I-Xeljanz Yayiqala I-JAK Inhibitor evunyelwe e-US; I-Baricitinib ilandelayo
I-Baricitinib ngumlomo we- JAK (uJanus kinase) inhibitor oza kuthathwa kwi- arthritis ye- rheumatoid . Kwikota yokuqala ka-2016, i-baricitinib yangeniswa ngokuphononongwa ngokusemthethweni kunye nokuvunyelwa kokuthengisa eMelika, i-European Union kunye neJapan. IKomiti yeAgrikhi yeeYurophu zeeMicrosoft yeeMveliso zoLuntu ikhuthaze ukuvunyelwa ngoDisemba 2016.
Ngo-Februwari 13, ngo-2017, isicatshulwa savunywa ukuba sithengiswe kwi-arthritis ye-rheumatoyi e-European Union njenge- Olumiant (baricitinib) . E-US, i-FDA yabhengeza ngoJanuwari 13, 2017 ukuba yongeze ixesha lokuphonononga kwesicelo seziyobisi esitsha se-baricitinib. Ukongezwa kuvunyelwe ukuhlaziywa kwedatha eyongezelelweyo eyathunyelwa emva kokufakwa kwesicelo seziyobisi sokuqala.
Ngomhla ka-Apreli 14, 2017, i-FDA iyanqabile i-baricitinib kwakhona. I-FDA ikhuphe incwadi ephendulayo epheleleyo echaza ukuba i-arhente "ayikwazi ukuvuma isicelo kwisimo sayo samanje". I-FDA yathi iinkcukacha ezongezelelweyo zeklinikhi zifunekayo ukuze zichongwe amanani athile afanelekileyo. Kwakhona, iinkcukacha ezongezelelweyo ziyimfuneko ukuqhubeka nokubonakalisa ukuxhalabisa ukhuseleko kwizixhobo zonyango. Isikhathi sokubuya kwakhona siya kulandela intetho eqhubekayo kunye ne-FDA.
Ukongezelela, isilingo sesi-2 siqhutyelwa ukuba siphando i-baricitinib kwi- systemic lupus erythematosus kunye ne- atopic dermatitis .
Isigaba sesi-3 sesilingo se-baricitinib se- psoriatic arthritis kulindeleke ukuba siqale ngo-2017.
I-Xeljanz Yayiqala I-JAK Inhibitor ye-Rheumatoid Arthritis
I-Xeljanz (tofacitinib) yayiyi-JAK inhibitor yokuqala evunywe yi-FDA ngo-2012 kubantu abadala abanomlinganiselo othe ngqo kwi-arthritis ye-rheumatoyi enesifo esingekho ngokwaneleyo kwimpendulo ye- methotrexate .
Kukho ezine i-JAK enzymes: JAK1, JAK2, JAK3, kunye neTyk2. I-Xeljanz ikhusela ngokubanzi iJAK1 ne-JAK3, kwaye ithathwa kabini imihla ngemihla. Ngokwahlukileyo, i-baricitinib inqanda iJAK1 ne-JAK2 kwaye ithathwa kanye ngosuku.
Iimvavanyo ezine zeSigaba sesi-3 seBaricitinib
Eli Lilly & Inkampani kunye ne-Incyte Corporation yintsebenziswano ekuphuhlisweni kwe-baricitinib. ULilly no-Incyte baqhuba izilingo ezine zesigaba se-klinikhi kwizifundo ezithatha inxaxheba ngokuthe ngqo kwi-arthritis esebenzayo.
- I-RA-BUILD yophando - 684 izigulane ze-rheumatoid arthritis ezinezifo ezikhutheleyo zanikwa i-milligrams ezi-2 okanye ii-milligram ze-baricitinib, okanye i-placebo iiveki ezingama-24. Xa kuthelekiswa ne-placebo, amaqela amabini e-baricitinib abonise ukuphucuka okubalulekileyo kusekelwe kwi- ACR20 , i-ACR50 kunye ne-ACR70 impendulo yokuphendula. Kwakhona okuphawulekayo kule sifundo kwakukho ubungqina kwi-x-ray yokunciphisa ukunyuka kwesifo kunye ne-baricitinib, kunye nokuba impendulo kwi-baricitinib yenzeke ngokukhawuleza, ngamanye amaxesha emva kweveki enye nje.
- I-RA-BEACON - 527 izigulane ze-arthritis ze-rheumatoid ezineempendulo ezinganeleyo kumnye okanye ngaphezulu kwe- TNF inhibitors zanikezwa ngezigidi ezimbini i-baricitinib, ii-4 milligrams ze-baricitinib, okanye i-placebo iiveki ezingama-24. Amazinga okuphendula ama-ACR20 aphakamileyo afunyanwe kumaqela amabini e-baricitinib xa kuthelekiswa ne-placebo. Inkxaso enyango eqhubekayo yenzeka kuphela nge-4 milligrams ye-baricitinib.
