Ejaz Samrah, Gurugubelli Simhachalam, Prathi Suviksh K, Palou Martinez Yaneisi, Arrey Agbor Divine Besong, Panday Priyanka, Yu Ann Kashmer
Internal Medicine, California Institute of Behavioral Neurosciences and Psychology, Fairfield, USA.
Internal Medicine, Memorial Healthcare, Gulfport, USA.
Cureus. 2024 Apr 12;16(4):e58112. doi: 10.7759/cureus.58112. eCollection 2024 Apr.
Etanercept (ETN) is a disease-modifying anti-rheumatic drug (DMARD) used in the treatment of rheumatoid arthritis (RA) that works as a tumor necrosis factor inhibitor (TNF inhibitor) by blocking the effects of naturally occurring TNF. This review will evaluate the effect of ETN as a monotherapy or combination therapy with methotrexate (MTX) in the treatment of RA. This systematic review was carried out in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) 2020 guidelines. A systematic search was done on PubMed and Google Scholar from 1999 to 2023. Predefined eligibility criteria were set for selected studies, which include: free full-text articles published; randomized control trials (RCTs); systematic reviews and meta-analyses; and observational studies in a patient with RA treated with ETN as initial therapy or as an add-on to conventional disease-modified therapy. Hence, the data had been extracted, and a quality assessment of each study was done by two individual authors. When comparing patients who received 15-25 mg of MTX with those who also received 25 mg of ETN in combination, 71% achieved American College of Rheumatology 20 (ACR20) by 24 weeks, compared to 27% in the MTX and placebo groups (p<0.001), and 39% achieved American College of Rheumatology 50 (ACR50), compared to 3% in the placebo + MTX group (p<0.001). Low disease activity (DAS 28) was more common in patients who had both MTX and ETN (64.5% with DAS <2.4 and 56.3% with DAS 28 <3.2) compared to patients who received only one medication (44.4% with DAS <2.4 and 33.2% with DAS 28 <3.2 for ETN and 38.6% with DAS <2.4 and 28.5% with DAS 28 <3.2 for MTX, with P<0.01). ETN demonstrated smaller changes from baseline in the modified Sharp score (TSS) and erosion scores (ES) at 12 months and two years, as well as a decreased change in the ES score at one year (with a trend of P value = 0.06 for the TSS score), in comparison to those receiving DMARD. Reactions at the injection site (42% vs. 7%, P<0.001) were the only events that occurred significantly more frequently in the ETN plus-MTX group. Combining ETN and MTX appears to help control RA symptoms by decreasing the American College of Rheumatology (ACR) response and DAS score, as well as halting the disease's progression on X-rays. The most common adverse effects were reactions to ETN administered alone at the injection site, likely because of patient awareness of the treatment received. There was also concern about tuberculosis and malignancy, but no recent data is available. Therefore, a larger clinical trial with longer follow-up is required to ascertain long-term safety and benefits.
依那西普（ETN）是一种用于治疗类风湿关节炎（RA）的改善病情抗风湿药（DMARD），它通过阻断天然存在的肿瘤坏死因子（TNF）的作用，作为一种肿瘤坏死因子抑制剂（TNF抑制剂）发挥作用。本综述将评估ETN作为单一疗法或与甲氨蝶呤（MTX）联合疗法治疗RA的效果。本系统评价按照系统评价与Meta分析的首选报告项目（PRISMA）2020指南进行。对1999年至2023年期间的PubMed和谷歌学术进行了系统检索。为入选研究设定了预定义的纳入标准，包括：已发表的免费全文文章；随机对照试验（RCT）；系统评价和Meta分析；以及以ETN作为初始治疗或作为传统改善病情治疗的附加治疗的RA患者的观察性研究。因此，已提取数据，并由两位独立作者对每项研究进行了质量评估。将接受15 - 25mg MTX的患者与同时接受25mg ETN联合治疗的患者进行比较时，71%的患者在24周时达到美国风湿病学会20%改善标准（ACR20），而MTX和安慰剂组为27%（p<0.001）；39%的患者达到美国风湿病学会50%改善标准（ACR50），而安慰剂 + MTX组为3%（p<0.001）。与仅接受一种药物治疗的患者相比，同时使用MTX和ETN的患者低疾病活动度（DAS28）更为常见（DAS<2.4的患者中，ETN组为44.4%，MTX组为38.6%；DAS28<3.2的患者中，ETN组为56.3%，MTX组为28.5%，P<0.01）。与接受DMARD的患者相比，ETN在12个月和2年时改良夏普评分（TSS）和侵蚀评分（ES）从基线的变化较小，并且在1年时ES评分的变化也有所减少（TSS评分P值趋势为0.06）。注射部位反应（42%对7%，P<0.001）是ETN加MTX组中唯一显著更频繁发生的事件。联合使用ETN和MTX似乎有助于通过降低美国风湿病学会（ACR）反应和DAS评分以及阻止疾病在X射线上的进展来控制RA症状。最常见的不良反应是单独使用ETN时注射部位的反应，可能是因为患者知晓所接受的治疗。也有人担心结核病和恶性肿瘤，但目前没有最新数据。因此，需要进行一项随访时间更长的更大规模临床试验，以确定长期安全性和益处。
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