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白介素-13 抑制剂在特应性皮炎中的疗效和安全性:系统评价和荟萃分析。

The efficacy and safety of IL-13 inhibitors in atopic dermatitis: A systematic review and meta-analysis.

机构信息

Department of Respiratory Medicine, Xiangya Hospital, Central South University, Changsha, China.

Department of Dermatology, Xiangya Hospital, Central South University, Changsha, China.

出版信息

Front Immunol. 2022 Jul 27;13:923362. doi: 10.3389/fimmu.2022.923362. eCollection 2022.

Abstract

BACKGROUND

Several clinical trials have evaluated the efficacy and safety of interleukin-13 (IL-13) with lebrikizumab and tralokinumab in patients with moderate to severe atopic dermatitis (AD). However, the safety and efficacy of IL-13 inhibitors as a potent biologic for AD remain elusive.

OBJECTIVE

To assess the efficacy and safety of IL-13 inhibitors in moderate to severe AD.

METHOD

Randomized clinical trials (RCTs), comparing IL-13 inhibitors vs placebo treatment in patients with moderate to severe AD, were identified from public database from its inception to November 9, 2021. The study was registered in PROSPERO (CRD42021254920).

RESULTS

Six studies reporting 7 RCTs involving 2946 patients with moderate-to-severe AD were included for the pooled analysis. Compared with placebo, antagonizing IL-13 with lebrikizumab and tralokinumab showed a greater improvement in percentage change of EASI (MD -20.37, 95%CI -32.28, -8.47), and a larger proportion of patients achieving numerical rating scale (NRS) with more than 4-points improvement (RR 1.59, 95%CI 1.23, 2.05). Additionally, IL-13 inhibitors also improved impaired dermatology life quality index (DLQI) (MD -14.49, 95%CI -19.23, -9.75). In terms of safety, both lebrikizumab and tralokinumab were well tolerated, with the except that they were linked to an increased risk of conjunctivitis compared to placebo treatment.

CONCLUSION

Antagonizing IL-13 with lebrikizumab and tralokinumab have demonstrated encouraging clinical efficacy against moderate-to-severe AD with excellent safety profile, albeit they did come with a higher risk of conjunctivitis than placebo treatment.

SYSTEMATIC REVIEW REGISTRATION

https://www.crd.york.ac.uk/prospero/, identifier ID=CRD42021254920.

摘要

背景

多项临床试验评估了白细胞介素-13(IL-13)联合 lebrikizumab 和 tralokinumab 治疗中重度特应性皮炎(AD)的疗效和安全性。然而,IL-13 抑制剂作为 AD 的强效生物制剂的安全性和疗效仍不清楚。

目的

评估 IL-13 抑制剂在中重度 AD 中的疗效和安全性。

方法

从公共数据库中检索自成立至 2021 年 11 月 9 日比较 IL-13 抑制剂与安慰剂治疗中重度 AD 患者的随机临床试验(RCT)。研究在 PROSPERO(CRD42021254920)注册。

结果

纳入 7 项 RCT 共 2946 例中重度 AD 患者的 6 项研究进行汇总分析。与安慰剂相比,拮抗 IL-13 的 lebrikizumab 和 tralokinumab 治疗可显著改善 EASI 的百分比变化(MD-20.37,95%CI-32.28,-8.47),且有更大比例的患者达到 NRS 改善 4 分以上(RR 1.59,95%CI 1.23,2.05)。此外,IL-13 抑制剂还可改善受损的皮肤病生活质量指数(DLQI)(MD-14.49,95%CI-19.23,-9.75)。安全性方面,lebrikizumab 和 tralokinumab 均具有良好的耐受性,但与安慰剂相比,它们与结膜炎风险增加相关。

结论

拮抗 IL-13 的 lebrikizumab 和 tralokinumab 治疗中重度 AD 具有令人鼓舞的临床疗效,且安全性良好,但与安慰剂相比,结膜炎风险更高。

系统评价注册

https://www.crd.york.ac.uk/prospero/,标识符 ID=CRD42021254920。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/92dd/9364267/e9877887a680/fimmu-13-923362-g001.jpg

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