AbbVie i aso nei ua faʻailoa mai e le US Food and Drug Administration (FDA) ua faʻamaonia le RINVOQ® (upadacitinib) mo le togafitia o tagata matutua o loʻo maua i le maʻaleʻale ma le ogaoga o le ulcerative colitis (UC) o loʻo i ai le le lava o le tali poʻo le le faapalepale i se tasi pe sili atu o le tumo necrosis factor. (TNF) poloka. O lenei faʻamaoniga a le FDA o le faʻamatalaga muamua lea mo le RINVOQ i le gastroenterology ma e lagolagoina e le aoga ma le saogalemu o faʻamatalaga mai le tolu Vaega 3 faʻasolosolo, faʻalua-tauaso, suʻesuʻega faʻapitoa e pulea e le placebo.
"O loʻo tumau pea se manaʻoga e leʻi faʻataunuʻuina mo tagata mamaʻi e feololo i le malosi o le UC, o loʻo mafatia i faʻamaʻi faʻavaivaia e masani ona le mautonu ma mamafa," o le tala lea a Thomas Hudson, MD, sui peresitene sinia o suʻesuʻega ma atinaʻe, ofisa faʻasaienisi sili, AbbVie. "Faatasi ai ma le faʻatagaina o le RINVOQ o se togafitiga fou, o loʻo faʻaauauina e AbbVie la matou taʻitaʻiga i le faʻalauteleina o suʻesuʻega e mafai ona fesoasoani e aʻafia ai olaga o tagata o loʻo nonofo i le ulcerative colitis."
O suʻesuʻega faʻapitoa e lua (U-ACHIEVE ma U-ACCOMPLISH) faʻaaogaina RINVOQ 45 mg faʻatasi i aso taʻitasi mo 8 vaiaso, ona sosoo ai lea ma le 15 mg poʻo le 30 mg faʻatasi i aso taʻitasi mo le suʻesuʻega o le tausiga (U-ACHIEVE tausiga) i le 52 vaiaso. I faʻataʻitaʻiga faʻataʻitaʻiga uma, e sili atu le tele o tagata mamaʻi na togafitia i le RINVOQ na maua le faʻamagaloina o falemaʻi i vaiaso 8 ma 52, o le pito muamua e faʻavae i luga o le mMS: stool frequency subscore (SFS) ≤ 1 ma e le sili atu nai lo le Baseline, rectal bleeding subscore (RBS) = 0 , endoscopy subscore (ES) o le ≤ 1 e aunoa ma se fa'aletonu, fa'atusatusa ile placebo. E le gata i lea, o suʻesuʻega na ausia uma tulaga maualuga lona lua, e aofia ai le faʻaleleia o le endoscopic ma le histologic-endoscopic mucosal improvement (HEMI), faʻapea foʻi ma le faʻamagaloina o le falemaʻi e leai se corticosteroid i le suʻesuʻega tausiga. O fa'ai'uga tulagalua uma ma tulaga lua na maua le p-taua ole <0.001 fa'asaga ile placebo.
"O tagata gasegase o le ulcerative colitis e ola i faʻamaoniga e le mafaamatalaina e pei o le faateleina o le feʻau ma le tafe toto, lea e mafai ona faigata ai gaioiga i aso uma," o le tala lea a Maria T. Abreu, MD, Polofesa o Vailaau Faʻafomaʻi, Polofesa o Microbiology ma Immunology, Iunivesite o Miami Miller School of Medicine ma Fa'atonu, Crohn's & Colitis Center, University of Miami Health System.* “I su'esu'ega fa'afoma'i, na fa'aalia ai e le RINVOQ lona gafatia e vave fa'atonutonu fa'ailoga i le na'o le valu vaiaso mo le tele o gasegase ma tali tumau i le tausaga e tasi. Ou te talitonu o nei ituaiga o faʻaleleia e mafai ona faia se suiga lelei mo oʻu gasegase.
OA MEA E AVEA MAI LENEI TUSI:
- Food and Drug Administration (FDA) has approved RINVOQ® (upadacitinib) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.
- “With the approval of RINVOQ as a new treatment option, AbbVie continues our leadership in advancing research that can help impact the lives of people living with ulcerative colitis.
- Across all clinical trials, significantly more patients treated with RINVOQ achieved clinical remission at weeks 8 and 52, the primary endpoint based on the mMS.
