Department of Neurology, Melbourne MS Centre, Royal Melbourne Hospital, Parkville, VIC, 3050, Australia.
Clinical Outcomes Research Unit, University of Melbourne, Melbourne, VIC, 3010, Australia.
CNS Drugs. 2021 Aug;35(8):907-918. doi: 10.1007/s40263-021-00810-3. Epub 2021 Apr 13.
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.
The aim of this study was to examine factors determining risk of self-reported infections and antimicrobial use in patients receiving ocrelizumab for MS.
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.
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.
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.
奥瑞珠单抗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，在真实环境中，接受奥瑞珠单抗治疗的多发性硬化症（MS）患者感染的风险因素尚未得到广泛研究。
本研究旨在研究决定接受奥瑞珠单抗治疗 MS 的患者发生自身报告感染和使用抗菌药物的风险因素。
这是一项在皇家墨尔本医院接受奥瑞珠单抗治疗的患者中进行的回顾性、观察性队列研究。患者报告感染类型和数量，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危险因素与自身报告感染和使用抗菌药物之间的关联。
共纳入 185 例患者，89 例患者（46.1%）报告了 176 例感染，47 例患者（25.3%）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）与感染几率降低相关。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，而多发性硬化症病程较长（OR 1.22，95%CI 1.06-1.41）和扩展残疾状态量表（EDSS）评分较高（OR 1.99，95%CI 1.02-3.86）与抗菌药物使用几率增加相关。
较高的血清 IgA 和 IgG 以及年龄较大与感染几率降低相关。我们的研究结果表明，接受奥瑞珠单抗治疗的 MS 患者的感染风险并非一致，并证实了在治疗前和治疗期间监测免疫球蛋白水平的必要性。
