Dupixent 300 mg i vaiaso ta'itasi e na'o le pau lea o vaila'au fa'aola e fa'aalia ai le lelei, fa'amanino aoga Fa'asologa 3 i'uga i tagata matutua ma talavou e maua i le eosinophilic esophagitis.
Eosinophilic esophagitis ose faʻamaʻi faʻamaʻi, faʻasolosolo faʻasolosolo ituaiga 2 e faʻaleagaina ai le esophagus ma taofia ai mai le galue lelei.
US ma fa'atonuga fa'atulafonoina fa'atulafonoina o lo'o fuafua ile 2022
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) ma Sanofi i aso nei na faʻasalalau faʻamatalaga auʻiliʻili lelei mai se faʻataʻitaʻiga lona lua Phase 3 lea na faʻaalia ai Dupixent® (dupilumab) 300 mg vaiaso taʻitasi faʻaleleia atili faʻailoga ma faʻamaoniga o le eosinophilic esophagitis (EoE) i 24 vaiaso faʻatusatusa i placebo i gasegase 12 tausaga ma luga atu. O nei fa'amatalaga taua o le a tu'uina atu i le aso i le 2022 American Academy of Allergy, Asthma and Immunology (AAAAI) Fonotaga Fa'aletausaga i le taimi o se sauniga tu'u tu'u tuai.
"Eosinophilic esophagitis e mafai ona matua aʻafia ai le mafai e le tagata ona 'ai masani, ma faʻalagolago fomaʻi i togafitiga faʻafomaʻi e mataʻituina ma, i tulaga sili atu ona ogaoga, faʻalautele le esophagus," o le tala lea a Evan S. Dellon, MD, MPH, Polofesa o Gastroenterology ma Hepatology i le Iunivesite o North Carolina School of Medicine ma le au suʻesuʻe autu o le faamasinoga. "I le taimi nei, e leai ni togafitiga faʻamaonia e le FDA e faʻatatau i taʻavale autu o lenei faʻamaʻi. O faʻamaumauga mai lenei faʻataʻitaʻiga na faʻaalia ai le dupilumab na ave i vaiaso taʻitasi e le gata ina faʻaleleia ai le malosi o tagata mamaʻi e foloina, ae faʻaitiitia ai faʻailoga o le ituaiga 2 mumu i totonu o le esophagus, e faʻaalia ai lona gafatia e foia ai se mafuaʻaga autu o le eosinophilic esophagitis.
O faʻaiʻuga pito i luga mai le Dupixent 300 mg vaiaso taʻitasi lima o le faamasinoga, lea na lesitalaina ai 80 tagata gasegase i le vaega Dupixent ma 79 tagata gasegase i le placebo vaega, na faʻasalalau ia Oketopa 2021 ma faʻamaonia iuga mai le faʻataʻitaʻiga muamua Vaega 3. O faʻaiʻuga autu i 24 vaiaso na suʻesuʻeina e le maʻi na lipotia mai le faigata o le foloina (suia mai le laina faʻavae i le 0-84 Dysphagia Symptom Questionnaire, poʻo le DSQ), ma le mumū o le esophage (vaega o tagata mamaʻi e ausia le faʻamagaloina o faʻamaʻi faʻamaʻi, faʻamatalaina o le pito i luga ole esophageal intraepithelial. numera eosinophil o ≤6 eos/maualuga malosi fanua [hpf]).
O faʻamatalaga na tuʻuina atu i le 2022 AAAAI Annual Meeting na faʻaalia ai o tagata mamaʻi na togafitia i le Dupixent 300 mg i vaiaso taʻitasi na oʻo i suiga nei ile vaiaso 24 pe a faʻatusatusa ile placebo:
• 64% fa'aitiitiga o fa'ama'i fa'ama'i mai le laina fa'atusatusa ile 41% mo placebo (p=0.0008). O maʻi na mauaina Dupixent na maua le 23.78 faʻaleleia atili i luga o le DSQ, faʻatusatusa i le 13.86 point faʻaleleia mo placebo (p <0.0001); fua fa'atatau DSQ e tusa ma le 38 ma le 36 'ai, fa'asologa.
• Toeitiiti 10 taimi e sili atu le tele o gasegase maua Dupixent na ausia le faʻamaʻi faʻamaʻi faʻamaʻi: 59% o tagata mamaʻi na ausia le faʻamaʻi faʻamaʻi faʻamaʻi faʻatusatusa i le 6% o tagata mamaʻi maua placebo (p<0.0001); o lona uiga o le maualuga maualuga e 89 ma le 84 eos/hpf.
O taunu'uga saogalemu o le su'ega sa masani ona ogatasi ma le fa'amatalaga saogalemu a Dupixent i ona fa'ailoga fa'amaonia. Mo le 24-vaiaso togafitiga vaitaimi (Dupixent n = 80, placebo n = 78), o le aofaʻi o fua faatatau o mea leaga na tutupu e 84% mo Dupixent 300 mg vaiaso ma 71% mo placebo. O mea leaga e masani ona masani ai (≥5%) na matauina i le Dupixent i vaiaso uma e aofia ai le tuiina o mea e fai (38% Dupixent, 33% placebo), fiva (6% Dupixent, 1% placebo), sinusitis (5% Dupixent, 0% placebo. ), COVID-19 (5% Dupixent, 0% placebo) ma le toto maualuga (5% Dupixent, 1% placebo). E leai se faaletonu na matauina i fua faatatau o le faamutaina o togafitiga ona o aafiaga leaga i le va o le Dupixent (3%) ma le placebo (3%) vaega ao lei oo i le vaiaso 24.
Na maua foi e le faamasinoga e sili atu le tele o tagata gasegase e togafitia i le Dupixent 300 mg i vaiaso uma e lua na faʻaitiitia ai le numera o le eosinophilic esophageal i le tulaga masani pe a faʻatusatusa i le placebo; ae ui i lea, e leʻi i ai se faʻaleleia tele o faʻamaoniga o le dysphagia. O fa'ai'uga au'ili'ili ile ta'i lua vaiaso ole tui ole a tu'uina atu ile fono o lo'o loma.
O faʻamatalaga mai le polokalame faʻataʻitaʻiga falemaʻi ua tuʻuina atu i le US Food and Drug Administration (FDA). O faʻamaumauga faʻatulafonoina a le lalolagi i isi atunuʻu o loʻo fuafuaina foi i le 2022.
Ia Setema 2020, na tuʻuina atu ai e le US FDA le igoa Breakthrough Therapy i Dupixent mo togafitiga o gasegase 12 tausaga ma matutua atu ma le EoE. Na tu'uina atu fo'i i Dupixent le igoa ole Orphan Drug mo togafitiga fa'apitoa ole EoE ile 2017. O le fa'aogaina ole Dupixent ile EoE o lo'o i lalo o le atina'eina o falema'i, ma e le'i iloiloina atoatoa le saogalemu ma le aoga e so'o se pulega fa'atonutonu.
