改善接受托法替尼治疗的强直性脊柱炎患者的疲劳状况：3期随机对照试验分析》。
IF 2.9
3区 医学
Q2 RHEUMATOLOGY
引用次数: 0
摘要
简介：疲劳是强直性脊柱炎（AS）患者的主要症状：疲劳是强直性脊柱炎（AS）患者的一个主要症状。本分析的目的是估算接受托法替尼治疗的强直性脊柱炎患者的疲劳症状得到初步改善和稳定改善的中位时间：这项事后分析采用了一项3期试验（NCT03502616）的数据，活动性强直性脊柱炎患者接受托法替尼5毫克，每天两次或安慰剂治疗。采用慢性疾病治疗功能评估-疲劳（FACIT-F）总分、体验域得分和影响域得分评估疲劳改善的时间。通过时间到事件分析（非参数 Kaplan-Meier 模型）评估改善的速度；研究了初始改善事件（即 FACIT-F 改善第一周的时间）和稳定改善事件（即 FACIT-F 改善第一周的时间，持续 16 周）：结果：共对 269 名患者进行了评估（平均病程为 14.2 天[标准差（standard deviation）]）：平均基线 FACIT-F 总分：27.2 [SD: 9.3]）。与安慰剂相比，接受托法替尼治疗的患者FACIT-F总分和领域得分的初始改善和稳定改善的中位时间明显更短。服用托法替尼后，FACIT-F总分达到6分的初始和稳定改善事件的中位时间分别为8周和12周（安慰剂：未达到）；分别有70.0%和48.5%服用托法替尼和安慰剂的患者在16周内FACIT-F总分达到6分：结论：与安慰剂相比，托法替尼能更快地改善患者的疲劳状况。这些结果可能有助于医疗服务提供者与患者讨论对托法替尼治疗的期望：试验注册：ClinicalTrials.gov：NCT03502616（2018年6月7日）。本文章由计算机程序翻译，如有差异，请以英文原文为准。
Improvement of Fatigue in Patients with Ankylosing Spondylitis Receiving Tofacitinib: Analyses of a Phase 3 Randomized Controlled Trial.
Introduction: Fatigue is a key symptom in patients with ankylosing spondylitis (AS). The objective of this analysis was to estimate the median time to initial and stable improvement events in fatigue in patients with AS receiving tofacitinib.
Methods: This post hoc analysis used data from a phase 3 trial (NCT03502616) in patients with active AS receiving tofacitinib 5 mg twice daily or placebo. Time to improvement in fatigue was assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) total score, experience domain score, and impact domain score. The rapidity of improvement was assessed by time-to-event analyses (nonparametric Kaplan-Meier models); initial improvement events (i.e., time to first week of FACIT-F improvement) and stable improvement events (i.e., time to first week of FACIT-F improvement, sustained to 16 weeks) were examined.
Results: Overall, 269 patients were assessed (mean disease duration: 14.2 [standard deviation (SD): 9.8] years; mean baseline FACIT-F total score: 27.2 [SD: 9.3]). Median times to initial and stable improvement events in FACIT-F total and domain scores were significantly shorter and occurred in more patients receiving tofacitinib than placebo. Median time to initial and stable improvement events of 6 points in FACIT-F total score were 8 and 12 weeks with tofacitinib, respectively (placebo: not reached); 70.0% versus 48.5% of patients receiving tofacitinib versus placebo, respectively, experienced initial improvements of 6 points in FACIT-F total score within 16 weeks.
Conclusions: Improvements in fatigue occurred more rapidly with tofacitinib than with placebo. These results may be useful for healthcare providers when discussing tofacitinib treatment expectations with patients.
Trial registration: ClinicalTrials.gov: NCT03502616 (June 7, 2018).
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来源期刊
Rheumatology and Therapy
RHEUMATOLOGY-
CiteScore
6.00
自引率
5.30%
发文量
91
审稿时长
6 weeks
期刊介绍：
Aims and Scope
Rheumatology and Therapy is an international, open access, peer reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world and health outcomes research around the discovery, development, and use of rheumatologic therapies. Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also welcomed.
Areas of focus include, but are not limited to, rheumatoid arthritis, gout, gouty arthritis, psoriatic arthritis, osteoarthritis, juvenile idiopathic/rheumatoid arthritis, systemic lupus erythematosus, axial spondyloarthritis, Pompe’s disease, inflammatory joint conditions, musculoskeletal conditions, systemic sclerosis, and fibromyalgia.
The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, case reports, trial protocols, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Rheumatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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The journal is a member of the Committee on Publication Ethics (COPE) and subscribes to its principles on how to deal with acts of misconduct thereby committing to investigate allegations of misconduct in order to ensure the integrity of research. Content in this journal is peer-reviewed (Single-blind). For more information on our publishing ethics policies, please see here: https://www.springer.com/gp/editorial-policies
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The journal’s rapid publication timelines aim for a peer review decision within 2 weeks of submission. If an article is accepted it will be published online 3-4 weeks from acceptance. These rapid timelines are achieved through the combination of a dedicated in-house editorial team, who closely manage article workflow, and an extensive Editorial and Advisory Board who assist with rapid peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model this allows for the rapid and efficient communication of the latest research and reviews, allowing the advancement of rheumatologic therapies.
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The journal’s dedicated in-house editorial team offer a personal “concierge service” meaning that authors will always have a personal point of contact able to update them on the status of their manuscript. The editorial team check all manuscripts to ensure that articles conform to the most recent COPE, GPP and ICMJE publishing guidelines. This supports the publication of ethically sound and transparent research. We also encourage pre-submission enquiries and are always happy to provide a confidential assessment of manuscripts.
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