I-Dupixent 300 mg masonto onke ukuphela komuthi we-biologic obonisa imiphumela emihle, enenjongo yomtholampilo yeSigaba sesi-3 kubantu abadala kanye nentsha ene-eosinophilic esophagitis.
I-Eosinophilic esophagitis yisifo sokuvuvukala esingapheli, esiqhubekayo sohlobo 2 esilimaza umphimbo futhi siwuvimbele ekusebenzeni kahle.
Ukufakwa kwemibhalo elawulwa yi-US kanye nomhlaba wonke kuhlelwa ngo-2022
I-Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) kanye ne-Sanofi namuhla bamemezele imiphumela enemininingwane emihle evela esivivinyweni sesibili seSigaba se-3 esabonisa i-Dupixent® (dupilumab) 300 mg masonto onke ithuthukise kakhulu izimpawu nezimpawu ze-eosinophilic esophagitis (EoE) emavikini angu-24 uma kuqhathaniswa ne i-placebo ezigulini ezineminyaka engu-12 nangaphezulu. Le datha ebalulekile izokwethulwa namuhla ku-2022 American Academy of Allergy, Asthma and Immunology (AAAAI) Umhlangano Waminyaka Yonke ngesikhathi seseshini yomlomo ephuke sekwephuzile.
"I-Eosinophilic esophagitis ingaba nomthelela omkhulu ekutheni umuntu adle ngendlela evamile, futhi odokotela bathembele ezinqubweni zezokwelapha ezihlaselayo ukuze baqaphe futhi, ezimweni ezimbi kakhulu, belule umgudu," kusho u-Evan S. Dellon, MD, MPH, uProfesa we-Gastroenterology kanye ne-Hepatology. i-University of North Carolina School of Medicine kanye nomphenyi oyinhloko wecala. “Okwamanje, azikho izindlela zokwelapha ezigunyazwe yi-FDA ezibhekelela abashayeli balesi sifo. Idatha evela kulolu cwaningo ibonise ukuthi i-dupilumab ethathwa masonto onke ayigcini nje ukuthuthukisa ikhono leziguli lokugwinya, kodwa futhi yanciphisa izimpawu zokuvuvukala kohlobo lwe-2 ku-esophagus, okubonisa amandla ayo okubhekana nembangela enkulu ye-eosinophilic esophagitis.
Imiphumela ephezulu evela engalweni yamasonto onke ye-Dupixent 300 mg yocwaningo, eyabhalisa iziguli ezingama-80 eqenjini le-Dupixent kanye neziguli ezingama-79 eqenjini le-placebo, yamenyezelwa ngo-Okthoba 2021 futhi yaqinisekisa imiphumela yocwaningo lweSigaba sesi-3 sokuqala. Ama-co-primary endpoints emavikini e-24 ahlole izinyathelo ezibikiwe ngesiguli zobunzima bokugwinya (ushintsho olusuka kusisekelo ku-0-84 Dysphagia Symptom Questionnaire, noma i-DSQ), nokuvuvukala kwe-esophageal (ingxenye yeziguli ezithola ukukhululwa kwesifo se-histological, okuchazwa njenge-peak esophageal intraepithelial inani le-eosinophil elingu-≤6 eos/inkambu yamandla aphezulu [hpf]).
Idatha eyethulwe kuMhlangano Wonyaka we-2022 AAAAI ibonise ukuthi iziguli ezelashwa nge-Dupixent 300 mg masonto onke zibe nezinguquko ezilandelayo ngeviki lama-24 uma kuqhathaniswa ne-placebo:
• Ukwehliswa okungama-64% kwezimpawu zesifo kusukela kwesisekelo uma kuqhathaniswa nama-41% we-placebo (p=0.0008). Iziguli ezithola i-Dupixent zithole ukuthuthukiswa kwamaphuzu angu-23.78 ku-DSQ, uma kuqhathaniswa nokuthuthukiswa kwamaphuzu angu-13.86 ku-placebo (p<0.0001); amaphuzu ayisisekelo e-DSQ ayecishe abe ngamaphoyinti angama-38 nangama-36, ngokulandelana.
• Cishe izikhathi eziyi-10 kuneziguli eziningi ezithola i-Dupixent zazuza ukukhululwa kwesifo se-histological: Amaphesenti angu-59 eziguli athola ukukhululwa kwesifo se-histological uma kuqhathaniswa ne-6% yeziguli ezithola i-placebo (p<0.0001); Amazinga aphezulu aphezulu esisekelo ayengama-89 kanye nama-84 eos/hpf, ngokulandelanayo.
Imiphumela yokuphepha yocwaningo ngokuvamile ibihambisana nephrofayili yokuphepha eyaziwayo ye-Dupixent kuzinkomba zayo ezigunyaziwe. Esikhathini sokwelashwa samaviki angu-24 (i-Dupixent n=80, i-placebo n=78), amanani ayonke ezehlakalo ezingezinhle abengu-84% ku-Dupixent 300 mg masonto onke kanye nama-71% e-placebo. Izehlakalo ezimbi ebezivamise ukubonwa (≥5%) nge-Dupixent masonto onke zihlanganisa ukusabela kwendawo yomjovo (38% Dupixent, 33% placebo), fever (6% Dupixent, 1% placebo), sinusitis (5% Dupixent, 0% placebo). ), i-COVID-19 (5% Dupixent, 0% placebo) kanye nomfutho wegazi ophakeme (5% Dupixent, 1% placebo). Akukho ukungalingani okubonwe emazingeni okuyeka ukwelashwa ngenxa yezenzakalo ezimbi phakathi kwamaqembu e-Dupixent (3%) kanye ne-placebo (3%) ngaphambi kweviki le-24.
Uhlolo luphinde lwathola ukuthi iziguli eziningi kakhulu ezilashwa nge-Dupixent 300 mg njalo emavikini amabili zehlisa ukubalwa kwazo kwe-eosinophilic esophageal kuya ebangeni elijwayelekile uma kuqhathaniswa ne-placebo; Nokho, kwakungekho ukuthuthukiswa okuphawulekayo kwezimpawu ze-dysphagia. Imiphumela enemininingwane yomthamo wanjalo emavikini amabili izokwethulwa engqungqutheleni ezayo.
Idatha evela ohlelweni lwesilingo somtholampilo ihanjiswe ku-US Food and Drug Administration (FDA). Ukugcwaliswa kokulawulwa komhlaba wonke kwamanye amazwe nakho kuhlelwe ngo-2022.
NgoSepthemba 2020, i-US FDA yanikeza i-Breakthrough Therapy igama ku-Dupixent lokwelapha iziguli ezineminyaka engu-12 nangaphezulu nge-EoE. I-Dupixent iphinde yanikezwa igama le-Orphan Drug lokwelashwa okungaba khona kwe-EoE ngo-2017. Ukusetshenziswa okungaba khona kwe-Dupixent ku-EoE okwamanje kungaphansi kokuthuthukiswa komtholampilo, futhi ukuphepha nokusebenza akukakahlolwa ngokugcwele yinoma isiphi isiphathimandla esilawulayo.
LOKHO ONGAKUTHATHE KULESI SIHLOKO:
- 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]).
