March 2022: I-Abatacept (Orencia, Inkampani yaseBristol-Myers Squibb) igunyazwe yi-Food and Drug Administration ukuze kuvinjwe isifo esiyingozi sokuxhunyelelwa ngokumelene ne-host (i-aGVHD) kubantu abadala kanye neziguli zezingane ezineminyaka engu-2 ubudala nangaphezulu ezithola i-hematopoietic stem cell transplantation (HSCT) evela ku-matched noma 1 allele- umnikeli ongahlobene. Lokhu ukwelashwa kokuqala kwe-aGVHD okugunyazwe yi-FDA. Idatha yomhlaba wangempela (RWD) isetshenziswe kuhlelo lokusebenza ukucacisa ukusebenza kahle komtholampilo. I-RWD ibhekisela kudatha yomtholampilo eqoqwe ngokuhlelekile kusuka emithonjeni eminingi, kuhlanganise nedatha yokubhalisa, ukuze kunikezwe ubufakazi bomhlaba wangempela (RWE).
Ophenyweni olubili, izingane ezineminyaka eyisithupha kuya phezulu ezithole i-HSCT kumnikeli ofanayo noma ongu-1 we-allele-okungafani nhlobo zahlolelwa ukusebenza kahle.
I-GVHD-1 (NCT 01743131) bekuyisivivinyo somtholampilo esingahleliwe (1:1), esingaboni kabili, esilawulwa yi-placebo lapho iziguli zithole i-abatacept noma i-placebo ngokuhlangene ne-CNI kanye ne-MTX ngemva kokuthola i-8 ye-8 Human Leukocyte Antigen (HLA )-ifaniswe ne-HSCT. Nakuba ukusinda kwe-aGVHD kanzima (ibanga lesi-III-IV) akuzange kuthuthukiswe kakhulu ezigulini ezathola i-Orencia uma kuqhathaniswa neziguli ezathola i-placebo ngoSuku 180 ngemva kokufakelwa kabusha (HR 0.55; 95 amaphesenti CI 0.26, 1.18), izinga le-OS ngoSuku I-180 ngemuva kwe-HSCT ibingamaphesenti angama-97 (amaphesenti angama-95 CI: amaphesenti angama-89, amaphesenti angama-99) ezigulini ezithole i-abatacept uma kuqhathaniswa namaphesenti angama-84 (amaphesenti angama-95 CI: amaphesenti angama-73, amaphesenti angama-91) eziguli (HR 0.33; 95 amaphesenti CI: 0.12, 0.93 ). Ngosuku lwe-180 ngemva kwe-HSCT, izinga lokusinda kwe-abatacept emaphakathi (ibanga II-IV) ezigulini ezithole i-abatacept lalingu-50% (95 amaphesenti CI: 38 amaphesenti, 61), uma kuqhathaniswa nama-32% (95 amaphesenti CI : amaphesenti angu-21, amaphesenti angu-43) ezigulini ezithole i-placebo (HR 0.54; 95 amaphesenti CI: 0.35, 0.83).
I-GVHD-2, ukuhlaziya komtholampilo okusekelwe kudatha evela ku-Center for International Blood and Marrow Transplant Research (CIBMTR) ezigulini ezithole i-HSCT engu-7 kweziyi-8 ezifaniswe ne-HLA phakathi kuka-2011 no-2018, kwembule ubufakazi obengeziwe bokusebenza. Imiphumela yeziguli ezingama-54 ezelashwe nge-abatacept ngokuhlanganyela ne-CNI kanye ne-MTX yokuvimbela i-aGVHD yaqhathaniswa neziguli eziyi-162 ezikhethwe ngokungahleliwe kurejista ye-CIBMTR ezalashwa nge-CNI ne-MTX kuphela. Iziguli ezithole i-abatacept ngokuhlanganiswa ne-CNI kanye ne-MTX zazinamaphesenti angu-98 (amaphesenti angu-95 CI: amaphesenti angu-78, amaphesenti angu-100) izinga le-OS ngoSuku 180 ngemva kwe-HSCT, uma kuqhathaniswa namaphesenti angu-75 (amaphesenti angu-95 CI: amaphesenti angu-67, amaphesenti angu-82) ezigulini. owathola i-CNI ne-MTX yedwa.
I-anemia, umfutho wegazi ophakeme, ukuvuselelwa kabusha kwe-CMV/ukutheleleka kwe-CMV, i-pyrexia, inyumoniya, i-epistaxis, amaseli e-CD4 ancishisiwe, i-hypermagnesemia, nokulimala kwezinso okukhulu yizenzakalo ezivame kakhulu eziseceleni (amaphesenti ayishumi) we-abatacept yokuvimbela i-AGVHD. Iziguli ezithola i-abatacept kufanele zinikezwe i-antiviral prophylaxis yokutheleleka ngegciwane le-Epstein-Barr ngaphambi kokuqala ukwelashwa kanye nezinyanga eziyisithupha ngemva kwalokho, futhi ziqashelwe ukutheleleka/ukuvuselelwa kwe-cytomegalovirus.
Umthamo we-abatacept ophakanyisiwe unqunywa eminyakeni yobudala yesiguli futhi ufakwe ohlwini lwezinto ezinikezwayo. Imininingwane ye-Orencia kadokotela iyatholakala iyonke.
I-Project Orbis, i-FDA Oncology Center of Excellence imizamo, yasetshenziswa ukwenza lokhu kubuyekezwa. I-Project Orbis idala indlela yokuba ozakwethu bomhlaba wonke balethe futhi babuyekeze imithi ye-oncology ngesikhathi esisodwa. I-FDA isebenze kulokhu kubuyekezwa ne-Health Canada, Swissmedic, kanye noMnyango Wezempilo wakwa-Israel. Ezinye izindikimba ezilawulayo zisabuyekeza izicelo.
