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.
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.