Majinyatan Lebrikizumab Sun Cimma Cimma Ciwon Fata daga monotherapy

A KYAUTA Kyauta 7 | eTurboNews | eTN
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Written by Linda Hohnholz

Fiye da kashi 50 cikin 75 na marasa lafiya tare da matsakaici-zuwa mai tsanani atopic dermatitis (AD) sun sami aƙalla kashi 75 cikin 16 na raguwa a cikin tsananin cutar (EASI-13*) a cikin makonni XNUMX lokacin da aka karbi lebrikizumab monotherapy a cikin shirin ADvocate, Eli Lilly da Company (NYSE). : LLY) ya sanar a yau a Cibiyar Nazarin Kwayoyin cuta ta Amurka (AAD) Taron Shekara-shekara. Lebrikizumab, mai hanawa na IL-XNUMX na bincike, kuma ya haifar da haɓaka ma'anar asibiti a cikin ƙaiƙayi da sauran mahimman sakamakon rahoton marasa lafiya idan aka kwatanta da placebo.

"Masu fama da cututtukan fata suna fama da ciwon kai, bushe fata, ciwo mai tsanani da kumburi, wanda zai iya zama marar tabbas kuma zai shafi aikin su, zamantakewar zamantakewa, lafiyar hankali da tunani," in ji Emma Guttman-Yassky, MD, Ph.D., Farfesa Waldman. da kuma tsarin tsarin ilimin cututtukan fata a Makarantar Magunguna ta Icahn a Dutsen Sinai a New York, kuma babban marubucin nazarin ADvocate. "Lebrikizumab wani labari ne na magani wanda ke nufin hanyar IL-13, wanda shine babban direban cytokine na kumburi da ke cikin AD. Bayanai na yau sun ƙarfafa ni da ke nuna saurin haɓaka fata, ƙaiƙayi da matakan ingancin rayuwa. ”

Lebrikizumab wani antibody ne na monoclonal (mAb) wanda ke ɗaure da furotin na interleukin 13 (IL-13) tare da babban alaƙa don hana samuwar IL-13Rα1 / IL-4Ra (Nau'in 2 mai karɓa) wanda ke toshe siginar ƙasa ta hanyar IL-13 hanya. 1-5 IL-13 tana taka muhimmiyar rawa a cikin kumburin Nau'in 2 A AD, IL-6 yana ƙarƙashin alamomi da alamun bayyanar cututtuka da suka haɗa da rashin aiki na shinge na fata, ƙaiƙayi, kamuwa da cuta da wuya, wuraren da ke da kauri.13

A cikin ADvocate 1, kashi 43 cikin 16 na marasa lafiya da ke karɓar lebrikizumab sun sami cikakkiyar fata ko kusan bayyanan fata (IGA) a cikin makonni 13 idan aka kwatanta da kashi 59 na marasa lafiya da ke shan placebo. Daga cikin wadanda ke karbar lebrikizumab, kashi 75 cikin dari sun sami amsa EASI-16, idan aka kwatanta da kashi XNUMX tare da placebo.

A cikin ADvocate 2, kashi 33 cikin 16 na marasa lafiya da ke shan lebrikizumab sun sami cikakkiyar fata ko kusan bayyanan fata (IGA) a cikin makonni 11, idan aka kwatanta da kashi 51 na marasa lafiya akan placebo. Daga cikin wadanda ke karbar lebrikizumab, kashi 75 cikin 18 sun sami amsa EASI-XNUMX, idan aka kwatanta da kashi XNUMX na shan placebo.

A cikin makonni huɗu, marasa lafiya da ke karɓar lebrikizumab sun sami ƙwaƙƙwaran ƙididdiga a cikin gogewar fata da ƙaiƙayi, da kuma ingantuwar kutsewar ƙaiƙayi akan barci, da ingancin rayuwa, kamar yadda aka auna ta maɓalli na biyu na ƙarshe.

Bayanan aminci na tsawon makonni 16 ya yi daidai da binciken lebrikizumab na farko a AD. Marasa lafiya da ke shan lebrikizumab, idan aka kwatanta da placebo, sun ba da rahoton ƙananan abubuwan da ba su da kyau a cikin ADvocate 1 (lebrikizumab: 45%, placebo: 52%) da ADvocate 2 (lebrikizumab: 53%, placebo: 66%). Yawancin abubuwan da ba su da kyau a cikin binciken biyu sun kasance masu sauƙi ko matsakaici a cikin tsanani da rashin ƙarfi kuma ba su haifar da dakatar da magani ba. Abubuwan da suka fi dacewa a cikin ADvocate 1 da 2 ga waɗanda ke kan lebrikizumab sune conjunctivitis (7% da 8% bi da bi), sanyi na kowa (nasopharyngitis) (4% da 5%, bi da bi) da ciwon kai (3% da 5% bi da bi). ).

Lotus Mallbris, MD, Ph.D, ya ce: "Kwarewar mutane da gwagwarmayar cututtuka na autoimmune, irin su atopic dermatitis, sun kori mu a Lilly don neman ilimin kimiyyar zamani da magunguna masu ma'ana waɗanda ke inganta rayuwa, musamman a wuraren da ake buƙatar gaggawar gaggawa," in ji Lotus Mallbris, MD, Ph.D. ., Mataimakin shugaban ci gaban rigakafi na duniya da harkokin kiwon lafiya a Lilly. "Wadannan bayanan suna ƙarfafa kyakkyawan sakamako a cikin babban shirin haɓakawa na Mataki na 3, kuma mun yi imanin cewa lebrikizumab yana wakiltar sabon ƙarni na ilimin halittu don AD."

Cikakkun sakamako na makonni 52 daga ADvocate 1 da 2, da kuma bayanan makonni 16 daga ADhere, binciken Phase 3 AD na lebrikizumab tare da magungunan ƙwayoyin cuta, za a bayyana a cikin watanni masu zuwa. Lilly da Almirall S.A. suna shirin gabatar da takardu ga hukumomin da suka dace a duniya nan da karshen 2022 bayan kammala karatun ADvocate.

“Masu lafiya suna buƙatar sabbin zaɓuɓɓukan magani waɗanda ke ba da ingantaccen inganci da haƙuri. Waɗannan ingantattun bayanai sun nuna cewa lebrikizumab yana da yuwuwar zama babban jiyya a AD, "in ji Karl Ziegelbauer, Ph.D., Babban Jami'in Kimiyya na Almirall.

Lilly tana da keɓantaccen haƙƙi don haɓakawa da kasuwancin lebrikizumab a cikin Amurka da sauran ƙasashen duniya a wajen Turai. Almirall ya ba da lasisin haƙƙin haɓakawa da tallata lebrikizumab don maganin alamun cututtukan fata, gami da AD, a Turai.

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Avatar na Linda Hohnholz

Linda Hohnholz

Edita a shugaba don eTurboNews bisa ga eTN HQ.

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