Actemra waxay u muuqataa mid waxtar leh oo loogu talagalay dadka qaangaarka ah ee qaangaarka ah iyo xannuunada rheumatoid-ka ee dhalinyarada
Actemra (tocilizumab) waa antibio monoclonal , oo ay soo saareen Genentech (xubin ka mid ah kooxda Roche) si loogu daaweeyo rheumatoid arthritis .
Sidee ayuu Actemra u shaqeynayaa?
Hadafka daaweynta ee Actemra waa inuu joojiyo jawaabaha bararka. Tani waxay sameeyneysaa adigoo xiraya interleukin-6. Actemra waxay dhab ahaantii joojisaa daawada interleukin-6, taas oo xannibaysa interleukin-6.
Tani waa daroogada ugu horeysa ee arrintani samayso, taas oo ka dhigaysa hab daaweyn cusub oo loogu talagalay RA. Waxaa loo kala saaraa sida cytokine , interleukin-6 waxaa loo yaqaanaa in ay door ka ciyaaraan jawaabaha difaaca jirka iyo bararka.
Actemra Performance ee Xanuunada Daaweynta
Barnaamijka horumarinta kiliiniga ee ballaaran ee 5 tijaabooyinka wajiga III ayaa loogu talagalay in lagu qiimeeyo Actemra. Afar daraasadood ayaa la dhammeystirey waxaana lagu soo waramey in ay la kulmayaan bartilmaameedkooda hoose (goolasha). Baadhitaan shanaad, oo lagu magacaabo LITHE (Ammaanka Tocilizumab iyo Ka-hortagga Dhismaha Wadajirka Dhismaha), waa tijaabo 2 sano ah oo hadda socda. Macluumaadka horudhaca ah ee kowaad ee sanadlaha ah ayaa la filayaa LITHE sannadkii 2008.
Xaaladaha 5aad ee wajiga Phase III ee loo yaqaan Actemra waxaa loo yaqaana: OPTION (Tocilizumab Pivotal Trial in Respondrexate Respondreated Responders), TOWARD (Tocilizumab ee isku-dhafka ah DMARD Therapy), RADIATE (Cilmi-baaris ku saabsan Actemra Go'aaminta Wax-ku-oolnimada Ka-dambi-celinta TNF), AMBITION (Actemra ka hor imtixaanka baaritaanka baaritaanka laba-cirib-yar ee baaritaanka daaweynta methotrexate in monotherapy), iyo LITHE.
Actemra ee Daraasadda OPTION
Daraasad OPTION, oo la soo sheegay 22-kii Maarso, 2008, qodobka The Lancet , 622 bukaanno qaba rheumatoid arthritis-dhexdhexaad ah oo firfircoon ayaa la kala saaray si loo helo 8 mg / kg Actemra, 4 mg / kg Actemra, ama placebo-duubo 4 asbuuc walba. Methotrexate ayaa la sii waday qiyaasta daawada ka hor (10-25 mg / toddobaad).
Natiijooyinka waxbarashadu waxay muujisay in toddobaadka 24, ay jiraan bukaanno badan oo qaata Actemra oo gaaray ACR20 marka loo eego kuwa ku jira xuddunta. Ka qaybgalayaasha daraasaddan, 59% bukaannada 8 mg / kg iyo 48% oo ah 4 mg / kg kooxeed iyo 26% oo ka mid ah kooxda xuubka waxaa lagu gaarey ACR20. Shuruudaha ACR20 waxaa ka mid ah 20% horumarinta tiro badan oo hindisada ah iyo isku-dhafka; ka weyn ama la mid ah 20% horumarinta ugu yaraan 3 ka mid ah 5 shuruudaha soo socda:
- Qiimaynta dhakhtarka cudurrada
- Qiimeynta bukaanka ee cudurka
- C-borotiinka C-reactive
- Xanuun
- Su'aalaha Qiimaynta Caafimaadka
Daraasad kale oo lagu daabacay Lancet bishii Maarso 22, 2008, ayaa ku soo gabagabeeyay in Actemra uu sidoo kale waxtar u leeyahay carruurta leh nidaamka xannuunka dhalinyarada ee nidaamka xannuun-xannuun-xannuun-jileeca - xaalad inta badan ay adag tahay in la daweeyo.
