Xeljanz Waiva Wokutanga JAK Inhibitor Yakagamuchirwa muUnited States; Bharicitinib Inotevera
Bharicitinib ndeyomuromo JAK (Janus kinase) inhibitor iyo inofanira kutorwa nokuda kwerhumatoid arthritis . Mukutanga kwegore ra20166, baricitinib yakatumirwa kutarisana nekugadzirisa nekugadzirwa kwemakambani muU.S., European Union, uye Japan. IEuropean Medicines Agency Committee yeMishonga yeMishonga yeHuman Use yakakurudzira kubvumirwa munaDisemba 2016.
Musi waFebruary 13, 2017, mushonga wacho wakabvumidzwa kuti utengeswe nehutatoid arthritis muEuropean Union se Olumiant (baricitinib) . MuUnited States, FDA yakashuma musi waJanuary 13, 2017 kuti yakawedzera nguva yekudzokorora kwekushandisa kwechirongwa chechirongwa chebhaicitinib. Kuwedzerwa kunobvumirwa kubvunzurudzwa kwemamwe mashoko akaendeswa mushure mokunge shanduro yekutanga yezvinodhaka yakaitwa.
Musi waApril 14, 2017, FDA inoshamisa yakaramba bhaicitinib zvakare. IA FDA yakabudisa tsamba yakakwana yekupindura iyo inotaura kuti sangano "harigoni kubvumira chikumbiro muhuwandu yaro yemazuva ano". Dhiyabhorosi akati FDC yakawedzerwa inowanikwa kuti inzwisise maitiro akakodzera. Uyezve, mamwe mashoko akadikanwa kuti awedzere kuratidza kunetseka kwehutano pamapuranga ekurapa. Nguva yekudzoka ichazotevera hurukuro dzinowedzera neCDA.
Mukuwedzera, chikamu chechipiri miedzo chiri kuitika chiri kuongorora bharititib ye systemic lupus erythematosus uye atopic dermatitis .
Chikamu chechitatu chemuedzo we baricitinib ye psoriatic arthritis inotarisirwa kutanga muna 2017.
Xeljanz Aiva Wokutanga JAK Inhibitor yeRheumatoid Arthritis
Xeljanz (tofacitinib) ndiyo yekutanga JAK inhibitor inogamuchirwa neDFA muna 2012 kuvanhu vakuru vane mwero wakakura kusvika kune yakaoma rheumatoid arthritis vakange vasina kupindura zvakakwana methotrexate .
Kune maine enzyme maJAK: JAK1, JAK2, JAK3, uye Tyk2. Xeljanz inonyanya inhibisa JAK1 neJAK3, uye inotorwa kaviri zuva rimwe nerimwe. Mukuenzanisa, baricitinib inhibits JAK1 uye JAK2 uye inotorwa kamwe kamwe zuva nezuva.
Zvitsva Zvitsva Zvitatu zveBaricitinib
Eri Lilly & Company neIncyte Corporation vanobatsirana mukugadzirwa kwebhaicitinib. Lilly naIncyte vakaita zvikamu zvina zvitatu zvemakiriniki muzvikamu zvekudzidza zvakanyatsotarisa kuti zvakanyanya kuoma rheumatoid arthritis.
- RA-BUILD kuongorora - 684 rheumatoid arthritis varwere vane hutachiona hwakarongeka zvakapiwa 2 milligrams kana 4 milligram ye baricitinib, kana placebo kwemavhiki makumi maviri nemaviri. Kuenzaniswa ne placebo, mapoka maviri ebaricitinib akaratidza kuwedzera kukuru kuburikidza ne ACR20 , ACR50, uye ACR70 mhinduro dzemhinduro. Zvimwewo zvakakosha mune chidzidzo ichi chaiva uchapupu pane x-ray yekuderedza kufambira mberi kwechirwere ne baricitinib, uye chokwadi chokuti kupindura kubicitinib kwakaitika nokukurumidza, dzimwe nguva mushure pevhiki imwe chete.
- RA-BEACON - 527 rheumatoid arthritis varwere vane kukwana kwakakwana kune imwe kana kupfuura TNF inhibitor vakangoerekana vapiwa 2 milligrams baricitinib, 4 milligrams baricitinib, kana placebo kwemavhiki makumi maviri nemana. Mapoka ekumusoro ACR20 akaonekwa mumapoka maviri ebaricitinib achienzaniswa ne placebo. Kusimudzirwa kurapwa kwakabatsirwa chete ne 4 milligrams baricitinib.
