Nuhou Uea

Loaʻa i nā maʻi Lebrikizumab ka hoʻomaʻemaʻe ʻili mai ka monotherapy

i kakauia ma hoʻoponopono

ʻOi aku ma mua o 50 ka nui o nā mea maʻi me ka dermatitis atopic (AD) ma kahi liʻiliʻi he 75 ka nui o ka emi ʻana o ka nui o ka maʻi (EASI-75*) ma 16 mau pule i ka wā e loaʻa ai ka lebrikizumab monotherapy i ka papahana ADvocate, Eli Lilly a me Company (NYSE). : LLY) i hoʻolaha ʻia i kēia lā ma ka American Academy of Dermatology (AAD) Annual Meeting. ʻO Lebrikizumab, kahi mea hoʻopaneʻe IL-13 hoʻokolokolo, ua alakaʻi pū ʻia i ka hoʻomaikaʻi ʻana i ke koʻikoʻi koʻikoʻi o ka ʻili a me nā hopena koʻikoʻi i hōʻike ʻia e ka mea maʻi i hoʻohālikelike ʻia me ka placebo.

"ʻO ka poʻe maʻi me ka dermatitis atopic e ʻike i ka ʻeha mau, ka ʻili maloʻo, ka ʻeha nui a me ka mumū, hiki ke ʻike ʻole ʻia a pili i kā lākou hana, ka pilina pili kanaka, ke olakino noʻonoʻo a me ka naʻau," wahi a Emma Guttman-Yassky, MD, Ph.D., Waldman professor a me ka luna ʻōnaehana o Dermatology ma ke kula ʻo Icahn School of Medicine ma Mount Sinai ma New York, a me ka mea kākau kiʻekiʻe o ka ADvocate analyses. "ʻO Lebrikizumab kahi lapaʻau hou e kuhikuhi ana i ke ala IL-13, ʻo ia ka mea hoʻokele cytokine nui o ka mumū e pili ana i AD. Paipai ʻia au e ka ʻikepili o kēia lā e hōʻike ana i ka hoʻomaikaʻi wikiwiki ʻana i ka ʻili, ka ʻili a me ka maikaʻi o ke ola.

ʻO Lebrikizumab kahi antibody monoclonal (mAb) e hoʻopaʻa ana i ka protein interleukin 13 (IL-13) me ka pilina kiʻekiʻe e pale pono ai i ka hoʻokumu ʻana o IL-13Rα1/IL-4Rα (Type 2 receptor) e poloka ana i ka hōʻailona ma lalo o ka IL-13. alahele. 1-5 IL-13 ke ko'iko'i o ka 'a'a 'ana o ke 'ano 2 I ka AD, ho'okumu 'o IL-6 i na hoailona a me na hoailona e like me ka ho'opau 'ole o ka 'ili, ka ma'i, ka ma'i a me nā wahi mānoanoa o ka 'ili.13

Ma ADvocate 1, 43 pakeneka o nā mea maʻi e loaʻa ana i ka lebrikizumab i loaʻa i ka ʻili maʻemaʻe a ʻaneʻane paha (IGA) ma 16 mau pule i hoʻohālikelike ʻia me 13 pakeneka o nā maʻi e lawe ana i kahi placebo. Ma waena o ka poʻe i loaʻa i ka lebrikizumab, 59 pakeneka i loaʻa i kahi pane EASI-75, hoʻohālikelike ʻia me 16 pakeneka me kahi placebo.

Ma ADvocate 2, 33 pakeneka o nā mea maʻi e lawe ana i ka lebrikizumab i loaʻa i ka ʻili maʻemaʻe a ʻaneʻane paha (IGA) ma 16 mau pule, hoʻohālikelike ʻia me 11 pakeneka o nā maʻi ma kahi placebo. Ma waena o ka poʻe e loaʻa ana i ka lebrikizumab, 51 pakeneka i loaʻa i kahi pane EASI-75, hoʻohālikelike ʻia me 18 pakeneka e lawe ana i kahi placebo.

