Comparative effectiveness of tofacitinib and tumour necrosis factor inhibitors in patients with rheumatoid arthritis in real-world practice: a prospective observational study.

IF 4.7 2区 医学 Q1 RHEUMATOLOGY
Soo-Kyung Cho, Yeo-Jin Song, Hye Won Kim, Eunwoo Nam, Ja-Young Jeon, Hyun-Jeong Yoo, Yoon-Kyoung Sung
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引用次数: 0

Abstract

Objective: The objective of this study was to assess the effectiveness of tofacitinib vs TNF inhibitors (TNFis) in Korean patients with RA.

Methods: The study used data from a single academic referral hospital's registries of biologic DMARDs (bDMARDs) and tofacitinib and examined remission rates based on the DAS28-ESR after 12 months. Multivariable logistic regression analysis was used to estimate the odds ratio (OR) for achieving remission with tofacitinib compared with TNFi, adjusting for potential confounders.

Results: This analysis included 665 patients (200 on tofacitinib and 455 on TNFis) who were followed up for at least 12 months. Of these, 96 patients in the tofacitinib group (48.0%) and 409 patients in the TNFi group (89.9%) were treatment-naïve to bDMARDs. Intention-to-treat analysis revealed no significant difference in the remission rates between the two groups (18.0% vs 19.6%, P = 0.640). Multivariable analysis demonstrated comparable remission rates with tofacitinib and TNFi (OR 1.204, 95% CI 0.720-2.013). In the subpopulation naïve to Janus kinase inhibitors (JAKis) and bDMARDs, tofacitinib showed better remission rates than TNFis (OR 1.867, 95% CI 1.033-3.377). Tofacitinib had more adverse events but similar rates of serious adverse events to TNFis.

Conclusion: In real-world settings, there was no significant difference in remission rates at 12 months between the tofacitinib and TNFi groups. In terms of safety, tofacitinib exhibited a higher incidence of adverse events compared with TNFis, while the occurrence of serious adverse events was comparable between the groups.

Trial registration: ClinicalTrials.gov, https://clinicaltrials.gov, NCT02602704.

类风湿关节炎患者服用托法替尼和肿瘤坏死因子抑制剂在实际应用中的疗效比较:一项前瞻性观察研究。
目的评估托法替尼与肿瘤坏死因子抑制剂(TNFi)对韩国类风湿关节炎(RA)患者的疗效:该研究使用了一家学术转诊医院的生物改善病情抗风湿药(bDMARDs)和托法替尼登记数据,并根据疾病活动评分(DAS)28-红细胞沉降率(ESR)对12个月后的缓解率进行了研究。多变量逻辑回归分析用于估算托法替尼与 TNFi 相比获得缓解的几率比(OR),并对潜在的混杂因素进行了调整:该分析纳入了随访至少12个月的665名患者(200名服用托法替尼,455名服用TNFi)。其中,96名托法替尼组患者(48.0%)和409名TNFi组患者(89.9%)对bDMARDs治疗无效。意向治疗分析显示,两组患者的缓解率无显著差异(18.0% vs 19.6%,P = 0.640)。多变量分析显示,托法替尼和 TNFi 的缓解率相当(OR 1.204,95% 置信区间 [CI] 0.720-2.013)。在未使用 JAKi 和 bDMARD 的亚群中,托法替尼的缓解率高于 TNFi(OR 1.867,95% CI 1.033-3.377)。托法替尼的不良事件(AEs)较多,但严重不良事件(SAEs)发生率与TNFi相似:结论:在真实世界中,托法替尼组和TNFi组在12个月的缓解率上没有显著差异。在安全性方面,托法替尼的AE发生率高于TNFi,而SAE的发生率在两组之间不相上下:临床试验注册:ClinicalTrials.gov,NCT02602704。
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来源期刊
Rheumatology
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.
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