- RA-KUTANGA - 584 varwere vane rheumatoid arthritis avo vakanga vasingakwanisi kana kuti vasina kurapwa nemaitiro eDMARD avo vaigara vachishandisa methotrexate monotherapy, 4 milligrams baricitinib, kana 4 milligrams baricitinib ne methotrexate kusvikira masvondo makumi mashanu. Zvigumisiro zvaive zvakanaka zvikuru ne baricitinib monotherapy kufananidzwa ne methotrexate monotherapy. Kuwedzerwa kwe methotrexate ku baricitinib kwakanga kusingaiti zvakanaka kunobatsira kubatsirwa, kunyange zvazvo kusanganiswa kwakaratidzika kunge kunonoka kupupurira kwekuwedzera kwezvirwere pa x-ray.
- RA-BEAM - 1307 varwere vane chirwere chinonzi rheumatoid arthritis, avo vaigamuchira mamiriro ekure methotrexate asi vasina kupindura zvakakwana, vakagoverwa 4 milligrams baricitinib kamwe chete zuva nezuva, kana 40 milligram Humira (adalimumab) mamwe mavhiki, kana placebo. Kukosha kwekugadziriswa kwekliniki kwaibatanidza ne-baricitinib pamwe ne placebo kana Humira.
Vadzidzi vadzidza vakagumisa RA-BUILD, RA-BEGIN, kana RA-BEAM vakakodzera kubatanidzwa muchikwata chekuwedzera, chinonzi RA-BEYOND. Kuwedzerwa kwekudzidza kwakagumisa kuti 4 milligram yaita bhaicitinib yakanga yakabudirira zvikuru.
Kuchengetedzwa kweBaricitinib
Mashoko pamusoro pekuchengeteka kwebhaicitinib akaunganidzwa nekuongorora zvose zvirwere zvemakiriniki kubva muchikamu chekutanga kusvika muchikamu chechitatu, pamwe nekuwedzera kwekudzidza. Miedzo yaisanganisira varwere 3 464 zvachose. Kutevera kusangana nebhaicitinib, pakanga pasina kuwedzera kwekufa, kuipa, zvirwere zvakakomba, zvirwere zvinopesana, kana zviitiko zvakashata zvakakonzera kuregererwa kwemishonga. Kuenzaniswa ne placebo kwaive nekuwedzera kwekuwedzera kwehuwandu hwehutachiona hwemaperembudzi mukati mevarwere vaibata ne 4 milligram dose ye baricitinib. Kurapa nebhaicitinib kwaibatanidzawo kuchinja kwemazinga e hemoglobin, lymphocytes, transaminases, creatine kinase, uye creatinine-asi kazhinji haina kukwana zvakakwana kuti irege kudziviswa kwechirwere.
Shoko Rinobva
JAK inhibitors iri kirasi yechitatu yeDMARDS, inonzi inonzi molecule DMARDS. Kuwanikwa kwebhaicitinib kuchapa imwezve nzira yekurapa yeramumatoid arthritis, kana yakabvumidzwa. Chibvumirano ichocho chinotarisirwa muna 2017. Varwere vakanga vasina kukwana mhinduro ye methotrexate, mamwe maDMARD, kana madhiragi anonzi biologic , vachazove nemumwe mushonga wemuromo sekusarudza. Kune vamwe varwere, inogona kunge yakanyanya kuve yakasarudzwa uye inoshandiswa kuzvizviisa-injectable biologic zvinodhaka kana biologics iyo inotungamirirwa nekukanganiswa.
> Sources:
> Kuriya, Bindee et al. Bharicitinib muRheumatoid Arthritis: Uchapupu-kusvika-nguva uye Chipatara Chingaitika. Kurapa Kwokurapa muMusculoskeletal Disease. 2017 Feb; 9 (2): 37-44.
> Smolen, Josef S. et al. Mwoyo-Mitsva yakabuda Mitsva inobva kuRandomized Phase III Kudzidza kweBaricitinib muVachipatara neRumatoid Arthritis uye Kupindura Kwakakwana kune Vashandi Vezvipenyu (RA-BEACON). Annals weRheumatic Diseases. 2017; 76: 694-700.
> Taylor, Peter C. MD, PhD et al. Bharicitinib pamwe ne Placebo kana Adalimumab muRheumatoid Arthritis. New England Journal of Medicine. 2017; 376: 652-662. February 16, 2017.
> US FDA Inowedzera Period Period yeBaricitinib, iyo Investigational Rheumatoid Arthritis Treatment. Lilly. Musi waJanuary 13, 2017.
> US FDA Nyaya Dzose Kupindura Tsamba yeBaricitinib. Lilly naIncyte kuburikidza neBusinessWire. April 14, 2017.