Satumba 2022: Cibiyar Abinci da Magunguna ta amince da Ibrutinib (Imbruvica, Pharmacyclics LLC) don amfani a cikin marasa lafiya na yara masu fama da cutar rashin lafiya (cGVHD) waɗanda ke ƙasa da shekara 1 kuma sun kasa layi ɗaya ko fiye na tsarin jiyya. Maganin baka, kwayoyi, da capsules misalai ne na tsari.
An kimanta ingancin Ibrutinib a cikin iMAGINE (NCT03790332), alamar buɗewa, cibiyar da yawa, gwajin hannu ɗaya ga yara da matasa masu matsakaici ko matsananciyar cGVHD. Mahalarta taron sun kasance daga shekara 1 zuwa kasa da shekaru 22. Marasa lafiya 47 sun buƙaci ƙarin magani bayan ɗaya ko fiye da layin magungunan tsarin sun gaza kuma an sanya su cikin gwaji. Idan shigar genitourinary a cikin gabo ɗaya shine kawai alamar cGVHD, an cire marasa lafiya.
Matsakaicin shekarun haƙuri shine shekaru 13 (kewaye, 1 zuwa 19). Wadannan su ne wasu daga cikin kididdigar alkalumma na marasa lafiya 47: 70% na yawan jama'a maza ne, 36% fari ne, 9% Bakar fata ne ko Ba'amurke, kuma 55% ba a ba da rahoto ba.
Matsakaicin ƙimar amsa gabaɗaya (ORR) zuwa Makon 25 yayi aiki azaman babban alamar sakamako na tasiri. Bisa ga 2014 NIH Consensus Development Project Ma'aunin Amsa, ORR ya haɗa da cikakken ko ɓangaren amsa. A mako na 25, ORR ya kai 60% (95% CI: 44, 74). Matsakaicin lokacin da aka ɗauka don amsawa shine watanni 5.3 (95% CI: 2.8, 8.8). Tsawon tsaka-tsaki na cGVHD shine watanni 14.8 (95% CI: 4.6, ba mai ƙima ba) daga amsawar farko ga mutuwa ko sabon tsarin jiyya.
Anemia, musculoskeletal pain, pyrexia, diarrhoea, pneumonia, abdominal pain, stomatitis, thrombocytopenia, and headache were the most frequent adverse events (20%), as were pyrexia, diarrhoea, pneumonia, abdominal pain, and stomatitis.
Adadin da aka ba da shawarar na IMBRUVICA shine 420 MG na baki sau ɗaya kowace rana don marasa lafiya 12 shekaru da haihuwa tare da cGVHD da 240 mg / m2 baki sau ɗaya kowace rana (har zuwa kashi na 420 MG) ga marasa lafiya 1 zuwa ƙasa da shekaru 12 tare da cGVHD , har zuwa ci gaban cGVHD, sake dawowa da rashin lafiya mai zurfi, ko guba mara yarda.
Duba cikakken bayanin rubutawa na Imbruvica.
