多中心观察性研究：选择性 Janus 激酶-1 抑制剂 upatacitinib 在类风湿关节炎中的疗效。

Multicenter observational study on the efficacy of selective Janus Kinase-1 inhibitor upatacitinib in rheumatoid arthritis.

机构信息

Rheumatology Unit, ARNAS Garibaldi, Catania, Italy -

Rheumatology Department, A.O.U. Città della Salute e della Scienza, Turin, Italy.

出版信息

Minerva Med. 2024 Aug;115(4):430-438. doi: 10.23736/S0026-4806.24.09409-6.

DOI:10.23736/S0026-4806.24.09409-6

PMID:39376099

Abstract

BACKGROUND

Upadacitinib (UPA) is a selective, reversible Janus kinase inhibitor (JAKi) approved for the treatment of RA. However, there is still no solid evidence on the long-term efficacy of UPA in treated patients. The purpose of this study was to determine the efficacy of UPA to obtain remission or low disease activity (LDA) in a series of UPA patients in patients with RA after 6 and 12 months of treatment in a real-world setting.

METHODS

A series of 111 consecutive patients treated with UPA in 23 rheumatology centers were enrolled. Personal history, treatment history and disease activity at baseline, after 6 and 12 months were recorded. Intention-to-treat (ITT) and per-protocol (PP) analyses assessed achievement of remission or LDA or defined as DAS28 <2.6 and ≤3.2, respectively. Logistic regression analysis examined the role of several independent factors on the reduction of disease activity after 6 months of treatment.

RESULTS

Of the initial group of 111 subjects at baseline, 86 and 29 participants completed clinical assessments at 6 and 12 months. According to ITT analysis, the rates of remission and LDA were 18% and 18% at 6 months and 31.5% and 12.5% at 12 months, respectively. PP analysis showed higher rates of remission and LDA at 6 (23.3% and 19.8%) and 12 months (55.2% and 20.7%). Results of multivariate logistic regression analysis indicated that a low DAS28 score (P=0.045) was the only predictor of achieving remission at 6 months. None of the baseline factors predicted remission/LDA at 6 months.

CONCLUSIONS

RA patients treated with UPA achieved a significant rate of disease remission or LDA in a real-world setting. The 6-month response was found to depend only on the baseline value of DAS28, while it was not influenced by other factors such as disease duration, line of treatment or concomitant therapy with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or corticosteroids.

摘要

背景

Upadacitinib（UPA）是一种选择性、可逆的 Janus 激酶抑制剂（JAKi），已被批准用于治疗类风湿关节炎（RA）。然而，目前仍缺乏 UP 治疗 RA 患者长期疗效的确凿证据。本研究旨在确定 UP 在真实环境中治疗 6 个月和 12 个月后 RA 患者获得缓解或低疾病活动度（LDA）的疗效。

方法

纳入了 23 个风湿病中心的 111 例连续接受 UP 治疗的患者。记录个人史、治疗史和基线、治疗 6 个月和 12 个月时的疾病活动度。意向治疗（ITT）和符合方案（PP）分析分别评估 DAS28<2.6 和≤3.2 时缓解或 LDA 的达标率。Logistic 回归分析检查了 6 个月治疗后疾病活动度降低的几个独立因素的作用。

结果

在基线时的 111 例初始患者中，86 例和 29 例分别完成了 6 个月和 12 个月的临床评估。根据 ITT 分析，6 个月时缓解和 LDA 的发生率分别为 18%和 18%，12 个月时分别为 31.5%和 12.5%。PP 分析显示，6 个月时缓解和 LDA 的比例较高（23.3%和 19.8%），12 个月时缓解和 LDA 的比例较高（55.2%和 20.7%）。多变量 logistic 回归分析结果表明，DAS28 评分低（P=0.045）是 6 个月时达到缓解的唯一预测因素。基线时的任何因素均不能预测 6 个月时的缓解/LDA。