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, Almirall SA (BME: ALM). ) ya sanar a yau a Cibiyar Nazarin Kwayoyin cuta ta Amirka (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.

“Alamomin cutar dermatitis kamar ƙaiƙayi, bushewar fata, zafi mai tsanani da kumburi suna ɗaukar nauyi mai nauyi a kan rayuwar marasa lafiya da kuma lafiyarsu. Marasa lafiya suna neman magunguna waɗanda ke ba da zaɓuɓɓukan magani masu inganci da jurewa waɗanda za su iya magance waɗannan alamun da haɓaka ingancin rayuwarsu. Lebrikizumab sabon magani ne tare da takamaiman hana IL-13, matsakanci na pathogenic na tsakiya a AD. Ayyukan da aka lura na lebrikizumab a cikin waɗannan nazarin ya tabbatar da yiwuwar wannan magani na sabon labari, wanda zai zama wani abu mai kyau da aka samu ga atopic dermatitis armamentarium, "in ji Farfesa Dr. med. Diamant Thaçi, Darakta a Cibiyar Nazarin Magungunan Cutar kumburi a Jami'ar Lübeck a Jamus, kuma babban mai binciken ADvocate 2.

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). ).

“Sabbin bayanai masu inganci daga nazarin nazarin monotherapy na Phase 3 ADvocate 1 da ADvocate 2 da aka gabatar a Cibiyar Nazarin Kwayoyin cuta ta Amurka ta Shekara-shekara sun nuna cewa lebrikizumab yana da yuwuwar zama jagorar jiyya ga sabon ƙarni na ilimin halitta. Marasa lafiya suna buƙatar sabbin zaɓuɓɓukan magani waɗanda ke ba da ingantaccen inganci da mafi kyawun jurewa. Wannan ci gaban ya kara sa mu ci gaba da mai da hankali kan yunƙurinmu kan ɗaya daga cikin mahimman samfuran da ke cikin bututunmu na ƙarshen zamani da kuma ci gaba da himma don inganta rayuwar marasa lafiya ta hanyar sabbin hanyoyin jiyya,” in ji Karl Ziegelbauer, Ph.D. Almirall SA'S Babban Jami'in Kimiyya.

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. Almirall da Eli Lilly da Kamfanin suna shirin ƙaddamar da takaddun ga hukumomin gudanarwa a duniya a ƙarshen 2022 bayan kammala karatun ADvocate.

"Muna fatan raba sakamako mai tsawo daga ADvocate 1 da 2 a wannan shekara, wanda muka yi imanin zai kara nuna cewa lebrikizumab zai iya ba da agajin da ake bukata ga mutanen da ke fama da wannan ciwo mai tsanani, kuma sau da yawa, cututtuka na rayuwa," in ji Lotus. Mallbris, MD, Ph.D., mataimakin shugaban ci gaban rigakafi na duniya da harkokin kiwon lafiya a Lilly.

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

ABUBUWAN DA ZA KU GUDU DAGA WANNAN LABARI:

“New positive data from the Phase 3 monotherapy studies ADvocate 1 and ADvocate 2 presented at the American Academy of Dermatology Annual Meeting demonstrate that lebrikizumab has the potential to be a leading treatment for a new generation of biologics.
This milestone further drives us to continue to focus our efforts on one of the key products in our late-stage pipeline and to progress our commitment to improving the quality of patients’.
In ADvocate 2, 33 percent of patients taking lebrikizumab achieved clear or almost clear skin (IGA) at 16 weeks, compared to 11 percent of patients on placebo.