An Amince Dupixent ga Yara masu tsananin Asthma

Regeneron Pharmaceuticals, Inc. da Sanofi a yau sun sanar da cewa Hukumar Tarayyar Turai (EC) ta fadada izinin tallace-tallace na Dupixent® (dupilumab) a cikin Tarayyar Turai. Dupixent yanzu kuma an yarda da shi a cikin yara masu shekaru 6 zuwa 11 a matsayin ƙarin magani don kulawa mai tsanani don asma mai tsanani tare da nau'in kumburi na 2 wanda ke da alaƙa da eosinophils na jini da / ko tayar da nitric oxide na juzu'i (FeNO), waɗanda ba su da isasshen sarrafawa tare da matsakaici zuwa matsakaici. babban kashi inhaled corticosteroids (ICS) da wani samfurin magani don kulawa da kulawa.

"Yin amincewa da yau a Turai ya fahimci fa'idodin Dupixent wajen taimaka wa yara masu fama da mummunar cutar asma, ciki har da hare-haren fuka da ba a iya ganewa ba, rushewar yau da kullum ga ayyukan yau da kullum da kuma amfani da kwayoyin cutar steroid wanda zai iya hana ci gaban yara," in ji George D. Yancopoulos. , MD, Ph.D., Shugaba da Babban Jami'in Kimiyya a Regeneron. "Dupixent shine kawai magani da ake samu wanda ke toshe manyan direbobi guda biyu na nau'in kumburin nau'in 2, IL-4 da IL-13, wanda gwajin mu ya nuna yana taka muhimmiyar rawa a cutar asma na yara, da kuma yanayin da ke da alaƙa kamar rhinosinusitis na hanci. polyposis da kuma sau da yawa co-cututtuka yanayi, atopic dermatitis. A cikin gwaje-gwajen asibiti, Dupixent ya rage yawan hare-haren asma, yana taimakawa yara numfashi mafi kyau da kuma inganta yanayin rayuwarsu. Mun kuma jajirce wajen binciken Dupixent a wasu yanayi inda nau'in kumburin nau'in 2 na iya tasiri sosai ga rayuwar marasa lafiya, gami da eosinophilic esophagitis, prurigo nodularis da urticaria na yau da kullun.

Asthma yana daya daga cikin cututtukan da suka fi yawa a cikin yara. Har zuwa kashi 85 cikin 2 na yara masu fama da asma na iya samun kumburin nau'in XNUMX kuma suna iya samun nauyin cututtuka mafi girma. Duk da jiyya tare da ma'aunin kulawa na yanzu ICS da bronchodilator, waɗannan yaran na iya ci gaba da fuskantar munanan alamomi kamar tari, hushi da wahalar numfashi. Tsananin asma na iya yin tasiri ga haɓakar hanyoyin iska na yara kuma ya haifar da ɓarna mai haɗari da rayuwa. Yaran da ke fama da asma mai tsanani kuma na iya buƙatar amfani da darussa da yawa na corticosteroids na tsarin da ke ɗauke da manyan haɗari. Ciwon asma mai tsanani wanda ba a sarrafa shi zai iya tsoma baki tare da ayyukan yau da kullun, kamar barci, halartar makaranta da wasanni.

Dupixent, wanda aka ƙirƙira ta amfani da fasaha na VelocImmune® na Regeneron, cikakkiyar rigakafin mutum ce ta monoclonal wacce ke hana siginar hanyoyin interleukin-4 (IL-4) da interleukin-13 (IL-13) kuma ba maganin rigakafi ba ne. Ta hanyar nuna fa'idar asibiti mai mahimmanci tare da raguwar nau'in kumburi na 2 bayan IL-4 da IL-13 blockade tare da Dupixent, shirin Dupixent Phase 3 na asibiti ya tabbatar da cewa IL-4 da IL-13 sune manyan direbobi na nau'in kumburin 2. yana taka muhimmiyar rawa a cikin cututtukan da ke da alaƙa da yawa kuma galibi waɗanda aka amince da Dupixent waɗanda suka haɗa da asma, atopic dermatitis da rhinosinusitis na yau da kullun tare da polyposis na hanci (CRSwNP), da cututtukan bincike irin su eosinophilic esophagitis da prurigo nodularis, waɗanda aka yi nazari. a cikin gwaji na Phase 3.

