Department of Pharmacology, The First People's Hospital of Shuangliu District, West China (Airport) Hospital of Sichuan University, Chengdu, Sichuan, China.
Department of TCM Pharmacy, Chengdu Integrated TCM and Western Medicine Hospital, Chengdu, Sichuan, China.
PLoS One. 2024 Jul 26;19(7):e0306463. doi: 10.1371/journal.pone.0306463. eCollection 2024.
To evaluate the efficacy and safety of upadacitinib in the treatment of moderate-to-severe atopic dermatitis (AD), and provide reference for rational clinical medication.
PubMed, Medline, Embase, Web of Science, Clinical Trials Website, and Cochrane Library databases were searched from the time of establishment until January 6, 2024, to compile a list of all randomized controlled trials (RCTs) including upadacitinib in the treatment of moderate-to-severe AD. The quality of the included studies was evaluated using the Cochrane Systematic Review. Review Manager 5.3 software was utilized for statistical analysis of outcome measures.
A total of five studies were included in the meta-analysis. The results revealed that the 15 mg and 30 mg upadacitinib significantly improved Eczema Area and Severity Index (EASI) 75% {[Odds Ratio (OR) = 8.58, 95% confidence interval (CI) (5.84-12.60), P < 0.00001] [OR = 15.62, 95% CI (10.89-22.42), P < 0.00001]}, Numerical Rating Scale (NRS) ≥ 4 {[OR = 7.13, 95% CI (5.63-9.01), P < 0.00001] [OR = 11.30, 95% CI (8.93-14.31), P < 0.00001]}, and Investigator's Global Assessment (IGA) 0/1 {[OR = 8.63, 95% CI (6.60-11.27), P < 0.00001] [OR = 16.04, 95% CI (12.26-20.99), P < 0.00001]} compared to placebo. In terms of safety, although 15 mg and 30 mg upadacitinib significantly increased the overall adverse events rate compared to placebo {[OR = 1.31, 95% CI (1.09-1.58), P = 0.004] [OR = 1.85, 95% CI (1.54-2.21), P < 0.00001]}, there was no significant difference in the serious adverse events rate {[OR = 0.73, 95% CI (0.41-1.29), P = 0.28] [OR = 0.69, 95% CI (0.39-1.23), P = 0.21]} and withdrawal rate due to adverse events {[OR = 0.66, 95% CI (0.39-1.11), P = 0.12] [OR = 0.85, 95% CI (0.52-1.38), P = 0.50]} compared to placebo.
This meta-analysis preliminarily suggests that upadacitinib is effective and safe for usage in the treatment of moderate-to-severe AD. Additionally, upadacitinib can instantly relieve itchiness and effectively reduce symptoms and signs, with its 30-mg dose being more effective than the 15-mg dose.
评估 upadacitinib 治疗中重度特应性皮炎（AD）的疗效和安全性，为合理临床用药提供参考。
检索 PubMed、Medline、Embase、Web of Science、ClinicalTrials.gov 及 Cochrane 图书馆数据库，自建库至 2024 年 1 月 6 日，纳入 upadacitinib 治疗中重度 AD 的随机对照试验（RCT），采用 Cochrane 系统评价手册评价纳入研究的质量，使用 Review Manager 5.3 软件对结局指标进行统计学分析。
共纳入 5 项研究进行荟萃分析。结果显示，15mg 和 30mg upadacitinib 可显著改善 Eczema Area and Severity Index（EASI）75%[优势比（OR）=8.58，95%置信区间（CI）（5.84-12.60），P＜0.00001][OR=15.62，95%CI（10.89-22.42），P＜0.00001]、Numeric Rating Scale（NRS）≥4[OR=7.13，95%CI（5.63-9.01），P＜0.00001][OR=11.30，95%CI（8.93-14.31），P＜0.00001]和 Investigator's Global Assessment（IGA）0/1[OR=8.63，95%CI（6.60-11.27），P＜0.00001][OR=16.04，95%CI（12.26-20.99），P＜0.00001]，与安慰剂相比。安全性方面，15mg 和 30mg upadacitinib 组的总体不良反应发生率明显高于安慰剂组[OR=1.31，95%CI（1.09-1.58），P=0.004][OR=1.85，95%CI（1.54-2.21），P＜0.00001]，但严重不良反应发生率[OR=0.73，95%CI（0.41-1.29），P=0.28][OR=0.69，95%CI（0.39-1.23），P=0.21]和因不良反应停药率[OR=0.66，95%CI（0.39-1.11），P=0.12][OR=0.85，95%CI（0.52-1.38），P=0.50]与安慰剂相比，差异无统计学意义。
该荟萃分析初步提示，upadacitinib 治疗中重度 AD 有效且安全，可即刻缓解瘙痒，有效改善症状和体征，且 30mg 剂量的疗效优于 15mg 剂量。
