Background

Ocrelizumab safety outcomes have been well evaluated in clinical trials and open-label extension (OLE) studies. However, risk factors for infection in patients with multiple sclerosis (MS) receiving ocrelizumab have not been extensively studied in the real-world setting.

Objective

The aim of this study was to examine factors determining risk of self-reported infections and antimicrobial use in patients receiving ocrelizumab for MS.

Methods

A retrospective, observational cohort study was conducted in patients receiving ocrelizumab at the Royal Melbourne Hospital. Infection type and number were reported by patients, and the associations of potential clinical and laboratory risk factors with self-reported infection and antimicrobial use were estimated using univariate and multivariable logistic regression models.

Results

A total of 185 patients were included in the study; a total of 176 infections were reported in 89 patients (46.1%), and antimicrobial use was identified in 47 patients (25.3%). In univariate analyses, a higher serum IgA was associated with reduced odds of infection (OR 0.44, 95% CI 0.25–0.76). In multivariable analyses, older age (OR 0.94, 95% CI 0.88–0.99), higher serum IgA (OR 0.37, 95% CI 0.17–0.80) and higher serum IgG (OR 0.81, 95% CI 0.67–0.99) were associated with reduced odds of infection. Older age (OR 0.85, 95% CI 0.75–0.96) and higher serum IgA (OR 0.23, 95% CI 0.07–0.79) were associated with reduced odds of antimicrobial use, whilst longer MS disease duration (OR 1.22, 95% CI 1.06–1.41) and higher Expanded Disability Status Scale (EDSS) score (OR 1.99, 95% CI 1.02–3.86) were associated with increased odds of antimicrobial use.

Conclusions

Higher serum IgA and IgG and older age were associated with reduced odds of infection. Our findings highlight that infection risk is not uniform in patients with MS receiving ocrelizumab and substantiate the need to monitor immunoglobulin levels pre-treatment and whilst on therapy.

中文翻译：

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预测接受 Ocrelizumab 治疗的多发性硬化症患者的感染风险：一项回顾性队列研究

背景

Ocrelizumab 的安全性结果已在临床试验和开放标签扩展 (OLE) 研究中得到很好的评估。然而，在现实世界中尚未对接受 ocrelizumab 治疗的多发性硬化症 (MS) 患者感染的危险因素进行广泛研究。

客观的

本研究的目的是检查在接受 ocrelizumab 治疗 MS 的患者中决定自我报告感染和抗菌药物使用风险的因素。

方法

在皇家墨尔本医院接受 ocrelizumab 的患者中进行了一项回顾性观察性队列研究。患者报告感染类型和数量，并使用单变量和多变量逻辑回归模型估计潜在临床和实验室风险因素与自我报告的感染和抗菌药物使用的关联。

结果

该研究共纳入 185 名患者；89 名患者 (46.1%) 共报告了 176 次感染，47 名患者 (25.3%) 确定使用了抗菌药物。在单变量分析中，较高的血清 IgA 与感染几率降低相关（OR 0.44，95% CI 0.25-0.76）。在多变量分析中，年龄较大（OR 0.94，95% CI 0.88-0.99）、较高的血清 IgA（OR 0.37，95% CI 0.17-0.80）和较高的血清 IgG（OR 0.81，95% CI 0.67-0.99）与降低感染几率。年龄较大 (OR 0.85, 95% CI 0.75–0.96) 和较高的血清 IgA (OR 0.23, 95% CI 0.07–0.79) 与抗菌药物使用几率降低相关，而 MS 病程较长 (OR 1.22, 95% CI 1.06) –1.41）和更高的扩展残疾状态量表（EDSS）评分（OR 1.99, 95% CI 1.02–3.86）与抗生素使用几率增加有关。

结论

较高的血清 IgA 和 IgG 以及年龄较大与感染几率降低有关。我们的研究结果强调，接受 ocrelizumab 的 MS 患者的感染风险并不一致，并证实需要在治疗前和治疗期间监测免疫球蛋白水平。