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Kamohelo e Ncha ea FDA Phekolong ea Ulcerative Colitis

ngotsoeng ke mohlophisi

Kajeno AbbVie o phatlalalitse hore Tsamaiso ea Lijo le Lithethefatsi ea US (FDA) e amohetse RINVOQ® (upadacitinib) bakeng sa kalafo ea batho ba baholo ba nang le lefu la ho ruruha ha ulcerative (UC) ba nang le karabelo e sa lekaneng kapa ho se mamelle ntho e le 'ngoe kapa ho feta tumor necrosis factor. (TNF) li-blockers. Tumello ena ea FDA ke pontšo ea pele bakeng sa RINVOQ ho gastroenterology 'me e tšehetsoa ke lintlha tsa ts'ebetso le ts'ireletso ho tsoa ho liphuputso tsa kliniki tse laoloang ke Mokhahlelo oa boraro oa Mokhahlelo oa 3 o sa sebetseng, o sa boneng habeli, o laoloang ke placebo.

"Ho ntse ho e-na le tlhokahalo e sa tsitsang bakeng sa bakuli ba nang le UC e sebetsang ka mokhoa o itekanetseng, ba nang le matšoao a fokolang ao hangata a sa lebelloang le a boima," ho boletse Thomas Hudson, MD, motlatsi oa motlatsi oa mopresidente oa lipatlisiso le nts'etsopele, ofisiri e kholo ea saense, AbbVie. "Ka tumello ea RINVOQ e le khetho e ncha ea phekolo, AbbVie e tsoela pele boeta-pele ba rona ho nts'etsopele ea lipatlisiso tse ka thusang bophelo ba batho ba nang le lefu la ho ruruha ha ulcerative colitis."

Lithuto tse peli tsa induction (U-ACHIEVE le U-ACCOMPLISH) li sebelisitse RINVOQ 45 mg hang ka letsatsi bakeng sa libeke tse 8, ebe 15 mg kapa 30 mg hang ka letsatsi bakeng sa thuto ea tlhokomelo (Tlhokomelo ea U-ACHIEVE) ka libeke tse 52. Ho pholletsa le liteko tsohle tsa kliniki, bakuli ba bangata haholo ba phekoloang ka RINVOQ ba fihletse phomolo ea kliniki libeke tsa 8 le 52, qetello e ka sehloohong e thehiloeng ho mMS: stool frequency subscore (SFS) ≤ 1 le eseng e kholo ho feta Baseline, rectal blood subscore (RBS) = 0 , endoscopy subscore (ES) ea ≤ 1 ntle le friability, ha e bapisoa le placebo. Ho feta moo, liphuputso li ile tsa kopana le lintlha tsohle tsa boemo ba bobeli, ho kenyelletsa ntlafatso ea endoscopic le histologic-endoscopic mucosal improvement (HEMI), hammoho le pholiso ea mahala ea corticosteroid thutong ea tlhokomelo. Liphetho tsohle tsa mantlha le tsa maemo a bobeli li fihlelletse boleng ba p ba <0.001 khahlano le placebo.

"Bakuli ba lefu la ulcerative ba phela le matšoao a sa lebelloang a kang ho eketseha ha setulo le ho tsoa mali, ho ka etsang hore mesebetsi ea letsatsi le letsatsi e be thata," ho boletse Maria T. Abreu, MD, Moprofesa oa Meriana, Moprofesa oa Microbiology le Immunology, Univesithi ea Miami Miller School of Medicine le. Motsamaisi, Crohn's & Colitis Center, Univesithi ea Miami Health System.* “Litekong tsa bongaka, RINVOQ e bontšitse bokhoni ba eona ba ho laola matšoao ka potlako ka libeke tse robeli feela ho bakuli ba bangata le likarabo tse tsitsitseng ka selemo se le seng. Ke lumela hore mefuta ena ea ntlafatso e ka etsa phapang e ntle ho bakuli ba ka. ”

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mohlophisi

Mohlophisi e moholo oa eTurboNew ke Linda Hohnholz. O lula ntlong e kholo ea eTN e Honolulu, Hawaii.

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