Xeljanz wuxuu ahaa JAK Inhibitor ee ugu horreysay ee la ogolaaday ee Maraykanka; Baricitinib waa xiga
Baricitinib waa JAK (Janus kinase) inhibitor ah oo loo baahan yahay in loo qaato rheumatoid arthritis . Seddexdii bilood ee hore ee sannadka 2016, baricitinib ayaa loo gudbiyay dib-u-eegis sharciyadeed iyo oggolaanshaha suuq-galka Maraykanka, Midowga Yurub, iyo Japan. Guddiga Agaasinka Caafimaadka ee Yurub ee Maareynta Caafimaadka ee loogu talagalay Isticmaalka Bani-aadamka ayaa kugula taliyey in la ansixiyo bisha Disembar 2016
Febraayo 13, 2017, daroogada ayaa loo ansixiyay in lagu iibiyo xanuunka 'rheumatoid arthritis' ee Midowga Yurub sida Olumiiste (baricitinib) . Dalka Mareykanka, FDA ayaa ku dhawaaqday 13-Janaayo, 2017 in ay kordhisay muddada dib-u-eegista codsiga cusub ee daroogada ee baricitinib. Faahfaahinta dheeriga ah waxaa loo oggol yahay in dib loo eego xogta dheeraadka ah ee la soo gudbiyay ka dib markii la sameeyey arjigii hore ee dawada.
Abriil 14, 2017, FDA waxay si la yaab leh u diideen baricitinib markale. FDA waxay soo saartay warqad jawaabta oo dhamaystiran oo sheegaysa in wakaaladda "aysan awoodin in ay ansixiso codsiga foomka hadda". FDA waxay sheegtay in xogta dheeraadka ah ee bukaan-socodka loo baahan yahay si loo go'aamiyo qiyaasaha ugu habboon. Sidoo kale, xog dheeri ah ayaa lagama maarmaan u ah inay sii sharaxaan cabashooyinka amniga ee hubka daaweynta. Waqtiga dib u soo noqoshada ayaa la socon doona wadahadal dheeraad ah FDA.
Waxaa intaa dheer, marxaladda 2aad ee tijaabada ah ayaa socota kuwaas oo baaraya baricitinib loogu talagalay lupus leryus eritematosus iyo dermatitis atopic .
Marxaladda 3aad ee tijaabada baricitinib ee loogu talagalay cudurka psoriatic arthritis ayaa la filayaa inay bilaabato 2017.
Xeljanz wuxuu ahaa JAK Inhibitor ee ugu horeysay ee loo yaqaan 'Rheumatoid Arthritis'
Xeljanz (tofacitinib) wuxuu ahaa JAK horjooge ugu horeysay ee uu ansixiyey FDA 2012-kii loogu talagalay dadka qaangaarka ah ee leh rheumatoid arthritis-ka dhexdhexaad ah iyo mid daran oo leh jawaab aan ku filnayn daaweynta methotrexate .
Waxaa jira afar xabbadood oo JAK ah: JAK1, JAK2, JAK3, iyo Tyk2. Xeljanz wuxuu horjoogsanayaa JAK1 iyo JAK3, waxaana la qaadaa laba jeer maalin kasta. Taa macquul ahaan, baricitinib wuxuu joojiyaa JAK1 iyo JAK2 waxaana la qaataa hal mar maalin kasta.
Afarta Wajiga 3aad ee Maxkamadaynta Baricitinib
Eli Lilly & Shirkadda iyo Incyte Corporation waa wada-hawlgalayaasha horumarinta baricitinib. Lilly iyo Incyte waxay sameeyeen afar marxaladood oo tijaabo ah oo tijaabo ah oo ay ka qaybgalayaashu ay ka qaybgalayaashu ay la yeesheen rheumatoid arthritis-ka dhexdhexaad ah oo aad u firfircoon.
- Daraasad RA-BUILD - 684 bukaanka rheumatoid arthritis-ka ee qaba cudurka firfircooni ayaa loo xilsaaray 2 milligram ama 4 milligram oo baricitinib, ama placebo muddo 24 toddobaad ah. Marka la barbardhigo placebo, kooxaha baricitinib waxay muujiyeen horumarin weyn oo ku saleysan ACR20 , ACR50, iyo heerka jawaab celinta ACR70. Sidoo kale daraasaddan daraasaddan waxay caddayn u tahay raajada ciribtirka cudurada gaabinta baricitinib, iyo xaqiiqda jawaabta baricitinib degdeg u dhacdey, mararka qaarkood hal toddobaad kadib.
- RA-BEACON - 527 bukaan-socodka rheumatoid arthritis-ka ee qaba jawaab-celin ku filan mid ka mid ah ama in ka badan oo ka- hortagayaasha TNF ayaa si aan kala sooc lahayn loogu qoondeeyey 2 milligram baricitinib, 4 milligram baricitinib, ama placebo muddo 24 toddobaad ah. Heerarka jawaab celinta sare ee ACR20 ayaa lagu arkay labadii kooxood ee baricitirib marka loo eego xuddunta. Lacagta daaweynta joogtada ah waxay ku dhacday kaliya 4 milligram baricitinib.
