AbbVie i aso nei na faʻasalalau taunuʻuga lelei pito i luga mai U-EXCEL, o se suʻesuʻega faʻaulufaleina o le Vaega 3, e faʻaalia ai le upadacitinib (45 mg tasi i aso taʻitasi) ausia uma pito i tua o le remissiona falemaʻi, b ma le tali endoscopic i le vaiaso 12.1 U-EXCEL o le lona lua o le lua Vaega 3 induction suʻesuʻega e iloilo ai le saogalemu ma le aoga o le upadacitinib i tagata matutua o loʻo i ai le faʻamaʻi faʻapitoa i le ogaoga o le maʻi o Crohn o loʻo i ai se tali le lelei poʻo le le faapalepale i togafitiga masani poʻo meaola.1
O le U-EXCEL na aofia ai le pito muamua ma le pito sili lona lua e pei o le U-EXCEED, faʻatasi ai ma le faʻamagaloina o le falemaʻi e fuaina e le Crohn's Disease Activity Index (CDAI) ma e ala i faʻamaʻi na lipotia mai e le maʻi o le faʻasolosolo taimi / tiga o le manava (SF / AP).1 A sili atu le tele o tagata gasegase na togafitia i le 12-vaiaso induction regimen o upadacitinib 45 mg i aso uma na ausia le faʻamagaloga ile CDAI ile vaiaso 12 faʻatusatusa ile placebo (49 pasene versus 29 pasene; p<0.0001). SF / AP (1 pasene i le upadacitinib-togafitiga maʻi ma 51 pasene i placebo-togafitiga maʻi; p<22) .0.0001 I le vaiaso 1, o se vaega sili atu o tagata mamaʻi na togafitia i le upadacitinib 12 mg na maua le tali endoscopic faʻatusatusa i le vaega placebo ( 45 pasene ma le 46 pasene; p<13).0.0001
E ogatasi ma taunuʻuga mai le suʻesuʻega faʻauluina U-EXCEED, o se vaega sili atu le maualuga o tagata mamaʻi na mauaina le upadacitinib 45 mg na ausia foi le faʻamagaloina o le falemaʻi e leai se steroid i le CDAI ma le SF / AP faʻatusatusa i le placebo i le vaiaso 12 i maʻi o loʻo ave corticosteroids i le amataga.1 Early faʻaleleia o faʻamaoniga e fuaina e le CR-100 (faʻamatalaina o le faʻaitiitia o le CDAI ≥100 points mai le laina faʻavae) i le vaiaso lua faʻapea foʻi ma le faʻamagaloina o falemaʻi i le vaiaso fa na ausia foi e se vaega sili atu le maualuga o tagata mamaʻi na mauaina le upadacitinib 45 mg.1
I le 12-vaiaso, lua-tauaso, placebo-pulea vaitaimi, o le talaaga saogalemu o le upadacitinib 45 mg sa ogatasi ma le talaaga saogalemu na matauina i suʻesuʻega talu ai i faʻamatalaga, e aunoa ma se lamatiaga fou o le saogalemu na matauina. ma le anemia i le upadacitinib 1 mg group.45 Tulaga leaga na tutupu i le 1 pasene o tagata mamaʻi i le upadacitinib 6.9 mg faʻatusatusa i le 45 pasene o tagata gasegase i le placebo group.6.8 O fua faatatau o faʻamaʻi pipisi e 1 pasene i tagata gasegase na togafitia i le upadacitinib 1.1. mg ma le 45 pasene i latou na mauaina placebo.1.7 Herpes zoster na lipotia i le 1 pasene o tagata gasegase na togafitia i le upadacitinib 2.9 mg, o mataupu uma e le afaina.45 E leai ni mataupu o le faʻasalaga o le gastrointestinal perforation poʻo le oti i le vaitaimi o le placebo-controlled period.1 E tasi le mataupu o le fa'amasinoga autu o le cardiovascular event (MACE) na lipotia i le placebo group.1
O ma'i na i ai i luga o le upadacitinib 45 mg ma e le'i ausia le tali atu i le falema'i i le vaiaso 12 sa aofia i se fa'aopoopoga 12-vaiaso togafitiga fa'atasi ma le upadacitinib 30 mg.1 I lenei vaega, e to'atasi le ma'i na maliu i le COVID-19.1 O ma'i na i ai i le placebo ma faia. e leʻi ausia le tali atu a le falemaʻi i le vaiaso 12 na aofia ai i le 12-vaiaso togafitiga faʻatasi ma le upadacitinib 45 mg.1 I totonu o nei gasegase, sa i ai se tasi o mataupu o le faʻasalaga gastrointestinal perforation.1
I totonu o le U-EXCEL, e leai se togafitiga-faʻaalia mataupu o MACE faʻamasinoina, faʻamaʻi poʻo le faʻamaonia o le thromboembolic venous mea na lipotia i tagata mamaʻi ile togafitiga upadacitinib.1
O fa'ai'uga atoa mai le su'esu'ega a le U-EXCEL o le a tu'uina atu i fono fa'afoma'i o lo'o loma ma fa'asalalauina i totonu o se api talaaga fa'afoma'i su'esu'e a tupulaga. O fa'ai'uga pito i luga mai le Vaega 3 o le su'esu'ega fa'auluuluga muamua, U-EXCEED, na fa'asalalauina ia Tesema 2021 ma o lo'o fa'aauau pea le su'esu'ega fa'aleleia mo mea uma e lua. O le faʻaaogaina o le upadacitinib i le faʻamaʻi o Crohn e le faʻatagaina ma o lona saogalemu ma le aoga e leʻi iloiloina e pulega faʻatonutonu.
dSteroid-leai se fa'amagaloina falema'i ua faauigaina o le fa'amagaloga fa'ama'i (i le CDAI <150, po'o le SF/AP ma le averesi o aso ta'itasi SF ≤2.8 ma e le sili atu le leaga nai lo le fa'avae ma le averesi AP aso ta'itasi sikoa ≤1 ae le sili atu le leaga nai lo le fa'avae) ma le fa'agataina o le fa'aogaina o le corticosteroid. i totonu o tagata gasegase o loʻo ave corticosteroids i le laina faʻavae.
OA MEA E AVEA MAI LENEI TUSI:
- Consistent with results from the U-EXCEED induction study, a significantly higher proportion of patients receiving upadacitinib 45 mg also achieved steroid-free clinical remissiond per CDAI and per SF/AP compared to placebo at week 12 among patients taking corticosteroids at baseline.
- 1 A significantly greater proportion of patients treated with a 12-week induction regimen of upadacitinib 45 mg daily achieved clinical remission per CDAI at week 12 compared to placebo (49 percent versus 29 percent.
- 1 Early symptom improvement measured by CR-100 (defined as reduction of CDAI ≥100 points from baseline) at week two as well as clinical remission at week four were also achieved by a significantly higher proportion of patients receiving upadacitinib 45 mg.
