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ʻO ka hānō kamaliʻi: ʻo ka lāʻau lapaʻau hou e hōʻemi nui ai i nā hōʻeha hānō

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Ua hoʻolaha ʻo Regeneron Pharmaceuticals, Inc. a me Sanofi i kēia lā ua paʻi ka New England Journal of Medicine i nā hopena maikaʻi mai kahi pivotal Dupixent® (dupilumab) hoʻokolohua lapaʻau i nā keiki mai 6 a hiki i 11 mau makahiki me ka maʻi hānō haʻahaʻa ʻole. Ua hoʻokumu ʻia kēia mau ʻikepili i kumu no ka ʻae ʻana o ka FDA iā Dupixent ma ʻOkakopa 20, 2021 ma ke ʻano he mālama mālama hoʻohui i nā maʻi mai 6 a 11 mau makahiki me ka hānō haʻahaʻa a koʻikoʻi i hōʻike ʻia e kahi eosinophilic phenotype a i ʻole me ka hānō pili corticosteroid waha.

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Ua hōʻike ʻia kēia mau hopena i paʻi ʻia iā Dupixent, i ka wā i hoʻohui ʻia i ka mālama maʻamau, ua hōʻemi nui ʻia nā hōʻeha hānō nui a, i loko o ʻelua pule, ua hoʻomaikaʻi wikiwiki ʻia ka hana o ka māmā i nā heluna me kahi phenotype eosinophilic, e like me ka hōʻike ʻia e nā eosinophils koko kiʻekiʻe, kahi ʻano o ke koko keʻokeʻo. a/a i ʻole me ka fractional exhaled nitric oxide (FeNO) kiʻekiʻe, he hōʻailona biomarker o ke ea o ka mumū e pāʻani nui ana i ka hānō.

"ʻO ka paʻiʻiaʻana o kēia mau hopena Phase 3 no Dupixent ma ka New England Journal of Medicine e hōʻike ana i ko lākou koʻikoʻi a me ka waiwai o ke kino no nā keiki liʻiliʻi me ka maʻi hānō maʻamauʻole," wahi a Leonard B. Bacharier, MD, Professor of Pediatrics and Director o ka Center for Pediatric Asthma Research, Monroe Carell Jr. Children's Hospital ma Vanderbilt University Medical Center ma Nashville, Tennessee, a me ka mea noiʻi nui o ka hoʻokolokolo. "ʻO kēia mau ʻikepili e hoʻonui i ko mākou ʻike i ke ʻano o ka hoʻoponopono ʻana i ke ʻano 2 ʻeha, kahi kaʻina olaola e hoʻokumu i ka hapa nui o nā hihia o ka hānō kamaliʻi, hiki ke hoʻomaikaʻi i nā hōʻailona a me nā hopena no nā keiki e loaʻa ana i kēia maʻi maʻamau."

ʻO ka hānō kekahi o nā maʻi maʻamau maʻamau i nā keiki. Ma kahi o 75,000 mau keiki mai ka 6 a hiki i ka 11 makahiki e noho nei me ka maʻi maʻi maʻamau a paʻa ʻole i ka US, a me nā mea hou aku ma ka honua holoʻokoʻa. ʻOiai ka mālama ʻana me nā corticosteroids inhaled maʻamau a me nā bronchodilators i kēia manawa, hiki i kēia mau keiki ke hoʻomau i ka ʻike i nā hōʻailona koʻikoʻi e like me ka ʻuʻu ʻana, ka ʻuhū a me ka pilikia o ka hanu. Pono paha lākou i nā papa he nui o nā corticosteroids systemic i hiki ke lawe i nā pilikia palekana.

Ua kūlike nā hopena palekana mai ka hoʻokolokolo ʻana me ka ʻike palekana ʻike ʻia o Dupixent i nā poʻe maʻi he 12 mau makahiki a ʻoi aku me ka maʻi hānō haʻahaʻa a me ka paʻakikī, me ka hoʻohui ʻana o nā maʻi helminth i hōʻike ʻia ma 2.2% o nā maʻi Dupixent a me 0.7% o na ma'i placebo. ʻO ka nui o nā hanana ʻino he 83% no Dupixent a me 80% no kahi placebo. ʻO nā hopena ʻino maʻamau i ʻike pinepine ʻia me Dupixent i hoʻohālikelike ʻia me ka placebo, ʻo ia ka hopena o ka wahi injection (18% Dupixent, 13% placebo), nā maʻi maʻi maʻi maʻi maʻi o ka ʻōpū o ka hanu (12% Dupixent, 10% placebo) a me eosinophilia (6% Dupixent, 1% placebo).

ʻO Dupixent, ka mea i hana ʻia me ka ʻenehana VelocImmune® proprietary o Regeneron, he antibody monoclonal piha kanaka e pale ana i ka hōʻailona o nā ala interleukin-4 (IL-4) a me interleukin-13 (IL-13) a ʻaʻole ia he immunosuppressant. ʻO IL-4 a me IL-13 nā mea hoʻokele koʻikoʻi o ke ʻano 2 ʻona e pāʻani nui i ka dermatitis atopic, ka hānō a me ka rhinosinusitis maʻi me ka nasal polyposis (CRSwNP).

Ua hoʻokomo pū ʻia nā hopena o kēia hoʻāʻo Phase 3 i ka hoʻopiʻi hoʻoponopono ʻEulopa, a ua manaʻo ʻia kahi hoʻoholo mai ka European Medicines Agency i nā keiki me ka hānō koʻikoʻi ʻole i ka Q1 2022.

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