Uphononongo lubonise ukuba i-Otezla yomlomo i-30 mg kabini imihla ngemihla iphumelele uphuculo olunentsingiselo yeklinikhi kunye nezibalo, xa kuthelekiswa ne-placebo, kwinqanaba eliphambili le-static Physician's Global Assessment ye-Genitalia (sPGA-G) impendulo (echazwe njengenqaku le-sPGA-G). ecacileyo (0) okanye ephantse yacaca (1) ubuncinane ngamanqaku ama-2 ukusuka kwisiseko) ngeveki ye-16.
Ukongezelela, zonke isiphelo sesibini zaye zadibana nokuphuculwa okunentsingiselo kunye nokubalulekayo kwi-Genital Psoriasis Itch Numerical Rating Scale (GPI-NRS) impendulo (echazwe ubuncinane i-4-point inciciation ukusuka kwisiseko kwi-GPI-NRS amanqaku amanqaku ngaphakathi kwe-Genital Psoriasis Symptoms. kwizifundo ezinamanqaku asisiseko ≥ 4); indawo yomzimba ochaphazelekayo (BSA) utshintsho ukusuka kwisiseko; I-Dermatology Life Quality Index (DLQI) utshintsho ukusuka kwisiseko; kunye ne-static Physician's Global Assessment (sPGA) impendulo (echazwe njenge-sPGA amanqaku acacileyo (0) okanye aphantse acace (1) kunye nokunciphisa amanqaku angama-2 ukusuka kwisiseko) ngeveki ye-16 kunye ne-Otezla ngokumelene ne-placebo.
Uhlobo kunye nezinga leziganeko ezimbi ezibonwe kolu vavanyo lwaluhambelana neprofayili eyaziwayo yokhuseleko lwe-Otezla. Iziganeko ezibi kakhulu ezichazwe ngokuqhelekileyo ezenzeke ubuncinane kwi-5% yezigulane kulo naliphi na iqela lonyango yayiyi-diarrhea, intloko ebuhlungu, isicaphucaphu kunye ne-nasopharyngitis.
Izigulane ezigqiba isigaba se-double-blind-blind of the trial yaqhubeka okanye itshintshelwe kwi-Otezla ngexesha lokwandiswa kwesigaba sophando kwaye iya kunyangwa ngeveki 32. Uphononongo luyaqhubeka kwaye lucetywa ukugqiba kwisiqingatha sokuqala se-2022.
Iziphumo ezicacileyo ezivela kwi-16-iveki ye-double blind-blind isigaba sophononongo iya kuhanjiswa ukuba iboniswe kwinkomfa yezonyango ezayo.
E-US, i-Otezla ivunyiwe kunyango lwabaguli abadala abane-plaque ephakathi ukuya kwi-psoriasis enzima abangabaviwa be-phototherapy okanye unyango lwenkqubo, abaguli abadala abane-psoriatic arthritis esebenzayo kunye nabaguli abadala abanezilonda zomlomo ezinxulumene ne-Behçet's Disease. Ukususela ekuvunyweni kwayo kokuqala kwe-FDA ngo-2014, i-Otezla iye yamiselwa ngaphezu kwezigulane ze-650,000 kwihlabathi jikelele ezine-plaque psoriasis ephakathi, i-psoriatic arthritis esebenzayo okanye i-Behçet's Disease.