Recombinant human thrombopoietin (rhTPO) of different dosing regimens for refractory/relapsed primary immune thrombocytopenia: a multicenter, randomized controlled trial and pharmacokinetics study.
Xiaofan LiuYusheng BaiTao WangYanping SongFeng SunRuixiang XiaFeiyue ZhuJun MaQuanyi LuXu YeXinrong ZhanLinjie LiXinhong GuoShuqin ChengYan LiZhiqiang GuoYouhua ChenShenxian QianLing QinQing ZhangSunqiong CaoRenchi YangPublished in: Platelets (2023)
Recombinant human TPO (rhTPO) is effective for refractory/relapsed primary immune thrombocytopenia (ITP), but optimal dosing regimen remains elusive. In this multicenter, randomized, controlled trial, a total of 282 adult ITP patients (mean age 47.3 years; 82 men) with a platelet count ≤30 × 10 9 /L or >30 × 10 9 /L with active bleeding randomly received a once daily (QD) subcutaneous injection of 7500 U (n = 64) or 15000 U rhTPO for 14 injections, or 15000 U or 30000 U rhTPO once every other day (QOD) for 7 injections. The primary outcomes included change from baseline in platelet count and total response rate (TRR) on day 14. On day 14, the median increase of platelet count from baseline was the highest in the 15000-U QD group (167.5 × 10 9 /L, interquartile range [IQR] 23.0-295.0 × 10 9 /L), followed by the 30000-U QOD group (57.5 × 10 9 /L, IQR 9.0-190.0 × 10 9 /L) (ANCOVA P < .001; P = .266 with baseline count as a covariate). The TRR on day 14 was also the highest in the 15000-U QD group (63.2%), followed by the 30000-U QOD group (59.7%). The rate of grade 3 and above adverse events did not differ among the four groups. There were no new safety concerns. All 4 regimens are safe and well-tolerated. The 30000-U QOD regimen is practically indistinguishable in efficacy to the 15000-U QD regimen.
Keyphrases
- recombinant human
- randomized controlled trial
- peripheral blood
- acute lymphoblastic leukemia
- end stage renal disease
- acute myeloid leukemia
- study protocol
- ultrasound guided
- newly diagnosed
- diffuse large b cell lymphoma
- multiple myeloma
- ejection fraction
- hodgkin lymphoma
- chronic kidney disease
- cross sectional
- prognostic factors
- atrial fibrillation
- peritoneal dialysis
- type diabetes
- adipose tissue
- metabolic syndrome
- systematic review
- patient reported outcomes
- double blind
- middle aged
- weight loss