March 2022: Abatacept (Orencia, Bristol-Myers Squibb Kambaniyakagamuchirwa neChikafu neDrug Administration kuitira kudzivirira acute graft versus host disease (aGVHD) kune vanhu vakuru uye varwere vevana vane makore maviri nepamusoro avo vari kugamuchira hematopoietic stem cell transplantation (HSCT) kubva kune yakafananidzwa kana 2 allele- zvisingaenderani zvisina hukama donor. Uku ndiko kurapwa kwekutanga kweGVHD kwakabvumidzwa neFDA. Real-world data (RWD) yakashandiswa muchikumbiro kuona kushanda kwekiriniki. RWD inoreva data rekiriniki rinounganidzwa zvakarongeka kubva kune akawanda zvinyorwa, kusanganisira registry data, kuitira kupa humbowo hwepasirese (RWE).
Mukuferefeta kuviri, vana vane makore matanhatu zvichikwira vakagamuchira HSCT kubva kune akafananidzwa kana 1 allele-isina kufananidzwa nemupi asina hukama vakaongororwa kushanda.
GVHD-1 (NCT 01743131) yakanga iri randomized (1: 1), kaviri-bofu, placebo-inodzorwa nekliniki yekuedza umo varwere vakagamuchira abatacept kana placebo pamwe chete neCNI uye MTX mushure mekugamuchira 8 ye8 Human Leukocyte Antigen (HLA). )-inofananidzwa neHSCT. Kunyange zvakakomba (giredhi III-IV) aGVHD-yemahara kupona hakuna kunyanya kuvandudzwa kune varwere vakagamuchira Orencia kana vachienzaniswa nevarwere vakagamuchira placebo paZuva 180 mushure mekuisirwa (HR 0.55; 95 muzana CI 0.26, 1.18), iyo OS chiyero paZuva. 180 mushure meHSCT yaive 97 muzana (95 muzana CI: 89 muzana, 99 muzana) yevarwere vakagamuchira abatacept vachienzaniswa ne84 muzana (95 muzana CI: 73 muzana, 91 muzana) yevarwere (HR 0.33; 95 muzana CI: 0.12, 0.93 ) PaZuva 180 mushure meHSCT, mwero wepakati-yakaoma (giredhi II-IV) aGVHD-yemahara kupona kune varwere vakawana abatacept yaive 50% (95 muzana CI: 38 muzana, 61 muzana), zvichienzaniswa ne32% (95 muzana CI. : 21 muzana, 43 muzana) kune varwere vakagamuchira placebo (HR 0.54; 95 muzana CI: 0.35, 0.83).
GVHD-2, kuongororwa kwekiriniki kwakavakirwa padhata kubva kuCentre for International Ropa uye Marrow Transplant Research (CIBMTR) muvarwere vakagamuchira 7 ye8 HLA-inofananidzwa neHSCT pakati pa2011 na2018, yakaratidza humwe humbowo hwekushanda. Migumisiro yevarwere makumi mashanu nevana vakabatwa neabatacept pamwe chete neCNI neMTX yekudzivirira GVHD yakaenzaniswa nevarwere ve54 vakasarudzwa kubva kuCIBMTR registry avo vakarapwa neCNI neMTX chete. Varwere vakawana abatacept musanganiswa neCNI neMTX vaive ne162 muzana (98 muzana CI: 95 muzana, 78 muzana) OS chiyero paZuva 100 mushure meHSCT, zvichienzaniswa ne180 muzana (75 muzana CI: 95 muzana, 67 muzana) yevarwere. uyo akagamuchira CNI uye MTX chete.
Anemia, hypertension, CMV reactivation / CMV infection, pyrexia, pneumonia, epistaxis, kuderedzwa kweCD4 masero, hypermagnesemia, uye kukuvara kwakanyanya kwetsvo ndizvo zvinowanzoitika (gumi muzana) yeabatacept yekudzivirira kweGVHD. Varwere vanogamuchira abatacept vanofanira kupihwa antiviral prophylaxis yeEpstein-Barr hutachiona hwehutachiona vasati vatanga kurapwa uye kwemwedzi mitanhatu mushure, pamwe nekutariswa cytomegalovirus utachiona / reactivation.
Mushonga weabatacept unofungidzirwa unoenderana nezera remurwere uye wakanyorwa muzvinyorwa zvinorairwa. Orencia ruzivo rwechiremba runowanikwa rwakazara.
Project Orbis, iyo FDA Oncology Center yeKunakisa kuedza, yakashandiswa kuita ongororo iyi. Project Orbis inogadzira nzira yekuti vadyidzani vepasi rese vaendese uye vaongorore mishonga yeoncology panguva imwe chete. FDA yakashanda pakuongorora uku neHealth Canada, Swissmedic, uye Israel Ministry of Health. Mamwe masangano anodzora achiri kuongorora zvikumbiro.
