Li Biao, Li Haoran, Zhang Li, Zheng Yanlin
Department of Ophthalmology, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.
Front Pharmacol. 2021 Apr 26;12:673984. doi: 10.3389/fphar.2021.673984. eCollection 2021.
Patients with noninfectious uveitis (NIU) are at risk of systemic side effects of long-term glucocorticoid therapy and uncontrolled inflammatory complications. In urgent need to identify more aggressive therapies, adalimumab (ADA) may be the right choice. To summarize the current evidence from randomized controlled trials (RCTs) regarding the efficacy and safety of ADA in the treatment of NIU. We searched Pubmed, Embase, Web of Science, Cochrane Library databases, and Clinical Trials Registry for qualifying articles from their inception to November 19, 2020, with no language restriction. Randomized controlled trials comparing ADA with conventional routine treatment in noninfectious uveitis patients of any age, gender, or ethnicity were included. The primary outcome was the time to treatment failure (TF). The secondary outcomes were the change in best-corrected visual acuity (BCVA), change in the anterior chamber (AC) cell grade, change in vitreous haze (VH) grade, and adverse events (AEs). The six studies comprised 605 participants in all, and the sample size of each study ranged from 16 to 225. The overall pooled results of the primary outcome (HR = 0.51; 95% CI, 0.41 to -0.63) showed that ADA nearly halved the risk of treatment failure compared to placebo for NIU patients. The pooled mean difference of change in BCVA was -0.05 (95% CI, -0.07 to -0.02). The pooled mean difference of change in AC cell grade and VH grade was -0.29 (95% CI, -0.62 to -0.05) and -0.21 (95% CI, -0.32 to -0.11), respectively. The incidence of AEs in the ADA group was numerically higher than that of AEs in the placebo group (2,237 events and 9.40 events per patient-year, equivalent to 1,257 events and 7.79 events per patient-year). This meta-analysis of six RCTs further confirmed that ADA considerably lowered the risk of treatment failure or visual loss, and moderately reduced AC cell grades and VH grades with slightly more AEs, as compared to placebo. ADA is both effective and safe in treating NIU. [https://clinicaltrials.gov], identifier [CRD42020217909].
非感染性葡萄膜炎(NIU)患者面临长期糖皮质激素治疗的全身副作用和炎症并发症控制不佳的风险。迫切需要确定更积极的治疗方法,阿达木单抗(ADA)可能是正确的选择。总结目前来自随机对照试验(RCT)的关于ADA治疗NIU有效性和安全性的证据。我们在PubMed、Embase、Web of Science、Cochrane图书馆数据库和临床试验注册中心搜索了从创立到2020年11月19日符合条件的文章,无语言限制。纳入了比较ADA与常规常规治疗在任何年龄、性别或种族的非感染性葡萄膜炎患者中的随机对照试验。主要结局是治疗失败时间(TF)。次要结局是最佳矫正视力(BCVA)的变化、前房(AC)细胞分级的变化、玻璃体混浊(VH)分级的变化以及不良事件(AE)。这六项研究总共包括605名参与者,每项研究的样本量从16到225不等。主要结局的总体汇总结果(HR = 0.51;95%CI,0.41至 -0.63)表明,与安慰剂相比,ADA使NIU患者治疗失败的风险几乎减半。BCVA变化的合并平均差为-0.05(95%CI,-0.07至-0.02)。AC细胞分级和VH分级变化的合并平均差分别为-0.29(95%CI,-0.62至-0.05)和-0.21(95%CI,-0.32至-0.11)。ADA组不良事件的发生率在数值上高于安慰剂组(每位患者每年2237次事件和9.40次事件,相当于每位患者每年1257次事件和7.79次事件)。这项对六项RCT的荟萃分析进一步证实,与安慰剂相比,ADA显著降低了治疗失败或视力丧失的风险,并适度降低了AC细胞分级和VH分级,但不良事件略多。ADA治疗NIU既有效又安全。[https://clinicaltrials.gov],标识符[CRD42020217909]