Iziphumo ezilungileyo kwiimpawu kunye neempawu ze-Eosinophilic Esophagitis

I-Dupixent 300 mg ngeveki kuphela kweyeza le-biologic elibonisa iziphumo ezilungileyo, ezinentsingiselo yeklinikhi yeSigaba sesi-3 kubantu abadala kunye nolutsha olune-eosinophilic esophagitis.

I-Eosinophilic esophagitis sisifo esingapheliyo, esiqhubekayo sohlobo lwe-2 isifo sokuvuvukala esonakalisa ummizo kwaye sithintele ekusebenzeni kakuhle. 

Iifayile zase-US kunye nehlabathi jikelele zicwangcisiwe ngo-2022

I-Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) kunye ne-Sanofi namhlanje babhengeze iziphumo ezintle ezicacileyo ezivela kwisilingo sesibini seSigaba se-3 esabonisa i-Dupixent® (dupilumab) i-300 mg ngeveki iphucule kakhulu iimpawu kunye neempawu ze-eosinophilic esophagitis (EoE) kwiiveki ze-24 xa kuthelekiswa ne i-placebo kwizigulane ezineminyaka eyi-12 nangaphezulu. Ezi datha zibalulekileyo ziya kuboniswa namhlanje kwi-2022 American Academy of Allergy, Asthma and Immunology (AAAAI) iNtlanganiso yoNyaka ngexesha leseshini yomlomo yomlomo.

"I-Eosinophilic esophagitis inokuchaphazela kakhulu amandla omntu okutya ngokuqhelekileyo, kwaye oogqirha baxhomekeke kwiinkqubo zonyango ezihlaselayo zokubeka iliso kwaye, kwiimeko ezinzulu, zolule i-esophagus," kusho uEvan S. Dellon, MD, MPH, uNjingalwazi weGastroenterology kunye neHepatology. IYunivesithi yaseNorth Carolina School of Medicine kunye nomphandi oyintloko wolingo. “Okwangoku, azikho iindlela zonyango ezivunyiweyo yi-FDA ezijongana nabaqhubi besi sifo. Idatha evela kolu vavanyo ibonise ukuba i-dupilumab ithathwa ngeveki ayiphuculanga kuphela amandla ezigulane zokugwinya, kodwa yanciphisa amanqaku ohlobo lwe-2 yokuvuvukala kwi-esophagus, ebonisa amandla ayo okujongana neyona nto ibangela ukuba i-eosinophilic esophagitis."

Iziphumo eziphambili ezivela kwi-Dupixent 300 mg ingalo yeveki yolingo, ebhalise izigulane ezingama-80 kwiqela le-Dupixent kunye nezigulane ezingama-79 kwiqela le-placebo, zabhengezwa ngo-Oktobha ka-2021 kwaye ziqinisekisa iziphumo zolingo lokuqala lweSigaba sesi-3. I-co-primary endpoints kwiiveki ze-24 zivavanya izigulane-imilinganiselo yobunzima bokugwinya (utshintsho ukusuka kwisiseko kwi-Questionnaire ye-0-84 ye-Dysphagia Symptom, okanye i-DSQ), kunye nokuvuvukala kwe-esophageal (inxalenye yezigulane ezifumana ukuxolelwa kwesifo se-histological, esichazwa njenge-peak esophageal intraepithelial inani le-eosinophil ye-≤6 eos/indawo yamandla aphezulu [hpf]).

Idatha eboniswe kwiNtlanganiso yoNyaka ye-2022 AAAAI ibonise ukuba izigulane eziphathwe nge-Dupixent 300 mg ngeveki ziye zafumana utshintsho olulandelayo ngeveki ye-24 xa kuthelekiswa ne-placebo:

• I-64% yokunciphisa iimpawu zesifo ukusuka kwisiseko xa kuthelekiswa ne-41% ye-placebo (p = 0.0008). Izigulane ezifumana i-Dupixent ziye zafumana uphuculo lwamanqaku angama-23.78 kwi-DSQ, xa kuthelekiswa nokuphuculwa kwamanqaku ayi-13.86 kwi-placebo (p<0.0001); isiseko samanqaku e-DSQ ayemalunga ne-38 kunye ne-36 amanqaku, ngokulandelanayo.

• Phantse amaxesha ali-10 izigulane ezininzi ezifumana i-Dupixent zifumene uxolelo lwesifo se-histological: i-59% yezigulane ifumene uxolelo lwesifo se-histological xa kuthelekiswa ne-6% yezigulane ezifumana i-placebo (p<0.0001); Amanqanaba encopho yesiseko ayengama-89 kunye nama-84 eos/hpf, ngokulandelanayo.

Iziphumo zokhuseleko zolingo ngokubanzi bezingqinelana neprofayile yokhuseleko eyaziwayo ye-Dupixent kwizikhombisi ezivunyiweyo. Ngexesha le-24-iveki yonyango (i-Dupixent n = 80, i-placebo n = 78), amazinga apheleleyo eemeko ezimbi ayengama-84% kwi-Dupixent 300 mg ngeveki kunye ne-71% ye-placebo. Iziganeko ezimbi ebeziqhelekile (≥5%) ezijongwa ngeDupixent qho ngeveki zibandakanya ukusabela kwendawo yokutofa (38% Dupixent, 33% placebo), fever (6% Dupixent, 1% placebo), sinusitis (5% Dupixent, 0% placebo). ), COVID-19 (5% Dupixent, 0% placebo) kunye noxinzelelo lwegazi (5% Dupixent, 1% placebo). Akukho kungalingani kubonwe kumazinga okuyeka unyango ngenxa yeziganeko ezimbi phakathi kweDupixent (3%) kunye namaqela e-placebo (3%) ngaphambi kweveki ye-24.

Ulingo luphinde lwafumanisa ukuba izigulane ezininzi eziphathwa nge-Dupixent 300 mg rhoqo kwiiveki ezimbini zanciphisa ukubalwa kwe-eosinophilic ye-esophageal ukuya kuluhlu oluqhelekileyo xa kuthelekiswa ne-placebo; nangona kunjalo, akukho phuculo olubalulekileyo kwiimpawu ze-dysphagia. Iziphumo ezineenkcukacha kwidosi yeeveki ezimbini ziya kuboniswa kwinkongolo ezayo.

Idatha evela kwinkqubo yovavanyo lweklinikhi ifakwe kwi-US Food and Drug Administration (FDA). Iifayile zolawulo lwehlabathi kwamanye amazwe nazo zicwangcisiwe ngo-2022.

NgoSeptemba ka-2020, i-US FDA yanika i-Breakthrough Therapy igama ku-Dupixent kunyango lwabaguli abaneminyaka eli-12 nangaphezulu nge-EoE. I-Dupixent iphinde inikwe i-Orphan Drug ukutyunjwa konyango olunokubakho lwe-EoE ngo-2017. Ukusetyenziswa okunokwenzeka kwe-Dupixent kwi-EoE okwangoku kuphantsi kophuhliso lwezonyango, kwaye ukhuseleko kunye nokusebenza kakuhle akuzange kuvavanywe ngokupheleleyo naliphi na igunya elilawulayo.