Itsva data inoratidza kuregererwa kwekiriniki muCrohn's Disease

Makambani eJanssen Pharmaceutical Companies aJohnson & Johnson nhasi azivisa mitsva kubva kuChikamu chechipiri GALAXI 2 chekiriniki yekuedza inoratidza ruzhinji (1-57.4 muzana) yevakuru vane chirwere cheCrohn's (CD) zvine mwero kusvika kune chakanyanya kushanda vakarapwa TREMFYA® (guselkumab) yakawana kuregererwa kwekliniki (Crohn's Disease Activity Index [CDAI] <73)a pavhiki 150 Vhiki ye48.1 migumisiro inoratidzawo ruzhinji (48-57.4 muzana) yevarwere vakawana kuregererwa kwekliniki ne TREMFYA vakanga vasina corticosteroid kurapwa.73,b TREMFYA. haisati yatenderwa kurapwa kweCD muUS1 Iyi data iri kuratidzwa nhasi sehurukuro yemuromo (OP2) pa24th Congress yeEuropean Crohn's and Colitis Organisation (ECCO), iri kuitika kubva muna Kukadzi 17-16       

"Idzi 48-vhiki GALAXI 1 data inomiririra danho rakakura mukuvandudzwa kweTREMFYA," akadaro munyori wekudzidza Purofesa Silvio Danese, Director, Gastroenterology uye Endoscopy, IRCCS Ospedale San Raffaele uye University Vita-Salute San Raffaele, Milan, Italy. "Uyezve, kuregererwa kwakagoneka kune varwere muchidzidzo ichi pasina corticosteroids, izvo zvakakosha kucherechedza sekudziviswa kwekushandisa kwenguva refu steroid chinhu chakakosha kufunga pakurapa varwere ava."

Vhiki 48 zvabuda zvakaratidza

• Clinical remission: a 63.9 muzana yevarwere vakarapwa ne TREMFYA 200 mg intravenous (IV)/100 mg subcutaneous (SC), 73 muzana vakarapwa ne TREMFYA 600 mg IV/200 mg SC uye 57.4 muzana vakarapwa ne TREMFYA 1200 mg IV/200 mg SC yakawana kuregererwa kwekliniki.1, a Ne STELARA® (ustekinumab), iyo yakashandiswa sechinyorwa chekutaura, 58.7 muzana yevarwere vakawana kuregererwa kwechipatara.1 Chidzidzo chacho chakanga chisina simba rekuongorora kusiyana pakati pemapoka ekurapa.1

• Corticosteroid-free clinical remission: b 59 muzana yevarwere vakarapwa neTREMFYA 200 mg IV/100 mg SC, 71.4 muzana vakarapwa neTREMFYA 600 mg IV/200 mg SC, uye 55.7 muzana vakarapwa neTREMFYA 1200 mg IV/200 mg SC, yakawana corticosteroid-isina kliniki remissionb (CDAI <150 uye hapana corticosteroid therapy pavhiki 48). Huwandu hwevarwere muboka reSTELARA hwaive 58.7 percent.1

• Patient-Reported Outcome (PRO)-2 kuregererwa: e 57.4 muzana yevarwere vakabatwa neTREMFYA 200 mg IV/100 mg SC, 69.8 muzana vakabatwa neTREMFYA 600 mg IV/200 mg SC, uye 50.8 vakabatwa neTREMFYA 1200 mg IV/ 200 mg SC yakawana PRO-2 remission.1,e Chiyero chevarwere muboka reSTELARA chaive 46 muzana.1

Zvose TREMFYA mapoka emadhora panguva ye48-vhiki yekurapa muGALAXI 1 yakanga ine data yakaenzana yekuchengetedza, inopindirana nehuwandu hwekuchengetedzwa kweTREMFYA muzviratidzo zvakagamuchirwa.1,2 Zviitiko zvakakosha zvekuchengetedza zviitiko zvakafanana pakati pemapoka matatu ekuderedza.1 MuTREMFYA 200 mg IV / 100 mg SC, 600 mg IV / 200 mg SC, 1200 mg IV / 200 mg SC uye mapoka eSTELARA, zviitiko zvakashata (AEs) zvakaitika mu71.2 muzana, 80.8 muzana, 69.9 muzana, uye 84.5 muzana, maererano.1. Zviitiko zvakakomba zvakashata (SAEs) zvakaitika mu8.2 muzana, 6.8 muzana, 6.8 muzana, uye 12.7 muzana, maererano. 1 muzana, uye 1 muzana, zvakateerana.34.2 Zvirwere zvakakomba zvakaitika mu41.1 muzana, 34.2 muzana, 36.6 muzana, uye 1 muzana, zvichiteerana.2.7

"Nehupenyu hwehupenyu hunoramba huchifambira mberi sechirwere cheCrohn, zvakakosha kuti tiongorore nzira itsva dzokurapa nekunzwisisa kuti kuregererwa ndicho chinangwa chikuru," akadaro Jan Wehkamp, ​​MD, Ph.D., Mutevedzeri weMutungamiri, Gastroenterology Disease Area Leader. Janssen Research & Development, LLC. "Idzi data nyowani dzinosimbisa kuzvipira kwaJanssen kuferefeta nzira sainzi neTREMFYA mukuvandudza mamwe marapirwo anogona kugadzirisa huwandu hwakawanda hwezvirwere zvinodzivirira zvirwere seCrohn's disease."

Janssen akambozivisa mhedzisiro kubva ku12-vhiki yenguva yekuongorora uye yepamusoro-mutsara 48-vhiki data kubva kuGALAXI Phase 2 kudzidza.3,4 Phase 3 kiriniki miedzo inoongorora TREMFYA yekurapwa kwepakati kusvika kune yakanyanya kushanda CD irikuenderera uye ichishingairira kunyoresa vatori vechikamu. . Dzidza zvakawanda kuburikidza neJanssen Global Trial Finder.