Methotrexate Maintenance After Initiation of Biological or Targeted Synthetic DMARDs in Rheumatoid Arthritis: Results from the 2-Year Longitudinal Prospective Non-interventional STRATEGE2 Study.
IF 3.1
3区 医学
Q2 RHEUMATOLOGY
引用次数: 0
Abstract
Introduction: The primary objective was to describe the therapeutic approach to methotrexate (MTX) use at the initiation of the first biologic or targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD) in the treatment of rheumatoid arthritis (RA). Secondary objectives included characterising participants initiating b/tsDMARD treatment, examining treatment strategies over time, monitoring disease progression, and identifying factors influencing treatment choices.
Methods: This longitudinal, prospective, non-interventional, multicentre study (STRATEGE2) enrolled adult participants with RA who had been treated with MTX for at least 3 months and required b/tsDMARD treatment due to persistent disease activity. Outcomes were assessed at 12 months (M12) and 24 months (M24) after initiating b/tsDMARD treatment.
Results: At baseline, 173 participants with RA had a mean (SD) disease duration of 5.6 (7.3) years and a mean Disease Activity Score in 28 joints (DAS28) score of 4.3 (1.2). Approximately two-thirds had been on MTX for over a year, with a mean weekly dose of 18.8 (4.2) mg (median 20.0), and 72.3% received it subcutaneously. MTX was continued at the initiation of b/tsDMARD therapy in 97.7% of participants. By M12, 83.2% of participants remained on MTX, with 39.9% (95% CI 32.5-47.6) maintaining the same dosage and route of administration. Discontinuation of MTX was primarily due to participant choice or adverse events. At M24, the mean change in DAS28 score was - 2.0 (1.3), with 66.0% of participants achieving remission. On the basis of European Alliance of Associations for Rheumatology (EULAR) classification criteria, 65.2% had a good response, 19.1% a moderate response, and 15.6% an inadequate response.
Conclusion: The STRATEGE2 study investigators adhered to current clinical guidelines by continuing MTX in combination with b/tsDMARD initiation for the management of RA.
Trial registration: ClinicalTrials.gov: Therapeutic Strategy Associated with bDMARDs or tsDMARDs in Rheumatoid Arthritis and Psoriatic Arthritis (STRATEGE2), NCT05082805.
类风湿关节炎开始使用生物或靶向合成DMARDs后维持甲氨蝶呤：来自2年纵向前瞻性非干预性STRATEGE2研究的结果
简介：主要目的是描述甲氨蝶呤（MTX）在首个生物或靶向合成疾病改善抗风湿药物（b/tsDMARD）开始时用于治疗类风湿性关节炎（RA）的治疗方法。次要目标包括描述开始b/tsDMARD治疗的参与者的特征，随着时间的推移检查治疗策略，监测疾病进展，并确定影响治疗选择的因素。方法：这项纵向、前瞻性、非介入性、多中心研究（STRATEGE2）招募了接受MTX治疗至少3个月且因持续疾病活动而需要b/tsDMARD治疗的成年RA患者。在开始b/tsDMARD治疗后12个月（M12）和24个月（M24）评估结果。结果：在基线时，173名RA患者的平均病程（SD）为5.6（7.3）年，28个关节的平均疾病活动评分（DAS28）为4.3（1.2）。大约三分之二的患者接受MTX治疗超过一年，平均每周剂量为18.8 (4.2)mg（中位20.0），72.3%接受皮下注射。在b/tsDMARD治疗开始时，97.7%的参与者继续使用MTX。到M12时，83.2%的参与者仍在使用MTX，其中39.9% （95% CI 32.5-47.6）保持相同的剂量和给药途径。MTX的停药主要是由于参与者的选择或不良事件。在M24时，DAS28评分的平均变化为- 2.0(1.3)，66.0%的参与者获得缓解。根据欧洲风湿病协会联盟（European Alliance of Associations for Rheumatology， EULAR）的分类标准，65.2%的患者反应良好，19.1%为中度反应，15.6%为不良反应。结论：STRATEGE2研究人员坚持当前的临床指南，继续MTX联合b/tsDMARD起始治疗RA。试验注册：ClinicalTrials.gov: bDMARDs或tsDMARDs治疗类风湿性关节炎和银屑病关节炎的相关治疗策略（STRATEGE2）， NCT05082805。
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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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Rheumatology and Therapy offers a range of additional features designed to increase the visibility, readership and educational value of the journal’s content. Each article is accompanied by key summary points, giving a time-efficient overview of the content to a wide readership. Articles may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand the scientific content and overall implications of the article. The journal also provides the option to include various types of digital features including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations. All additional features are peer reviewed to the same high standard as the article itself. If you consider that your paper would benefit from the inclusion of a digital feature, please let us know. Our editorial team are able to create high-quality slide decks and infographics in-house, and video abstracts through our partner Research Square, and would be happy to assist in any way we can. For further information about digital features, please contact the journal editor (see ‘Contact the Journal’ for email address), and see the ‘Guidelines for digital features and plain language summaries’ document under ‘Submission guidelines’.
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