“I-Plaque psoriasis inokubeka umthwalo obalulekileyo kubomi bezigulana, nokuba bubunzulu bokubandakanyeka kolusu. Isidingo esikhulu esingafezekiswanga sishiyekile kwizigulana ze-psoriasis ezithambileyo ezinokuthi zingonelanga, ngakumbi kwezo zinendawo ekunzima ukuzinyanga, njengesikhumba sentloko, utshilo uDavid M. Reese, MD, usekela mongameli wezoPhando. kunye noPhuhliso e-Amgen. "Ngalo mqondiso owandisiweyo we-Otezla, izigulana kuwo onke amanqanaba obunzima besifo ngoku zinokhetho lomlomo, olucwangcisiweyo olusele lusetyenziswe ngabantu abangaphezu kwama-650,000 kwihlabathi jikelele kwaye alunamfuneko yokubeka iliso kwilebhu."1
"Ngenxa yokuba i-psoriasis yinkqubo yesifo sokuvuvukala, ezinye izigulana zingadinga ngaphezu kokukhululeka kwinqanaba eliphezulu," kusho uDkt Linda Stein Gold, umlawuli weDermatology Clinical Research kwi-Henry Ford Health System, Detroit, kunye nomphandi we-ADVANCE. "Okwesihlandlo sokuqala, oogqirha besikhumba banokunika abaguli abanengxaki ye-plaque psoriasis yayo nayiphi na idigri kunyango lomlomo olusebenzayo kunye neprofayili eqinisekisiweyo yokhuseleko."
Ukwamkelwa kwe-FDA kusekelwe kwiziphumo ezivela kwiSigaba 3 solingo lwe-ADVANCE, apho ngokuphindwe kahlanu abantu abadala abane-plaque epholileyo ukuya kwimodareyitha efumana i-Otezla yomlomo i-30 mg kabini imihla ngemihla iphumelele isiphelo sokuqala se-Global Physician's Assessment (sPGA) impendulo ngeveki ye-16. xa kuthelekiswa ne-placebo (i-21.6% ngokuchasene ne-4.1%, p <0.0001), umahluko obaluleke kakhulu ngokwezibalo. U-Otezla uphinde wabonisa ukuphuculwa kwezibalo kwiimpawu eziphambili, ezifana nempendulo ye-Whole Body Itch NRS (43.2% ngokuchasene ne-18.6%), kunye nommandla onzima ukunyanga, i-scalp, ilinganiswa ne-Scalp Physician's Global Assessment (ScPGA) impendulo (44% xa kuthelekiswa ne-16.6%), ngeveki ye-16 xa kuthelekiswa ne-placebo. Ukuphuculwa kwempendulo ye-sPGA, i-Whole Body Itch NRS kunye ne-ScPGA impendulo yabonwa kwangoko kwiveki ye-2 kwaye igcinwe kwiveki ye-32.
Iziganeko ezimbi ezibonwe kulingo zazihambelana neprofayili eyaziwayo yokhuseleko lwe-Otezla. Ezona ngxelo zixhaphakileyo (≥5%) zonyango-iziganeko ezimbi eziye zavela ngonyango lwe-Otezla yayisisirhudo, intloko ebuhlungu, isicaphucaphu kunye ne-nasopharyngitis.
Phantse abantu abazizigidi ezisi-8 e-US bane-plaque psoriasis, kwaye abantu abazizigidi ezi-5 e-US banesifo esincinci ukuya kwimodareyitha. Ngaphandle kokuxhaphaka kunye nenkqubela phambili yonyango kwiminyaka yakutshanje, imfuno ebalulekileyo engafezekiyo isekho, ngakumbi kubantu abanobuphakathi ukuya kwephakathi kwe-plaque psoriasis okanye abo bafumana iimpawu ezizingisileyo ngaphandle konyango.
"I-Plaque psoriasis ihlala ichaphazela izigulane kakhulu kunokuba inokulinganiswa nguMmandla we-Body Surface Area yodwa, ngakumbi abo banezibonakaliso kwiindawo ezinzima-ukunyanga njenge-scalp. Indawo abekwe kuyo amacwecwe inokwenza indawo ibe nenkathalo kunyango lwangaphakathi okanye kube nzima ukuzisebenzisa,” utshilo u-Stacie Bell, Ph.D., igosa eliyintloko lezenzululwazi kunye nezonyango kwi-National Psoriasis Foundation. "Ziindaba ezamkelweyo ukuba ekugqibeleni sibe nenkqubo yomlomo eneprofayili yokhuseleko esekwe kakuhle ekhoyo kuzo zonke izigulana ze-psoriasis yabantu abadala."
I-Otezla yamkelwe ngemiqondiso emithathu e-US, kubandakanywa izigulana zabantu abadala abane-plaque psoriasis abangabaviwa befototherapy okanye unyango lwenkqubo, abaguli abadala abane-psoriatic arthritis esebenzayo kunye nabaguli abadala abanezilonda zomlomo ezinxulumene ne-Behçet's Disease. I-Otezla iyona nto ichazwe kakhulu kwi-plaque psoriasis izigulane eziqala unyango lwe-systemic.3 U-Amgen uzibophelele ekuphandeni amandla e-Otezla kulo lonke ixesha lokuqhubeka kwe-psoriasis, kubandakanywa nezigulane ezingagcinwanga nge-psoriasis yangasese, i-psoriasis yabantwana, i-juvenile psoriatic arthritis kunye nezinye iindawo ezinomthwalo ophezulu.
