Xeljanz Yoyamba YAK Inhibitor Yavomerezedwa mu US; Baricitinib Ndi Yotsatira
Baricitinib ndi JAK (Janus kinase) inhibitor yomwe imayenera kutengedwa chifukwa cha matenda a nyamakazi . M'gawo loyamba la 2016, baricitinib inavomerezedwa ndikuyang'aniridwa ndi malamulo ogulitsa ku US, European Union, ndi Japan. Komiti ya European Medicines Agency ya Medicine Products for Human Use inalimbikitsa chivomerezo mu December 2016.
Pa February 13, 2017, mankhwalawa anavomerezedwa kuti agulitsidwe ndi nyamakazi ya nyamakazi ku European Union monga Olumiant (baricitinib) . Ku US, a FDA adalengeza pa January 13, 2017 kuti adatambasula nthawi yowonjezeramo ntchito yatsopano ya mankhwala a baricitinib. Kuonjezera kunaloledwa kubwereza deta yowonjezera yomwe inatumizidwa pambuyo pempho loyamba la mankhwala.
Pa April 14, 2017, chipani cha FDA chinakaniratu. A FDA adalemba kalata yeniyeni yonena kuti bungweli "silingavomereze ntchitoyi pakali pano". A FDA adanena kuti deta yowonjezera yowonjezera ikufunika kuti mudziwe mlingo woyenera kwambiri. Komanso, deta yowonjezera ndi yofunikira kuti iwonetsenso zodetsa nkhawa pazitsulo zamankhwala. Nthawi ya kubweranso idzakambanso kukambirana ndi FDA.
Kuonjezera apo, mayesero a magawo awiri akuyendera omwe akufufuzira baricitinib kwa dongosolo la lupus erythematosus ndi atermic dermatitis .
Chiyeso chachitatu cha baricitinib cha psoriatic arthritis chiyenera kuyamba mu 2017.
Xeljanz Anali Woyamba JAK Inhibitor wa Matenda a Matenda a Nyamakazi
Xeljanz (tofacitinib) inali yoyamba ya JAK inhibitor yomwe inavomerezedwa ndi FDA mu 2012 kwa akuluakulu omwe ali ndi nyamakazi yovuta kwambiri yomwe imakhala ndi yankho lokwanira kwa methotrexate .
Pali zamoyo zinayi za JAK: JAK1, JAK2, JAK3, ndi Tyk2. Xeljanz amalepheretsa kwambiri JAK1 ndi JAK3, ndipo imatengedwa kawiri tsiku lililonse. Mosiyana, baricitinib imaletsa JAK1 ndi JAK2 ndipo imatengedwa kamodzi tsiku ndi tsiku.
Mayesero anayi a Gawo 3 a Baricitinib
Eli Lilly & Company ndi Incyte Corporation ndi ogwirizana pa chitukuko cha baricitinib. Lilly ndi Incyte amapanga mayesero anayi omwe ali ndi matenda odwala matenda a chifuwa chachikulu.
- Kuphunzira kwa anthu ambiri - 684 odwala matenda a nyamakazi odwala matenda opatsirana amapatsidwa ma milligrams kapena 4 milligrams a baricitinib, kapena placebo kwa masabata 24. Poyerekeza ndi placebo, magulu awiri a baricitinib adawonetsa kusintha kwakukulu pogwiritsa ntchito ACR20 , ACR50, ndi ACR70. Komanso zochititsa chidwi pa phunziroli zinali umboni pa x-ray ya kuchepetsa matenda opatsirana ndi baricitinib, komanso kuti yankho la baricitinib linapezeka mwamsanga, nthawi zina patatha sabata limodzi.
- RA-BEACON - 527 odwala matenda a nyamakazi odwala matenda a nyamakazi omwe alibe yankho lokwanira kwa amodzi kapena ochulukirapo a TNF anapatsidwa ma milligrams a baricitinib, 4 milligrams baricitinib, kapena placebo kwa masabata makumi awiri ndi awiri. Mitengo yowonjezera ya ACR20 inkaonekera m'magulu onse a baricitinib poyerekeza ndi placebo. Thandizo lochiritsidwa lochiritsidwa linayambira kokha ndi ma milligrams a baricitinib 4.
