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1.苏州大学附属第一医院药学部,江苏 苏州 215006
2.苏州大学药学院,江苏 苏州 215021
硕士研究生。研究方向:临床药学。E-mail:yinkerui124@163.com
主任药师,硕士生导师。研究方向:医院药学。 E-mail:15950005195@163.com
收稿日期:2023-12-27,
修回日期:2024-02-09,
录用日期:2024-04-09,
纸质出版日期:2024-06-30
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殷科蕊,吴紫阳,汪皖青,等.3种口服Janus激酶抑制剂治疗特应性皮炎的临床综合评价[J].中国药房,2024,35(12):1419-1425.
YIN Kerui,WU Ziyang,WANG Wanqing,et al.Clinical comprehensive evaluation of three oral Janus kinase inhibitors for atopic dermatitis[J].ZHONGGUO YAOFANG,2024,35(12):1419-1425.
殷科蕊,吴紫阳,汪皖青,等.3种口服Janus激酶抑制剂治疗特应性皮炎的临床综合评价[J].中国药房,2024,35(12):1419-1425. DOI: 10.6039/j.issn.1001-0408.2024.12.02.
YIN Kerui,WU Ziyang,WANG Wanqing,et al.Clinical comprehensive evaluation of three oral Janus kinase inhibitors for atopic dermatitis[J].ZHONGGUO YAOFANG,2024,35(12):1419-1425. DOI: 10.6039/j.issn.1001-0408.2024.12.02.
目的
2
对乌帕替尼、阿布昔替尼和巴瑞替尼3种口服Janus激酶抑制剂(JAKi)治疗特应性皮炎进行临床综合评价。
方法
2
从安全性、有效性、经济性、适宜性、可及性、创新性6个维度进行评价。使用Meta分析评价3种口服JAKi的安全性和有效性;检索国内外药物经济学研究并计算各JAKi治疗费用以评价经济性;结合文献和药品说明书等评价适宜性;使用问卷调查评价3种口服JAKi的可及性;从JAKi的作用机制角度阐述其创新性。
结果
2
安全性方面,乌帕替尼30 mg组上呼吸道感染发生率[OR=1.47,95%CI(1.04,2.08),
P
=0.03
]
和鼻咽炎发生率[OR=1.44,95%CI(1.06,1.95),
P
=0.02
]
显著高于安慰剂组;巴瑞替尼4 mg组的鼻咽炎发生率显著高于安慰剂组[OR=2.24,95%CI(1.39,3.61),
P
=0.000 8
]
和巴瑞替尼2 mg组[OR=0.48,95%CI(0.31,0.74),
P
=0.001
]
。有效性方面,3种口服JAKi无论剂量如何,有效性均显著优于安慰剂组,且乌帕替尼和阿布昔替尼的有效性呈剂量依赖性(
P
<0.000 1)。经济性方面,巴瑞替尼的年治疗费用最低(13 870.0元),但其在我国没有获批AD适应证;其次为乌帕替尼(27 192.5元)。3种JAKi的总体适宜性较好,但均不适用于重度肝损伤患者。巴瑞替尼的可获得率最高(59.4%),但在我国医保体系下乌帕替尼的可负担性较好。3种JAKi中,乌帕替尼与阿布昔替尼的创新性更优。
结论
2
3种口服JAKi治疗特应性皮炎的安全性可控,有效性良好;考虑到医保报销问题,建议我国患者优先使用乌帕替尼。
OBJECTIVE
2
To comprehensively evaluate the three oral Janus kinase inhibitors (JAKi) such as upadacitinib, abrocitinib and baricitinib in the treatment of atopic dermatitis.
METHODS
2
The six dimensions of safety, efficacy, economy, appropriateness, accessibility and innovativeness were used for evaluation. Meta-analysis was conducted to evaluate the safety and efficacy of three oral JAKi; pharmacoeconomic studies were searched, and the treatment costs were calculated to evaluate the economy of each JAKi. Appropriateness was described based on literature review and drug labels. Accessibility of three oral JAKi was assessed by using a questionnaire survey. The innovation of JAKi was elucidated from the perspective of its mechanism of action.
RESULTS
2
In terms of safety, the incidence of upper respiratory tract infection (OR=1.47, 95%CI of 1.04-2.08,
P
=0.03) and nasopharyngitis (OR=1.44,
95%CI of 1.06-1.95,
P
=0.02) in the upadacitinib 30 mg group was significantly higher than that in the placebo group; the incidence of nasopharyngitis in baricitinib 4 mg group was significantly higher than that in the placebo group (OR=2.24, 95%CI of 1.39-3.61,
P
=0.000 8) and baricitinib 2 mg group (OR=0.48, 95%CI of 0.31-0.74,
P
=0.001). In terms of efficacy, regardless of the dosage, all three JAKi groups were superior to the placebo group, and the high-dose groups of upadacitinib and abrocitinib were superior to the low-dose groups (
P
<0.000 1). In terms of economy, the annual treatment cost of baricitinib was the lowest (13 870.0 yuan), but it has not been approved for atopic dermatitis indication in China; next was upadacitinib (27 192.5 yuan). In terms of appropriateness, the overall appropriateness of the three JAKis was good, but none of them was suitable for patients with severe liver injury. In terms of accessibility, baricitinib had the highest availability rate (59.4%), but the affordability of upadacitinib was relatively good under China’s medical insurance system. In terms of innovation, among the three types of JAKi, upadacitinib and abrocitinib had better innovation.
CONCLUSIONS
2
Three oral JAKi treatments for atopic dermatitis have controllable safety and good efficacy. Considering the issue of medical insurance reimbursement, it is recommended that Chinese patients use upadacitinib.
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