Ulwazi olusha lokwelashwa kokuvutha kweGPP

U-Boehringer Ingelheim umemezele namuhla idatha entsha evela ocwaningweni olubalulekile lweSigaba II se-Effisayil™ 1, olwethulwa ku-2022 American Academy of Dermatology (AAD) Umhlangano Wonyaka e-Boston.              

Uhlolo lwe-Effisayil™ 1, olusanda kushicilelwa kuyi-New England Journal of Medicine, lubonise ukukhululeka okuphawulekayo kwama-pustules esikhumba ezigulini ezine-generalized pustular psoriasis (GPP) flares phakathi nesonto lokuqala ngemva kokwelashwa nge-spesolimab ngokumelene ne-placebo. Lo mphumela wagcinwa ngaphezu kwamasonto e-12, ngokusho kwedatha eyethulwa ku-AAD, ethola ukuthi i-84.4% yeziguli yayingenawo ama-pustules abonakalayo ngemva kokuhlolwa kweviki le-12 futhi i-81.3% yayinesikhumba esicacile / esicishe sicace.

"I-GPP iyisifo sesikhumba esingavamile esingalindelekile, esibuhlungu, futhi esingase sibe sengozini yokuphila ngaphandle kwezinketho zokwelapha ezigunyazwe yi-FDA," kusho u-Boni Elewski, MD, umphenyi wesilingo kanye noSihlalo, uMnyango Wezesikhumba e-University of Alabama School of Medicine. “Okutholakele okwethulwe eMhlanganweni Wonyaka we-AAD walo nyaka kubonise ukuthi ukusebenza kahle kwe-spesolimab kuyaqhubeka emasontweni ayi-12, okunikeza ubufakazi obengeziwe benzuzo esheshayo i-spesolimab engayiletha ezigulini eziphila nomthwalo wokuvutha kweGPP.”

I-GPP iyisifo sesikhumba esine-neutrophilic esingavamile, esingase sibe yingozi empilweni, esihlukile kune-plaque psoriasis. Ibonakala ngeziqephu zokuqhuma okusabalele kwama-pustules abuhlungu, oyinyumba (amabhamuza obomvu obungatheleleki). Ukuqubuka kweGPP kuthinta kakhulu izinga lempilo yomuntu futhi kungaholela ezinkingeni ezimbi kakhulu nezisongela ukuphila, okuhlanganisa ukuhluleka kwenhliziyo, ukwehluleka kwezinso, kanye ne-sepsis.

Ngokolwazi olwengeziwe olwethulwe eMhlanganweni Wonyaka we-AAD, ukukhululeka kwesikhumba okusheshayo okubonwe evikini lokuqala ngemuva kokwelashwa nge-spesolimab ngokuvamile kwakungaguquguquki kuwo wonke amaqenjana esiguli, okuhlanganisa iminyaka, ubulili, ubuhlanga, nesimo soguquko sofuzo se-IL-36. Futhi, ukuthuthukiswa okuphawulekayo kuboniswe phakathi nesonto elilodwa emiphumeleni ebikwe isiguli ehlobene nobuhlungu, ukukhathala, izinga lokuphila, nezimpawu zesikhumba ngemva kokwelashwa nge-spesolimab.

Ocwaningweni lwe-Effisayil™ 1, izehlakalo ezimbi zabikwa kuma-66% eziguli ezalashwa nge-spesolimab kanye nama-56% alezo ezithola i-placebo ngemva kwesonto lokuqala. Ukutheleleka kubikwe yi-17% kanye ne-6% yeziguli kuqembu le-spesolimab ne-placebo, ngokulandelana (ngesonto lokuqala). Izehlakalo ezimbi kakhulu zabikwa ku-6% weziguli eziphathwe nge-spesolimab (ngesonto lokuqala). Iziguli ezimbili ezithola i-spesolimab kubikwe ukuthi zinokusabela kwezidakamizwa ezine-eosinophilia kanye nezimpawu zesistimu.

"Ngale datha eyengeziwe, sithola isithombe esiphelele kakhulu se-spesolimab njengendlela yokwelashwa kwesigaba sokuqala evunyelwe iziguli ze-GPP," kusho u-Matt Frankel, MD, iPhini Likamongameli, UkuThuthukiswa Komtholampilo kanye Nezindaba Zezokwelapha, Ukunakekelwa Okukhethekile, u-Boehringer Ingelheim. . "I-GPP inomthelela omkhulu empilweni yesiguli, futhi sisazimisele ukuletha i-spesolimab ezigulini ngokushesha okukhulu."

I-US Food and Drug Administration (FDA) yamukele Isicelo Selayisensi Ye-Biologics (BLA) futhi yanikeza Ukubuyekezwa Okubalulekile kwe-spesolimab yokwelapha ukuvutha kwe-GPP. I-FDA inikeze i-spesolimab Orphan Drug Designation yokwelapha i-GPP kanye ne-Breakthrough Therapy Designation ye-spesolimab yokwelapha ukuvutha kwe-GPP kubantu abadala.