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.

He aha e lawe ʻia mai kēia ʻatikala:

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.