ntawm cov neeg mob uas muaj kab mob flares (mob hnyav) tau raug txheeb cais tsawg (p=0.0007). Kev ua tau zoo ntawm cov menyuam yaus PsA subtype cov neeg mob zoo ib yam li ntawm pcJIA cov neeg mob. Hauv txoj kev tshawb fawb no, kab mob kis tau piav raws li: tom qab randomization, tsawg kawg 3 ntawm 6 qhov sib txawv hauv JIA ACR cov txheej txheem teeb tsa tsis zoo ≥30%, thiab tsis muaj JIA qhov tseem ceeb tshem tawm cov ntsiab lus hloov pauv ≥30%. Zuag qhia tag nrho, hom kev phom sij tsis haum tshuaj hauv pcJIA cov neeg mob thiab cov menyuam yaus PsA cov neeg mob tau zoo ib yam nrog kev paub txog kev nyab xeeb ntawm Xeljanz.

Tofacitinib cov txheej txheem ntawm kev nqis tes ua: inhibition of JAK (daim duab los ntawm daim ntawv PMID: 24883332)

Cov khoom siv tshuaj muaj zog ntawm Xeljanz yog tofacitinib, uas yog qhov ncauj JAK inhibitor uas tuaj yeem xaiv txwv JAK kinase thiab thaiv txoj kev JAK/STAT, uas yog lub teeb liab hloov pauv txoj kev txhawb los ntawm cytokines thiab koom nrog hauv kev nthuav dav ntawm tes. , Kev sib txawv, apoptosis thiab kev tswj hwm kev tiv thaiv kab mob thiab ntau lwm yam txheej txheem lom tseem ceeb.