"Muna farin cikin kawo ingantaccen ingantaccen bayanin martaba da ingancin Dupixent har ma da ƙananan marasa lafiya da ke zaune tare da asma mai tsanani a Turai. Baya ga rage yawan hare-haren asma da inganta aikin huhu, marasa lafiya a cikin gwajin mu na asibiti sun kuma rage amfani da corticosteroid na baki. Wannan yana da ma'ana musamman saboda waɗannan magunguna ne waɗanda za su iya ɗaukar manyan haɗarin aminci idan aka yi amfani da su na dogon lokaci, "in ji Naimish Patel, Shugaban MD na Ci gaban Duniya, Immunology da Kumburi a Sanofi. "Wannan amincewar tana nuna ci gaba da jajircewarmu na kawo Dupixent ga yawancin marasa lafiya da ke fama da mummunan tasirin asma tare da fatan inganta rayuwarsu." 

Shawarar EC ta dogara ne akan mahimman bayanai daga gwaji na VOYAGE na Phase 3 da ke kimanta inganci da amincin Dupixent haɗe tare da daidaitaccen maganin cutar asma a cikin yara 408 tare da asma matsakaici-zuwa-tsanani.

An ƙididdige yawan ƙididdiga guda biyu da aka ƙayyade tare da shaidar nau'in kumburi na 2 don bincike na farko: 1) marasa lafiya tare da eosinophils na jini (EOS) ≥300 sel / μl (n = 259) da 2) marasa lafiya tare da ko dai tushen FeNO ≥20 sassa a kowace. biliyan (ppb) ko tushe EOS ≥150 Kwayoyin / μl (n = 350). Marasa lafiya waɗanda suka ƙara Dupixent zuwa daidaitaccen kulawa a cikin waɗannan ƙungiyoyi biyu, bi da bi, sun ɗanɗana:

• An rage raguwa sosai na hare-haren asma, tare da raguwar 65% da 59% sama da shekara guda idan aka kwatanta da placebo (0.24 da 0.31 abubuwan a kowace shekara don Dupixent vs. 0.67 da 0.75 don placebo, bi da bi).

• Inganta aikin huhu da aka gani a farkon makonni biyu kuma yana dawwama har zuwa makonni 52, wanda aka auna da kashi FEV1 (FEV1pp).

• A makonni 12, marasa lafiya da ke shan Dupixent sun inganta aikin huhu da kashi 5.32 da 5.21 bisa dari idan aka kwatanta da placebo, bi da bi.

• Ingantacciyar kulawar asma, tare da 81% da 79% na marasa lafiya suna ba da rahoton ci gaba mai ma'ana na asibiti a cikin makonni 24, dangane da alamun cututtuka da tasiri idan aka kwatanta da 64% da 69% na marasa lafiya na placebo, bi da bi.

• Ingantacciyar rayuwa mai alaƙa da lafiya, tare da 73% da 73% na marasa lafiya suna ba da rahoton ingantaccen ingantaccen asibiti a cikin makonni 24, idan aka kwatanta da 63% da 65% na marasa lafiya na placebo, bi da bi.

• Rage amfani da tsarin corticosteroid da matsakaita na 66% da 59% sama da shekara guda idan aka kwatanta da placebo (darussan 0.27 da 0.35 a kowace shekara don Dupixent vs. 0.81 da 0.86 don placebo, bi da bi).

Sakamakon aminci daga gwajin ya yi daidai da sanannen bayanin martabar aminci na Dupixent a cikin marasa lafiya masu shekaru 12 da haihuwa tare da matsakaici-zuwa mai tsanani asma. Jimlar ƙimar abubuwan da ba su da kyau sun kasance 83% na Dupixent da 80% na placebo. Abubuwan da ba su da kyau waɗanda aka fi gani tare da Dupixent idan aka kwatanta da placebo sun haɗa da halayen wurin allura (18% Dupixent, 13% placebo), cututtukan ƙwayoyin cuta na ƙwayoyin cuta na sama (12% Dupixent, 10% placebo) da eosinophilia (7% Dupixent, 1% placebo). ). Har ila yau, cututtukan Helminth an fi lura da su tare da Dupixent a cikin marasa lafiya masu shekaru 6 zuwa 11 kuma an ruwaito su a cikin 2% na marasa lafiya Dupixent da 0% na marasa lafiya na placebo.