Ulwazi olutsha ngonyango lwamadangatya eGPP

U-Boehringer Ingelheim ubhengeze namhlanje idatha entsha evela kulingo olubalulekileyo lweSigaba sesi-II se-Effisayil™ 1, ezinikezelwe kwiNtlanganiso yoNyaka ka-2022 ye-American Academy of Dermatology (AAD) eBoston.              

Ulingo lwe-Effisayil™ 1, olusandul’ ukupapashwa kwiThe New England Journal of Medicine, lubonise ukucocwa okubonakalayo kweepustules zesikhumba kwizigulana ezine-generalized pustular psoriasis (GPP) flares kwiveki yokuqala emva konyango nge-spesolimab ngokuchasene ne-placebo. Esi siphumo sigcinwe kwiiveki ze-12, ngokweenkcukacha ezivezwe kwi-AAD, efumene ukuba i-84.4% yezigulane zazingenayo i-pustules ebonakalayo emva kwexesha le-12-iveki yovavanyo kwaye i-81.3% inesikhumba esicacileyo / esicacileyo.

"I-GPP ayinakucingelwa, ibuhlungu, kwaye inobungozi obunqabileyo besifo solusu ngaphandle kokukhethwa konyango oluvunyiweyo lwe-FDA," utshilo uBoni Elewski, MD, umphandi welingo kunye noSihlalo, iSebe leDermatology kwiYunivesithi yaseAlabama School of Medicine. "Izinto ezifunyaniswe kwiNtlanganiso yoNyaka ye-AAD yalo nyaka zibonise ukuba ukusebenza kwe-spesolimab kuzinzile kwiiveki ze-12, kunika ubungqina obungakumbi benzuzo ekhawulezayo enokuthi i-spesolimab izise kwizigulana eziphila nomthwalo wokuvutha kwe-GPP."

I-GPP sisifo solusu esine-neutrophilic esinqabileyo, esinokuba yingozi ebomini, esahlukileyo kwi-plaque psoriasis. Ibonakaliswa ngeziqephu zokuqhuma okuxhaphakileyo kweepustules ezibuhlungu, ezinyumba (i-blisters of non-infectious pus). Ukudangala kwe-GPP kuchaphazela kakhulu umgangatho wobomi bomntu kwaye kunokukhokelela kwiingxaki ezimandundu nezibeka ubomi esichengeni, kubandakanywa ukusilela kwentliziyo, ukungaphumeleli kwezintso, kunye ne-sepsis.

Ngokwedatha eyongezelelweyo enikezelwe kwiNtlanganiso yoNyaka ye-AAD, ukucocwa kwesikhumba ngokukhawuleza okubonwe kwiveki yokuqala emva konyango nge-spesolimab kwakungaguquguquki ngokuqhelekileyo kuwo wonke amacandelwana ezigulane, kubandakanywa iminyaka, isini, ubuhlanga, kunye ne-IL-36 yokuguqulwa kofuzo. Kwakhona, ukuphuculwa okuphawulekayo kuboniswe kwiveki enye kwiziphumo ezichazwe ngesigulane ezinxulumene nentlungu, ukukhathala, umgangatho wobomi, kunye neempawu zesikhumba emva kokunyanga nge-spesolimab.

Kulingo lwe-Effisayil™ 1, iziganeko ezibi zixelwe kwi-66% yezigulane eziphathwe nge-spesolimab kunye ne-56% yabo bafumana indawo ye-placebo emva kweveki yokuqala. Usulelo luxelwe yi-17% kunye ne-6% yezigulane kwi-spesolimab kunye namaqela e-placebo, ngokulandelanayo (ngeveki enye). Iziganeko ezimbi kakhulu zichazwe kwi-6% yezigulane eziphathwe nge-spesolimab (ngeveki enye). Izigulana ezibini ezifumana i-spesolimab ziye zaxelwa ukuba zineempendulo zeziyobisi ezine-eosinophilia kunye neempawu zenkqubo.

"Ngale datha eyongezelelweyo, sifumana umfanekiso opheleleyo we-spesolimab njengonyango olunokwenzeka lokuqala kwiklasi evunyiweyo kwizigulane ze-GPP," watsho uMat Frankel, MD, uSekela Mongameli, uPhuhliso lwezonyango kunye neMicimbi yezoNyango, ukuKhathalela okuKhethekileyo, uBoehringer Ingelheim. . "I-GPP inefuthe elibonakalayo kubomi besigulane, kwaye sihlala sizimisele ukuzisa i-spesolimab kwizigulana ngokukhawuleza."

I-US Food and Drug Administration (FDA) yamkele iSicelo seLayisensi ye-Biologics (BLA) kwaye inike uPhononongo oluPhambili lwe-spesolimab kunyango lwe-GPP flares. I-FDA inike i-spesolimab Orphan Drug Designation yonyango lwe-GPP kunye ne-Breakthrough Therapy Designation ye-spesolimab yonyango lwe-GPP flares kubantu abadala.