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I-FDA ivume i-belumosudil ekwelashweni kwesifo esingelapheki se-graft-versus-host

Yabelana ngalokhu okuthunyelwe

Agasti 2021: Ngemuva kokwehluleka okungenani kwemigqa emibili yokwelashwa kwesistimu, Ukuphathwa Kwezokudla Nezidakamizwa kugunyaziwe i-belumosudil (Rezurock, Kadmon Pharmaceuticals, LLC), i-kinase inhibitor, yeziguli zabantu abadala nezengane ezineminyaka engu-12 nangaphezulu ezinesifo esingapheli se-graft-versus-host (i-chronic GVHD).

I-KD025-213 (NCT03640481), ukuhlolwa okungahleliwe, kwelebuli evulekile, okuhlolwa okulingene umthamo lapho iziguli ezingama-65 ezine-GVHD engalapheki zelashwa nge-belumosudil 200 mg elawulwa ngomlomo kanye ngosuku, isetshenziselwe ukuhlola ukusebenza kahle.

Izinga lokuphendula eliphelele (ORR) nge-Cycle 7 Day 1 kwakuyisilinganiso sokuphela sokusebenza ngempumelelo, nempendulo iyonke echazwa njengempendulo egcwele (CR) noma impendulo eyingxenye (PR) ngokusho kwe-2014 NIH Consensus Development Project on Clinical Trials in Chronic Graft. -versus-Host Disease imihlahlandlela. I-ORR yayingu-75% (amaphesenti angu-95 CI: 63, 85); I-6% yeziguli ibe nempendulo ephelele, kanti amaphesenti angu-69 abe nempendulo eyingxenye. Isikhathi esivamile esisithathile ukuze uthole impendulo yokuqala kwakuyizinyanga ezingu-1.8 (amaphesenti angu-95 CI: 1.0, 1.9). Ubude besikhathi esimaphakathi sokuphendula kwe-GVHD engapheli kwakuyizinyanga ezingu-1.9, zikalwa kusukela ekuphenduleni kokuqala ngokuqhubeka, ukufa, noma ukwelashwa okusha kwesistimu (amaphesenti angu-95 CI: 1.2, 2.9). Akukho ukufa noma ukuqaliswa kwemithi emisha yesistimu okwenzeka kumaphesenti angu-62 (amaphesenti angu-95 CI: 46, 74) eziguli ezithole impendulo okungenani izinyanga ezingu-12 ngemva kokuphendula.

Ukutheleleka, i-asthenia, isicanucanu, isifo sohudo, i-dyspnea, ukukhwehlela, i-edoema, ukuphuma kwegazi, ubuhlungu besisu, ubuhlungu besisu, ikhanda, i-phosphate yehlile, i-gamma glutamyl transferase yanda, ama-lymphocyte ancipha, futhi umfutho wegazi ophakeme kwakuyizinto ezivame kakhulu ukuphazamiseka (i-20%), kufaka phakathi i-laboratory ukungajwayelekile.

I-Belumosudil kufanele ithathwe kanye ngosuku, ngokudla, ngomthamo wama-200 mg.

Thatha umbono wesibili ngokufakelwa komnkantsha wethambo


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