- RA-BEGIN - Odwala 584 omwe ali ndi matenda a nyamakazi omwe anali ndi mankhwala ochepa kapena opanda mankhwala ndi miyambo ya DMARD yomwe inkaperekedwa mwachisawawa, ma milligrams baricitinib, kapena 4 milligrams baricitinib ndi methotrexate kwa masabata 52. Zotsatira zinali zabwino kwambiri ndi baricitinib monotherapy poyerekeza ndi methotrexate monotherapy. Kuwonjezera kwa methotrexate ku baricitinib sikukuwoneka bwino kumakhudza ubwino, ngakhale kuphatikiza kwawoneka ngati kuchepetsa umboni wa matenda opatsirana pa x-ray.
- RA-BEAM - 1307 odwala matenda a nyamakazi, omwe analandira methotrexate koma omwe sanayankhepo bwino, anapatsidwa ma milligrams baricitinib kamodzi tsiku lililonse, kapena ma miligalamu 40 Humira (adalimumab) sabata iliyonse, kapena placebo. Kusintha kwakukulu kwa kachipangizo kunayanjanitsidwa ndi baricitinib ndi malobo kapena Huma.
Phunzirani ophunzira omwe anamaliza RA-BUILD, RA-BEGIN, kapena RA-BEAM akuyenera kutenga nawo mbali pa phunziro lowonjezera, lotchedwa RA-BEYOND. Maphunzirowa adatsimikizira kuti mlingo wa 4 milligram wa baricitinib unali wovuta kwambiri.
Chitetezo Chotsatira cha Baricitinib
Zomwe zokhudzana ndi chitetezo cha baricitinib zinasonkhanitsidwa pofufuza mayesero onse a kuchipatala kuyambira gawo 1 mpaka gawo 3, kuphatikizapo phunziro lowonjezera. Mayeserowa anali odwala 3,464 onse. Pambuyo pofika ku baricitinib, panalibe kuwonjezeka kwa imfa, malungo, matenda akuluakulu, matenda opatsirana, kapena zovuta zomwe zinayambitsa kusokoneza mankhwala. Poyerekeza ndi placebo panali kuwonjezeka kwakukulu kwa chiwerengero cha matenda a herpes zoster kwa odwala omwe anachitidwa ndi 4 milligram mlingo wa baricitinib. Kuchiza ndi baricitinib kunalumikizidwanso ndi kusintha kwa maselo a hemoglobin, lymphocytes, transaminases, creatine kinase, ndi creatinine-koma kawirikawiri ndizofunika kwambiri kuti zithetse kusokoneza kwa mankhwala.
Mawu Ochokera
JAK inhibitors ndi kalasi yachitatu ya DMARDS, yomwe imatchedwa kuti molecule DMARDS. Kupezeka kwa baricitinib kudzapatsanso njira ina yothetsera matenda a nyamakazi, ikavomerezedwa. Chivomerezo chimenecho chiyembekezeredwa mu 2017. Odwala omwe alibe yankho lokwanira kwa methotrexate, ma DMARD ena, kapena mankhwala osokoneza bongo , adzakhala ndi mankhwala ena osokoneza bongo. Kwa odwala ena, zikhoza kukhala njira yabwino kwambiri komanso yosakondera mankhwala osokoneza bongo omwe amachititsa kuti asakanikizidwe kapena biologics omwe amaperekedwa ndi kulowetsedwa.
> Zotsatira:
> Kuya, Bindee et al. Baricitinib mu Matenda a Nyamakazi: Chiwonetsero cha nthawi ndi chipatala chotheka. Kupititsa Patsogolo pa Matenda a Musculoskeletal. 2017 Feb; 9 (2): 37-44.
> Smolen, Josef S. ndi al. Zotsatira za Odwala Kuchokera ku Zomwe Zidasintha Gawo III Kuphunzira kwa Baricitinib kwa Odwala Ndi Matenda a Matenda a Nyamakazi ndi Kulephera Kwambiri kwa Ogwiritsira Ntchito Zamoyo (RA-BEACON). Annals wa Rheumatic Diseases. 2017; 76: 694-700.
> Taylor, Peter C. MD, PhD ndi al. Baricitinib ndi Placebo kapena Adalimumab mu Matenda a Chifuwa. New England Journal of Medicine. 2017; 376: 652-662. February 16, 2017.
> US FDA Ikupitiliza Nyengo Yowonjezereka kwa Baricitinib, Chifuwa Chofufuzira Chifuwa cha Amagazi. Lilly. January 13, 2017.
> Maofesi a US FDA Yotsutsa Kalata Yoyera ya Baricitinib. Lilly ndi Incyte kudzera pa BusinessWire. April 14, 2017.