I loko o ʻehā pule, nā mea maʻi e loaʻa ana i ka lebrikizumab i ʻike i ka hoʻomaikaʻi nui ʻana i ka ʻili a me ka ʻili, a me ka hoʻomaikaʻi ʻana i ka interference o ka itch ma ka hiamoe, a me ka maikaʻi o ke ola, e like me ke ana ʻana i nā kiʻi hope lua.

ʻO kaʻike palekana o ka manawa 16-wiki i kūlike me nā haʻawina mua lebrikizumab ma AD. ʻO ka poʻe maʻi e lawe ana i ka lebrikizumab, i hoʻohālikelike ʻia me kahi placebo, hōʻike i kahi haʻahaʻa haʻahaʻa o nā hanana ʻino ma ADvocate 1 (lebrikizumab: 45%, placebo: 52%) a me ADvocate 2 (lebrikizumab: 53%, placebo: 66%). ʻO ka hapa nui o nā hanana ʻino ma waena o nā haʻawina ʻelua he haʻahaʻa a haʻahaʻa paha i ka paʻakikī a ʻaʻole i alakaʻi i ka hoʻopau ʻana i ka mālama ʻana. ʻO nā hanana maʻamau maʻamau i ADvocate 1 a me 2 no ka poʻe ma lebrikizumab he conjunctivitis (7% a me 8%, kēlā me kēia), ke anu maʻamau (nasopharyngitis) (4% a me 5%, kēlā me kēia) a me ke poʻo (3% a me 5%, kēlā me kēia. ).

"ʻO ka ʻike a me ka hakakā ʻana o nā kānaka me nā maʻi autoimmune, e like me ka dermatitis atopic, e alakaʻi iā mākou ma Lilly e ʻimi i ka ʻepekema hou a me nā lāʻau lapaʻau koʻikoʻi e hoʻomaikaʻi ai i ke ola, ʻoi aku hoʻi ma nā wahi i loaʻa koke ka hemahema," wahi a Lotus Mallbris, MD, Ph.D ., Hope Peresidena o ka hoʻomohala ʻana i ka immunology honua a me nā hana lapaʻau ma Lilly. "Ke hoʻoikaika nei kēia mau ʻikepili i nā hopena maikaʻi i kā mākou papahana hoʻomohala Phase 3 ākea, a ke manaʻoʻiʻo nei mākou ʻo lebrikizumab kahi hanauna hou o nā mea olaola no AD."

Nā hualoaʻa kiko'ī 52-wiki mai ADvocate 1 a me 2, a me ka 16-week data mai ADhere, ka Phase 3 AD study o lebrikizumab me nā steroids topical, e hōʻike ʻia i nā mahina e hiki mai ana. Hoʻolālā ʻo Lilly lāua ʻo Almirall SA e waiho i nā faila i nā luna hoʻoponopono a puni ka honua ma ka hopena o 2022 ma hope o ka pau ʻana o nā haʻawina ADvocate.

"Pono nā mea maʻi i nā koho lapaʻau hou e hāʻawi i ka pono kiʻekiʻe a me ka hoʻomanawanui. Hōʻike kēia mau ʻikepili maikaʻi i ka hiki ke lilo i ka lebrikizumab i mea lapaʻau alakaʻi ma AD, "wahi a Karl Ziegelbauer, Ph.D., Luna Nui ʻepekema ʻo Almirall.

Loaʻa iā Lilly nā kuleana kūʻokoʻa no ka hoʻomohala ʻana a me ka hoʻolaha ʻana o lebrikizumab ma United States a me ke koena o ka honua ma waho o ʻEulopa. Ua laikini ʻo Almirall i nā kuleana e hoʻomohala a kūʻai aku i ka lebrikizumab no ka mālama ʻana i nā hōʻailona dermatology, me AD, ma ʻEulopa.

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