Kulolu cwaningo lweSigaba sesi-3, i-Dupixent yengeze kuma-antihistamine okunakekelwa okujwayelekile acishe aphindeka kabili amaphuzu omsebenzi we-itch kanye ne-urticaria uma kuqhathaniswa nokunakekelwa okujwayelekile kuphela emavikini angu-24 ezigulini ze-biologic-naïve ezingalawulwa kuma-antihistamine.
Idatha iqinisa amandla okukhomba i-IL-4 ne-IL-13, abashayeli ababalulekile bokuvuvukala kohlobo 2, kulesi sifo esiyinkimbinkimbi esingapheli.
I-Regeneron Pharmaceuticals, Inc. kanye ne-Sanofi namuhla bamemezele imiphumela enemininingwane emihle ye-Dupixent® (dupilumab) ezigulini ezine-urticaria ezenzakalelayo (CSU) ezingelapheki nge-biologic-naïve (okungukuthi, ezingazange zilashwe ngaphambilini nge-omalizumab). Uhlolo olubalulekile lubonise ukungeza i-Dupixent kuma-antihistamine okunakekelwa okujwayelekile kunciphisa kakhulu ukulunywa kanye nokuqunjelwa emasontweni angama-24 uma kuqhathaniswa nama-antihistamine kuphela kulesi silungiselelo sophenyo. Le miphumela izokwethulwa namuhla kuseshini ephuke sekwephuzile eMhlanganweni Wonyaka wezi-2022 we-American Academy of Allergy, Asthma and Immunology (AAAI).
"Naphezu kwama-antihistamine okunakekelwa okujwayelekile, iziguli eziningi ezine-urticaria engavamile ziyaqhubeka nokulwa nokuluma okukhulu, ukushisa nobuhlungu obuhambisana nesifuba nokuvuvukala ngaphansi kwesikhumba, okungaphazamisa kakhulu ukuphila kwabo kwansuku zonke," kusho uMarcus Maurer, MD, uProfessor. we-Dermatological Allergology, Clinic for Dermatology, Venerology and Allergology e-Charité University of Medicine eBerlin, eJalimane. "Le miphumela ekhuthazayo ibonise ukuthi, kulabo abangakwazi ukufinyelela ukulawula izifo ngama-antihistamine kuphela, iziguli ezengeze i-dupilumab zathola izimpawu nezimpawu ezithuthukisiwe nokulawula kangcono isifo sazo."
Imiphumela yomugqa ophezulu evela ocwaningweni olubalulekile olulawulwa ngokungahleliwe, oluyimpumputhe kabili, olulawulwa yi-placebo, oluhlangabezane neziphetho eziyinhloko nawo wonke ukhiye wesibili ngeviki lama-24, lwamenyezelwa ngoJulayi 2021. Idatha eyethulwa kuMhlangano Waminyaka Yonke ka-2022 AAAAI ibonise ukuthi iziguli ezengeze i-Dupixent ezingeni elijwayelekile. ama-antihistamine -of-care acishe aphindwe kabili ukuncishiswa komsebenzi we-itch kanye ne-urticaria uma kuqhathaniswa nokunakekelwa okujwayelekile kuphela (i-placebo) ngokuthuthukiswa okuqhubekayo kuze kufike kumaviki angu-24. Lezi ziguli zahlangabezana noku:
• Ukwehliswa ngo-63% kobunzima bokuluma nge-Dupixent uma kuqhathaniswa no-35% nge-placebo, njengoba kukalwa nge-0-21 point itch severity scale (amaphoyinti angu-10.24 ancishiswa nge-Dupixent uma kuqhathaniswa namaphoyinti angu-6.01 okunciphisa nge-placebo, p<0.001), isiphetho esiyinhloko e-US (indawo yokugcina yesibili e-EU).
• Ukwehliswa okungama-65% komsebenzi we-urticaria (ukuluma nesidleke) ubunzima nge-Dupixent uma kuqhathaniswa no-37% we-placebo, njengoba kukalwa ngesilinganiso somsebenzi we-urticaria wamaphoyinti angu-0-42 (amaphoyinti angu-20.53 ancishiswa nge-Dupixent uma kuqhathaniswa namaphoyinti angu-12.00 ekwehliswa nge-placebo, p<0.001), indawo yokugcina eyinhloko e-EU (indawo yokugcina yesibili e-US).
Uhlolo lubonise imiphumela yokuphepha efana nephrofayili yokuphepha eyaziwayo ye-Dupixent kuzinkomba zayo ezigunyaziwe ze-dermatology. Esikhathini sokwelashwa samasonto angama-24, amanani aphelele ezehlakalo ezimbi ngokuvamile ayefana phakathi kwamaqembu e-Dupixent ne-placebo (50% Dupixent, 59% placebo). Isehlakalo esibi esivame kakhulu kwaba ukusabela kwendawo yomjovo (11% Dupixent, 13% placebo).
Ukusetshenziswa okungaba khona kwe-Dupixent ku-CSU okwamanje kungaphansi kokuthuthukiswa komtholampilo, futhi ukuphepha nokusebenza akukahlolwa ngokugcwele yinoma yisiphi isiphathimandla esilawulayo.
LOKHO ONGAKUTHATHE KULESI SIHLOKO:
- Data presented at the 2022 AAAAI Annual Meeting showed that patients who added Dupixent to standard-of-care antihistamines nearly doubled the reduction in itch and urticaria activity compared to standard-of-care alone (placebo) with continuous improvement out to 24 weeks.
- In this Phase 3 trial, Dupixent added to standard-of-care antihistamines nearly doubled reduction in itch and urticaria activity scores compared to standard-of-care alone at 24 weeks in biologic-naïve patients uncontrolled on antihistamines.
- The pivotal trial showed adding Dupixent to standard-of-care antihistamines significantly reduced itch and hives at 24 weeks compared to antihistamines alone in this investigational setting.
