Avgust 2021: Tizimli terapiyaning kamida ikkita oldingi bosqichi muvaffaqiyatsiz tugagandan so'ng, Oziq -ovqat va farmatsevtika idorasi tasdiqladi belumosudil (Rezurock, Kadmon Pharmaceuticals, MChJ), kinaz inhibitori, 12 yoshdan oshgan va kattalar va bolalar uchun, surunkali greft-xost kasalligi (surunkali GVHD).
Samaradorlikni baholash uchun KD025-213 (NCT03640481), randomizatsiyalangan, ochiq markazli, ko'p markazli dozali diapazonli eksperiment o'tkazildi, bunda surunkali GVHD bilan og'rigan 65 bemorga 200 mg belumosudil XNUMX mg dozada og'iz orqali yuborildi.
The overall response rate (ORR) through Cycle 7 Day 1 was the primary efficacy end measure, with overall response defined as a full response (CR) or partial response (PR) according to the 2014 NIH Consensus Development Project on Clinical Trials in Chronic Graft-versus-Host Disease guidelines. The ORR was 75% (95 percent CI: 63, 85); 6% of patients had a complete response, and 69 percent had a partial response. The average time it took to get a first answer was 1.8 months (95 percent CI: 1.0, 1.9). The median duration of response for chronic GVHD was 1.9 months, measured from first response through progression, death, or new systemic treatments (95 percent CI: 1.2, 2.9). No mortality or new systemic medication initiation occurred in 62 percent (95 percent CI: 46, 74) of patients who achieved response for at least 12 months after response.
Infektsiyalar, asteniya, ko'ngil aynishi, diareya, nafas qisilishi, yo'tal, shish, qon ketishi, qorin og'rig'i, tayanch -harakat skeletining og'rig'i, bosh og'rig'i, fosfatning pasayishi, gamma glutamil transferazasining ko'payishi, limfotsitlarning kamayishi va gipertenziya eng ko'p uchraydigan salbiy reaktsiyalar (20%), shu jumladan laboratoriya. anormalliklar.
Belumosudilni kuniga bir marta, ovqat bilan, 200 mg dozada olish kerak.
