Efficacy and safety of intravenous immunoglobulin therapy in systemic sclerosis: a systematic review.

IF 3.2 3区医学 Q2 RHEUMATOLOGY Rheumatology International Pub Date : 2024-11-01 Epub Date: 2024-05-15 DOI:10.1007/s00296-024-05613-5

Sandra Garrote-Corral, Diana Botello Corzo, Jesús Loarce-Martos, Carlos de la Puente Bujidos, Loreto Carmona

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Abstract

Background and objective: Systemic sclerosis (SSc) is a highly heterogeneous disease whose treatment is based mainly on immunosuppressants, antifibrotics, and vasodilators. Intravenous immunoglobulin (IVIG) have proved effective in other autoimmune diseases. The objective of this study is to evaluate the efficacy and safety of IVIG in SSc.

Methods: The systematic review was conducted according to the PRISMA Statement. Medline, Embase and Cochrane Library databases were searched until March 2024. We assessed the quality of included studies using the Cochrane Risk of Bias 2.0 tool (RoB 2) for randomised clinical trials and the Cochrane Risk in non-randomized studies (ROBINS-I) tool for observational studies.

Results: From 1242 studies identified, 15 studies were included, of which 14 were observational studies. In total, 361 patients with SSc were included, and 295 received treatment with IVIG. Most of the studies used a dose of 2 g/kg IVIG. Ten studies, including the clinical trial, showed high risk of bias, and five had a critical risk. Skin involvement was assessed using modified Rodnan skin score, in 11 studies and the authors reported cutaneous efficacy in 9 of them. The 6 studies that assessed muscle involvement reported an improvement. Six studies reported data on gastrointestinal efficacy. Other domains such as lung and joint involvement and steroid-sparing effect were evaluated. The most frequent adverse events were mild, including headache, abdominal pain, fever, and skin rash.

Conclusion: Treatment with IVIG in SSc patients could be helpful and safe in patients with cutaneous, muscular, or digestive manifestations.

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静脉注射免疫球蛋白治疗系统性硬化症的有效性和安全性：系统性综述。

背景和目的：系统性硬化症（SSc）是一种高度异质性疾病，其治疗主要依靠免疫抑制剂、抗纤维化药物和血管扩张剂。静脉注射免疫球蛋白（IVIG）已被证明对其他自身免疫性疾病有效。本研究旨在评估 IVIG 对 SSc 的疗效和安全性：方法：根据 PRISMA 声明进行系统综述。对 Medline、Embase 和 Cochrane Library 数据库进行了检索，直至 2024 年 3 月。对于随机临床试验，我们使用 Cochrane Risk of Bias 2.0 工具（RoB 2）评估了纳入研究的质量；对于观察性研究，我们使用 Cochrane Risk in non-randomized studies (ROBINS-I) 工具评估了纳入研究的质量：在确定的 1242 项研究中，纳入了 15 项研究，其中 14 项为观察性研究。共纳入 361 名 SSc 患者，其中 295 人接受了 IVIG 治疗。大多数研究使用的 IVIG 剂量为 2 克/千克。包括临床试验在内的十项研究显示存在高偏倚风险，五项存在严重偏倚风险。11 项研究使用改良罗德南皮肤评分法评估了皮肤受累情况，作者报告了其中 9 项研究的皮肤疗效。6 项评估肌肉受累情况的研究报告了肌肉受累情况的改善。6 项研究报告了胃肠道疗效数据。还对肺部和关节受累情况以及类固醇保护效果等其他方面进行了评估。最常见的不良反应是轻微的，包括头痛、腹痛、发热和皮疹：结论：对于有皮肤、肌肉或消化系统表现的 SSc 患者来说，使用 IVIG 治疗是有益且安全的。

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来源期刊

Rheumatology International 医学-风湿病学

CiteScore

7.30

自引率

5.00%

发文量

191

审稿时长

16. months

期刊介绍： RHEUMATOLOGY INTERNATIONAL is an independent journal reflecting world-wide progress in the research, diagnosis and treatment of the various rheumatic diseases. It is designed to serve researchers and clinicians in the field of rheumatology. RHEUMATOLOGY INTERNATIONAL will cover all modern trends in clinical research as well as in the management of rheumatic diseases. Special emphasis will be given to public health issues related to rheumatic diseases, applying rheumatology research to clinical practice, epidemiology of rheumatic diseases, diagnostic tests for rheumatic diseases, patient reported outcomes (PROs) in rheumatology and evidence on education of rheumatology. Contributions to these topics will appear in the form of original publications, short communications, editorials, and reviews. "Letters to the editor" will be welcome as an enhancement to discussion. Basic science research, including in vitro or animal studies, is discouraged to submit, as we will only review studies on humans with an epidemological or clinical perspective. Case reports without a proper review of the literatura (Case-based Reviews) will not be published. Every effort will be made to ensure speed of publication while maintaining a high standard of contents and production. Manuscripts submitted for publication must contain a statement to the effect that all human studies have been reviewed by the appropriate ethics committee and have therefore been performed in accordance with the ethical standards laid down in an appropriate version of the 1964 Declaration of Helsinki. It should also be stated clearly in the text that all persons gave their informed consent prior to their inclusion in the study. Details that might disclose the identity of the subjects under study should be omitted.