Natiijooyinka Wanaagsan ee Calaamadaha iyo Calaamadaha Eosinophilic Esophagitis

Dupixent 300 mg asbuucii waa daawada kaliya ee bayooloji si ay u muujiso togan, natiijooyin bukaan-socod ah Wajiga 3 ee dadka waaweyn iyo dhalinyarada ee qaba esophagitis eosinophilic

Eosinophilic esophagitis waa cudur barar ah oo daba-dheeraaday, nooca 2aad ee caabuqa kaas oo waxyeelo u geysta hunguriga kana ilaaliya inuu si fiican u shaqeeyo. 

Diiwaangelinta sharciyeynta Maraykanka iyo caalamiga ah ayaa la qorsheeyay 2022

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) iyo Sanofi ayaa maanta ku dhawaaqay natiijooyin faahfaahsan oo faahfaahsan oo ka soo baxay tijaabada labaad ee wajiga 3 taas oo muujisay Dupixent® (dupilumab) 300 mg todobaadkii si weyn u wanaajiyey calaamadaha iyo calaamadaha eosinophilic esophagitis (EoE) ee 24 toddobaad marka la barbar dhigo placebo ee bukaanada 12 sano iyo ka weyn. Xogtan muhiimka ah waxaa lagu soo bandhigi doonaa maanta 2022 Akademiyada Xasaasiyadda, Neefta iyo Immunology-ga Mareykanka (AAAAI) Kulanka Sanadlaha ah inta lagu guda jiro kalfadhi aan la taaban karo oo afka ah oo soo daahay.

"Eosinophilic esophagitis waxay si weyn u saameyn kartaa awoodda qofka ee in uu si caadi ah wax u cuno, takhaatiirtuna waxay ku tiirsan yihiin hababka caafimaad ee qallafsan si ay ula socdaan iyo, xaaladaha aadka u daran, waxay fidiyaan hunguriga," ayuu yiri Evan S. Dellon, MD, MPH, Professor of Gastroenterology iyo Hepatology at Jaamacadda North Carolina School of Medicine iyo kormeeraha maamulaha ee tijaabada. Hadda, ma jiraan doorashooyin daweyn oo ay FDA ogolaatay oo wax ka qabta darawallada hoose ee cudurkan. Xogta laga helay tijaabadan ayaa muujisay in dupilumab la qaato toddobaadle kaliya ma wanaajin kartid kartida bukaanka ee liqidda, laakiin sidoo kale waxay hoos u dhigtay calaamadaha caabuqa nooca 2 ee hunguriga, taas oo muujinaysa suurtogalnimada inay wax ka qabato sababta ugu weyn ee asaasiga ah ee eosinophilic esophagitis. "

Natiijooyinka ugu sarreeya ee Dupixent 300 mg cudud toddobaadle ah ee tijaabada, oo ka diiwaangashan 80 bukaan oo ka tirsan kooxda Dupixent iyo 79 bukaan oo ku jira kooxda placebo, ayaa lagu dhawaaqay Oktoobar 2021 waxayna xaqiijinayaan natiijooyinka tijaabada Wajiga 3 ee koowaad. Qodobbada ugu dambeeya ee asbuucyada 24 waxay qiimeeyeen cabbirada bukaanka laga soo sheegay ee dhibaatada liqitaanka (isbeddelka asalka ah ee 0-84 Dysphagia Symptom Questionnaire, ama DSQ), iyo bararka hunguriga (qaybta bukaannada helaya cafiska cudurka histological, oo lagu qeexay sida ugu sarreysa hunguriga intraepithelial Tirada eosinophils ee ≤6 eos/beegga tamarta sare [hpf]).

Xogta lagu soo bandhigay Kulanka Sannadlaha ah ee 2022 AAAAI waxay muujisay in bukaannada lagu daweeyay Dupixent 300 mg usbuuc kasta ay la kulmeen isbeddelada soo socda usbuuca 24 marka loo eego placebo:

• 64% hoos u dhaca calaamadaha cudurka marka loo eego 41% placebo (p=0.0008). Bukaannada qaata Dupixent waxay la kulmeen 23.78 hagaajinta DSQ, marka la barbar dhigo 13.86 hagaajinta placebo (p <0.0001); buundooyinka asaasiga ah ee DSQ waxay ahaayeen ku dhawaad ​​38 iyo 36 dhibcood, siday u kala horreeyaan.

• Ku dhawaad ​​10 jeer in ka badan bukaanada qaata Dupixent ayaa lagu guuleystey cafiska cudurada histological: 59% bukaanada waxay heleen cafis cudurka histological marka la barbardhigo 6% bukaanada qaata placebo (p<0.0001); celceliska heerarka ugu sarreeya ee aasaasiga ahi waxay ahaayeen 89 iyo 84 eos/hpf, siday u kala horreeyaan.

Natiijooyinka badbaadada tijaabada ayaa guud ahaan waafaqay astaanta nabdoonaanta ee Dupixent ee tilmaamaheeda la ansixiyay. Muddada daaweynta 24-usbuuc (Dupixent n=80, placebo n=78), guud ahaan heerarka dhacdooyinka xun waxay ahaayeen 84% Dupixent 300 mg todobaadkii iyo 71% placebo. Dhacdooyinka xunxun ee inta badan (≥5%) lagu arkay Dupixent todobaad kasta waxaa ka mid ah falcelinta goobta la isku duro (38% Dupixent, 33% placebo), qandho (6% Dupixent, 1% placebo), sinusitis (5% Dupixent, 0% placebo). ), COVID-19 (5% Dupixent, 0% placebo) iyo hypertension (5% Dupixent, 1% placebo). Isku dheelitir la'aan laguma arag heerarka joojinta daaweynta sababtoo ah dhacdooyinka xun ee u dhexeeya Dupixent (3%) iyo placebo (3%) kooxaha kahor usbuuca 24.

Tijaabadu waxay sidoo kale ogaatay in bukaanno aad u badan oo lagu daaweeyay Dupixent 300 mg labadii toddobaadba mar ay hoos u dhigtay tirooyinka eosinophilic hunguriga ilaa heerka caadiga ah marka loo eego placebo; si kastaba ha ahaatee, ma jirin horumar la taaban karo oo ku yimid calaamadaha dysphagia. Natiijooyin faahfaahsan oo ku saabsan qiyaasta daawada labadii toddobaadba mar ayaa lagu soo bandhigi doonaa shirweynaha soo socda.

Xogta laga helay barnaamijka tijaabada caafimaadka waxa loo gudbiyay Maamulka Cuntada iyo Dawooyinka ee Maraykanka (FDA). Diiwaangelinta sharciyeynta caalamiga ah ee wadamada kale ayaa sidoo kale la qorsheeyay 2022.

Bishii Sebtembar 2020, US FDA waxay siisay Breakthrough Therapy magacaabista Dupixent ee daaweynta bukaannada 12 sano iyo ka weyn ee leh EoE. Dupixent ayaa sidoo kale la siiyay Magacaabista Daroogada Orphan ee loogu talagalay daaweynta suurtagalka ah ee EoE ee 2017. Isticmaalka suurtagalka ah ee Dupixent ee EoE ayaa hadda ku hoos jira horumarinta bukaan-socodka, iyo badbaadada iyo waxtarka si buuxda looma qiimeeyo hay'ad sharciyeed.