"Plaque psoriasis na iya sanya nauyi mai yawa a kan rayuwar marasa lafiya, ba tare da la'akari da tsananin shigar fata ba. Babban buƙatun da ba a biya ba ya rage ga marasa lafiya na psoriasis masu sauƙi zuwa matsakaici waɗanda hanyoyin kwantar da hankali ba za su isa ba, musamman ga waɗanda ke da wuraren da ke da wahalar magancewa, kamar fatar kan kai, ”in ji David M. Reese, MD, mataimakin shugaban zartarwa na Bincike. da Ci gaba a Amgen. "Tare da wannan faɗaɗa nuni ga Otezla, marasa lafiya a duk matakan tsananin cutar yanzu suna da zaɓi na baka, zaɓi na tsari wanda sama da mutane 650,000 suka rigaya suka yi amfani da su a duk duniya kuma basu da buƙatun sa ido na lab."1

"Idan aka yi la'akari da cewa psoriasis cuta ce mai kumburin ƙwayar cuta, wasu marasa lafiya na iya buƙatar fiye da matakan taimako," in ji Dokta Linda Stein Gold, darektan Binciken Clinical na Dermatology a Tsarin Lafiya na Henry Ford, Detroit, da kuma ADVANCE mai bincike. "A karon farko, likitocin fata na iya ba wa marasa lafiya fama da plaque psoriasis na kowane digiri ingantaccen magani na baka tare da ingantaccen bayanin martaba."

Yardar FDA ta dogara ne akan binciken daga gwaji na 3 ADVANCE, wanda sau biyar fiye da manya masu laushi zuwa matsakaicin plaque psoriasis suna karɓar Otezla 30 MG sau biyu a rana sau biyu a rana sun sami babban ƙarshen ƙarshen Static Physician's Global Assessment (sPGA) a mako 16. idan aka kwatanta da placebo (21.6% da 4.1%, p<0.0001), bambancin da ke da mahimmanci. Otezla ya kuma nuna ingantaccen ingantaccen ƙididdiga a cikin mahimman alamun bayyanar cututtuka, irin su Gabaɗayan Jiki Itch NRS amsa (43.2% da 18.6%), da yanki mai wuyar magani, fatar kan kai, wanda aka auna ta amsawar Kima ta Duniya na Likita (ScPGA) (44% a kan 16.6%), a mako 16 idan aka kwatanta da placebo. Haɓakawa a cikin amsawar sPGA, Dukan Jikin Itch NRS da amsa SPGGA an lura da su a farkon mako na 2 kuma ana kiyaye su ta cikin mako 32.

Abubuwan da ba su da kyau da aka gani a cikin gwaji sun yi daidai da sanannun bayanan tsaro na Otezla. Mafi yawan rahoton (≥5%) na jiyya - abubuwan da suka faru na gaggawa tare da maganin Otezla sune gudawa, ciwon kai, tashin zuciya da nasopharyngitis.

Kimanin mutane miliyan 8 a Amurka suna da cutar psoriasis, kuma mutane miliyan 5 a Amurka suna da cuta mai laushi zuwa matsakaici. Duk da ci gaban da aka samu da ci gaban jiyya a cikin 'yan shekarun nan, buƙatun da ba a cika su ba ya rage, musamman ga mutanen da ke da ƙwayar psoriasis mai laushi zuwa matsakaici ko waɗanda ke fama da alamun ci gaba duk da jiyya na gida.

"Plaque psoriasis sau da yawa yana rinjayar marasa lafiya fiye da yadda za a iya auna su ta wurin Jikin Sama kaɗai, musamman ga waɗanda ke da alamun bayyanar a wuraren da ke da wuyar magani kamar gashin kai. Wurin da allunan na iya sa yankin ya kula da jiyya na zahiri ko kuma ƙalubalanci a yi amfani da su," in ji Stacie Bell, Ph.D., babban jami'in kimiyya da likita a Gidauniyar Psoriasis ta ƙasa. "Yana da maraba da labarai don a ƙarshe samun zaɓi na tsarin baka tare da ingantaccen bayanin martabar aminci da ke akwai ga duk masu cutar psoriasis manya."

An amince da Otezla don alamomi guda uku a cikin Amurka, gami da manya marasa lafiya tare da plaque psoriasis waɗanda 'yan takara ne don phototherapy ko tsarin jiyya, manya marasa lafiya tare da cututtukan cututtukan psoriatic mai aiki da kuma ga manya masu fama da cututtukan baki masu alaƙa da Cutar Behcet. Otezla ita ce alamar da aka fi ba da izini ga plaque psoriasis marasa lafiya da ke farawa tsarin tsarin.3 Amgen ya himmatu don bincika yiwuwar Otezla a fadin ci gaba da psoriasis, ciki har da marasa lafiya marasa lafiya tare da psoriasis na al'aura, psoriasis na yara, yara psoriatic arthritis da sauran wurare masu nauyi.

ABUBUWAN DA ZA KU GUDU DAGA WANNAN LABARI:

The FDA approval is based on findings from the Phase 3 ADVANCE trial, in which five times as many adults with mild to moderate plaque psoriasis receiving oral Otezla 30 mg twice daily achieved the primary endpoint of Static Physician’s Global Assessment (sPGA) response at week 16 compared to placebo (21.
Despite the prevalence and treatment advances in recent years, a significant unmet need remains, particularly for people with mild to moderate plaque psoriasis or those who experience persistent symptoms despite topical treatment.
A substantial unmet need remains for mild to moderate plaque psoriasis patients for whom topical therapies may not be sufficient, especially for those with difficult-to-treat areas, like the scalp,”.