Uphulo lwe-Oral Treatment lwe-Psoriatic Arthritis ne-Psoriasis
Ngo-Matshi 21, 2014, i-FDA yamenyezela ukuvunyelwa kuka-Otezla (apremilast) kunyango lwe- psoriatic arthritis kubantu abadala. I-Otezla yi-inhibitor ekhethiweyo ye-phosphodiesterase-4 (PDE4). I-Otezla yiyo kuphela yonyango yomlomo evunyiweyo ka-FDA ngokukhethekileyo kwi-psoriatic arthritis. NgoSeptemba 23, 2014, i-FDA ivume i-OLAla ngolwazi olongezelelweyo, unyango lwezigulane ezinomlinganiselo ochanekileyo kwi-plaque psoriasis enokuthi i-phototherapy okanye ityhilo yonyango ifanelekile.
Ngaphambi kokuvunywa kwe-Otezla, i-psoriatic arthritis yayiphathwa ngohlobo lwe- corticosteroids , i- TNF blockers , okanye i- Stelara (ustekinumab ) , i-interleukin-12 / interleukin-23 inhibitor yamkelwa ngoSeptemba 2013.
U-Otezla ulawulwa njani?
I-Otezla iza njengeephilisi ezifakwe idayimani eziphetshana ngefilimu ezinamandla amathathu: 10 mg, 20 mg, kunye no-30 mg. Umlinganiselo wokuqala ophakanyisiweyo we-Otezla uquka ukubhaliswa ukususela ngosuku 1 ukuya ku-5 ukuya kwi-dose yesondlo ephakanyisiweyo ye-30 mg. ngokuphindwe kabini imihla ngemihla ukuqala ngomhla we-6.
Usuku 1: 10 mg. ekuseni
Usuku 2: 10 mg. kusasa kunye no-10 mg. ngokuhlwa
Usuku 3: 10 mg. kusasa kunye no-20 mg. ngokuhlwa
Usuku 4: 20 mg. kusasa kunye no-20 mg. ngokuhlwa
Usuku 5: 20 mg. kusasa kunye no-30 mg. ngokuhlwa
Usuku 6 nangaphezulu: 30 mg. kusasa kunye no-30 mg. ngokuhlwa
(Qaphela: Izigulane ezinobungozi obuthakathaka obuyingozi ziya kufuna ukulungiswa kwishedyuli yesilinganiso).
Ziziphi iimpembelelo eziqhelekileyo eziye zahlanganisana ne-Otezla?
Kwizilingo zeeklinikhi, isifo sohudo, intloko yesifo, kunye nesicathulo se-nasusia kwakuyimiphumo echaphazelekayo echazwe ngokuqhelekileyo e-Otezla. Uninzi lweziganeko ezimbi zenzeke kwiiveki zokuqala zonyango kwaye zichithwe ngokuhamba kwesikhathi kunye nokusetyenziswa okuqhubekayo kwe-Otezla.
Ngaba kukho ukuphikisana okanye izilumkiso kunye nokuCetyiswa okudibana no-Otezla?
I-Otezla iyachaswa kwizigulane ezine-hypersensitivity eyaziwa kwi-apremilast. Ngokuphathelele izilumkiso kunye nokulumkisa, i-Otezla idibene nomngcipheko wokwanda kwengcinezelo. Ukuncipha kwesisindo kwaphawulwa kwakhona ngexesha leemvavanyo zeclini njengemicimbi enobungozi. Izigulane kufuneka zibukele ukuchazwa kwesisindo esingakhange sichazwe kunye nesifo.
Kwakhona, kukho ukubandakanywa kweziyobisi phakathi kwe-Otezla kunye ne-cytochrome P450 enzyme inducme, njenge-rifampin, i-phenobarbital, i-carbamazepine, kunye ne-phenytoin eya kunciphisa ukusebenza kwe-Otezla. Ukuhlanganiswa akukhuthazwa.
Ucwaningo olulawulwa kakuhle kunye no-Otezla aluzange luqhutywe kwabasetyhini abakhulelweyo. I-Otezla kufuneka isetyenziswe ngexesha lokukhulelwa kuphela xa inzuzo enokuthi iphakame kakhulu ingozi ebantwini. Akwazanga kwakhona ukuba i-Otezla okanye i-metabolites ye-Otezla ikhona kubisi lomntu, ngoko umfazi onesihlengikazi kufuneka alumke. Njengengxenye ye-FDA imvume, kuya kubakho irejista yabasetyhini abakhulelweyo kunye nokuphathwa nge-Otezla.
U-Otezla wenza njani kwiimvavanyo zezonyango?
Ukhuseleko kunye nokusebenza kwe-Otezla zavavanywa kwizilingo ezintathu zonyango ezibandakanya izigulane ezingama-1,493 ezine-arthritis esebenzayo.
Kwiimvavanyo, ezibizwa ngokuba yi-PALACE-1, i-PALACE-2, kunye ne-PALACE-3, abathathi-nxaxheba bathe bafumana indawo ye-placebo, i-Otezla 20 mg. okanye 30 mg. kabini imihla ngemihla. Izigulane zavunyelwa ukuba ziqhubeke ne-DMARD, ii-corticosteroids zamanqanaba aphantsi, okanye ii-NSAID ngexesha lovavanyo. Isiphelo sokugqibela sasiyi- ACR20 ngeveki 16. I-Otezla kunye ne-DMARD xa kuthelekiswa ne-placebo kunye ne-DMARD yayidibene nokuphucula okukhulu kwiimpawu kunye neempawu ze-arthritis ye-psoriatic. Kwakukho ubungqina bokuphucula okukhulu emsebenzini wokusebenza kunye no-Otezla (30 mg kabini imihla ngemihla) kune-placebo.
Iyini Indleko ye-Otezla?
Umenzi weziyobisi, u-Celgene, usethe ixabiso elingama-22,500 zamaRandi ngonyaka nge-Otezla.
Imithombo:
Otezla (apremilast). Ulwaziso loLwazi. Matshi 2014.
http://media.celgene.com/content/uploads/otezla-pi.pdf
Uhlaziyo 2 - I-US FDA ivuma i-Celgene Drug ye-Arthritis ye-Psoriatic. UBill Berkrot. Reuters. Matshi 21, 2014.
http://www.reuters.com/article/2014/03/21/celgene-fda-idUSL2N0MI1ED20140321
I-Otezla evunywe yi-FDA ye-Plaque Psoriasis. Shishini. Septemba 23, 2014.
http://www.businesswire.com/news/home/20140923006559/en/Oral-OTEZLA%C2%AE-apremilast-Approved-US-Food-Drug%23.VCHKX_ldV8E#.VCIn1Bb4Kr8