{"title":"托法替尼和阿达木单抗在轴性脊柱关节炎中的疗效比较:真实世界临床背景下的多中心研究》。","authors":"Rudra Prosad Goswami, Debanjali Sinha, Moumita Chatterjee, Danveer Bhadu, Shyamashis Das","doi":"10.1097/RHU.0000000000002069","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Tofacitinib, an oral Janus kinase inhibitor, is a putative choice in the treatment of axial spondyloarthritis (AxSpA). The objective of this study was to compare the effectiveness and tolerability of tofacitinib with adalimumab, in AxSpA, in a real-world clinical setting.</p><p><strong>Methods: </strong>In this multicentric medical records review study, adult patients with active AxSpA treated with either tofacitinib 5 mg twice daily or adalimumab 40 mg subcutaneously fortnightly were recruited. Effectiveness was measured with Ankylosing Spondylitis Disease Activity Score (ASDAS) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Drug-cost analysis was calculated with Incremental Cost-Effectiveness Ratio (ICER drug ).</p><p><strong>Results: </strong>Among the 266 patients, 135 were treated with tofacitinib and 131 with adalimumab (follow-up: 6.5 ± 1.6 months). Mean improvement of BASDAI (3.39 ± 0.09 vs. 3.14 ± 1.16, respectively) and that of ASDAS (1.78 ± 0.68 vs. 2.07 ± 2.08, respectively) were comparable between the adalimumab and tofacitinib groups. A higher proportion of patients achieved BASDAI50 response in the second (49.5% vs. 31.6%) and fourth month (83.9% vs. 62.8%) and ASDAS low disease activity in the fourth month (71.6% vs. 47.9%) in the adalimumab group. All disease activity measurements were similar by the sixth month in both groups. A higher proportion of patients in the tofacitinib group than in the adalimumab group required change in therapy (14.8% vs. 7.6%, respectively). ICER drug for adalimumab compared with tofacitinib was US $188.8 per patient in the adalimumab group for each person-month with BASDAI <4.</p><p><strong>Conclusions: </strong>Tofacitinib showed comparable effectiveness with adalimumab in patients with AxSpA at the sixth month, despite lesser response in the initial months, with favorable ICER drug .</p>","PeriodicalId":14745,"journal":{"name":"JCR: Journal of Clinical Rheumatology","volume":" ","pages":"e108-e114"},"PeriodicalIF":2.4000,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Comparative Effectiveness of Tofacitinib and Adalimumab in Axial Spondyloarthritis: A Real-World Clinical Context Multicenter Study.\",\"authors\":\"Rudra Prosad Goswami, Debanjali Sinha, Moumita Chatterjee, Danveer Bhadu, Shyamashis Das\",\"doi\":\"10.1097/RHU.0000000000002069\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Tofacitinib, an oral Janus kinase inhibitor, is a putative choice in the treatment of axial spondyloarthritis (AxSpA). The objective of this study was to compare the effectiveness and tolerability of tofacitinib with adalimumab, in AxSpA, in a real-world clinical setting.</p><p><strong>Methods: </strong>In this multicentric medical records review study, adult patients with active AxSpA treated with either tofacitinib 5 mg twice daily or adalimumab 40 mg subcutaneously fortnightly were recruited. Effectiveness was measured with Ankylosing Spondylitis Disease Activity Score (ASDAS) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Drug-cost analysis was calculated with Incremental Cost-Effectiveness Ratio (ICER drug ).</p><p><strong>Results: </strong>Among the 266 patients, 135 were treated with tofacitinib and 131 with adalimumab (follow-up: 6.5 ± 1.6 months). Mean improvement of BASDAI (3.39 ± 0.09 vs. 3.14 ± 1.16, respectively) and that of ASDAS (1.78 ± 0.68 vs. 2.07 ± 2.08, respectively) were comparable between the adalimumab and tofacitinib groups. A higher proportion of patients achieved BASDAI50 response in the second (49.5% vs. 31.6%) and fourth month (83.9% vs. 62.8%) and ASDAS low disease activity in the fourth month (71.6% vs. 47.9%) in the adalimumab group. All disease activity measurements were similar by the sixth month in both groups. A higher proportion of patients in the tofacitinib group than in the adalimumab group required change in therapy (14.8% vs. 7.6%, respectively). ICER drug for adalimumab compared with tofacitinib was US $188.8 per patient in the adalimumab group for each person-month with BASDAI <4.