Sabbin bayanai kan maganin flares GPP

Boehringer Ingelheim ya sanar a yau sabbin bayanai daga gwaji mai mahimmanci na Phase II Effisayil ™ 1, wanda aka gabatar a Taron Kwalejin Kasuwancin Amurka na 2022 (AAD) na shekara-shekara a Boston.              

Gwajin Effisayil ™ 1, wanda aka buga kwanan nan a cikin Jarida ta New England Journal of Medicine, ya nuna mahimmancin kawar da pustules na fata a cikin marasa lafiya tare da faɗuwar pustular psoriasis (GPP) a cikin makon farko bayan jiyya tare da spesolimab tare da placebo. An ci gaba da wannan tasirin a cikin makonni 12, bisa ga bayanan da aka gabatar a AAD, wanda ya gano cewa 84.4% na marasa lafiya ba su da kullun da aka gani bayan gwajin gwaji na 12-mako kuma 81.3% yana da tsabta / kusan fata.

"GPP wani rashin tabbas ne, mai raɗaɗi, kuma mai yuwuwar cutar cututtukan fata mai haɗari mai haɗari ba tare da samun zaɓuɓɓukan magani na FDA da aka yarda da su ba," in ji Boni Elewski, MD, mai binciken gwaji da kuma Shugaban, Sashen Nazarin Dermatology a Jami'ar Alabama School of Medicine. "Binciken da aka gabatar a taron shekara-shekara na AAD na wannan shekara ya nuna cewa tasirin spesolimab yana dawwama a cikin makonni 12, yana ba da ƙarin shaida na saurin fa'idar da spesolimab zai iya kawo wa marasa lafiya da ke fama da nauyin GPP."

GPP cuta ce mai wuyar gaske, mai yuwuwar cutar da fata neutrophilic, wacce ta bambanta da plaque psoriasis. Yana da alaƙa da ɓarnawar fashewar tartsatsi na raɗaɗi, pustules mara kyau (blisters na maras kamuwa da ƙwayar cuta). GPP flares yana shafar ingancin rayuwar mutum sosai kuma yana iya haifar da rikice-rikice masu haɗari da haɗari, gami da gazawar zuciya, gazawar koda, da sepsis.

Dangane da ƙarin bayanan da aka gabatar a taron shekara-shekara na AAD, saurin kawar da fata da aka lura a cikin makon farko bayan jiyya tare da spesolimab gabaɗaya ya kasance daidai a tsakanin ƙungiyoyin marasa lafiya, gami da shekaru, jinsi, ƙabila, da matsayin maye gurbi na IL-36. Har ila yau, an nuna ci gaba mai mahimmanci a cikin mako guda a cikin sakamakon da aka ba da rahoton haƙuri game da ciwo, gajiya, ingancin rayuwa, da bayyanar cututtuka na fata bayan jiyya tare da spesolimab.

A cikin gwajin Effisayil™ 1, an ba da rahoton abubuwan da ba su da kyau a cikin 66% na marasa lafiya da aka yi wa maganin spesolimab da 56% na waɗanda ke karɓar placebo bayan makon farko. An ruwaito cututtuka ta hanyar 17% da 6% na marasa lafiya a cikin spesolimab da kungiyoyin placebo, bi da bi (a mako daya). An ba da rahoton mummunan abubuwan da suka faru a cikin 6% na marasa lafiya da aka bi da su tare da spesolimab (a mako daya). An ba da rahoton marasa lafiya biyu da ke karɓar spesolimab suna da halayen ƙwayoyi tare da eosinophilia da alamun tsarin tsarin.

"Tare da waɗannan ƙarin bayanan, muna samun ƙarin cikakken hoto na spesolimab a matsayin yiwuwar maganin farko da aka amince da marasa lafiya na GPP," in ji Matt Frankel, MD, Mataimakin Shugaban Kasa, Ci gaban Clinical da Harkokin Kiwon Lafiya, Kulawa na Musamman, Boehringer Ingelheim. . "GPP yana da tasiri mai mahimmanci ga rayuwar majiyyaci, kuma muna ci gaba da kawowa marasa lafiya spesolimab da sauri."

Hukumar Abinci da Magunguna ta Amurka (FDA) ta karɓi Aikace-aikacen lasisin Halittu (BLA) kuma ta ba da Bita ta Farko don spesolimab don maganin flares na GPP. FDA ta ba spesolimab Orphan Drug Designation don kula da GPP da Breakthrough Therapy Designation don spesolimab don kula da GPP flares a cikin manya.