Comparison of the efficacy and safety of methotrexate injection and methotrexate tablets in active active rheumatoid arthritis

IF 4.7 2区医学 Q1 RHEUMATOLOGY

Rheumatology Pub Date : 2025-02-07 DOI:10.1093/rheumatology/keaf054

Lin Qiao, Jiankang Hu, Daming Ou, Mixia Liu, Xiaofei Shi, Xiaomei Li, Rui Wu, Liyun Zhang, Yuan Liu, Changhong Xiao, Zili Fu, Jin Lin, Rongsheng Wang, Dongmei Zhou, Jing Yu, JingChun Jin, Shulin Song, Lin Tang, Hongsheng Sun, Yuanyuan Yin, Xiaofeng Zeng

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引用次数: 0

Abstract

Objectives This study aimed to compare the efficacy and safety of subcutaneous methotrexate (SC MTX) and oral MTX (OR MTX) in treating Chinese patients with active rheumatoid arthritis (RA). Methods This study included patients with active RA in China. All patients were randomly assigned to receive SC MTX or OR MTX. The primary end point was Disease Activity Score-28 for erythrocyte sedimentation rate (DAS28-ESR) after 12 weeks of treatment. Results DAS28-ESR scores of the SC MTX and OR MTX groups significantly decreased compared with baseline at week 12. The least squares mean (± standard error) of the change in DAS28-ESR scores were −1.972 ± 0.1448 and −1.800 ± 0.1438 in the SC MTX and OR MTX groups. The intergroup difference was −0.173 ± 0.2041, indicating that the SC MTX group was not inferior to the OR MTX group. With respect to the secondary endpoints of ACR20/50/70, DAS28-CRP, and the proportion of patients in disease remission by DAS28(CRP) but not with DAS28(ESR), SC MTX was numerically better than OR MTX during the first 8 weeks but not all by week 12. The safety profile of SC MTX is similar to that of OR MTX in general, and the incidence, occurrences and Preferred Term types of drug-related TEAE of gastrointestinal system disorders were lower. Conclusions SC MTX had similar overall therapeutic effects compared with OR MTX and was generally well tolerated. Some efficacy results showed greater improvement during the first 8 weeks of SC MTX vs OR MTX but not by week 12. Clinical trial registration https://www.chictr.org.cn, identifier ChiCTR2200066425

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来源期刊

Rheumatology 医学-风湿病学

CiteScore

9.40

自引率

7.30%

发文量

1091

审稿时长

2 months

期刊介绍： Rheumatology strives to support research and discovery by publishing the highest quality original scientific papers with a focus on basic, clinical and translational research. The journal’s subject areas cover a wide range of paediatric and adult rheumatological conditions from an international perspective. It is an official journal of the British Society for Rheumatology, published by Oxford University Press. Rheumatology publishes original articles, reviews, editorials, guidelines, concise reports, meta-analyses, original case reports, clinical vignettes, letters and matters arising from published material. The journal takes pride in serving the global rheumatology community, with a focus on high societal impact in the form of podcasts, videos and extended social media presence, and utilizing metrics such as Altmetric. Keep up to date by following the journal on Twitter @RheumJnl.