FDA menyetujui penggunaan Bryhali untuk terapi perawatan psoriasis plak

FARMASI-ID.COM > BLOG | FARMASI-ID.COM > FDA menyetujui penggunaan Bryhali untuk terapi perawatan psoriasis plak

FDA menyetujui penggunaan Bryhali (halobetasol propionate) berbentuk losion untuk digunakan dalam terapi perawatan pasien dewasa penderita psoriasis plak. Menurut Bill Humphries, presiden Ortho Dermatologics selaku pengembang Bryhali, pihaknya sangat senang dengan disetujuinya Bryhali oleh FDA dan pihaknya akan mulai mendistribusikan obat tersebut pada akhir bulan ini.

Bryhali merupakan produk kortikosteroid yang diklaim aman untuk digunakan hingga delapan minggu. Berdasarkan penelitian mengenai produk ini, penerapan Bryhali sekali sehari selama delapan minggu, terbukti dapat ditoleransi dengan baik tanpa terjadi peningkatan atrofi epidermal. Uji klinis dilakukan secara multicenter, random, double-blind, untuk menguji tingkat keamanan dan efikasi Bryhali. Setidaknya 430 pasien penderita psoriasis moderat hingga parah berusia 18 tahun keatas terlibat dalam uji klinis ini. Pada percobaan pertama dan kedua, 37 dan 38 persen pasien dapat menerima pengobatan dengan Bryhali dan mencapai kesuksesan terapi (setidaknya perkembangan dua peringkat dari baseline IGA (investigator’s global assessment) dan nilai itu setara dengan “bebas” atau “hampir bebas”, dibandingkan dengan 8 persen dan 12 persen pasien yang diberikan produk topical steroid lainnya . Tidak ada peningkatan atrofi epidermal selama delapan minggu pemberian Bryhali.

Efek samping yang paling umum terjadi akibat pemberian Bryhali adalah infeksi saluran pernapasan atas (2%), dermatitis (1%), dan hiperglikemia (1%).

Selama ini psoriasis diterapi dengan topical steroid, namun hanya dalam jangka waktu terbatas karena efek sampingnya seperti atrofi epidermal, striae, telangiectasias, hipopigmentasi dan dermatitis yang mana efek samping tersebut sifatnya dapat permanen, sehingga perawatan hanya dilakukan antara dua hingga empat minggu saja.

Psoriasis merupakan penyakit autoimun yang mengenai kulit, ditandai dengan sisik yang berlapis berwarna keperakan, disertai dengan penebalan warna kemerahan dan rasa gatal atau perih. Bila sisik ini dilepaskan maka akan timbul bintik perdarahan di kulit dibawahnya. Psoriasis plak merupakan tipe psoriases yang paling umum terjadi.

Psoriasis sering timbul di kuku, dimulai dari bintik putih pada kuku sampai ke penebalan kuku, juga mengenai kulit kepala (skalp) ditandai dengan sisik besar dan penebalan dengan warna kemerahan yang akan melewati batas rambut. Selain itu penyakit ini sering mengenai siku dan lutut, walaupun dapat juga mengenai wajah, lipat lutut dan siku, genitalia, telapak tangan dan kaki, sesuai tingkat keparahannya penyakit ini bisa meluas keseluruh tubuh (eritroderma) yang akan menimbulkan kegawatan dan dapat mengancam jiwa.

Bryhali tersedia dalam bentuk losion mengandung 0,01% halobetasol propionate yang dikembangkan oleh Ortho Dermatologics, anak perusahaan dari Bausch Health Companies Inc yang berfokus pada produk-produk terapi perawatan penyakit kulit seperti psoriasis, actinic keratosis, jerawat, dermatitis atopik dan tipe dermatitis lainnya, anti-jamur, dan produk-produk anti-infeksi.

Daftar pustaka:

  • Bausch Health’s BRYHALI™(halobetasol propionate) Lotion, 0.01%, Receives Tentative FDA Approval For Plaque Psoriasis In Adults. https://www.prnewswire.com/news-releases/bausch-healths-bryhalihalobetasol-propionate-lotion-0-01-receives-tentative-fda-approval-for-plaque-psoriasis-in-adults-300726671.html. Diakses 03 Desember 2018.
  • FDA approves Bryhali Lotion for psoriasis. https://www.psoriasis.org/advance/fda-approves-bryhali-lotion-psoriasis?utm_source=social&utm_medium=FB+post. Diakses 03 Desember 2018.
  • FDA Approves Bryhali Lotion for Plaque Psoriasis for 8 Weeks of Use. https://www.mdmag.com/medical-news/fda-approves-bryhali-lotion-plaque-psoriasis-8-weeks. Diakses 03 Desember 2018.
  • Bryhali Lotion Is the Latest Psoriasis Drug Approved by the FDA. https://www.allure.com/story/bryhali-lotion-psoriasis-treatment-fda-approval. Diakses 03 Desember 2018.
  • Bausch Health’s BRYHALI Lotion receives tentative FDA approval for plaque psoriasis in adults. https://seekingalpha.com/news/3395676-bausch-healths-bryhali-lotion-receives-tentative-fda-approval-plaque-psoriasis-adults. Diakses 03 Desember 2018.

 

10 thoughts on “FDA menyetujui penggunaan Bryhali untuk terapi perawatan psoriasis plak

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