Zambiri pazamankhwala a GPP flares

Boehringer Ingelheim alengeza lero zatsopano kuchokera ku mayeso ofunikira a Phase II Effisayil™ 1, omwe adaperekedwa pa Msonkhano Wapachaka wa 2022 American Academy of Dermatology (AAD) ku Boston.              

Mayesero a Effisayil ™ 1, omwe adasindikizidwa posachedwa mu The New England Journal of Medicine, adawonetsa kuvomerezeka kwakukulu kwa ziphuphu zapakhungu mwa odwala omwe ali ndi flares ya pustular psoriasis (GPP) mkati mwa sabata yoyamba atalandira chithandizo ndi spesolimab motsutsana ndi placebo. Zotsatirazi zinakhazikika pa masabata a 12, malinga ndi deta yomwe inaperekedwa ku AAD, yomwe inapeza kuti 84.4% ya odwala analibe ma pustules owoneka pambuyo pa nthawi ya mayesero a masabata a 12 ndipo 81.3% anali ndi khungu loyera / pafupifupi loyera.

"GPP ndi matenda osadziŵika bwino, opweteka, komanso omwe angakhale oopsa kwambiri a khungu omwe alibe njira zochiritsira zovomerezeka ndi FDA," adatero Boni Elewski, MD, wofufuza milandu ndi Wapampando, Dipatimenti ya Dermatology ku The University of Alabama School of Medicine. "Zomwe zaperekedwa pa Msonkhano Wapachaka wa AAD wa chaka chino zawonetsa kuti mphamvu ya spesolimab imapitilira masabata 12, ndikupereka umboni winanso wa phindu lomwe spesolimab lingabweretse kwa odwala omwe ali ndi vuto la GPP."

GPP ndi matenda apakhungu osowa, omwe atha kukhala pachiwopsezo cha neutrophilic, omwe ndi osiyana ndi plaque psoriasis. Amadziwika ndi kuphulika kofalikira kwa ma pustules opweteka, osabala (matuza a mafinya osapatsirana). Kuyaka kwa GPP kumakhudza kwambiri moyo wa munthu ndipo kungayambitse zovuta zazikulu komanso zoopsa, monga kulephera kwa mtima, kulephera kwaimpso, ndi sepsis.

Malinga ndi zina zomwe zidaperekedwa pa Msonkhano Wapachaka wa AAD, kutulutsa khungu mwachangu komwe kunachitika sabata yoyamba kutsatira chithandizo ndi spesolimab nthawi zambiri kumagwirizana m'magulu a odwala, kuphatikiza zaka, jenda, fuko, ndi kusintha kwa majini a IL-36. Komanso, kusintha kwakukulu kunasonyezedwa mkati mwa sabata imodzi muzotsatira zomwe zafotokozedwa ndi odwala zokhudzana ndi ululu, kutopa, moyo wabwino, ndi zizindikiro za khungu pambuyo pa chithandizo ndi spesolimab.

Mu mayeso a Effisayil™ 1, zovuta zidanenedwa mu 66% ya odwala omwe adalandira spesolimab ndi 56% mwa omwe amalandila placebo sabata yoyamba. Matendawa adanenedwa ndi 17% ndi 6% ya odwala omwe ali m'magulu a spesolimab ndi placebo, motsatana (sabata imodzi). Zoyipa zazikulu zidanenedwa mu 6% ya odwala omwe adalandira spesolimab (sabata imodzi). Odwala awiri omwe amalandila spesolimab adanenedwa kuti ali ndi vuto la eosinophilia komanso zizindikiro za systemic.

"Ndizidziwitso zowonjezera izi, tikupeza chithunzi chokwanira cha spesolimab ngati chithandizo choyambirira chovomerezeka kwa odwala a GPP," adatero Matt Frankel, MD, Wachiwiri kwa Purezidenti, Clinical Development and Medical Affairs, Specialty Care, Boehringer Ingelheim. . "GPP imakhudza kwambiri moyo wa wodwala, ndipo tikudzipereka kubweretsa spesolimab kwa odwala mwachangu momwe tingathere."

Bungwe la US Food and Drug Administration (FDA) linavomereza License Application (BLA) ndikupereka Priority Review ya spesolimab pochiza kuphulika kwa GPP. A FDA apereka spesolimab Orphan Drug Designation yochizira GPP ndi Breakthrough Therapy Designation ya spesolimab yochizira ma flares a GPP mwa akulu.