在持续缓解的类风湿关节炎患者中逐渐减少生物改善病情抗风湿药物的疗效和安全性：一项非劣效性随机、对照、单盲试验的研究方案。

Efficacy and safety of progressively reducing biologic disease-modifying antirheumatic drugs in patients with rheumatoid arthritis in persistent remission: a study protocol for a non-inferiority randomized, controlled, single-blind trial.

机构信息

Department of Rheumatology, Gansu Provincial People's Hospital, 204 Donggang West Road, Lanzhou, 730000, People's Republic of China.

Department of Thoracic surgery, Gansu Provincial People's Hospital, Lanzhou, 730000, People's Republic of China.

出版信息

Trials. 2022 Jul 27;23(1):600. doi: 10.1186/s13063-022-06543-y.

DOI:10.1186/s13063-022-06543-y

PMID:35897052

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9327307/

Abstract

BACKGROUND

To compare the effects of two biologic disease-modifying antirheumatic drug (bDMARD) administration strategies on the maintenance effect and safety of patients with rheumatoid arthritis (RA) in remission, to analyze the effects of gradual drug reduction and dose maintenance treatment on clinical outcomes in patients who have achieved remission with different types of bDMARDs, to search and screen out people who may benefit from drug reduction strategies, and to provide references for drug reduction strategies and treatment options for patients with RA in remission, so as to help improve the safety of the treatment and reduce the economic burden.

METHODS

The study will be a 24-month non-inferiority randomized, controlled, single-blind trial and is planned to be launched in our hospital from September 2021 to August 2023. Patients will be randomized in a ratio of 2:1 to two groups: maintenance or injection spacing by 50%/gradual reduction of dosage every 3 months up to complete stop. When the patient relapses, return to the last effective dose. If the remission can be maintained, the medication of bDMARDs can be stopped 9 months after enrollment. The primary outcome will be the persistent flare rate.

DISCUSSION

Our study may provide a reference for the selection of drug reduction strategies and treatment options for patients with RA in remission, so as to help improve the safety of the treatment and reduce the economic burden.

TRIAL REGISTRATION

Chinese Clinical Trial Registry ChiCTR2100044751. Registered on 26 March 2021.

摘要

背景

比较两种生物性疾病修饰抗风湿药物（bDMARD）给药策略对缓解期类风湿关节炎（RA）患者维持效果和安全性的影响，分析不同类型 bDMARD 达到缓解的患者逐渐减少药物剂量和维持治疗对临床结局的影响，筛选出可能从减药策略中获益的人群，为缓解期 RA 患者的减药策略和治疗选择提供参考，有助于提高治疗安全性，减轻经济负担。

方法

该研究将是一项 24 个月的非劣效性随机、对照、单盲试验，计划于 2021 年 9 月至 2023 年 8 月在我院开展。患者将按照 2:1 的比例随机分为两组：维持组或注射间隔延长 50%/每 3 个月逐渐减少剂量至完全停药。当患者复发时，恢复至最后一次有效剂量。如果能够维持缓解，则在入组后 9 个月停止 bDMARD 治疗。主要结局将是持续复发率。