Dupixent Yovomerezeka kwa Ana Amene Ali ndi Chifuwa Choopsa

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Written by Linda Hohnholz

Regeneron Pharmaceuticals, Inc. ndi Sanofi lero adalengeza kuti European Commission (EC) yawonjezera chilolezo cha malonda a Dupixent® (dupilumab) ku European Union. Dupixent tsopano imavomerezedwanso mwa ana azaka zapakati pa 6 mpaka 11 monga chithandizo chowonjezera cha mphumu yoopsa kwambiri ndi kutupa kwamtundu wa 2 komwe kumadziwika ndi kuwonjezeka kwa magazi a eosinophils ndi / kapena kukwezedwa kwa fractional exhaled nitric oxide (FeNO), omwe samayendetsedwa mokwanira ndi sing'anga mpaka. mlingo waukulu wa corticosteroids (ICS) kuphatikiza mankhwala ena ochizira.

"Chivomerezo chamasiku ano ku Ulaya chimazindikira ubwino wa Dupixent pothandiza ana omwe ali ndi zotsatira za chifuwa chachikulu cha mphumu, kuphatikizapo mphumu yosayembekezereka, kusokonezeka kwachizolowezi kuntchito za tsiku ndi tsiku komanso kugwiritsa ntchito mankhwala otchedwa systemic steroids omwe angalepheretse kukula kwa ana," anatero George D. Yancopoulos. , MD, Ph.D., Purezidenti ndi Chief Scientific Officer ku Regeneron. "Dupixent ndiye chithandizo chokhacho chomwe chilipo chomwe chimatsekereza madalaivala awiri ofunikira a kutupa kwamtundu wa 2, IL-4 ndi IL-13, omwe mayeso athu akuwonetsa kuti amathandizira kwambiri pakukula kwa mphumu yaubwana, komanso pamikhalidwe yofananira monga rhinosinusitis yokhala ndi mphuno. polyposis ndi nthawi zambiri co-morbid chikhalidwe, atopic dermatitis. M'mayesero azachipatala, Dupixent adachepetsa kwambiri matenda a mphumu, adathandizira ana kupuma bwino ndikuwongolera moyo wawo wokhudzana ndi thanzi. Timapitirizabe kufufuza Dupixent muzochitika zina zomwe kutupa kwa mtundu wa 2 kungakhudze kwambiri miyoyo ya odwala, kuphatikizapo eosinophilic esophagitis, prurigo nodularis ndi urticaria yosatha.

Matenda a mphumu ndi amodzi mwa matenda omwe amafala kwambiri mwa ana. Mpaka 85% ya ana omwe ali ndi mphumu amatha kukhala ndi kutupa kwamtundu wa 2 ndipo amatha kukhala ndi matenda ambiri. Ngakhale kuti akulandira chithandizo chamakono cha ICS ndi bronchodilators, anawa akhoza kupitirizabe kukhala ndi zizindikiro zazikulu monga kutsokomola, kupuma komanso kupuma movutikira. Mphumu yoopsa imatha kusokoneza njira za ana zomwe zikukula ndikupangitsa kuti pakhale chiopsezo chowopsa. Ana omwe ali ndi mphumu yoopsa angafunikenso kugwiritsa ntchito njira zingapo za systemic corticosteroids zomwe zimakhala ndi zoopsa zambiri. Matenda a mphumu osalamuliridwa amatha kusokoneza zochitika za tsiku ndi tsiku, monga kugona, kupita kusukulu komanso kusewera masewera.

Dupixent, yomwe idapangidwa pogwiritsa ntchito ukadaulo wa Regeneron's VelocImmune®, ndi anti-monoclonal antibody yathunthu yomwe imalepheretsa kuwonetsa njira za interleukin-4 (IL-4) ndi interleukin-13 (IL-13) ndipo sichiritsire. Powonetsa kupindula kwakukulu kwachipatala pamodzi ndi kuchepa kwa kutupa kwa mtundu wa 2 pambuyo pa kutsekedwa kwa IL-4 ndi IL-13 ndi Dupixent, pulogalamu yachipatala ya Dupixent Phase 3 yatsimikizira kuti IL-4 ndi IL-13 ndi omwe amachititsa kuti kutupa kwa mtundu wa 2 amatenga gawo lalikulu m'matenda ogwirizana komanso omwe nthawi zambiri amalumikizana nawo omwe Dupixent amavomerezedwa kuphatikiza mphumu, atopic dermatitis ndi rhinosinusitis yokhala ndi m'mphuno polyposis (CRSwNP), komanso matenda ofufuza monga eosinophilic esophagitis ndi prurigo nodularis, omwe adaphunziridwa. m'mayesero a Gawo 3.

