Department of Pharmacology, The First People's Hospital of Shuangliu District, West China (Airport) Hospital of Sichuan University, Chengdu, China.
Medicine (Baltimore). 2023 Aug 4;102(31):e34516. doi: 10.1097/MD.0000000000034516.
To assess the efficacy and safety of Tralokinumab in the treatment of moderate-to-severe atopic dermatitis (AD).
PubMed, Embase, Clinical Trials Website, and Cochrane Library were systematically searched for eligible randomized controlled trials which assessed the effects of Tralokinumab on AD. Primary outcomes included Scoring Atopic Dermatitis score, EASI-75%, and Investigator's Global Assessment score of 0 or 1 in 12 to 16 weeks. Secondary outcomes included the Eczema area and severity index score, the Numeric Rating Scales score, the dermatology life quality index score, and the overall incidence of adverse events. The quality of included studies was evaluated using the Cochrane System and the modified Jadad scale. Analysis was performed using Stata 16 software.
Eight randomized controlled trials involving 2878 patients were included in this meta-analysis. Compared to placebo, Tralokinumab treatment exhibited a significantly higher Scoring Atopic Dermatitis score [SMD = -0.53, 95% confidence intervals [CI]: -0.62 to -0.44, P < .00001], an increased number of patients with EASI-75% [odds ratio (OR) = 2.44, 95% CI: 2.00-2.97, P < .00001] and Investigator's Global Assessment score of 0 or 1 in 12 to 16 weeks [OR = 2.12, 95% CI: 1.71-2.63, P < .00001]. No significant difference was observed in the incidence of overall adverse events [OR = 1.00, 95% CI: 0.85-1.18, P = 1.00] between the 2 groups.
Tralokinumab is effective and safe in treatment of moderate-to-severe AD.
评估特利鲁单抗治疗中重度特应性皮炎(AD)的疗效和安全性。
系统检索 PubMed、Embase、临床试验网站和 Cochrane 图书馆中评估特利鲁单抗治疗 AD 效果的合格随机对照试验。主要结局包括 12-16 周时 Scoring Atopic Dermatitis 评分、EASI-75%、研究者全球评估评分 0 或 1。次要结局包括湿疹面积和严重程度指数评分、数字评分量表评分、皮肤病生活质量指数评分和不良事件总发生率。使用 Cochrane 系统和改良 Jadad 量表评价纳入研究的质量。采用 Stata 16 软件进行分析。
纳入的 8 项随机对照试验共纳入 2878 例患者。与安慰剂相比,特利鲁单抗治疗后 Scoring Atopic Dermatitis 评分明显更高[SMD=-0.53,95%置信区间(CI):-0.62 至-0.44,P<0.00001],EASI-75%患者比例[比值比(OR)=2.44,95%CI:2.00-2.97,P<0.00001]和研究者全球评估评分在 12-16 周时为 0 或 1 的患者比例[OR=2.12,95%CI:1.71-2.63,P<0.00001]均增加。两组间不良事件总发生率[OR=1.00,95%CI:0.85-1.18,P=1.00]无显著差异。
特利鲁单抗治疗中重度 AD 有效且安全。