ʻIke hou e pili ana i ka mālama ʻana i nā lapalapa GPP

A HOLD Hoʻokuʻu ʻole 8 | eTurboNews | eTN
Avatar o Linda Hohnholz
i kakauia ma Linda Hohnholz

Ua hoʻolaha ʻo Boehringer Ingelheim i kēia lā i nā ʻikepili hou mai ka hoʻāʻo pivotal Phase II Effisayil ™ 1, i hōʻike ʻia ma ka 2022 American Academy of Dermatology (AAD) Annual Meeting ma Boston.              

ʻO ka hoʻāʻo ʻo Effisayil ™ 1, i paʻi ʻia ma The New England Journal of Medicine, ua hōʻike i ka hoʻomaʻemaʻe nui ʻana o nā pustules ʻili i nā maʻi me nā pustular psoriasis ākea (GPP) i loko o ka pule mua ma hope o ka mālama ʻana me spesolimab versus placebo. Ua hoʻomauʻia kēia hopena ma luna o nā wiki 12, e like me kaʻikepili i hōʻikeʻia ma AAD, iʻikeʻia he 84.4% o nā maʻiʻaʻole iʻikeʻia nā pustules ma hope o ka lōʻihi o ka ho'āʻo 12-week a me ka 81.3% heʻili māmā / kokoke.

"ʻO GPP kahi maʻi hikiʻole ke ʻike ʻole ʻia, ʻeha, a hiki ke hoʻoweliweli i ke ola me ka loaʻa ʻole o nā koho lapaʻau i ʻae ʻia e FDA," wahi a Boni Elewski, MD, ka mea noiʻi hoʻokolokolo a me ka noho, ke Keʻena o Dermatology ma ke Kulanui o Alabama School of Medicine. "Ua hōʻike ʻia nā ʻike i hōʻike ʻia ma ka AAD Annual Meeting o kēia makahiki e hoʻomau ʻia ka maikaʻi o ka spesolimab ma luna o 12 mau pule, e hāʻawi ana i nā hōʻike hou aʻe o ka pōmaikaʻi wikiwiki e hiki ai i ka spesolimab ke lawe mai i nā poʻe maʻi e noho ana me ke kaumaha o nā lapalapa GPP."

ʻO ka GPP kahi maʻi ʻili neutrophilic hiki ke hoʻoweliweli i ke ola, ʻokoʻa mai ka psoriasis plaque. Hōʻike ʻia ia e nā ʻāpana o ka hū ākea o ka ʻeha, sterile pustules (nā ʻōpū o ka pus non-infectious). Hoʻopilikia nui ʻo GPP i ka maikaʻi o ke ola o ke kanaka a hiki ke alakaʻi i nā pilikia koʻikoʻi a weliweli i ke ola, e like me ka hāʻule ʻana o ka naʻau, ka hōʻino ʻole ʻana, a me ka sepsis.

Wahi a nā ʻikepili hou i hōʻike ʻia ma ka AAD Annual Meeting, ʻike ʻia ka wikiwiki o ka ʻili i ka pule mua ma hope o ka mālama ʻana me spesolimab ma ke ʻano maʻamau ma waena o nā pūʻulu maʻi, me ka makahiki, ke kāne, ka lāhui, a me ke kūlana mutation gene IL-36. Eia kekahi, ua hōʻike ʻia nā hoʻomaikaʻi koʻikoʻi i loko o hoʻokahi pule i nā hopena i hōʻike ʻia e ka mea maʻi e pili ana i ka ʻeha, ka luhi, ka maikaʻi o ke ola, a me nā hōʻailona ʻili ma hope o ka mālama ʻana me spesolimab.

Ma ka ho'āʻo Effisayil ™ 1, ua hōʻike ʻia nā hanana ʻino i 66% o nā maʻi i mālama ʻia me ka spesolimab a me 56% o ka poʻe i loaʻa kahi placebo ma hope o ka pule mua. Ua hōʻike ʻia nā maʻi maʻi e 17% a me 6% o nā mea maʻi i loko o nā hui spesolimab a me placebo, i kēlā me kēia (i ka pule hoʻokahi). Ua hōʻike ʻia nā hanana ʻino koʻikoʻi ma 6% o nā maʻi i mālama ʻia me ka spesolimab (i ka pule hoʻokahi). ʻElua mau mea maʻi e loaʻa ana i ka spesolimab i hōʻike ʻia e loaʻa nā hopena lāʻau me ka eosinophilia a me nā hōʻailona ʻōnaehana.

"Me kēia mauʻikepili hou, ke loaʻa nei iā mākou kahi kiʻi piha loa o spesolimab ma keʻano he lāʻau lapaʻau mua i'āponoʻia no nā maʻi GPP," wahi a Matt Frankel, MD, Hope Pelekikena, Clinical Development and Medical Affairs, Specialty Care, Boehringer Ingelheim . "He hopena koʻikoʻi ko GPP i ke ola o ka mea maʻi, a ke hoʻomau nei mākou i ka lawe ʻana i ka spesolimab i nā mea maʻi i ka wikiwiki."

Ua ʻae ka US Food and Drug Administration (FDA) i kahi Biologic License Application (BLA) a hāʻawi i ka Priority Review no spesolimab no ka mālama ʻana i nā lapalapa GPP. Ua hāʻawi ka FDA i ka spesolimab Orphan Drug Designation no ka mālama ʻana i ka GPP a me ka Breakthrough Therapy Designation no ka spesolimab no ka mālama ʻana i nā lapalapa GPP i nā pākeke.

No ka mea kākau

Avatar o Linda Hohnholz

Linda Hohnholz

Lunahooponopono no eTurboNews ma ka eTN HQ.

kakau
E hoʻomaopopo i
malihini
0 Comments
Nā ʻōlelo Hoʻohui Kūʻai
E nānā i nā ʻōlelo āpau
0
E aloha nui i kou mau manaʻo, e ʻoluʻolu.x
()
x
Kaʻana like i...