"Ndife okondwa kubweretsa mbiri yotsimikizika yachitetezo cha Dupixent kwa odwala achichepere omwe ali ndi mphumu yayikulu yosalamulirika ku Europe. Kuphatikiza pakuchepetsa kwambiri matenda a mphumu komanso kukonza magwiridwe antchito am'mapapo, odwala m'mayesero athu azachipatala adachepetsanso kugwiritsa ntchito oral corticosteroid. Izi ndizofunikira makamaka chifukwa awa ndi mankhwala omwe amatha kukhala ndi ziwopsezo zazikulu zachitetezo ngati atagwiritsidwa ntchito nthawi yayitali, "adatero Naimish Patel, MD Mutu wa Global Development, Immunology and Inflammation ku Sanofi. "Chivomerezochi chikugogomezera kudzipereka kwathu pakubweretsa Dupixent kwa odwala ambiri momwe tingathere omwe akuvutika ndi vuto la mphumu yayikulu ndikuyembekeza kuwongolera moyo wawo." 

Chigamulo cha EC chimachokera pazidziwitso zofunika kwambiri kuchokera ku mayesero a Phase 3 VOYAGE omwe amayesa mphamvu ndi chitetezo cha Dupixent pamodzi ndi chithandizo chodziwika bwino cha mphumu mwa ana a 408 omwe ali ndi mphumu yosalamulirika mpaka yoopsa.

Anthu awiri omwe adadziwika kale omwe ali ndi umboni wa kutupa kwa mtundu wa 2 adayesedwa kuti ayambe kufufuza: 1) odwala omwe ali ndi magazi oyambira omwe ali ndi eosinophils (EOS) ≥300 maselo / μl (n = 259) ndi 2) odwala omwe ali ndi FeNO yoyambira ≥20 magawo pa biliyoni (ppb) kapena magazi oyambira EOS ≥150 maselo/μl (n=350). Odwala omwe adawonjezera Dupixent ku chisamaliro chokhazikika m'magulu awiriwa, motsatana, adakumana ndi izi:

• Kuchepetsa kwakukulu kwa chiwopsezo chachikulu cha mphumu, ndi 65% ndi 59% kuchepa kwapakati pa chaka chimodzi poyerekeza ndi placebo (zochitika za 0.24 ndi 0.31 pachaka kwa Dupixent vs. 0.67 ndi 0.75 kwa placebo, motsatira).

• Kuyenda bwino kwa mapapo kumawonedwa pakangotha ​​milungu iwiri ndikukhalabe kwa milungu 52, kuyesedwa ndi kuchuluka komwe kunanenedweratu kuti FEV1 (FEV1pp).

• Pamasabata a 12, odwala omwe amatenga Dupixent amawongolera mapapu awo ndi 5.32 ndi 5.21 peresenti poyerekeza ndi placebo, motsatira.

• Kuwongolera bwino kwa mphumu, ndi 81% ndi 79% ya odwala omwe amafotokoza kusintha kwabwino kwachipatala pa masabata a 24, malinga ndi zizindikiro za matenda ndi zotsatira zake poyerekeza ndi 64% ndi 69% ya odwala placebo, motero.

• Kupititsa patsogolo moyo wokhudzana ndi thanzi labwino, ndi 73% ndi 73% ya odwala omwe akuwonetsa kusintha kwachipatala pa masabata a 24, poyerekeza ndi 63% ndi 65% ya odwala placebo, motero.

• Kuchepetsa kugwiritsidwa ntchito kwa systemic corticosteroid ndi pafupifupi 66% ndi 59% pa chaka chimodzi poyerekeza ndi placebo (maphunziro a 0.27 ndi 0.35 pachaka a Dupixent vs. 0.81 ndi 0.86 a placebo, motsatira).

Zotsatira zachitetezo kuchokera pachiyeso nthawi zambiri zinali zogwirizana ndi mbiri yodziwika bwino yachitetezo cha Dupixent mwa odwala azaka 12 ndi kupitilira omwe ali ndi mphumu yolimba kwambiri. Miyezo yonse ya zochitika zoyipa inali 83% ya Dupixent ndi 80% ya placebo. Zoyipa zomwe zidawonedwa nthawi zambiri ndi Dupixent poyerekeza ndi placebo zidaphatikizapo momwe jakisoni amachitira (18% Dupixent, 13% placebo), matenda a virus kumtunda kwa kupuma (12% Dupixent, 10% placebo) ndi eosinophilia (7% Dupixent, 1% placebo. ). Matenda a Helminth adawonedwanso kwambiri ndi Dupixent mwa odwala azaka 6 mpaka 11 ndipo adanenedwa mu 2% ya odwala a Dupixent ndi 0% ya odwala omwe ali ndi placebo.

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Linda Hohnholz

Mkonzi wamkulu kwa eTurboNews zochokera ku eTN HQ.

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