Ua hoʻolaha ʻo AbbVie i kēia lā ua ʻae ka US Food and Drug Administration (FDA) i ka RINVOQ® (upadacitinib) no ka mālama ʻana i nā poʻe mākua me ka maʻi maʻi ulcerative colitis (UC) i loaʻa i ka pane kūpono ʻole a i ʻole ka intolerance i hoʻokahi a ʻoi aku ka nui o ka necrosis factor. (TNF) mea pale. ʻO kēia ʻae FDA ka hōʻailona mua no RINVOQ i ka gastroenterology a ua kākoʻo ʻia e ka pono a me ka ʻikepili palekana mai ʻekolu Phase 3 randomized, double-blind, placebo-controlled clinical studies.

"Ke mau nei ka pono ʻole o ka poʻe maʻi me ka UC maʻalahi a koʻikoʻi, ka poʻe i loaʻa i nā hōʻailona debilitating i hiki ʻole ke wānana a kaumaha," wahi a Thomas Hudson, MD, ka pelekikena kiʻekiʻe o ka noiʻi a me ka hoʻomohala ʻana, ka luna ʻepekema nui, AbbVie. "Me ka ʻae ʻana o RINVOQ ma ke ʻano he koho lapaʻau hou, hoʻomau ʻo AbbVie i kā mākou alakaʻi i ka holomua ʻana i ka noiʻi e hiki ke kōkua i ka hopena i ke ola o ka poʻe e noho nei me ka ulcerative colitis."

Ua hoʻohana nā haʻawina induction ʻelua (U-ACHIEVE a me U-ACCOMPLISH) i ka RINVOQ 45 mg hoʻokahi i kēlā me kēia lā no 8 mau pule, a laila 15 mg a i ʻole 30 mg hoʻokahi i kēlā me kēia lā no ka hoʻopaʻa ʻana (U-ACHIEVE mālama) ma o 52 wiki. Ma nā ho'āʻo hoʻokolohua āpau, ʻoi aku ka nui o nā maʻi i mālama ʻia me RINVOQ i loaʻa i ke kala kala ʻana i nā wiki 8 a me 52, ka hopena mua ma muli o ka mMS: stool frequency subscore (SFS) ≤ 1 a ʻaʻole i ʻoi aku ma mua o Baseline, rectal bleeding subscore (RBS) = 0 , endoscopy subscore (ES) o ≤ 1 me ka ʻole friability, hoʻohālikelike ʻia me kahi placebo. Eia kekahi, ua hoʻokō nā haʻawina i nā helu hope lua, me ka hoʻomaikaʻi ʻana i ka endoscopic a me ka histologic-endoscopic mucosal improvement (HEMI), a me ka corticosteroid-free clinical remission i ka mālama mālama. Loaʻa i nā helu hope a me nā kūlana kiʻekiʻe a pau nā p-values o <0.001 me kahi placebo.

"Ke ola nei nā poʻe maʻi maʻi Ulcerative colitis me nā hōʻailona ʻike ʻole e like me ka piʻi ʻana o ka stool frequency a me ke kahe ʻana o ke koko, hiki ke hana i nā hana o kēlā me kēia lā i mea paʻakikī," wahi a Maria T. Abreu, MD, Professor of Medicine, Professor of Microbiology and Immunology, University of Miami Miller School of Medicine a Luna Hoʻokele, Crohn's & Colitis Center, University of Miami Health System.* "Ma nā hoʻokolohua lapaʻau, hōʻike ʻo RINVOQ i kona hiki ke hoʻokele wikiwiki i nā hōʻailona i loko o ʻewalu pule wale nō no nā maʻi he nui a me nā pane hoʻomau i hoʻokahi makahiki. Manaʻo wau hiki i kēia mau ʻano hoʻomaikaʻi ke hoʻololi maikaʻi i kaʻu mau maʻi. "

He aha e lawe ʻia mai kēia ʻatikala:

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.