Xeljanz Da farko ne mai hana JAK da aka amince a Amurka; Baricitinib ne Next
Baricitinib wani mai gabatarwa JAK ne (Janus kinase) wanda ya kamata a dauka don maganin cututtuka na rheumatoid . A farkon kwata na 2016, an gabatar da baricitinib don sake dubawa da cinikayya a Amurka, Tarayyar Turai da Japan. Kwamitin Cibiyar Kula da Magunguna ta Tarayyar Turai don Kwayoyin Magunguna don Amfani da Mutum yayi amfani da shawarar a watan Disamba na shekara ta 2016.
Ranar 13 ga watan Febrairu, 2017, an amince da miyagun ƙwayoyi don sayar da cututtukan arthritis a Tarayyar Turai kamar Olumiant (baricitinib) . A Amurka, FDA ta sanar a ranar 13 ga watan Janairu, 2017, cewa ya mika lokaci na nazarin sabon aikace-aikacen magani don baricitinib. An ba da damar yin nazarin ƙarin bayanan da aka gabatar bayan an fara yin amfani da miyagun kwayoyi.
A ranar 14 ga Afrilu, 2017, FDA ya yi watsi da baricitinib. FDA ta ba da wata wasika mai amsawa ta nuna cewa hukumar "ba ta iya amincewa da aikace-aikace a halin yanzu". FDA ta ce an buƙaci ƙarin bayanan asibiti domin sanin ƙwayoyin da suka dace. Har ila yau, ƙarin bayanai sun zama dole don kara fadada abubuwan da suka shafi tsaro a fadin makamai. Lokacin da za a sake yin amfani da shi zai bi bayan tattaunawa da FDA.
Bugu da ƙari, gwaje-gwajen lokaci na lokaci 2 yana aiki ne wanda ke nazarin baricitinib na lupus erythematosus da kuma dermatitis .
An gwada gwaji na 3 game da baricitinib don cututtukan cututtuka na psoriatic zai fara a 2017.
Xeljanz shine mai gabatarwa na JAK na farko na Rheumatoid Arthritis
Xeljanz (tofacitinib) shi ne farkon mai gabatarwa JAK wanda FDA ta amince a shekara ta 2012 ga tsofaffi tare da matsanancin cututtuka na rheumatoid wanda ke da rashin dacewar amsawa ga hanya .
Akwai nau'o'in JAK guda hudu: JAK1, JAK2, JAK3, da Tyk2. Xeljanz da farko ya hana JAK1 da JAK3, kuma ana dauka sau biyu. Daidai ne, baricitinib inhibits JAK1 da JAK2 kuma ana dauka sau ɗaya a kowace rana.
Sakamakon gwaje-gwaje na hudu na uku na Baricitinib
Eli Lilly & Kamfani da Incyte Corporation sun kasance abokan tarayya a cigaban baricitinib. Lilly da Incyte sun gudanar da gwaje-gwaje hudu na gwaji a cikin masu binciken mahalarta zuwa matsanancin aiki na arthritis.
- RA-BUILD binciken - 684 marasa lafiya marasa cututtuka da cututtukan arthritis tare da cutar da aka ba da gangan ba da izini 2 milligrams ko 4 milligrams na baricitinib, ko placebo na 24 makonni. Idan aka kwatanta da placebo, ƙungiyoyi biyu na baricitinib sun nuna muhimmancin inganta bisa ga ACR20 , ACR50, da kuma ACR70. Har ila yau, lura a cikin wannan binciken shine shaida a kan x-ray na jinkirin cigaba da ciwon cuta tare da baricitinib, kuma gaskiyar cewa amsawa ga baricitinib ya faru da sauri, wani lokacin bayan mako guda.
- RA-BEACON - 527 marasa lafiya na arthritis tare da rashin amsa ga ɗaya ko fiye da masu hana TNF sun ba da izini 2 milligrams baricitinib, 4 milligrams baricitinib, ko placebo na 24 makonni. Ana lura da yawan karfin ACR20 mafi girma a cikin bangarorin biyu na baricitinib idan aka kwatanta da placebo. An samu nasarar ci gaba da kulawa da lafiyar kawai tare da 4 milligrams baricitinib.
