Phekolo ea Mantsoe bakeng sa Ramatiki ea Psoriatic le Psoriasis
Ka la 21 March, 2014, FDA e phatlalatsa tumello ea Otezla (apremilast) bakeng sa phekolo ea ramatiki e sebetsang ea psoriatic ho batho ba baholo. Otezla ke inhibitor e khethollang phosphodiesterase-4 (PDE4). Otezla ke eona feela phekolo ea molomo e amohelehang ka FDA ka ho toba bakeng sa ramatiki ea psoriatic. Ka la 23 September, 2014, FDA e amohetse Otezla bakeng sa pontšo e eketsehileng, phekolo ea bakuli ba psoriasis e nang le tekanyo e boima ho ea ho bao phototherapy kapa therapy e sebetsang e loketseng.
Pele ho amoheloa ke Otezla, ramatiki ea psoriatic e ne e tloaelehile ho phekoloa ka corticosteroids , TNF blockers , kapa Stelara (ustekinumab ) , inhibitor ea interleukin-12 / interleukin-23 e amohelehang ka September 2013.
Otezla o laoloa joang?
Otezla e tšoana le matlapa a mararo a koahetsoeng ke filimi ka matla a mararo: 10 mg, 20 mg, le 30 mg. Otezla tekanyo ea pele e khothalletsoang e amana le titration ho tloha letsatsing la 1 ho ea ho la 5 ho ea khoeling e khothalletsoang ho hlokomeloa ea 30 mg. ka makhetlo a mabeli letsatsi le leng le le leng ho qala ka letsatsi la 6.
Letsatsi la 1: 10 mg. hoseng
Letsatsi la 2: 10 mg. hoseng le 10 mg. mantsiboea
Letsatsi la 3: 10 mg. hoseng le 20 mg. mantsiboea
Letsatsi la 4: 20 mg. hoseng le 20 mg. mantsiboea
Letsatsi la 5: 20 mg. hoseng le 30 mg. mantsiboea
Letsatsi la 6 le ho feta: 30 mg. hoseng le 30 mg. mantsiboea
(Tlhokomeliso: Bakuli ba nang le bokooa bo matla ba likokoana-hloko ba tla hloka liphetoho ho kemiso ea tekanyo ea litekanyetso).
Ke Liphello Life Tse Tloaelehileng Tse Amanang le Otezla?
Litekong tsa meriana, letšollo, hlooho le ho nyeheloa ke pelo ke litla-morao tse atisang ho tlalehoa tse amanang le Otezla. Boholo ba liketsahalo tse bohloko li etsahetse libeke tse peli tsa pele tsa phekolo le ho rarolloa ha nako e ntse e feta ka tšebeliso e tsoelang pele ea Otezla.
Na ho na le Litlhaloso kapa Litemoso le Litlhokomelo Tse Amanang le Otezla?
Otezla e hanyetsanoa ho bakuli ba nang le hypersensitivity tse tsebahalang ho apremilast. Mabapi le litemoso le litlhokomelo, Otezla e amana le kotsi e eketsehileng ea ho tepella maikutlong. Ho fokotseha ha litekanyo ho ile ha boela ha hlokomeloa nakong ea liteko tsa meriana e le ketsahalo e bohloko. Bakuli ba lokela ho shebella ho lahleheloa ke boima ba 'mele bo sa hlalosoang le bo bong bo bobebe.
Hape, ho ka 'na ha e-ba le ho kopana ha lithethefatsi pakeng tsa Otezla le cytochrome P450 inzyme ea inzyme, e kang rifampin, phenobarbital, carbamazepine le phenytoin e neng e tla fokotsa katleho ea Otezla. Motsoako ha o kgothaletswe.
Lithuto tse laoloang hantle le Otezla ha lia etsoa ho basali ba imme. Otezla e lokela ho sebelisoa nakong ea bokhachane feela ha melemo e ka 'nang ea e-ba teng e feta menyetla e ka' nang ea e-ba teng ho lesea. Hape ha ho tsejoe haeba Otezla kapa metabolite ea Otezla e teng lebese la motho, kahoo mosali ea anyesang o lokela ho ba hlokolosi. E le karolo ea tumello ea FDA, ho tla ba le ngoliso bakeng sa basali ba nang le moimana le ba tšoaroang ke Otezla.
Otezla o ile a etsa joang litsing tsa meriana?
Tšireletso le katleho ea Otezla li ile tsa hlahlojoa litekong tse tharo tsa bongaka tse amang bakuli ba 1 493 ba nang le ramatiki ea psoriatic e sebetsang.
Litekong tsena, ho thoe PALACE-1, PALACE-2, le PALACE-3, barupeluoa ba ithutile sebaka sa placebo, Otezla 20 mg. kapa 30 mg. habeli ka letsatsi. Bakuli ba ne ba lumelloa ho tsoelapele ka DMARD, corticosteroids ea tekanyo e tlaase, kapa li- NSAID nakong ea nyeoe. Pheliso e ka sehloohong e ne e le ACR20 ka beke ea 16. Otezla hammoho le DMARD e bapisoa le placebo le DMARD e ne e amana le ntlafatso e kholo ea matšoao a lefu la psoriatic. Hape ho ne ho boetse ho e-na le bopaki ba ntlafatso e khōloanyane ea ho sebetsa hantle le Otezla (30 mg habeli ka letsatsi) ho feta placebo.
Ke bokae ba Otezla?
Moetsi oa lithethefatsi, Celgene, o behile Otala chelete e ngata ea $ 22,500 ka selemo.
Lisebelisoa:
Otezla (apremilast). Ho hlalosa litaba. Khoeli ea 2014.
http://media.celgene.com/content/uploads/otezla-pi.pdf
Phetoho ea 2 - US FDA e lumella li-Celgene Drug for Psoriatic Arthritis. Bill Berkrot. Reuters. La 21 March, 2014.
http://www.reuters.com/article/2014/03/21/celgene-fda-idUSL2N0MI1ED20140321
Otezla Approved by FDA bakeng sa Plaque Psoriasis. KhoeboWo. La 23 September, 2014.
http://www.businesswire.com/news/home/20140923006559/en/Oral-OTEZLA%C2%AE-apremilast-Approved-US-Food-Drug%23.VCHKX_ldV8E#.VCIn1Bb4Kr8