Litaba tsa mohala

Lintlha tse ncha li bonts'a tšoarelo ea kliniki ho Boloetse ba Crohn

ngotsoeng ke mohlophisi

Janssen Pharmaceutical Companies of Johnson & Johnson kajeno e phatlalalitse liphetho tse ncha ho tsoa tekong ea bongaka ea Phase 2 GALAXI 1 e bonts'ang boholo (liperesente tse 57.4-73) ea batho ba baholo ba nang le lefu la Crohn's (CD) le itekanetseng ho isa ho le matla haholo ba ileng ba phekoloa ka TREMFYA® (guselkumab) fihlellwe ho phokotso ya kliniki (Crohn's Disease Activity Index [CDAI]<150)a ka beke 48.1 Liphetho tsa beke ea 48 li boetse li bontša bongata (57.4-73 lekholong) ea bakuli ba fihletseng phekolo ea meriana ka TREMFYA ba ne ba se na phekolo ea corticosteroid.1,b TREMFYA. ha joale ha e amoheloe bakeng sa kalafo ea CD ho US2 Lintlha tsena li hlahisoa kajeno e le tlhahiso ea molomo (OP24) Kopanong ea bo17 ea European Crohn's and Colitis Organisation (ECCO), e etsahalang hoo e ka bang ho tloha ka la 16-19.1       

"Lintlha tsena tsa libeke tse 48 tsa GALAXI 1 li emela mohato o moholo ho nts'etsopele ea TREMFYA," ho boletse sengoli sa thuto ea Moprofesa Silvio Danese, Mookameli, Gastroenterology le Endoscopy, IRCCS Ospedale San Raffaele le University Vita-Salute San Raffaele, Milan, Italy.c "Ho feta moo, tšoarelo e ne e ka finyelloa bakeng sa bakuli thutong ena ntle le corticosteroids, e leng habohlokoa ho elelloa hore ho qoba tšebeliso ea nako e telele ea steroid ke ntho ea bohlokoa eo u ka e nahanang ha u phekola bakuli bana."

Liphetho tsa beke ea 48 li bonts'itse

• Phekolo ea meriana: karolo ea 63.9 lekholong ea bakuli ba phekoloang ka TREMFYA 200 mg intravenous (IV)/100 mg subcutaneous (SC), karolo ea 73 lekholong e phekoloa ka TREMFYA 600 mg IV/200 mg SC le karolo ea 57.4 lekholong e phekoloa ka TREMFYA 1200 mg IV/200 mg SC e ile ea finyella ts'oaetso ea kliniki.1, a Le STELARA® (ustekinumab), e neng e sebelisoa e le letsoho la litšupiso, karolo ea 58.7 lekholong ea bakuli e ile ea fumana phekolo ea meriana.1 Thuto e ne e sa fuoa matla a ho hlahloba phapang pakeng tsa lihlopha tsa phekolo.

• Corticosteroid-free clinical remission:b 59 lekholong ea bakuli ba tšoaroang ka TREMFYA 200 mg IV/100 mg SC, 71.4 lekholong ba phekoloa ka TREMFYA 600 mg IV/200 mg SC, le karolo ea 55.7 lekholong ba tšoaroa ka TREMFYA 1200 mg IV/200 mg SC, e fihletsoe ho tsoa ho corticosteroid-free clinical remissionb (CDAI <150 mme ha ho na phekolo ea corticosteroid ka beke ea 48). Palo ea bakuli sehlopheng sa STELARA e ne e le karolo ea 58.7 lekholong.1

Kopano ea maeto a lefats'e ka bophara Mmaraka oa maeto oa Lefatše London o khutlile! Mme o memilwe. Ona ke monyetla oa hau oa ho hokahana le basebetsi-'moho le uena indastering, marang-rang a lithaka, ho ithuta lintlha tsa bohlokoa le ho fihlela katleho ea khoebo ka matsatsi a 3 feela! Ngolisa ho boloka sebaka sa hau kajeno! e tla etsahala ho tloha ka la 7-9 Pulungoana 2022. Ngodisa hona joale!

• Phello e tlalehiloeng ke mokuli (PRO)-2: e 57.4 lekholong ea bakuli ba tšoaroang ka TREMFYA 200 mg IV/100 mg SC, karolo ea 69.8 lekholong e tšoaroa ka TREMFYA 600 mg IV/200 mg SC, le 50.8 e tšoaroang ka TREMFYA 1200 mg IV/ 200 mg SC e fihletse pheko ea PRO-2,e Palo ea bakuli sehlopheng sa STELARA e ne e le karolo ea 1 lekholong.46

Lihlopha tsohle tsa TREMFYA tsa litekanyetso nakong ea phekolo ea libeke tsa 48 ho GALAXI 1 li ne li e-na le boitsebiso bo tšoanang ba tšireletso, bo lumellanang le ts'ireletso e tsebahalang ea ts'ireletso bakeng sa TREMFYA ka lipontšo tse amohelehang.1,2 Litefiso tsa bohlokoa tsa ts'ireletso ea ts'ireletso li ne li tšoana le lihlopha tse tharo tsa dosing.1 Ho TREMFYA 200 mg IV/100 mg SC, 600 mg IV/200 mg SC, 1200 mg IV/200 mg SC le lihlopha tsa STELARA, liketsahalo tse mpe (AEs) li etsahetse ka karolo ea 71.2, karolo ea 80.8, karolo ea 69.9, le karolo ea 84.5, ka ho latellana.1 Liketsahalo tse mpe tse mpe (SAEs) li etsahetse liperesente tse 8.2, liperesente tse 6.8, liperesente tse 6.8, le liperesente tse 12.7, ka ho latellana.1 Ha ho mafu a tšoaetsanoang, lefuba kapa lefu le tlalehiloeng sehlopheng sefe kapa sefe. Liphesente tse 1, le liperesente tse 34.2, ka ho latellana.41.1 Tšoaetso e tebileng e etsahetse ho liperesente tse 34.2, liperesente tse 36.6, liperesente tse 1, le liperesente tse 2.7, ka ho latellana.2.7

"Ka boemo bo tsoelang pele ba bophelo bo kang lefu la Crohn, ke habohlokoa ho batlisisa mekhoa e mecha ea phekolo e ka 'nang ea e-ba teng ka kutloisiso ea hore tšoarelo ke sepheo sa ho qetela," ho boletse Jan Wehkamp, ​​MD, Ph.D., Motlatsi oa Motlatsi, Moeta-pele oa Sebaka sa Maloetse a Gastroenterology, Janssen Research & Development, LLC. "Lintlha tsena tse ncha li totobatsa boitlamo bo tsoelang pele ba Janssen ba ho batlisisa mahlale a tsela le TREMFYA ho nts'etsopele ea liphekolo tse ling tse ka sebetsanang le mefuta e mengata ea mafu a amanang le 'mele oa ho itšireletsa mafung joalo ka lefu la Crohn."

Janssen o kile a phatlalatsa liphetho tsa tlhahlobo ea nakoana ea libeke tse 12 le lintlha tse holimo tsa libeke tse 48 tse tsoang thutong ea GALAXI Phase 2. Liteko tsa kliniki tsa Phase 3,4 tse hlahlobang TREMFYA bakeng sa phekolo ea CD e itekanetseng ho isa ho e matla li ntse li tsoela pele le ho ngolisa barupeluoa ka mafolofolo. . Ithute haholoanyane ka Janssen Global Trial Finder.

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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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