</p><p><strong>Conclusions: </strong>Tofacitinib showed comparable effectiveness with adalimumab in patients with AxSpA at the sixth month, despite lesser response in the initial months, with favorable ICER drug .</p>\",\"PeriodicalId\":14745,\"journal\":{\"name\":\"JCR: Journal of Clinical Rheumatology\",\"volume\":\" \",\"pages\":\"e108-e114\"},\"PeriodicalIF\":2.4000,\"publicationDate\":\"2024-06-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"JCR: Journal of Clinical Rheumatology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/RHU.0000000000002069\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/3/20 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"RHEUMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"JCR: Journal of Clinical Rheumatology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/RHU.0000000000002069","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/3/20 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"RHEUMATOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
简介托法替尼是一种口服Janus激酶抑制剂,是治疗轴性脊柱关节炎(AxSpA)的可能选择。本研究旨在比较托法替尼与阿达木单抗在实际临床环境中治疗轴性脊柱关节炎的有效性和耐受性:在这项多中心病历回顾研究中,招募了接受托法替尼5毫克、每天两次或阿达木单抗40毫克、每两周一次皮下注射治疗的活动性AxSpA成年患者。用强直性脊柱炎疾病活动评分(ASDAS)和巴斯强直性脊柱炎疾病活动指数(BASDAI)来衡量疗效。药物成本分析采用增量成本效益比(ICERdrug)进行计算:在266名患者中,135人接受了托法替尼治疗,131人接受了阿达木单抗治疗(随访时间:6.5 ± 1.6个月)。阿达木单抗组和托法替尼组的BASDAI平均改善率(分别为3.39 ± 0.09 vs. 3.14 ± 1.16)和ASDAS平均改善率(分别为1.78 ± 0.68 vs. 2.07 ± 2.08)相当。阿达木单抗组在第二个月(49.5% vs. 31.6%)和第四个月(83.9% vs. 62.8%)达到BASDAI50反应和第四个月达到ASDAS低疾病活动度(71.6% vs. 47.9%)的患者比例更高。到第六个月时,两组患者的所有疾病活动度测量结果相似。托法替尼组需要改变疗法的患者比例高于阿达木单抗组(分别为14.8%对7.6%)。阿达木单抗与托法替尼相比,阿达木单抗组每名患者每人工月的BASDAI ICERdrug为188.8美元:托法替尼对 AxSpA 患者的疗效在第 6 个月时与阿达木单抗相当,尽管最初几个月的反应较小,但其 ICERdrug 有利。
Comparative Effectiveness of Tofacitinib and Adalimumab in Axial Spondyloarthritis: A Real-World Clinical Context Multicenter Study.
Introduction: Tofacitinib, an oral Janus kinase inhibitor, is a putative choice in the treatment of axial spondyloarthritis (AxSpA). The objective of this study was to compare the effectiveness and tolerability of tofacitinib with adalimumab, in AxSpA, in a real-world clinical setting.
Methods: In this multicentric medical records review study, adult patients with active AxSpA treated with either tofacitinib 5 mg twice daily or adalimumab 40 mg subcutaneously fortnightly were recruited. Effectiveness was measured with Ankylosing Spondylitis Disease Activity Score (ASDAS) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Drug-cost analysis was calculated with Incremental Cost-Effectiveness Ratio (ICER drug ).
Results: Among the 266 patients, 135 were treated with tofacitinib and 131 with adalimumab (follow-up: 6.5 ± 1.6 months). Mean improvement of BASDAI (3.39 ± 0.09 vs. 3.14 ± 1.16, respectively) and that of ASDAS (1.78 ± 0.68 vs. 2.07 ± 2.08, respectively) were comparable between the adalimumab and tofacitinib groups. A higher proportion of patients achieved BASDAI50 response in the second (49.5% vs. 31.6%) and fourth month (83.9% vs. 62.8%) and ASDAS low disease activity in the fourth month (71.6% vs. 47.9%) in the adalimumab group. All disease activity measurements were similar by the sixth month in both groups. A higher proportion of patients in the tofacitinib group than in the adalimumab group required change in therapy (14.8% vs. 7.6%, respectively). ICER drug for adalimumab compared with tofacitinib was US $188.8 per patient in the adalimumab group for each person-month with BASDAI <4.
Conclusions: Tofacitinib showed comparable effectiveness with adalimumab in patients with AxSpA at the sixth month, despite lesser response in the initial months, with favorable ICER drug .
期刊介绍:
JCR: Journal of Clinical Rheumatology the peer-reviewed, bimonthly journal that rheumatologists asked for. Each issue contains practical information on patient care in a clinically oriented, easy-to-read format. Our commitment is to timely, relevant coverage of the topics and issues shaping current practice. We pack each issue with original articles, case reports, reviews, brief reports, expert commentary, letters to the editor, and more. This is where you''ll find the answers to tough patient management issues as well as the latest information about technological advances affecting your practice.