ʻO Dupixent 300 mg i kēlā me kēia pule wale nō ka lāʻau lapaʻau olaola e hōʻike i ka hopena maikaʻi, koʻikoʻi o ka pae 3 i nā pākeke a me nā ʻōpio me ka eosinophilic esophagitis.
ʻO ka Eosinophilic esophagitis kahi maʻi maʻi maʻi maʻi ʻano 2 holomua e hōʻino i ka esophagus a pale i ka hana pono.
Hoʻolālā ʻia nā faila hoʻoponopono o ka US a me ka honua ma 2022
ʻO Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) a me Sanofi i kēia lā hoʻolaha i nā hopena kikoʻī maikaʻi mai kahi hoʻokolohua lua Phase 3 i hōʻike i ka Dupixent® (dupilumab) 300 mg i kēlā me kēia pule i hoʻomaikaʻi nui i nā hōʻailona a me nā hōʻailona o ka eosinophilic esophagitis (EoE) i nā wiki 24 i hoʻohālikelike ʻia me placebo i nā maʻi 12 makahiki a keu. E hōʻike ʻia kēia mau ʻikepili koʻikoʻi i kēia lā ma ka 2022 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting i ka wā o kahi hālāwai abstract waha hope.
"Hiki i ka Eosinophilic esophagitis ke hoʻoikaika nui i ka hiki o ke kanaka ke ʻai maʻamau, a ke hilinaʻi nei nā kauka i nā kaʻina hana lapaʻau invasive e nānā a, i nā hihia koʻikoʻi, e hoʻolōʻihi i ka esophagus," wahi a Evan S. Dellon, MD, MPH, Professor of Gastroenterology and Hepatology ma ke Kulanui o North Carolina School of Medicine a me ka mea noiʻi kumu nui o ka hoʻokolokolo. "I kēia manawa, ʻaʻohe koho lapaʻau i ʻae ʻia e FDA e hoʻoponopono i nā mea hoʻokele kumu o kēia maʻi. Ua hōʻike ʻia ka ʻikepili mai kēia hoʻāʻo ʻana i ka dupilumab i lawe ʻia i kēlā me kēia pule ʻaʻole i hoʻomaikaʻi wale i ka hiki o ka poʻe maʻi ke ale, akā ua hōʻemi pū kekahi i nā hōʻailona o ke ʻano 2 ʻeha i loko o ka esophagus, e hōʻike ana i kona hiki ke hoʻoponopono i kahi kumu kumu nui o ka eosinophilic esophagitis.
ʻO nā hualoaʻa kiʻekiʻe mai ka Dupixent 300 mg i kēlā me kēia pule o ka hoʻokolokolo, ka mea i hoʻopaʻa inoa i nā mea maʻi 80 i ka hui Dupixent a me 79 mau mea maʻi i ka hui placebo, i hoʻolaha ʻia ma ʻOkakopa 2021 a hōʻoia i nā hopena mai ka hoʻokolokolo mua Phase 3. ʻO nā helu hope mua ma nā wiki 24 i loiloi i nā ana i hōʻike ʻia e ka mea maʻi o ka paʻakikī o ka ʻai ʻana (hoʻololi mai ka baseline i ka 0-84 Dysphagia Symptom Questionnaire, a i ʻole DSQ), a me ka ʻeha o ka esophageal (ka hapa o nā maʻi e loaʻa ana i ke kala ʻana i ka maʻi histological, i wehewehe ʻia he peak esophageal intraepithelial. helu eosinophil o ≤6 eos/ke kahua mana kiʻekiʻe [hpf]).
Ua hōʻike ʻia nā ʻikepili i hōʻike ʻia i ka 2022 AAAAI Annual Meeting ua ʻike nā mea maʻi i mālama ʻia me Dupixent 300 mg i kēlā me kēia pule i nā loli aʻe ma ka pule 24 i hoʻohālikelike ʻia me kahi placebo:
• 64% ka ho'ēmiʻana i nā hōʻailona maʻi mai ka pae kumu hoʻohālikelike i ka 41% no kahi placebo (p=0.0008). ʻO nā poʻe maʻi e loaʻa ana iā Dupixent ua loaʻa iā 23.78 ka hoʻomaikaʻi ʻana i ka DSQ, ke hoʻohālikelike ʻia me kahi hoʻonui 13.86 no kahi placebo (p<0.0001); ʻO nā helu kumu DSQ ma kahi o 38 a me 36 mau helu, kēlā me kēia.
Ma kahi kokoke i 10 manawa i ka nui o nā maʻi e loaʻa ana iā Dupixent i loaʻa i ke kala ʻana o ka maʻi histological: 59% o nā maʻi i loaʻa i ke kala ʻana o ka maʻi histological i hoʻohālikelike ʻia me 6% o nā maʻi e loaʻa ana i kahi placebo (p<0.0001); ʻO ke kiʻekiʻe o ka pae kiʻekiʻe he 89 a me 84 eos/hpf.
Ua kūlike nā hopena palekana o ka hoʻokolokolo me ka ʻike palekana ʻike ʻia o Dupixent i kāna mau hōʻailona i ʻae ʻia. No ka manawa lapaʻau 24-wiki (Dupixent n=80, placebo n=78), ʻo ka nui o nā hopena ʻino he 84% no Dupixent 300 mg i kēlā me kēia pule a me 71% no kahi placebo. ʻO nā hanana ʻino i ʻike pinepine ʻia (≥5%) me Dupixent i kēlā me kēia pule, ʻo ia ka hopena o ka wahi injection (38% Dupixent, 33% placebo), ke kuni (6% Dupixent, 1% placebo), sinusitis (5% Dupixent, 0% placebo. ), COVID-19 (5% Dupixent, 0% placebo) a me ke ki'eki'e (5% Dupixent, 1% placebo). ʻAʻohe imbalance i ʻike ʻia i nā helu o ka hoʻopau ʻana i ka mālama ʻana ma muli o nā hanana ʻino ma waena o Dupixent (3%) a me nā hui placebo (3%) ma mua o ka pule 24.
Uaʻike pū ka ho'āʻo i ka nui o nā maʻi i mālamaʻia me Dupixent 300 mg i kēlā me kēia puleʻelua i hoʻemi i ko lākou helu eosinophilic esophageal i ka laulā maʻamau i hoʻohālikelikeʻia me kahi placebo; akā naʻe, ʻaʻole i hoʻomaikaʻi nui ʻia nā hōʻailona dysphagia. E hōʻike ʻia nā hopena kikoʻī o ka dosing ʻelua pule ma kahi ʻaha kūkā e hiki mai ana.
Ua waiho ʻia nā ʻikepili mai ka papahana hoʻokolohua lapaʻau i ka US Food and Drug Administration (FDA). Hoʻolālā ʻia nā faila hoʻoponopono honua ma nā ʻāina ʻē aʻe i 2022.
I Kepakemapa 2020, ua hāʻawi ka US FDA i ka inoa Breakthrough Therapy iā Dupixent no ka mālama ʻana i nā maʻi 12 mau makahiki a ʻoi aku me EoE. Ua hāʻawi ʻia ʻo Dupixent i ka inoa Orphan Drug no ka mālama pono ʻana iā EoE ma 2017. ʻO ka hoʻohana pono ʻana o Dupixent ma EoE i kēia manawa ma lalo o ka hoʻomohala ʻana i ka lāʻau lapaʻau, a ʻaʻole i loiloi piha ʻia ka palekana a me ka pono e kekahi mana hoʻoponopono.
