Lalela Funda Kudivayisi kuphela Kwengeziwe Buka Kufakiwe Oral Treatment for Psoriatic Arthritis and Psoriasis
Ngo-Mashi 21, 2014, i-FDA yamemezela ukuvunywa kuka-Otezla (apremilast) yokwelapha i- psoriatic arthritis esebenzayo kubantu abadala. I-Otezla iyi-inhibitor ekhethayo ye-phosphodiesterase-4 (i-PDE4). I-Otezla yiyona kuphela ukwelashwa komlomo okuvunyelwe i-FDA ngokuqondile kwe-psoriatic arthritis. NgoSeptemba 23, 2014, i-FDA ivumile i-Otezla ngencazelo eyengeziwe, ukwelashwa kweziguli ezinomqondo ohambelana ne-plaque psoriasis onobuchwepheshe bokuthi i-phototherapy noma i-systemic therapy ifanelekile.
Ngaphambi kokuba kuvunywe i-Otezla, i-psoriatic arthritis ngokuvamile yayiphathwa nge- corticosteroids , i- TNF blockers , noma i- Stelara (ustekinumab ) , i-interleukin-12 / interleukin-23 inhibitor evunyelwe ngoSepthemba 2013.
I-Otezla iphathwe kanjani?
U-Otezla ufana nezibhebhe ezidayiswe nge-diamond ezinamabala amathathu: 10 mg, 20 mg, no-30 mg. Isilinganiso sokuqala sokuphakanyiswa kwe-Otezla kuhilela ukufakwa kwe-titration kusukela ngosuku 1 kuya ku-5 ukuze ufike kumthamo wokunakekelwa okuphakanyisiwe we-30 mg. Kuqala kabili ngosuku ngalolu suku 6. Isikhathi esijwayelekile se-titration ngu:
Usuku 1: 10 mg. ekuseni
Usuku 2: 10 mg. ekuseni nangama-10 mg. ebusuku
Usuku lwesithathu: 10 mg. ekuseni nangama-20 mg. ebusuku
Usuku 4: 20 mg. ekuseni nangama-20 mg. ebusuku
Usuku 5: 20 mg. ekuseni nangama-30 mg. ebusuku
Usuku 6 nangaphezulu: 30 mg. ekuseni nangama-30 mg. ebusuku
(Qaphela: Iziguli ezinokukhubazeka okukhulu kwe-renal zizodinga ukulungiswa kwisimiso sesilinganiso).
Yiziphi Imiphumela Ezingavamile Eziye Zahlanganiswa No-Otezla?
Ezilingo zomtholampilo, isifo sohudo, ikhanda lokukhwabanisa, kanye nokuhlanza izinhlanzi kwakuyimiphumela emibi kakhulu ebikiwe ehlobene no-Otezla. Eziningi zezenzakalo ezimbi zenzeke phakathi kwamasonto amabili okuqala zokwelapha futhi zixazululwe ngokuhamba kwesikhathi nokusetshenziswa okuqhubekayo kwe-Otezla.
Zikhona Ukuphikisana Noma Izixwayiso Nezinyathelo Zokuqapha Ezihlobene No-Otezla?
U-Otezla uphikisana neziguli ezine-hypersensitivity eyaziwa ku-apremilast. Ngokuphathelene nezixwayiso nokuqapha, i-Otezla ihlotshaniswa nengozi eyengeziwe yokucindezeleka. Ukuncipha kwesisindo kwaphawulwa ngesikhathi sokuhlolwa kwemitholampilo njengesenzakalo esibi. Iziguli kufanele zibuke ukulahlekelwa kwesisindo esingachazwanga nesemtholampilo.
Futhi, kungaba khona ukusebenzisana kwezidakamizwa phakathi kwe-Otezla ne-cytochrome P450 inzyme inducers, njenge-rifampin, i-phenobarbital, i-carbamazepine, ne-phenytoin ezokwehlisa ukuphumelela kwe-Otezla. Inhlanganisela ayinconywa.
Ucwaningo olulawulwa kahle no-Otezla alukwenziwe kwabesifazane abakhulelwe. I-Otezla kufanele isetshenziswe ngesikhathi sokukhulelwa kuphela lapho inzuzo engase ibe khona ingaphezu kwengozi engaba khona enganeni. Ayaziwa ukuthi uma i-Otezla noma i-metabolite ye-Otezla ikhona ebisi lomuntu, ngakho-ke owesifazane oncelisayo kufanele aqaphe. Njengengxenye ye-FDA imvume, kuyoba nokubhalisa kwabesifazane abakhulelwe futhi bephathwa nge-Otezla.
U-Otezla Wenzani Kwenziwe Ezivivinyweni Zomtholampilo?
Ukuphepha nokusebenza kwe-Otezla kwahlolwa ngezivivinyo ezintathu zokwelashwa ezibandakanya iziguli ezingu-1,493 ezine-arthritis esebenzayo ye-psoriatic.
Kulezi zivivinyo, okuthiwa i-PALACE-1, i-PALACE-2, ne-PALACE-3, abahlanganyeli be-study bafaka indawo ye-placebo, i-Otezla 20 mg ngezikhathi ezithile. noma 30 mg. kabili nsuku zonke. Iziguli zavunyelwa ukuba ziqhubeke ne-DMARD, i-corticosteroids ye-dose ephansi, noma i- NSAID ngesikhathi sokuhlolwa. Isiphetho esiyinhloko kwakuyi- ACR20 ngesonto 16. I-Otezla plus i-DMARD eqhathaniswa ne-placebo kanye ne-DMARD yayihlotshaniswa nokuthuthukiswa okukhulu kwezibonakaliso nezimpawu ze-arthritis ye-psoriatic. Kwakukhona nobufakazi bokuthuthukiswa okukhulu ekusebenzeni ngokomzimba no-Otezla (30 mg kabili nsuku zonke) kune-placebo.
Iyini Indleko Ye-Otezla?
Umuthi wezidakamizwa, u-Celgene, usethe u-Otezla imali engama-$ 22,500 ngonyaka.
Imithombo:
Otezla (apremilast). Ukubeka imininingwane. Mashi 2014.
http://media.celgene.com/content/uploads/otezla-pi.pdf
Ukuvuselela 2 - I-US FDA ivumela i-Celgene Drug ye-Psoriatic Arthritis. UBill Berkrot. Ama-Reuters. Mashi 21, 2014.
http://www.reuters.com/article/2014/03/21/celgene-fda-idUSL2N0MI1ED20140321
I-Otezla evunyelwe yi-FDA ye-Plaque Psoriasis. IbhizinisiWire. Ngo-September 23, 2014.
http://www.businesswire.com/news/home/20140923006559/en/Oral-OTEZLA%C2%AE-apremilast-Ukusebenza-US-Food-Drug%23.VCHKX_ldV8E#.VCIn1Bb4Kr8