Abin da ya kamata ka sani game da Actemra

by Carol Eustice

Actemra yana da tasiri ga tsofaffi da ƙwayar wariyar launin fata na rheumatoid

Actemra (tocilizumab) wani ɓangare ne na daya , wanda Genentech ya kasance (memba na Roche group) don ciwon maganin cututtuka na rheumatoid .

Yaya Yayi Ayyukan Ma'aikata?

Manufar aikin likita na Actemra ita ce ta kayar da martani. Yana yin hakan ta hanyar hana interleukin-6. Actemra a hakika ya hana mai karɓa na interleukin-6, don haka ya hana interleukin-6.

Wannan shine magungunan farko don yin wannan, yana sa sabon tsarin kulawa da RA. An sanar da shi kamar yadda cytokine , interleukin-6 ke taka muhimmiyar mahimmanci a cikin maganin kumburi.

Ayyukan Actemra a gwaji na Clinical

An tsara babban ci gaba na asibiti na 5 Phase III gwaji don kimanta Actemra. An kammala nazarin hu] u kuma an bayar da rahoton kawo cikas game da manufofin su. Wani gwaji na biyar, wanda ake kira LITHE (Tsare-gyare na Tocilizumab da Rigakafin Harkokin Sadarwa na Gida), wani gwaji ne na shekaru biyu da ke faruwa yanzu. An sa ran bayanan farko na shekara-shekara don LITHE a 2008.

Aikin gwaji na 5 zuwa na Actemra da aka sani da: OPTION (Tocilizumab Pivotal Trial in Methotrexate Sufficient Responders), KASHI (Tocilizumab in Combination with Traditional DMARD Therapy), RADIATE (Bincike a kan Dokar Amfani da Ayyukan Cutar bayan Bayanai na TNF), AMBITION (Actemra game da gwajin bincike na ƙananan tafarkin Methotrexate a cikin Monotherapy), da LITHE.

Abinda ke ciki a cikin Binciken Hanya

A cikin binciken na OPTION, an bayar da rahoton a cikin Maris 22 ga watan Maris, 2008 na Lancet , 622 marasa lafiya da matsananciyar ciwon arthritis masu ƙwayar cuta sun kasance marasa galihu don karɓar 8 mg / kg Actemra, 4 mg / kg Actemra, ko placebo cikin intravenously kowane mako 4. Methotrexate aka ci gaba a pre-binciken dosages (10-25 MG / mako).

Sakamakon binciken ya nuna cewa a mako 24, akwai marasa lafiya da suka karbi Actemra wadanda suka isa ACR20 fiye da wadanda ke kan placebo. Daga cikin mahalarta nazarin, 59% na marasa lafiya a cikin 8 mg / kg kungiyar vs. 48% a cikin 4 mg / kg kungiyar vs. 26% a cikin placebo kungiyar cimma ACR20. Mahimmanci ga ACR20 sun hada da haɓaka 20% a cikin wasu ɗakuna masu tayi da kumbura; mafi girma ko ko daidai da ingantaccen kashi 20% a akalla 3 daga cikin waɗannan hukunce-hukuncen biyar:

Nazarin likita na cutar
Binciken gwajin cutar
Kwayar C-reactive
Pain
Binciken Bincike na Lafiya

Wani binciken da aka wallafa a The Lancet a ranar 22 ga Maris, 2008, ya tabbatar da cewa Actemra yana da tasiri ga yara da ƙwararrun ƙwayar cutar ƙanana - yanayin da yake da wuyar magance.

Ta yaya ake ba da aiki?

An ba Actemra cikin bala'in (ta hanyar IV). A cikin binciken na OPTION, an ba shi kowane mako 4.

Hanyoyin Farko Associated Tare da Actemra

A cewar mai kula da magungunan kwayoyi Roche, "Mahimman bayanin bayanan tsaro da aka yi a nazarin duniya na Actemra ya dace kuma an yarda da dokar Actemra. Babban mummunan abubuwan da suka faru a cikin binciken likitoci na Actemra sun hada da cututtuka masu tsanani da kuma cututtuka (rashin lafiyar) ciki har da wasu ƙananan anaphylaxis.

Abubuwa mafi banbanci wadanda suka faru a cikin binciken binciken asibiti sunadarin kamuwa da cutar numfashi, nasopharyngitis, ciwon kai, hauhawar jini. Ƙara yawan gwaje-gwajen hanta (ALT da AST) an gani a wasu marasa lafiya. Wadannan ƙarar suna cike da sauƙi da juyawa, ba tare da raunin cutar ba, ko wani tasirin da ya shafi hanta. "

Mene Ne damuwa da wasu masu zargi na Actemra?

Masu sukar wasu matsalolin gwaje-gwajen da suka shafi Actemra sun yi imanin bai isa ba sun koya ta hanyar kwatanta Actemra zuwa placebo. Mahimmanci, masu sukar sun ce yana da kyau a ɗauka cewa Actemra zai zama mafi kyau fiye da komai, amma za a sami ƙarin bayani mai amfani ta hanyar gwada Actemra don kafa maganin.

Shin Dokar FDA-ta amince da ita?

A cikin watan Nuwamba 2007, Roche ya ba da takardar izinin lasisi (BLA) zuwa Cibiyar Abinci da Druggun Amurka (FDA) ta neman amincewa da Dokar don rage alamomin da alamun da ke cikin tsofaffi tare da matsanancin ciwon hauka. Ranar 29 ga watan Yuli, 2008, kwamitin ƙwararrun Arthritis na FDA ya zabe 10-1 don bayar da shawarar amincewa da Actemra, amma FDA ta bukaci ƙarin bayani daga Roche kafin ya bada izinin karshe.

Ranar 8 ga watan Janairu, 2010, FDA ta amince da Dokar dokar marasa lafiyar marasa lafiya wanda ke fama da rashin lafiya, wadanda suka kasa daya ko fiye da masu tayar da hankulan TNF.

_Sources:

_{Hanyoyin haɓakar mai karɓa na interleukin-6 tare da tocilizumab a cikin marasa lafiya da cututtuka na rheumatoid (binciken bincike): mai makafi guda biyu, mai kulawa wuribo, gwajin gwaji.} _{Smolen et al.} _Lancet. _{Maris 22, 2008.} _{http://www.thelancet.com/journals/lancet/article/PIIS0140673608604535/abstract}

_{Aminci da aminci na tocilizumab a cikin marasa lafiya tare da maganin cututtuka na ƙwararrun ƙwararrun ƙwayoyin cuta na yara: wanda ba a daɗaɗɗo, mai makantar makafi, wuri mai sarrafawa, sauya lokaci na III.} _{Yokota et al.} _Lancet. _{Maris 22, 2008.} _{http://www.thelancet.com/journals/lancet/article/PIIS0140673608604547/abstract}

_{Roche ya aika Aikace-aikacen don FDA Approval of Actemra don maganin Rheumatoid Arthritis.} _{Nuwamba 21, 2007. Roche Media News.} _{http://www.roche.com/med-cor-2007-11-21}