巴西替尼治疗西班牙类风湿关节炎的真实证据:系统文献综述。

IF 3.4 3区 医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL
José Rosas, Joaquín Belzunegui, Blanca Hernández-Cruz, Itxaso Aguirregabiria, Sebastián Moyano, Amelia Cobo, Silvia Díaz-Cerezo
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引用次数: 0

摘要

Baricitinib是一种Janus激酶抑制剂,被批准用于治疗对改善疾病的抗风湿药物(DMARDs)反应不充分或不耐受的成人中度至重度类风湿性关节炎(RA)。本系统的文献综述是为了了解在西班牙现实环境中baricitinib在RA中的使用。方法:系统检索Embase和MEDLINE数据库2017年3月至2023年6月发表的文献(英文或西班牙文);还获得了西班牙在全国风湿病大会上提交的数据,其日期限制为2021-2023。结果:19篇符合条件的出版物(5篇论文全文,14篇会议摘要),包括1000多名接受baricitinib治疗RA的西班牙患者。患者多为老年女性,病程长,有中重度活动性疾病。研究包括生物dmard患者和DMARD-naïve患者,大多数患者接受巴西替尼4mg /天。Baricitinib的持续时间从6到48个月不等,无效(原发性或继发性)是最常见的停药原因。Baricitinib在所有结果测量(RA的疾病活动性评分为28分,简化和临床疾病活动性指数,肿胀和压痛关节计数以及患者报告的结果)中均显示出降低疾病活动性的效果。13项研究报告了安全性结果,不良事件导致的停药率从9.5%到20%不等。在这些研究中,令人感兴趣的不良事件包括11例带状疱疹,6例严重感染,2例主要不良心血管事件和3例恶性肿瘤。结论:这些结果表明baricitinib在西班牙的实际环境中是有效的,具有一致的安全性,类似于在其他国家进行的临床研究和实际研究报告的结果。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Real-World Evidence for Baricitinib in the Treatment of Rheumatoid Arthritis in Spain: A Systematic Literature Review

Introduction

Baricitinib is a Janus kinase inhibitor approved for the treatment of moderate-to-severe rheumatoid arthritis (RA) in adults who have responded inadequately, or are intolerant, to disease-modifying antirheumatic drugs (DMARDs). This systematic literature review was conducted to understand the use of baricitinib in RA in the real-world setting in Spain.

Methods

Embase and MEDLINE databases were systematically searched for publications (in English or Spanish) published between March 2017 and June 2023; Spanish data presented at national rheumatology congresses were also obtained, with a date limitation of 2021–2023.

Results

Nineteen eligible publications were identified (5 full papers, 14 conference abstracts), including more than 1000 patients who received baricitinib for RA in Spain. Most patients were older and female with long disease duration, and moderate-to-severe active disease. Studies included both biologic DMARD-experienced and DMARD-naïve patients, and most patients received baricitinib 4 mg/day. Baricitinib persistence ranged from 6 to 48 months, with ineffectiveness (primary or secondary) being the most frequently reported reason for discontinuation. Baricitinib was consistently shown to decrease disease activity, across all outcome measures (Disease Activity Score-28 for RA, the Simplified and Clinical Disease Activity Indexes, swollen and tender joint counts and patient-reported outcomes). Thirteen studies reported safety outcomes, with discontinuation rates due to adverse events ranging from 9.5 to 20%. Across these studies, adverse events of interest included eleven cases of herpes zoster, six serious infections, two major adverse cardiovascular events, and three malignant neoplasms.

Conclusion

These results suggest baricitinib is effective in the real-world setting in Spain, with a consistent safety profile, similar to findings reported in clinical studies and in real-world studies conducted in other countries.

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来源期刊
Advances in Therapy
Advances in Therapy 医学-药学
CiteScore
7.20
自引率
2.60%
发文量
353
审稿时长
6-12 weeks
期刊介绍: Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) 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 therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in 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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