- RA-BEGIN - 584 marasa lafiya da cututtuka masu ciwon daji wanda ke da iyakance ko ba tare da magani tare da DMARDs na gargajiya ba a ba da izinin magance ƙwayoyin cuta, 4 milligrams baricitinib, ko 4 milligrams baricitinib tare da methotrexate har zuwa makonni 52. Sakamako sun kasance mafi kyau tare da baricitinib monotherapy idan aka kwatanta da methotrexate monotherapy. Bugu da ƙari da ƙididdigar zuwa baricitinib ba alama ya tasiri amfanin ba, kodayake hada haɗin suna nuna jinkirin tabbatar da ci gaban cutar a kan x-ray.
- RA-BEAM - 1307 marasa lafiya da cututtuka na rheumatoid masu aiki, waɗanda suke samun ƙananan bayanan amma wanda bai dace da su ba, an sanya su 4 milligrams baricitinib sau ɗaya a kowace rana, ko Humira ( 40 % milligrams ) kowane mako, ko placebo. Ana inganta halayen ƙwayoyi na mahimmanci tare da baricitinib zuwa placebo ko Humira.
Masu halartar taron da suka gama RA-BUILD, RA-BEGIN, ko RA-BEAM sun cancanci shiga wani binciken lokaci, wanda ake kira RA-BEYOND. Nazarin binciken ya kara da cewa kashi 4 miliyon na baricitinib ya fi tasiri.
Bayanin Tsaro na Baricitinib
An tattara bayani game da lafiyar baricitinib ta hanyar nazarin duk gwaje-gwaje na asibiti daga lokaci na 1 zuwa lokaci na 3, tare da nazarin tsawo. Jarabawa sun shafi marasa lafiya 3,464 gaba daya. Bayan bayyanar da baricitinib, babu ƙarawa a mutuwa, rashin zaman lafiya, cututtuka mai tsanani, cututtuka masu dacewa, ko abubuwa masu banƙyama da suka haifar da katsewa daga miyagun ƙwayoyi. Idan aka kwatanta da placebo akwai karuwa mai mahimmanci a cikin kwayar cutar cututtuka a cikin marasa lafiyar da ake bi da shi da nauyin kilo 4 na baricitinib. Jiyya tare da baricitinib an danganta shi da canje-canje a cikin matakan haemoglobin, lymphocytes, transaminases, haifar da kinase, da kuma creatinine-amma da wuya ya isa ya buƙaci dakatar da miyagun ƙwayoyi.
Kalma Daga
Masu hana JAK sune kashi na uku na DMARDS, wanda ake kira DMARDS ƙananan kwayoyin. Samun baricitinib zai samar da wani zaɓi na zabin maganin arthritis, idan an yarda. An amince da wannan izinin a shekara ta 2017. Magunguna waɗanda basu da mahimmancin amsawa ga hanya, wasu DMARDs, ko kuma kwayoyin halitta , za su sami wata magungunan ƙwayar magunguna kamar wani zaɓi. Ga wasu marasa lafiya, yana iya zama wani zaɓi mafi dacewa kuma mafi dacewa ga magungunan ilimin kwayoyin halitta mai ma'ana ko ilimin halitta wanda ake gudanarwa ta jiko.
> Sources:
> Kuriya, Bindee et al. Baricitinib a Rheumatoid Arthritis: Ra'ayin shaida da kwanciyar hankali. Ci gaba da lafiya a ciwon ƙwayoyin cuta. 2017 Feb; 9 (2): 37-44.
> Smolen, Josef S. et al. Ma'aikata-ruwaito sakamakon Daga wani Randomed Phase III Nazarin Baricitinib a cikin marasa lafiya tare da Rheumatoid Arthritis da kuma rashin dacewa amsa ga masu rai halittu (RA-BEACON). Annals na Rheumatic Diseases. 2017; 76: 694-700.
> Taylor, Peter C. MD, PhD et al. Baricitinib zuwa Placebo ko Adalimumab a Rheumatoid Arthritis. New England Journal of Medicine. 2017; 376: 652-662. Fabrairu 16, 2017.
> FDA FDA ta kara tsawon lokaci don Baricitinib, Ra'ayin Rheumatoid Arthritis Jiyya. Lilly. Janairu 13, 2017.
> Fidigar FDA ta Amsa cikakke ga Baricitinib. Lilly da Incyte via BusinessWire. Afrilu 14, 2017.