Dupixent 300 mg svondo rega rega ndiyo chete mushonga webiologic unoratidza zvakanaka, zvine musoro Phase 3 inoguma muvakuru nevechiri kuyaruka vane eosinophilic esophagitis.
Eosinophilic esophagitis chirwere chisingaperi, chinofambira mberi chechipiri chechirwere chinokuvadza esophagus uye chinodzivirira kushanda zvakanaka.
US uye zvepasirese zvinodzora faira zvakarongwa muna 2022
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) uye Sanofi nhasi vakazivisa migumisiro yakanyatsojeka kubva muchikamu chechipiri cheChikamu che3 chakaratidza Dupixent® (dupilumab) 300 mg vhiki nevhiki zvakanyanya kuvandudza zviratidzo nezviratidzo zve eosinophilic esophagitis (EoE) pamasvondo e24 zvichienzaniswa ne placebo muvarwere vane makore 12 zvichikwira. Iyi data yakakosha ichaunzwa nhasi ku2022 American Academy yeAllergy, Asthma uye Immunology (AAAAI) Musangano Wepagore panguva yekunonoka-kutyora-tyora yemuromo abstract session.
"Eosinophilic esophagitis inogona kukanganisa zvakanyanya kukwanisa kwemunhu kudya zvakajairika, uye vanachiremba vanovimba nemaitiro ekurapa anokanganisa kuti vatarise uye, mumatambudziko akakomba, kutambanudza esophagus," akadaro Evan S. Dellon, MD, MPH, Purofesa weGastroenterology uye Hepatology pa. Yunivhesiti yeNorth Carolina Chikoro cheMishonga uye co-principal muongorori wekutongwa. "Parizvino, hapana nzira dzekurapa dzakatenderwa neFDA dzinogadzirisa vatyairi vechirwere ichi. Iyo data kubva muyedzo iyi yakaratidza dupilumab inotorwa vhiki nevhiki kwete kungovandudza kugona kwevarwere kumedza, asiwo yakaderedza mamakisi erudzi rwe2 kuzvimba musophagus, zvichiratidza kugona kwayo kugadzirisa chikonzero chikuru che eosinophilic esophagitis.
Topline mhedzisiro kubva kuDupixent 300 mg vhiki nevhiki ruoko rweyedzo, iyo yakanyoresa varwere makumi masere muboka reDupixent uye 80 varwere muboka re placebo, yakaziviswa muna Gumiguru 79 uye inosimbisa mhedzisiro kubva muyedzo yekutanga Chikamu 2021. Iyo co-primary endpoints pamasvondo e3 yakaongororwa nemurwere-yakarondedzerwa zviyero zvekuoma kwekumedza (kuchinja kubva pakutanga mu24-0 Dysphagia Symptom Questionnaire, kana DSQ), uye esophageal kuzvimba (chikamu chevarwere vanowana histological chirwere chekuregererwa, chinotsanangurwa sepamusoro esophageal intraepithelial eosinophil count ye ≤84 eos/high power field [hpf]).
Dhata yakaratidzwa pa2022 AAAAI Annual Meeting yakaratidza kuti varwere vanobatwa neDupixent 300 mg vhiki nevhiki vakawana shanduko dzinotevera nevhiki 24 zvichienzaniswa ne placebo:
• 64% kuderedza zviratidzo zvechirwere kubva pakutanga zvichienzaniswa ne41% ye placebo (p = 0.0008). Varwere vanogamuchira Dupixent vakawana 23.78 pfungwa yekuvandudza paDSQ, zvichienzaniswa ne13.86 point improvement ye placebo (p <0.0001); baseline DSQ mamakisi angangoita 38 uye 36 mapoinzi, zvichiteerana.
• Inenge nguva ye10 sevarwere vakawanda vanogamuchira Dupixent vakawana kuregererwa kwechirwere chechirwere chekare: 59% yevarwere vakawana kuregererwa kwechirwere chechirwere chechirwere chichienzaniswa ne6% yevarwere vanowana placebo (p <0.0001); zvinoreva yekutanga peak mazinga aive 89 uye 84 eos / hpf, zvichiteerana.
Mhedzisiro dzekuchengetedza muyedzo dzaiwanzoenderana neyaizivikanwa chengetedzo mbiri yeDupixent mune yayo yakatenderwa zviratidzo. Kwenguva ye24-vhiki yekurapa (Dupixent n = 80, placebo n = 78), zviyero zvezviitiko zvakashata zvaive 84% yeDupixent 300 mg vhiki nevhiki uye 71% ye placebo. Zviitiko zvakashata zvaiwanzoonekwa (≥5%) zvakaonekwa neDupixent svondo rega rega zvaisanganisira kuita kwejekiseni (38% Dupixent, 33% placebo), fivha (6% Dupixent, 1% placebo), sinusitis (5% Dupixent, 0% placebo). ), COVID-19 (5% Dupixent, 0% placebo) uye hypertension (5% Dupixent, 1% placebo). Hapana kusaenzana kwakaonekwa mumitengo yekurega kurapwa nekuda kwezviitiko zvakashata pakati peDupixent (3%) uye placebo (3%) mapoka pamberi pevhiki 24.
Muedzo wacho wakawanawo kuti zvakanyanya varwere vanobatwa neDupixent 300 mg mavhiki maviri ega ega vakaderedza esophageal eosinophilic count kusvika kune yakajairika yakaenzaniswa ne placebo; zvisinei, pakanga pasina kuwedzera kukuru kwezviratidzo zvedysphagia. Tsanangudzo yemhedzisiro pamavhiki maviri ega ega dosing ichaunzwa pane iri kuuya congress.
Dhata kubva kukiriniki yekuedza chirongwa chakaendeswa kuUS Food and Drug Administration (FDA). Global regulatory mafaera mune dzimwe nyika akarongwawo muna 2022.
MunaGunyana 2020, iyo US FDA yakapa Breakthrough Therapy zita rekuti Dupixent kurapwa kwevarwere vane makore gumi nemaviri zvichikwira neEoE. Dupixent yakapiwawo Orphan Drug designation for the potential treatment of EoE mu 12. Iko kushandiswa kweDupixent muEoE ikozvino pasi pekugadzirwa kwekiriniki, uye kuchengeteka uye kushanda hazvina kuongororwa zvizere nechiremera chipi nechipi chekutonga.
ZVOKUBVA MUNYAYA INO:
- 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]).
