Division of Rheumatology, Department of Medicine, UMass Memorial Medical Center, Worcester, Massachusetts, USA
Division of Rheumatology, Department of Medicine, University of Massachusetts Medical School, Worcester, Massachusetts, USA.
RMD Open. 2020 Oct;6(3). doi: 10.1136/rmdopen-2020-001370.
To characterise changes in selected haematological parameters following once-daily oral baricitinib dosing.
Data were pooled from eight randomised clinical trials (four phase 3, three phase 2, one phase 1b) and one long-term extension. Changes in haematological parameters were evaluated up to 128 weeks (N=2387); overall safety of baricitinib was assessed up to 6 years (N=3492).
Mean absolute neutrophil counts decreased (-1.36×10/L) within 1 month, followed by stabilisation within the normal reference range through week 128. The incidence of serious infections was not elevated in patients with neutropenia during the 24-week placebo-controlled period. Mean lymphocyte counts increased (+0.30×10/L) within 1 month, then decreased to baseline (weeks 12-24). Mean platelet counts increased at week 2 (+51×10/L), then decreased towards baseline. Overall, mean haemoglobin concentrations decreased (-0.12 mmol/L), then returned to baseline; however, reduced baseline haemoglobin concentrations observed in the highest baseline high-sensitivity C reactive protein quartile increased over time. Permanent drug discontinuation occurred due to laboratory abnormalities related to neutrophil count in 8 (0.2%), lymphocyte counts in 6 (0.2%), platelet counts in 8 (0.2%), and haemoglobin levels in 16 (0.5%) of all baricitinib-treated patients (N=3492 with 7993 total person-years of exposure).
Moderate decreases in neutrophils were seen during baricitinib treatment; however, serious infection was uncommon in patients with neutropenia. Transient increases were observed in lymphocytes and platelets, which returned to baseline over time. Changes in haemoglobin concentration were generally small. Haematological abnormalities seldom led to drug discontinuation.
描述每日口服巴瑞替尼后选定血液学参数的变化。
数据来自八项随机临床试验（四项 3 期，三项 2 期，一项 1b 期）和一项长期扩展。评估了长达 128 周的血液学参数变化（N=2387）；评估了长达 6 年的巴瑞替尼总体安全性（N=3492）。
中性粒细胞绝对计数在 1 个月内下降（-1.36×10/L），随后在 128 周内稳定在正常参考范围内。在 24 周安慰剂对照期间，中性粒细胞减少症患者的严重感染发生率并未升高。淋巴细胞计数在 1 个月内增加（+0.30×10/L），然后降至基线（12-24 周）。血小板计数在第 2 周（+51×10/L）增加，然后向基线下降。总体而言，平均血红蛋白浓度下降（-0.12 mmol/L），然后恢复到基线；然而，在最高基线高敏 C 反应蛋白四分位数中观察到的较低基线血红蛋白浓度随时间增加。由于与中性粒细胞计数相关的实验室异常（16 例患者中的 8 例，0.5%）、淋巴细胞计数（6 例患者中的 6 例，0.2%）、血小板计数（8 例患者中的 8 例，0.2%）和血红蛋白水平（3492 例患者中的 16 例，7993 人年暴露），16 例（0.5%）接受巴瑞替尼治疗的患者永久停药。
在巴瑞替尼治疗期间观察到中性粒细胞适度下降；然而，中性粒细胞减少症患者的严重感染并不常见。淋巴细胞和血小板短暂增加，随时间恢复到基线。血红蛋白浓度的变化通常较小。血液学异常很少导致药物停药。