- I-RA-BEGIN - izigulane ezingama-584 ezine-arthritis esebenzayo ye-rheumatoid eyayingenamkhawulo okanye akukho nonyango kunye ne- DMARD yendabuko yayisetyenziselwa i- methotrexate monotherapy, i-4 milligram ye-baricitinib okanye i-4 milligram ye-baricitinib kunye ne-methotrexate ukuya kwiiveki ezingama-52. Iziphumo zazibhetele ngakumbi nge-baricitinib monotherapy xa kuthelekiswa ne-methotrexate monotherapy. Ukongezwa kwe-methotrexate kwi-baricitinib kwakubonakala kungabonakali kakuhle kwintlawulo, nangona ukudibanisa kubonakala kubonakalisa ubungqina bokukhula kwesifo kwi-x-ray.
- I-RA-BEAM - 1307 izigulane ezine-arthritis esebenzayo, ezifumana imvelaphi ye-methotrexate kodwa ezingayiphenduliyo ngokwaneleyo, zabelwa ii-milligrams ze-baricitinib rhoqo imihla ngemihla, okanye ii-milligram ezingama-40 Humira (adalimumab) zonke iiveki, okanye i-placebo. Uphuculo olubalulekileyo lweklinikhi ludibene ne-baricitinib ngokubhekiselele kwi-placebo okanye i-Humira.
Abathathi-nxaxheba abaye bagqiba i-RA-BUILD, RA-BEGIN, okanye i-RA-BEAM bafanelekile ukuthatha inxaxheba kwisifundo sokwandisa, esaziwa njenge-RA-BEYOND. Uphando olongezelelweyo lugqiba ukuba i-milligram ye-4 milligram ye-baricitinib yayinempumelelo kakhulu.
Iprogram yoKhuseleko yeBaricitinib
Ulwazi malunga nokhuseleko lwe-baricitinib luhlanganiselwe ngokuhlalutya zonke izilingo zonyango ukusuka kwisigaba 1 ukuya kwisigaba sesi-3, kunye nesifundo sokwandisa. Izilingo zazibandakanya izigulane ezingama-3,464 ngokupheleleyo. Ukulandela ukutshatyalaliswa kwe-baricitinib, kwakungekho ukwanda kwezibhedlele, izigulane, izifo ezinzulu, izifo ezichaphazelekayo, okanye iziganeko ezimbi ezibangelwa ukuyeka ukusetyenziswa kweziyobisi. Ukuqhathaniswa ne placebo kwakukho ukwanda kwenani leentlobo ze- herpes zoster kwizifo eziphathwe nge-4 milligram dose ye-baricitinib. Unyango kunye ne-baricitinib yadibaniswa neenguqu ze-hemoglobin, i-lymphocytes, i-transaminases, i-creatine kinase, kunye ne-creinine-kodwa yayingabalulekanga ngokwaneleyo ukufuna ukuyeka ukusetyenziswa kweziyobisi.
ILizwi
I-JAK inhibitors yiklasi lesithathu le-DMARDS, ebizwa ngokuba yi-molecule encinci i-DMARDS. Ukufumaneka kwe-baricitinib kuya kunika enye inketho yokonyango kwi-rheumatoid arthritis, xa ivunyiwe. Loo mvume kulindeleke ngo-2017. Izigulane ezineempendulo ezinganeleyo kwi-methotrexate, ezinye i-DMARD, okanye iziyobisi ze-biologic , ziya kuba nezinye izidakamizwa zomlomo njengendlela yokukhetha. Kwezinye izigulane, kusenokuba ukhetho olungcono kwaye lukhethwayo kwiiyobisi ze-biologic ezizenzekelayo okanye eziphilayo ezilawulwa ngumxube.
> Imithombo:
> Kuriya, Bindee et al. I-Baricitinib kwi-Arthritis ye-Rheumatoid: Ubungqina bemihla kunye noKhenketho. Uphuhliso lwezeMpilo kwiMisculoskeletal Disease. 2017 Feb; 9 (2): 37-44.
> Smolen, uJosef S. et al. Iziphumo ezichazwe ngumonde ezivela kwi-Phase III ye-Baricitinib kwizigulane ezine-Rheumatoid Arthritis kunye neempendulo ezinganelanga kwi-Biological Agents (RA-BEACON). Iziganeko zeeRheumatic Diseases. 2017; 76: 694-700.
> Taylor, Peter C. MD, PhD et al. I-Baricitinib ngokubhekiselele kwi-Placebo okanye i-Adalimumab kwi-Arthritis ye-Rheumatoid. I-New England Journal of Medicine. 2017; 376: 652-662. NgoFebruwari 16, 2017.
> I-US FDA Yandisa ixesha lokuhlaziya iBaricitinib, i-Rheumatoid Arthritis Treatment. Lilly. NgoJanuwari 13, 2017.
> I-US FDA Imiba epheleleyo yokuphendula i-Letter yeBaricitinib. Lilly no-Incyte nge-BusinessWire. Ngo-Apreli 14, 2017.