Odwala a Crohn's Disease Akuwonetsa Zotsatira Zabwino

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Written by Linda Hohnholz

AbbVie lero adalengeza zotsatira zabwino zapamwamba kuchokera ku U-EXCEL, kafukufuku wowonjezera wa Phase 3, wowonetsa upadacitinib (45 mg kamodzi patsiku) adakwaniritsa zomaliza zachipatala, b ndi endoscopic responsec pa sabata 12.1 U-EXCEL ndi yachiwiri mwa ziwiri. Phase 3 induction maphunziro kuti ayese chitetezo ndi mphamvu ya upadacitinib mwa akuluakulu omwe ali ndi matenda a Crohn omwe anali ndi vuto losakwanira kapena osalolera mankhwala ochiritsira kapena a biologic.1

U-EXCEL inaphatikizapo mapeto oyambirira ndi ofunikira achiwiri monga U-EXCEED, ndi chikhululukiro chachipatala choyesedwa ndi Crohn's Disease Activity Index (CDAI) komanso ndi zizindikiro za odwala omwe amamva kupweteka kwa chimbudzi / m'mimba (SF / AP) .1 A. kuchuluka kwakukulu kwa odwala omwe amathandizidwa ndi 12-sabata induction regimen ya upadacitinib 45 mg tsiku lililonse apindula kukhululukidwa kwachipatala pa CDAI pa sabata 12 poyerekeza ndi placebo (peresenti ya 49 motsutsana ndi 29 peresenti; p <0.0001) .1 Zotsatira zofananazo zinawonedwa ndi chikhululukiro chachipatala pa SF / AP (peresenti ya 51 mwa odwala omwe amathandizidwa ndi upadacitinib poyerekeza ndi 22 peresenti ya odwala omwe amathandizidwa ndi placebo; p <0.0001) .1 Pa sabata 12, chiwerengero chachikulu cha odwala omwe amathandizidwa ndi upadacitinib 45 mg anapeza endoscopic yankho poyerekeza ndi gulu la placebo. 46 peresenti motsutsana ndi 13 peresenti; p<0.0001).1

Mogwirizana ndi zotsatira za phunziro la U-EXCEED induction induction, chiwerengero chapamwamba kwambiri cha odwala omwe amalandila upadacitinib 45 mg adapindulanso ndi steroid-free clinic remission pa CDAI ndi SF / AP poyerekeza ndi placebo pa sabata 12 pakati pa odwala omwe amatenga corticosteroids kumayambiriro.1 Poyambirira. Kusintha kwa zizindikiro zoyezedwa ndi CR-100 (kutanthauzidwa ngati kuchepetsa CDAI ≥100 mfundo kuchokera pachiyambi) pa sabata lachiwiri komanso kukhululukidwa kwachipatala pa sabata lachinayi kunapindulanso ndi chiwerengero chapamwamba cha odwala omwe amalandila upadacitinib 45 mg.1

Pa nthawi ya masabata a 12, akhungu awiri, olamulidwa ndi placebo, mbiri ya chitetezo cha upadacitinib 45 mg inali yogwirizana ndi mbiri ya chitetezo yomwe inawonedwa m'maphunziro apitalo pazisonyezero zonse, popanda zoopsa zatsopano zotetezedwa. ndi kuchepa kwa magazi m'gulu la upadacitinib 1 mg. 45 Zochitika zoopsa kwambiri zinachitika mu 1 peresenti ya odwala mu gulu la upadacitinib 6.9 mg poyerekeza ndi 45 peresenti ya odwala omwe ali m'gulu la placebo. mg ndi 6.8 peresenti mwa omwe adalandira placebo. 1 Herpes zoster inanenedwa mu 1.1 peresenti ya odwala omwe amachiritsidwa ndi upadacitinib 45 mg, milandu yonse inali yopanda phindu. Mlandu umodzi wa zochitika zazikulu za mtima (MACE) zomwe zinaweruzidwa zinanenedwa mu gulu la placebo.1.7

Odwala omwe anali pa upadacitinib 45 mg ndipo sanapeze yankho lachipatala pa sabata 12 adaphatikizidwa mgulu lina lachithandizo la milungu 12 lomwe lili ndi upadacitinib 30 mg. osakwaniritsa kuyankha kwachipatala pa sabata la 1 adaphatikizidwa mu gulu la mankhwala a 19.1-masabata ndi upadacitinib 12 mg.12 Pakati pa odwalawa, panali vuto limodzi lachigamulo cha kuphulika kwa m'mimba.45

Mu U-EXCEL, palibe milandu yodziwikiratu ya chithandizo cha MACE yoweruzidwa, zilonda zam'mimba kapena venous thromboembolic zomwe zidanenedwa mwa odwala omwe adalandira chithandizo cha upadacitinib.

Zotsatira zonse za kafukufuku wa U-EXCEL zidzaperekedwa pamisonkhano yachipatala yomwe ikubwera ndikusindikizidwa mumagazini yachipatala yowunikiridwa ndi anzawo. Zotsatira zapamwamba za gawo lachitatu la kafukufuku woyamba wophunzitsira, U-EXCEED, zidalengezedwa mu Disembala 3 ndipo kafukufuku wosamalira onse awiri akupitilira. Kugwiritsa ntchito upadacitinib mu matenda a Crohn sikuvomerezedwa ndipo chitetezo chake ndi mphamvu zake sizinawunikidwe ndi oyang'anira.

Kukhululukidwa kwachipatala kwa dSteroid kumatanthauzidwa ngati kukhululukidwa kwachipatala (pa CDAI <150, kapena pa SF/AP ndi pafupifupi tsiku lililonse SF ≤2.8 ndipo osati choipa kuposa chiyambi ndi chiwerengero cha AP tsiku lililonse ≤1 ndipo osati choipa kuposa chiyambi) ndi kusiya kugwiritsa ntchito corticosteroid mwa odwala omwe amatenga corticosteroids poyambira.

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Linda Hohnholz

Mkonzi wamkulu kwa eTurboNews zochokera ku eTN HQ.

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