Boehringer Ingelheim ayaa maanta ku dhawaaqay xog cusub oo ka timid tijaabadii ugu muhiimsanayd ee Wajiga II Effisayil ™ 1, oo lagu soo bandhigay 2022 Akademiyada Maqaarka Maraykanka (AAD) Kulanka Sannadlaha ah ee Boston.
Tijaabada Effisayil ™ 1, oo dhawaan lagu daabacay The New England Journal of Medicine, ayaa muujisay nadiifin weyn oo maqaarka maqaarka ah ee bukaannada qaba cudurka psoriasis ee malaxda guud (GPP) usbuuca ugu horreeya ka dib daaweynta spesolimab iyo placebo. Saamayntan ayaa lagu sii waday toddobaadyada 12, sida laga soo xigtay xogta lagu soo bandhigay AAD, taas oo lagu ogaaday in 84.4% bukaannada aan lahayn finan muuqda ka dib muddada tijaabada ee 12-usbuuc iyo 81.3% waxay lahaayeen maqaar cad / ku dhawaad cad.
"GPP waa cudur maqaarka naadir ah oo aan la saadaalin karin, xanuun badan, iyo nafta halis gelin kara iyada oo aan la helin fursadaha daawaynta ee FDA-ansixisay," ayuu yiri Boni Elewski, MD, baaraha tijaabada iyo Guddoomiyaha, Waaxda maqaarka ee Jaamacadda Alabama School of Medicine. Natiijooyinka lagu soo bandhigay Shirka Sannadlaha ah ee AAD ee sanadkan waxay muujiyeen in waxtarka spesolimab ay sii socoto 12 toddobaad, taasoo bixisa caddayn dheeraad ah oo ku saabsan faa'iidada degdegga ah ee spesolimab ay u keeni karto bukaannada la nool culeyska GPP.
GPP waa naadirka, nafta halis gelin kara cudurka maqaarka neutrophilic, kaas oo ka duwan cudurka psoriasis huurada. Waxaa lagu gartaa qaybo ka mid ah dillaacyada baahsan ee malaxyo xanuun badan, oo nadiif ah (finan aan fiicneyn oo malax ah). Daboolista GPP waxay si weyn u saamaysaa tayada nolosha qofka waxayna u horseedi kartaa dhibaatooyin halis ah oo nafta halis gelisa, oo ay ku jiraan wadne-gabka, kelyaha oo hawl-gab ah, iyo sepsis.
Marka loo eego xogta dheeraadka ah ee lagu soo bandhigay Kulanka Sannadlaha ah ee AAD, nadiifinta maqaarka degdega ah ee lagu arkay usbuuca ugu horreeya ka dib daaweynta spesolimab ayaa guud ahaan joogtaysa koox-hoosaadka bukaanka, oo ay ku jiraan da'da, jinsiga, qowmiyadda, iyo heerka isbeddelka hidda-wadaha IL-36. Sidoo kale, horumarro la taaban karo ayaa lagu muujiyay hal usbuuc gudihiis natiijooyinka bukaan-socodka ee la soo sheegay ee la xiriira xanuunka, daalka, tayada nolosha, iyo calaamadaha maqaarka ka dib daaweynta spesolimab.
Tijaabadii Effisayil™ 1, dhacdooyin aan fiicneyn ayaa lagu soo warramey 66% bukaanada lagu daweeyey spesolimab iyo 56% kuwa hela placebo kadib usbuuca ugu horeeya. Infekshannada waxaa soo sheegay 17% iyo 6% bukaannada ku jira kooxaha spesolimab iyo placebo, siday u kala horreeyaan (usbuuca koowaad). Dhacdooyin halis ah ayaa laga soo sheegay 6% bukaanada lagu daweeyay spesolimab (usbuuca koowaad). Laba bukaan oo helay spesolimab ayaa la soo sheegay inay dareen-celin daroogo leh oo eosinophilia leh iyo calaamadaha nidaamka.
"Xogtan dheeraadka ah, waxaan heleynaa sawir buuxa oo spesolimab ah sida suurtogalnimada daaweynta fasalka koowaad ee loo ansixiyey bukaannada GPP," ayuu yiri Matt Frankel, MD, Madaxweyne Ku-Xigeenka, Horumarinta Caafimaadka iyo Arrimaha Caafimaadka, Daryeelka Gaarka ah, Boehringer Ingelheim . "GPP waxay saameyn weyn ku leedahay nolosha bukaanka, waxaana naga go'an inaan u keeno spesolimab bukaannada sida ugu dhaqsaha badan."
Maamulka Cunnada iyo Dawooyinka ee Maraykanka (FDA) ayaa aqbashay Codsiga Shatiga Bayolojiga (BLA) waxayna siisay Dib-u-eegis Mudnaan leh oo loogu talagalay spesolimab ee daawaynta ololka GPP. FDA waxay siisay spesolimab Magacaabista Dawooyinka Agoonta ee daawaynta GPP iyo Breakthrough Therapy Designation for spesolimab ee daawaynta ololka GPP ee dadka waaweyn.
