Herpes Zoster Infections With Multiple Sclerosis Disease-Modifying Therapies: A Real-World Pharmacovigilance Study.

IF 2.3 Q3 CLINICAL NEUROLOGY
Neurology. Clinical practice Pub Date : 2025-04-01 Epub Date: 2025-03-11 DOI:10.1212/CPJ.0000000000200462
Alexandra Balshi, Grace Leuenberger, John Dempsey, Nova Manning, Ursela Baber, Jacob A Sloane
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引用次数: 0

Abstract

Background and objectives: Immunosuppressive multiple sclerosis (MS) disease-modifying therapies (DMTs) may increase the risk of opportunistic infections such as herpes zoster (HZ). We sought to evaluate the risk of HZ across various MS DMTs using publicly available pharmacovigilance reporting data.

Methods: We queried the Food and Drug Administration Adverse Event Reporting System (FAERS) and OpenVigil 2.1 for reports of HZ involving immunosuppressive MS DMTs (ocrelizumab [OCR], ofatumumab [OFT], rituximab [RTX], natalizumab [NTZ], alemtuzumab, dimethyl fumarate and diroximel fumarate [DRF], fingolimod [FING], siponimod [SIP], ozanimod [OZ], mitoxantrone [MITO], cladribine [CLAD], and teriflunomide [TERF]) and calculated reporting odds ratios and their 95% CIs.

Results: We identified 4,210 total reports of HZ across these MS DMTs. All had disproportionally higher RORs compared with all other FAERS medications. Alemtuzumab had the greatest reporting risk (ROR; 95% CI) (11.1; 9.7-12.6), followed by OCR (9.3; 8.6-10.0), FING (5.6; 5.2-6.0), CLAD (5.3; 3.7-4.2), NTZ (4.0; 3.7-4.2), RTX (3.8; 3.5-4.1), SIP (3.2; 2.4-4.2), DRF (3.1; 2.4-4.1), OFT (3.0; 2.6-3.6), dimethyl fumarate (2.5; 2.3-2.8), OZ (2.5; 1.8-3.6), MITO (2.4; 1.6-3.6), and TERF (1.6; 1.3-1.9).

Discussion: Immunosuppressive MS DMTs are associated with greater HZ reporting in the FAERS. These findings emphasize the importance of pre-DMT HZ vaccination because of avoidable HZ infections.

带状疱疹感染与多发性硬化症疾病改变疗法:真实世界药物警戒研究》。
背景和目的:免疫抑制性多发性硬化症(MS)疾病改善疗法(dmt)可能增加机会性感染(如带状疱疹(HZ))的风险。我们试图利用公开可获得的药物警戒报告数据来评估各种MS dmt中HZ的风险。方法:我们查询美国食品药品监督管理局不良事件报告系统(FAERS)和OpenVigil 2.1中涉及免疫抑制MS DMTs(奥克雷珠单抗[OCR]、奥伐单抗[OFT]、利妥昔单抗[RTX]、那他珠单抗[NTZ]、阿仑单抗、富马酸二甲酯和富马酸地洛西美尔[DRF]、fingolimod [FING]、西泊尼莫德[SIP]、奥扎尼莫德[OZ]、米托蒽醌[MITO]、克拉德里滨[CLAD]和特立氟米特[TERF])的HZ报告,并计算报告的优势比及其95% ci。结果:我们在这些MS dmt中确定了4210例HZ报告。与所有其他FAERS药物相比,所有药物的RORs都不成比例地高。阿仑单抗报告风险最高(ROR;95% ci) (11.1;9.7-12.6),其次是OCR (9.3;8.6-10.0), f_ (5.6;5.2-6.0),覆层(5.3;3.7-4.2), NTZ (4.0;3.7-4.2), RTX (3.8;3.5-4.1), sip (3.2;2.4-4.2), DRF (3.1;2.4-4.1), oft (3.0;2.6-3.6),富马酸二甲酯(2.5;2.3-2.8),盎司(2.5;1.8-3.6), mito (2.4;1.6-3.6), TERF (1.6;1.3 - -1.9)。讨论:免疫抑制性MS DMTs与FAERS中更高的HZ报告相关。这些发现强调了dmt前接种HZ疫苗的重要性,因为可以避免HZ感染。
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来源期刊
Neurology. Clinical practice
Neurology. Clinical practice CLINICAL NEUROLOGY-
CiteScore
4.00
自引率
0.00%
发文量
77
期刊介绍: Neurology® Genetics is an online open access journal publishing peer-reviewed reports in the field of neurogenetics. The journal publishes original articles in all areas of neurogenetics including rare and common genetic variations, genotype-phenotype correlations, outlier phenotypes as a result of mutations in known disease genes, and genetic variations with a putative link to diseases. Articles include studies reporting on genetic disease risk, pharmacogenomics, and results of gene-based clinical trials (viral, ASO, etc.). Genetically engineered model systems are not a primary focus of Neurology® Genetics, but studies using model systems for treatment trials, including well-powered studies reporting negative results, are welcome.
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