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Abstract：
BACKGROUND: Baricitinib, a JAK1/JAK2 inhibitor, is approved for treatment of moderate-to-severe rheumatoid arthritis (RA) in China. This single-arm, prospective, multi-center, post-marketing safety study (PMSS) evaluated the safety and effectiveness of baricitinib in Chinese patients.
METHODS: This study included adult patients with moderate-to-severe active RA who received baricitinib over periods of approximately 12 and 24 weeks. The primary endpoint was safety, defined as week 12 adverse event (AE)/serious AE incidence. Secondary endpoints were week 24 safety and effectiveness (disease activity score with 28 joints/C-reactive protein [DAS28-CRP] and simplified/Clinical Disease Activity Index [SDAI/CDAI]).
RESULTS: Safety analyses included 667 patients (female, 82.3%; mean age, 53.3 years; mean RA duration, 86.9 months); 106/667 (15.9%) were 65-74 years old and 19/667 (2.8%) were ≥ 75 years old; 87.0% received baricitinib 2 mg QD. Total exposure was 262.1 patient-years (PY). At week 12, AEs had occurred in 214 (32.1%; exposure-adjusted incidence rate [EAIR], 172.5 per 100 PY) patients (serious AEs: 22 [3.3%; EAIR, 15.0]). At week 24, AEs had occurred in 250 (37.5%; EAIR, 125.9) patients (serious AEs: 28 [4.2%; EAIR, 10.9]). Two patients (0.3%) died (of pneumonia and unknown cause); EAIR for death, 0.77. Serious infection occurred in 1.2% of patients (EAIR, 3.1). Hepatotoxicity occurred in 3.4% of patients (EAIR, 9.0). No patients met potential Hy\'s law laboratory criteria (alanine/aspartate aminotransferases ≥ 3 × upper limit of normal (ULN) and total bilirubin ≥ 2 × ULN). Malignancy occurred in one patient. No patients experienced venous thromboembolism (VTE) or major adverse cardiovascular events (MACE). At week 24, 52.4%, 27.5%, and 27.6% of patients achieved remission per DAS28-CRP, SDAI, and CDAI, respectively.
CONCLUSIONS: This PMSS investigated the safety and effectiveness of baricitinib in clinical practice in China. No VTE/MACE or new safety signals were reported and there was promising effectiveness, supporting the use of baricitinib in Chinese patients with moderate-to-severe active RA.
BACKGROUND: EU PAS Register: EUPAS34213.
METHODS: This study included adult patients with moderate-to-severe active RA who received baricitinib over periods of approximately 12 and 24 weeks. The primary endpoint was safety, defined as week 12 adverse event (AE)/serious AE incidence. Secondary endpoints were week 24 safety and effectiveness (disease activity score with 28 joints/C-reactive protein [DAS28-CRP] and simplified/Clinical Disease Activity Index [SDAI/CDAI]).
RESULTS: Safety analyses included 667 patients (female, 82.3%; mean age, 53.3 years; mean RA duration, 86.9 months); 106/667 (15.9%) were 65-74 years old and 19/667 (2.8%) were ≥ 75 years old; 87.0% received baricitinib 2 mg QD. Total exposure was 262.1 patient-years (PY). At week 12, AEs had occurred in 214 (32.1%; exposure-adjusted incidence rate [EAIR], 172.5 per 100 PY) patients (serious AEs: 22 [3.3%; EAIR, 15.0]). At week 24, AEs had occurred in 250 (37.5%; EAIR, 125.9) patients (serious AEs: 28 [4.2%; EAIR, 10.9]). Two patients (0.3%) died (of pneumonia and unknown cause); EAIR for death, 0.77. Serious infection occurred in 1.2% of patients (EAIR, 3.1). Hepatotoxicity occurred in 3.4% of patients (EAIR, 9.0). No patients met potential Hy\'s law laboratory criteria (alanine/aspartate aminotransferases ≥ 3 × upper limit of normal (ULN) and total bilirubin ≥ 2 × ULN). Malignancy occurred in one patient. No patients experienced venous thromboembolism (VTE) or major adverse cardiovascular events (MACE). At week 24, 52.4%, 27.5%, and 27.6% of patients achieved remission per DAS28-CRP, SDAI, and CDAI, respectively.