- RA-BEGIN - 584 bukaanno qaba rheumatoid arthritis-ka firfircoon ee xaddidan ama aan la daaweynin DMARD-ka caadiga ah ayaa loo dhigay daawada methotrexate monotherapy, 4 milligram baricitinib, ama 4 milligram baricitinib oo leh methotrexate ilaa 52 toddobaad. Natiijooyinka ayaa si aad ah ugu fiicnaa baricitinib monotherapy marka loo eego daaweynta daaweynta methotrexate. Qaadashada daawada methotrexate ee baricitinib uma muuqato in ay saameyn ku yeeshaan faa'iidada, inkasta oo isku-dhafku u muuqda inuu hoos u dhigo caddaynta cudurka raajada.
- RA-BEAM - 1307 bukaan qaba rheumatoid arthraad firfircoon, kuwaasoo hela daawada methotrexate oo aan caadi ahayn laakiin aan si haboon uga jawaabin, ayaa 4 jeer millitar ah baricitinib maalintii la geeyaa, ama 40 milligram Humira (adalimumab) toddobaadkii kale, ama placebo. Horumarinta bukaan-socodka ee muhiimka ah waxay la xiriirtay baricitinib iyo placebo ama Humira.
Ka-qaybgalayaasha ka-qaybgalayaasha oo dhammaystay RA-BUILD, RA-BEGIN, ama RA-BEAM waxay xaq u leeyihiin inay ka qaybqaataan daraasad dheeraad ah oo loo yaqaan 'RA-BEYOND'. Daraasadda dheeraynta ayaa lagu soo gebogebeeyay in 4 mg milligaraam oo baricitinib ah ay ugu waxtar badan yihiin.
Qalabka Nabadgelyada ee Baricitinib
Macluumaadka ku saabsan nabadgelyada baricitinib waxaa lagu soo ururiyey iyadoo lagu falanqaynayo dhammaan tijaabooyinka bukaan socodka laga bilaabo wajiga 1 ilaa iyo marxaladda 3, oo lagu daray daraasadda dheeraynta. Dhibaatooyinka waxay ku lug lahaayeen 3,464 bukaan oo wadajir ah. Ka dib markii la helay baricitinib, ma jirin wax kordhin ah dhimashada, cudurada halis ah, caabuqyada halista ah, infakshanka fursadaha, ama dhacdooyinka xun ee keena joojinta daroogada. Marka la barbardhigo placebo waxaa jiray isbeddel heer qaran ah oo ku yimid xaddiga herpes zosterter ee bukaannada lagu daaweeyo qiyaasta 4 milligrams oo baricitinib ah. Daaweynta baricitinib waxay sidoo kale ku xiran tahay isbeddelada heerarka dhiigbaxa, lymphocytes, transaminases, kinine creatase, iyo creatinine-laakiin marar dhif ah oo ku filan si loogu baahdo joojinta daroogada.
Ereyga
JAK-celiyeyaasha waa fasalka seddexaad ee DMARDS, oo loo yaqaan 'molecule molecule DMARDS'. Helitaanka baricitinib ayaa bixin doona doorasho kale oo daaweynta rheumatoid arthritis, marka la ansixiyo. Oggolaanshahaan waxaa la filayaa 2017. Bukaan-jiifka oo aan ku filneyn jawaab-celinta methotrexate, DMARD-ka kale, ama daawooyinka bayoolajiga , ayaa markaa yeelan doona daawo kale oo ah doorasho. Bukaanjiifka qaarkood, waxay noqon kartaa ikhtiyaarka ugu haboon ee la doorbido daawooyinka nafaqada leh ee nafsadda leh ama baayolojiyada lagu maamulo faleebo.
> Ilo:
> Kuriya, Bindee et al. Baricitinib ee Rheumatoid Xanuunka Arthritis: Calaamadaha Taariikhda iyo Xeeldheeraha. Horumarinta Therapeutic ee Cudurka Musqulaha. 2017 Feb; 9 (2): 37-44.
> Smolen, Josef S. et al. Natiijooyinka bukaan-socodka ee laga soo qaatay Daraasad Jajabeed III ee Baricitinib ee bukaan-socodka qaba Rheumatoid Arthritis iyo Jawaab aan ku filnayn oo ku saabsan Wareegyada Bayoolajiyadeed (RA-BEACON). Annals of Cudurada Rheumatic. 2017; 76: 694-700.
> Taylor, Peter C. MD, PhD et al. Baricitinib iyo Placebo ama Adalimumab ee Rheumatoid Arthritis. Somali Journal of Medicine. 2017; 376: 652-662. Febraayo 16, 2017.
> FDA-da Mareykanka ayaa kordhineysa muddada dib-u-eegista ee Baricitinib, oo ah Daaweynta Rheumatoid Xanuunka Arthritis-ka. Lilly. Janaayo 13, 2017.
> Arrimaha FDA ee Mareykanka ayaa dhameystiraya warqadda jawaabta ee Baricitinib. Lilly iyo Incyte iyada oo loo marayo BusinessWire. Abriil 14, 2017.