Ihe I Kwesịrị Ịmara Banyere Actemra

by Carol Eustice

Actemra dị irè maka okenye na ụmụaka na-arịa ọrịa ogbu na nkwonkwo

Actemra (tocilizumab) bụ mgbochi monoclonal , nke Genentech (onye òtù Roche) mepụtara maka ọgwụgwọ ọrịa ogbu na nkwonkwo .

Kedu ka ọrụ a ga-esi arụ ọrụ?

Ihe mgbaru ọsọ nke Actemra bụ igbochi mmeghachi omume mkpesa. Ọ na-eme nke a site na igbochi interleukin-6. Actemra n'emechibido onye na-anabata interleukin-6, si otú ahụ na-egbochi interleukin-6.

Nke a bụ ọgwụ mbụ iji mee nke a, na-eme ka ọ bụrụ usoro ọgwụgwọ ọhụrụ maka RA. A maara ọkwa dịka cytokine , interleukin-6 na-arụ ọrụ na mmeghachi omume na-adịghị mma.

Arụmọrụ na-arụ ọrụ na Nlekọta Ọgwụgwụ

Ebumnuche nke nnukwu usoro mmepe nke 5 nke agba nke III ka e mere iji nyochaa Actemra. Enwere ihe ọmụmụ anọ ma kọọrọ ha nzute ha (ihe mgbaru ọsọ). Nnwale nke ise, nke a na-akpọ LITHE (Tocilizumab Safety na Prevention of Damage Damage), bụ ikpe nke afọ 2 nke dị ugbu a. A na-atụ anya mmalite nke afọ mbụ maka LITHE na 2008.

A na - amata ọnwụnwa nke 5 nke Phase III maka Actemra: OPTION (Tocilizumab Pivotal Trial in Methotrexate Responseers), RADIATE (Research on Actemra Determining Efficacy after Anti-TNF Failures), AMBITION (Actemra) dịka Methotrexate Nchọpụta Nchọpụta Na-akpata Ịhụ Nchọpụta Na Monotherapy), na LITHE.

Mee ihe na nkuzi OPTION

N'ime nchọpụta OPTION, kọrọ na mbipụta Listet nke March 22, 2008, 622 ndị ọrịa na-eji nwayọọ nwayọọ na-arịa ọrịa ogbu na nkwonkwo na-arụ ọrụ na-enweta 8 mg / kg Actemra, 4 mg / kg Actemra, ma ọ bụ placebo n'ime izu anọ ọ bụla. A nọgidere na-eme Methotrexate tupu a mụọ ihe ọmụmụ (10-25 mg / izu).

Ihe nchoputa gosiri na na izu iri abuo na ise, enwere ndi ozo na-anata Actemra ndi ruru ACR20 karia ndi nobo. N'ime ndị na-amụ ihe ọmụmụ, 59% nke ndị ọrịa na 8 mg / kg otu vs. 48% na 4 mg / kg otu vs. 26% na placebo otu meriri ACR20. Nchịkọta maka ACR20 gụnyere mmụba 20% n'ọtụtụ nkwonkwo dị nro na nke fụrụ akpụ; karịrị ma ọ bụ hà nha anya nha 20% ma ọ dịkarịa ala 3 nke 5 ntụziaka ndị na-esonụ:

Nyocha ọgwụgwọ nke ọrịa
Nyocha nyocha nke ọrịa
Ntinye protein C-reactive
Mgbu
Nyochaa Ahụ Ike

Nnyocha ọzọ e bipụtara na Lancet na March 22, 2008, kwubiri na Actemra dịkwa irè maka ụmụaka nwere ọrịa ogbu na nkwonkwo nke ụmụaka - ọnọdụ nke na-esikarị ike ịgwọ.

Kedu Ka E Si Eme Ihe?

A na-enye ihe omimi n'ime ihe (site na IV). Na nkuzi OPTION, e nyere ya kwa izu anọ.

Emetụta mmetụta nke ejikọtara na Actemra

Dị ka onye na-eme ọgwụ na-eme nchọpụta bụ Roche si kwuo, "Nkọwa nchekwa zuru ezu dị na nchọpụta zuru ụwa ọnụ nke Actemra bụ nke kwadoro na Actemra kachasị mma. anaphylaxis.

Ihe kachasị njọ na-egosi na ịmalite ọmụmụ ihe bụ ọrịa strok strok, nasopharyngitis, isi ọwụwa, ọbara mgbali elu. A na-ahụkwu ule imeju ume (ALT na AST) na ụfọdụ ndị ọrịa. Ọganihu ndị a na-adịkarị nwayọọ ma na-agbanwe agbanwe, na-enweghị mmerụ hepatic ma ọ bụ mmetụta ọ bụla a hụrụ na ọrụ imeju. "

Olee Nchegbu Ụfọdụ Ndị Ntugbu nke Actemra?

Ndị na-akatọ ụfọdụ n'ime nsogbu ahụike nke metụtara Actemra ekwenyeghi na ha ezitewo site na iji Actemra tụnyere placebo. N'ikpeazụ, ndị nkatọ ahụ kwuru na ọ bụ ihe ezi uche dị na ya iche na Actemra ga-aka mma karịa ihe ọ bụla, ma a ga-enweta ozi bara uru site na iji Actemra tụnyere ọgwụgwọ edozi.

Ọ bụ FDA-Kwadoro na Dị?

Na November 2007, Roche wepụtara akwụkwọ ikikere biologics (BLA) na United States Food and Drug Administration (FDA) na-achọ nnwapụta maka Actemra iji belata ihe ịrịba ama na ihe mgbaàmà na ndị okenye nwere oke ogbu na nkwonkwo siri ike. Na July 29, 2008, Kọmitii Advisory Arthritis nke FDA buru votu 10-1 iji kwado nkwenye nke Actemra, mana FDA rịọrọ maka ozi ndị ọzọ n'aka Roche tupu ya akwado nkwenye ikpeazụ.

Na January 8, 2010, FDA kwadoro Actemra maka ndị okenye na-arịa ọrịa ogbu na nkwonkwo na-arịa ọrịa na-arịa ọrịa siri ike, ndị dara otu ma ọ bụ karịa TNS.

_{Isi mmalite:}

_{Mmetụta nke mgbochi nkwụnye nke interleukin-6 na-atụgharị uche na ndị ọrịa na-arịa ọrịa ogbu na nkwonkwo (nchọpụta OPTION): a na-enyocha isi abụọ, ebe a na-achịkwa ebe a na-achịkwa.} _{Smolen et al.} _{The Lancet.} _{March 22, 2008.} _{http://www.thelancet.com/journals/lancet/article/PIIS0140673608604535/abstract}

_{Ịgba mbọ na nchebe nke ndị na-arịa ọrịa na-arịa ọrịa na-akpata ọrịa na-egbuke egbuke: a na-achịkwa, abụọ-ìsì, ebe a na-achịkwa ebe a na-achịkwa, nkwụsị nke oge III.} _{Yokota et al.} _{The Lancet.} _{March 22, 2008.} _{http://www.thelancet.com/journals/lancet/article/PIIS0140673608604547/abstract}

_{Roche Na-enye Ngwa maka FDA Approval nke Actemra maka Ọgwụgwọ Arthritis Rheumatoid.} _{November 21, 2007. Roche Media News.} _{http://www.roche.com/med-cor-2007-11-21}