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.

OA MEA E AVEA MAI LENEI TUSI:

Topline results from the Dupixent 300 mg weekly arm of the trial, which enrolled 80 patients in the Dupixent group and 79 patients in the placebo group, were announced in October 2021 and confirm results from the first Phase 3 trial.
REGN) and Sanofi today announced positive detailed results from a second Phase 3 trial that showed Dupixent® (dupilumab) 300 mg weekly significantly improved the signs and symptoms of eosinophilic esophagitis (EoE) at 24 weeks compared to placebo in patients 12 years and older.
The co-primary endpoints at 24 weeks assessed patient-reported measures of difficulty swallowing (change from baseline in the 0-84 Dysphagia Symptom Questionnaire, or DSQ), and esophageal inflammation (proportion of patients achieving histological disease remission, defined as peak esophageal intraepithelial eosinophil count of ≤6 eos/high power field [hpf]).