Kuchiza Mankhwala kwa Psoriatic Arthritis ndi Psoriasis
Pa March 21, 2014, a FDA adalengeza kuti Otezla (apremilast) amavomereza kuti azisamalidwa ndi matenda a psoriatic akuluakulu. Otezla ndi njira yosankhira phosphodiesterase-4 (PDE4). Otezla ndi mankhwala okhawo ovomerezedwa ndi FDA ovomerezeka makamaka kwa psoriatic nyamakazi. Pa September 23, 2014, a FDA adavomereza Otezla kuti adziwonetsenso zowonjezereka, chithandizo cha odwala omwe ali ndi psoriasis omwe amawagwiritsa ntchito moyenera kapena ochizira.
Asanavomereze Otezla, nyamakazi yotchedwa psoriatic yamtunduwu inkachiritsidwa ndi corticosteroids , TNF blockers , kapena Stelara (ustekinumab ) , inhibitor ya interleukin-12 / interleukin-23 yomwe inavomerezedwa mu September 2013.
Kodi Otezla Amagwira Ntchito Motani?
Otezla imakhala ngati mapiritsi ovekedwa ndi diamondi, omwe ali ndi mphamvu zitatu: 10 mg, 20 mg, ndi 30 mg. Mlingo woyambirira wa Otezla umaphatikizapo titration kuyambira tsiku 1 mpaka 5 kuti apite ku mlingo wokwanira wokonza mlingo wa 30 mg. Kuyambira kawiri tsiku lililonse pa tsiku 6. Nthawi yambiri yolemba malemba ndi:
Tsiku 1: 10 mg. m'mawa
Tsiku 2: 10 mg. m'mawa ndi 10 mg. madzulo
Tsiku 3: 10 mg. m'mawa ndi 20 mg. madzulo
Tsiku 4: 20 mg. m'mawa ndi 20 mg. madzulo
Tsiku 5: 20 mg. m'mawa ndi 30 mg. madzulo
Tsiku 6 ndi kupitirira: 30 mg. m'mawa ndi 30 mg. madzulo
(Zindikirani: Odwala omwe ali ndi vuto lalikulu la nthendayi amafunikira kusintha pa nthawi yake).
Kodi Ndi Zotsatira Ziti Zomwe Zimagwirizanitsidwa ndi Otezla?
M'mayesero a kachipatala, kutsekula m'mimba, kupweteka mutu, ndi kunyoza ndizo zotsatira zofala kwambiri zomwe zimagwirizanitsidwa ndi Otezla. Zambiri mwa zovutazo zinachitika mkati mwa masabata awiri oyambirira a chithandizo ndi kuthetsedwa pakapita nthawi ndikugwiritsabe ntchito Otezla.
Kodi Pali Zotsutsana Kapena Zochenjezo Zomwe Zimayenderana ndi Otezla?
Otezla imatsutsana ndi odwala omwe amadziwika kuti hypersensitivity kuti apremilast. Ponena za machenjezo ndi zodzitetezera, Otezla imakhudzidwa ndi chiopsezo chowonjezeka cha kuvutika maganizo. Kuchepa kwa kuchepa kunanenenso pamayesero a zachipatala monga chotheka chochitika chovuta. Odwala ayenera kuyang'ana zosawerengeka zosadziwika komanso zofunikira kwambiri.
Komanso, pangakhale kugwiritsidwa ntchito kwa mankhwala pakati pa Otezla ndi cytochrome P450 enzyme inducers, monga rifampin, phenobarbital, carbamazepine, ndi phenytoin zomwe zingachepetse mphamvu ya Otezla. Kuphatikiza sikukulimbikitsidwa.
Maphunziro ogwirizana ndi Otezla sanachititsidwe ndi amayi apakati. Otezla ayenera kugwiritsidwa ntchito panthawi yomwe ali ndi mimba pokhapokha phindu limene lingapindule limapangitsa kuti mwanayo asatengeke. Sikudziwikanso ngati Otezla kapena metabolites a Otezla alipo mkaka waumunthu, choncho amayi akuyamwitsa ayenera kukhala osamala. Monga mbali ya chivomerezo cha FDA, padzakhala kulembetsa kwa amayi omwe ali ndi pakati ndi Otezla.
Kodi Otezla Ankachita Zotani M'mayesero Amakono?
Otezla anali otetezedwa komanso ogwira mtima poyesedwa m'mayesero atatu omwe amachititsa odwala 1,493 omwe ali ndi matenda a psoriatic.
M'mayeserowa, otchedwa PALACE-1, PALACE-2, ndi PALACE-3, ophunzira omwe amaphunzirawo amapatsidwa placebo, Otezla 20 mg mwachisawawa. kapena 30 mg. kawiri tsiku ndi tsiku. Odwala analoledwa kupitilira ndi DMARD, corticosteroids yazitsitsimu, kapena NSAID panthawi yamavuto. Choyambirira kumapeto chinali ACR20 ndi sabata 16. Otezla limodzi ndi DMARDs poyerekeza ndi placebo ndi DMARD zinkakhudzidwa ndi kusintha kwakukulu kwa zizindikiro za nyamakazi ya psoriatic. Panalinso umboni wa kusintha kwakukulu pa ntchito yogwira ntchito ndi Otezla (30 mg kawiri pa tsiku) kuposa placebo.
Kodi Mtengo wa Otezla Ndi Chiyani?
Wolemba mankhwalawa, Celgene, wagulitsa $ 22,500 pachaka kwa Otezla.
Zotsatira:
Otezla (apremilast). Kufotokozera Information. March 2014.
http://media.celgene.com/content/uploads/otezla-pi.pdf
Kusintha 2 - US FDA ikuvomereza mankhwala a Celgene a Psoriatic Arthritis. Bill Berkrot. Reuters. March 21, 2014.
http://www.reuters.com/article/2014/03/21/celgene-fda-idUSL2N0MI1ED20140321
Otezla Yavomerezedwa ndi FDA kwa Plaque Psoriasis. BwinoKuchita Bwino. September 23, 2014.
http://www.businesswire.com/news/home/20140923006559/en/Oral-OTEZLA%C2%AE-apremilast-Approved-US-Food-Drug%23.VCHKX_ldV8E#.VCIn1Bb4Kr8