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.
LOKHO ONGAKUTHATHE KULESI SIHLOKO:
- The Effisayil™ 1 trial, recently published in The New England Journal of Medicine, showed significant clearance of skin pustules in patients with generalized pustular psoriasis (GPP) flares within the first week after treatment with spesolimab versus placebo.
- “The findings presented at this year’s AAD Annual Meeting showed that the efficacy of spesolimab is sustained over 12 weeks, providing further evidence of the rapid benefit that spesolimab could bring to patients living with the burden of GPP flares.
- In the Effisayil™ 1 trial, adverse events were reported in 66% of patients treated with spesolimab and 56% of those receiving placebo after the first week.