CONCLUSIONS: This PMSS investigated the safety and effectiveness of baricitinib in clinical practice in China. No VTE/MACE or new safety signals were reported and there was promising effectiveness, supporting the use of baricitinib in Chinese patients with moderate-to-severe active RA.
BACKGROUND: EU PAS Register: EUPAS34213.
摘要：
背景：Baricitinib，JAK1/JAK2抑制剂，在中国被批准用于治疗中度至重度类风湿性关节炎（RA）。这个单臂，prospective,多中心,上市后安全性研究（PMSS）评估了巴利替尼在中国患者中的安全性和有效性。
方法：本研究纳入了中度至重度活动性RA的成年患者，这些患者接受了大约12周和24周的巴利替尼治疗。主要终点是安全性，定义为第12周不良事件（AE）/严重AE发生率。次要终点是第24周的安全性和有效性（28个关节的疾病活动评分/C反应蛋白[DAS28-CRP]和简化/临床疾病活动指数[SDAI/CDAI]）。
结果：安全性分析包括667例患者（女性，82.3%；平均年龄，53.3年；平均RA持续时间，86.9个月）；106/667（15.9％）为65-74岁，19/667（2.8％）为≥75岁；87.0％接受baricitinib2mgQD。总暴露量为262.1患者年（PY）。在第12周，214例发生了AE（32.1%；暴露调整后的发病率[EAIR]，172.5/100PY）患者（严重不良事件：22[3.3%；EAIR，15.0])。在第24周，不良事件发生在250例(37.5%；EAIR，125.9）患者（严重不良事件：28[4.2%；EAIR，10.9])。2名患者（0.3％）死亡（肺炎和原因不明）；EAIR死亡，0.77.1.2%的患者发生严重感染(EAIR，3.1).3.4%的患者出现肝毒性(EAIR，9.0).没有患者符合潜在的Hy's法律实验室标准（丙氨酸/天冬氨酸转氨酶≥3×正常上限（ULN）和总胆红素≥2×ULN）。1例患者发生恶性肿瘤。无患者出现静脉血栓栓塞（VTE）或主要不良心血管事件（MACE）。在第24周，52.4%，27.5%,根据DAS28-CRP，27.6%的患者达到缓解，SDAI,和CDAI,分别。
结论：本次PMSS调查了巴利替尼在中国临床实践中的安全性和有效性。未报告VTE/MACE或新的安全性信号，且疗效良好，支持在中国中度至重度活动性RA患者中使用巴利替尼。
背景：EUPAS注册：EUPAS34213。
方法：本研究纳入了中度至重度活动性RA的成年患者，这些患者接受了大约12周和24周的巴利替尼治疗。主要终点是安全性，定义为第12周不良事件（AE）/严重AE发生率。次要终点是第24周的安全性和有效性（28个关节的疾病活动评分/C反应蛋白[DAS28-CRP]和简化/临床疾病活动指数[SDAI/CDAI]）。
结果：安全性分析包括667例患者（女性，82.3%；平均年龄，53.3年；平均RA持续时间，86.9个月）；106/667（15.9％）为65-74岁，19/667（2.8％）为≥75岁；87.0％接受baricitinib2mgQD。总暴露量为262.1患者年（PY）。在第12周，214例发生了AE（32.1%；暴露调整后的发病率[EAIR]，172.5/100PY）患者（严重不良事件：22[3.3%；EAIR，15.0])。在第24周，不良事件发生在250例(37.5%；EAIR，125.9）患者（严重不良事件：28[4.2%；EAIR，10.9])。2名患者（0.3％）死亡（肺炎和原因不明）；EAIR死亡，0.77.1.2%的患者发生严重感染(EAIR，3.1).3.4%的患者出现肝毒性(EAIR，9.0).没有患者符合潜在的Hy's法律实验室标准（丙氨酸/天冬氨酸转氨酶≥3×正常上限（ULN）和总胆红素≥2×ULN）。1例患者发生恶性肿瘤。无患者出现静脉血栓栓塞（VTE）或主要不良心血管事件（MACE）。在第24周，52.4%，27.5%,根据DAS28-CRP，27.6%的患者达到缓解，SDAI,和CDAI,分别。
结论：本次PMSS调查了巴利替尼在中国临床实践中的安全性和有效性。未报告VTE/MACE或新的安全性信号，且疗效良好，支持在中国中度至重度活动性RA患者中使用巴利替尼。
背景：EUPAS注册：EUPAS34213。