Sidee loo Qabaa Actemra?
Actemra waxaa la siiyaa xidid (iyadoo loo marayo IV). Daraasadda OPTION-ka, waxaa la siiyey 4 todobaad kasta.
Waxyeelooyinka kale ee la xidhiidha Actemra
Sida laga soo xigtay daroogada daroogada Roche, "Daraasada guud ee amniga ee lagu arkay daraasadda caalamiga ah ee Actemra waa mid joogto ah, Actemra guud ahaan waa loo ixtiraamo Dhacdooyinka halista ah ee lagu soo bandhigay cilmi-baarista caafimaadka ee Actemra ayaa waxaa ku jira infekshin culus iyo xasaasiyad (xasaasiyadeed) oo ay ka mid yihiin xaalado yar anaphylaxis.
Dhacdooyinka ugu caansan ee lagu soo bandhigo daraasaddaha kiliinikada waxay ahaayeen infekshinka neefta sare ee neefta, naasofarjiyada, madax-xanuun, dhiig-karka. Kordhinta beeraha ee tijaabada shaqada (ALT iyo AST) ayaa lagu arkay bukaanno qaar. Korodhkaasi wuxuu ahaa mid sahlan oo la beddeli karo, iyada oo aan la helin dhaawacyo ciriiri ah ama wax kasta oo la arko saameynta beerka. "
Maxaa walwal ah qaar ka mid ah dadka nacaybka ku jira?
Dhaleeceynta qaar ka mid ah tijaabooyinka bukaan socodka ee ku lug leh Actemra waxay aaminsan yihiin in aysan ku filneyn in la barbardhigo Actemra oo la siinayo placebo. Dhab ahaantii, naqdiyeyaashu waxay sheegeen in ay macquul tahay in la yiraahdo Actemra inay ka fiicnaan laheyd wax, laakiin macluumaadka waxtarka leh ee faa'iido leh ayaa la siin doonaa marka loo barbardhigo Actemra si loo helo daaweyno la dhisay.
Miyuu jiraa Actemra FDA-la ansixiyey oo la heli karaa?
Bishii Nofembar 2007, Roche waxay soo gudbisay codsiga ruqsadda nafleyda (BLA) ee Maamulka Cuntada iyo Dawooyinka ee Maraykanka (FDA) oo raadineysa oggolaanshaha Actemra si loo yareeyo calaamadaha iyo astaamaha dadka qaangaarka ah ee leh xanuunka 'rheumatoid' arthritis. Bishii Luulyo 29, 2008, Guddiga La-talinta Arthritis-ka ee FDA ayaa u codeeyay 10-1 si uu kugula taliyo Actemra, laakiin FDA waxay codsatay macluumaad dheeraad ah Roche ka hor inta aysan bixin oggolaanshaha kama dambaysta ah.
Janaayo 8, 2010, Actemra waxaa ansixiyay FDA ee loogu talagalay dadka bukaanka ah ee rheumatoid arthritis-ka ee leh cudur dhexdhexaad ah oo aad u firfircoon, kuwaas oo ku fashilmay hal ama dhowr TNF.
Ilaha:
Saameynta daaweynta interleukin-6 ee daaweynta cagaarshowga ee bukaannada qaba rheumatoid arthritis-ka (barashada OPTION): laba-indho-laawe, xakameyn-la xakameynayo, tijaabin kala duwan. Smolen et al. Lancet. Maarso 22, 2008.
http://www.thelancet.com/journals/lancet/article/PIIS0140673608604535/about
Waxtarka iyo nabadgelyada tocilizumab ee bukaanada qaba xanuunka idiopathic daacuunka ah ee ilma-galeenka: isugeyn indho-indheyn, laban-indho-indhayn, xakamayn-xakameyn, jimicsi wajiga III. Yokota et al. Lancet. Maarso 22, 2008.
http://www.thelancet.com/journals/lancet/article/PIIS0140673608604547/abstract
Roche Submits Codsiga FDA Oggolaanshaha Actemra ee Daaweynta Rheumatoid Arthritis. November 21, 2007. Roche Media News.
http://www.roche.com/med-cor-2007-11-21