Ua hoʻolaha ka Janssen Pharmaceutical Companies o Johnson & Johnson i kēia lā i nā hopena hou mai ka Phase 2 GALAXI 1 hoʻokolohua hoʻokolohua e hōʻike ana i ka hapa nui (57.4-73 pakeneka) o nā pākeke me ka maʻi Crohn's maʻi a koʻikoʻi (CD) i mālama ʻia me TREMFYA® (guselkumab) loaʻa i ke kala kala ʻana (Crohn's Disease Activity Index [CDAI]<150)a i ka pule 48.1 Hōʻike pū ka hopena o ka pule 48 i ka hapa nui (57.4-73 pakeneka) o nā maʻi i loaʻa i ke kala kala me TREMFYA ʻaʻole i loaʻa i ka lāʻau corticosteroid.1,b TREMFYA ʻAʻole i ʻae ʻia i kēia manawa no ka mālama ʻana i ka CD ma ka US2 Ke hōʻike ʻia nei kēia mau ʻikepili i kēia lā ma ke ʻano he hōʻike waha (OP24) ma ka 17th Congress of the European Crohn's and Colitis Organization (ECCO), e hoʻomaka ana mai Pepeluali 16-19.1
"ʻO kēia mau 48-week GALAXI 1 data e hōʻike nei i kahi hana nui i ka hoʻomohala ʻana o TREMFYA," wahi a ka mea kākau noiʻi ʻo Professor Silvio Danese, Luna Hoʻokele, Gastroenterology a Endoscopy, IRCCS Ospedale San Raffaele a me University Vita-Salute San Raffaele, Milan, Italy.c "Eia hou, hiki ke kala ʻia no nā poʻe maʻi i kēia haʻawina me ka ʻole o corticosteroids, he mea nui ia e hoʻomaopopo i ka pale ʻana i ka hoʻohana ʻana i ka steroid lōʻihi he mea koʻikoʻi i ka wā e mālama ai i kēia mau maʻi."
Hōʻike nā hopena pule 48
• Ke kala kala maʻi: he 63.9 pakeneka o nā maʻi i mālamaʻia me TREMFYA 200 mg intravenous (IV) / 100 mg subcutaneous (SC), 73 pakeneka i mālamaʻia me TREMFYA 600 mg IV / 200 mg SC a me 57.4 pakeneka i mālamaʻia me TREMFYA 1200 mg IV / 200 mg Ua loaʻa iā SC ke kala kala lapaʻau.1,a Me STELARA® (ustekinumab), i hoʻohana ʻia ma ke ʻano he lima kuhikuhi, 58.7 pakeneka o nā maʻi i loaʻa i ke kala kala.
• Corticosteroid-free clinical kala:b 59 pakeneka o nā maʻi i mālamaʻia me TREMFYA 200 mg IV / 100 mg SC, 71.4 pakeneka i mālamaʻia me TREMFYA 600 mg IV / 200 mg SC, a me 55.7 pakeneka i mālamaʻia me TREMFYA 1200 mg IV / 200 mg SC, loaʻa ka corticosteroid-free clinical remissionb (CDAI<150 a ʻaʻohe corticosteroid therapy i ka pule 48). ʻO ka hapa o nā maʻi ma ka hui STELARA he 58.7 pakeneka.1
• ʻO ka hopena i hōʻikeʻia i ka maʻi (PRO)-2 kala:e 57.4 pakeneka o nā maʻi i mālamaʻia me TREMFYA 200 mg IV / 100 mg SC, 69.8 pakeneka i mālamaʻia me TREMFYA 600 mg IV / 200 mg SC, a me 50.8 i mālamaʻia me TREMFYA 1200 mg IV / 200 mg SC i loaʻa i ka PRO-2 kala.1,e ʻO ka hapa o nā maʻi ma ka hui STELARA he 46 pakeneka.1
ʻO nā pūʻulu hōʻailona TREMFYA a pau i ka manawa mālama 48-week ma GALAXI 1 heʻikepili palekana like, e like me kaʻike palekana iʻikeʻia no TREMFYA ma nā hōʻailona i'āponoʻia. 1,2 mg IV / 1 mg SC, 200 mg IV / 100 mg SC, 600 mg IV / 200 mg SC a me STELARA pūʻulu, nā hopena ʻino (AEs) i loaʻa i 1200 pākēneka, 200 pākēneka, 71.2 pākēneka, a me 80.8 pākēneka.69.9 He 84.5 pakeneka, he 1 pakeneka, he 8.2 pakeneka, a he 6.8 pakeneka.6.8 Aole i hoikeia na ma'i ma'i opportunistic, ma'i ma'i ma'i, a make paha ma kekahi hui.12.7 Ua loaa na ma'i ma 1 pakeneka, 1 pakeneka 34.2 pākēneka, a me 41.1 pākēneka.34.2 Ua loaʻa nā maʻi koʻikoʻi ma 36.6 pākēneka, 1 pākēneka, 2.7 pākēneka, a me 2.7 pākēneka, pākahi.1.4
"Me kahi kūlana holomua o ke ola e like me ka maʻi o Crohn, he mea koʻikoʻi ka noiʻi ʻana i nā koho lapaʻau hou me ka hoʻomaopopo ʻana ʻo ke kala ʻana ka pahuhopu hope loa," wahi a Jan Wehkamp, MD, Ph.D., Hope Pelekikena, Gastroenterology Disease Area Leader, Janssen Research & Development, LLC. "Ke hōʻike nei kēia mau ʻikepili hou i ka hoʻomau ʻana o Janssen i ka noiʻi ʻana i ka ʻepekema ala me TREMFYA i ka hoʻomohala ʻana i nā lāʻau lapaʻau ʻē aʻe e hiki ke hoʻoponopono i ke ʻano multifaceted o nā maʻi immune-mediated e like me ka maʻi o Crohn."
Ua hoʻolaha mua ʻo Janssen i nā hopena mai ka 12-week interim analysis and top-line 48-week data mai ka GALAXI Phase 2 study.3,4 Phase 3 clinical trials e loiloi ana iā TREMFYA no ka mālama ʻana i ka CD maʻalahi a koʻikoʻi ikaika ke hoʻomau nei a hoʻopaʻa inoa i nā mea komo. . E aʻo hou ma o ka Janssen Global Trial Finder.
