Panchal Viraj, Vyas Bhavya H, Sivasubramanian Barath Prashanth, Panchal Kanan, Patel Harshank
Internal Medicine, Smt Nathiba Hargovandas Lakhmichand Municipal Medical College, Ahmedabad, IND.
Internal Medicine, Employees' State Insurance Corporation Medical College and Post Graduate Institute of Medical Science and Research, Chennai, IND.
Cureus. 2023 Jan 30;15(1):e34384. doi: 10.7759/cureus.34384. eCollection 2023 Jan.
Upadacitinib, an oral () , is used to manage rheumatoid arthritis. The objective was to generate statistical evidence from the existing data for efficacy and safety in various treatment regimens with different dosages in active rheumatoid arthritis patients. We searched PubMed, Cochrane, and ClinicalTrials.gov using PRISMA guidelines, providing data on the efficacy and safety of u versus placebo in rheumatoid arthritis. 20% improvement in the American College of Rheumatology (ACR20) score response at 12 weeks was the primary outcome measure. Safety in adverse events, infections, or hepatic dysfunction was considered. The Mantel-Haenszel formula with random effect was used for the pooled odds ratio (OR) at a 95% confidence interval (CI) for dichotomous data. Meta-analysis was performed using RevMan version 5.4. Statistical heterogeneity was reported using I2 statistics; I2 > 75% was considered significant heterogeneity. A P value of less than 0.05 was considered significant. Data from 3233 patients were included in the analysis. The use of upadacitinib was associated with increased rates of achieving an ACR20 response compared with placebo (pooled OR 3.71; 95% CI 3.26-4.23; p-value <0.00001). Compared to a placebo, a 12 mg twice daily dose had the greatest effect, followed by a 15 mg once daily dose. Compared to the placebo, the incidence of any adverse event (pooled OR 1.66; 95% CI 1.36-2.02; p-value 0.0001) and infection (pooled OR 1.46; 95% CI 1.23-1.74; p-value 0.001) was found to be significantly higher in upadacitinib. Other adverse events, such as hepatic disorders and herpes zoster infections, were not statistically significant (p-value> 0.05). Maximum adverse events were seen at 12 mg twice daily. Upadacitinib, 15 mg once daily in combination with Methotrexate, was the most efficacious treatment regimen and was not associated with a significant risk for treatment-related adverse events in rheumatoid arthritis patients.
乌帕替尼是一种口服（此处原文括号内容缺失）药物，用于治疗类风湿性关节炎。目的是从现有数据中得出统计学证据，以证明其在活动性类风湿性关节炎患者中不同剂量的各种治疗方案的疗效和安全性。我们按照PRISMA指南检索了PubMed、Cochrane和ClinicalTrials.gov，提供了乌帕替尼与安慰剂在类风湿性关节炎中的疗效和安全性数据。12周时美国风湿病学会（ACR20）评分改善20%是主要结局指标。考虑了不良事件、感染或肝功能障碍方面的安全性。对于二分数据，采用具有随机效应的Mantel-Haenszel公式计算合并比值比（OR），95%置信区间（CI）。使用RevMan 5.4版进行荟萃分析。使用I²统计量报告统计异质性；I²>75%被认为具有显著异质性。P值小于0.05被认为具有显著性。3233名患者的数据纳入分析。与安慰剂相比，使用乌帕替尼达到ACR20反应的比例增加（合并OR 3.71；95%CI 3.26 - 4.23；p值<0.00001）。与安慰剂相比，每日两次12毫克剂量效果最佳，其次是每日一次15毫克剂量。与安慰剂相比，乌帕替尼组任何不良事件（合并OR 1.66；95%CI 1.36 - 2.02；p值0.0001）和感染（合并OR 1.46；95%CI 1.23 - 1.74；p值0.001）的发生率显著更高。其他不良事件，如肝脏疾病和带状疱疹感染，无统计学显著性（p值>0.05）。每日两次12毫克时不良事件最多。每日一次15毫克的乌帕替尼与甲氨蝶呤联合使用是最有效的治疗方案，且在类风湿性关节炎患者中与治疗相关不良事件的显著风险无关。
