Drug-Induced Progressive Multifocal Leukoencephalopathy: Lessons Learned From Contrasting Natalizumab and Rituximab
| Autor: | Vermeer, N S, Straus, S M J M, Mantel-Teeuwisse, A K, Hidalgo-Simon, A, Egberts, A C G, Leufkens, H G M, De Bruin, M L, Sub Pharmacoepidemiology, Sub Pharmacotherapy, Theoretical, Sub Clinical Pharmacy, Pharmacoepi, Pharmacoepidemiology and Clinical Pharmacology |
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| Přispěvatelé: | Medical Informatics, Hematology, Sub Pharmacoepidemiology, Sub Pharmacotherapy, Theoretical, Sub Clinical Pharmacy, Pharmacoepi, Pharmacoepidemiology and Clinical Pharmacology |
| Rok vydání: | 2015 |
| Předmět: |
Oncology
Adult Male medicine.medical_specialty Databases Factual OSTEONECROSIS Context (language use) Research Support THERAPY DISEASE Leukoencephalopathy Natalizumab Internal medicine Pharmacovigilance Taverne medicine Journal Article Adverse Drug Reaction Reporting Systems Humans Immunologic Factors Pharmacology (medical) Non-U.S. Gov't Aged RISK Pharmacology DISPROPORTIONALITY business.industry Multiple sclerosis Progressive multifocal leukoencephalopathy Research Support Non-U.S. Gov't Leukoencephalopathy Progressive Multifocal MULTIPLE-SCLEROSIS CHEMOTHERAPY Middle Aged medicine.disease JAW SAFETY PHARMACOVIGILANCE Immunology Rituximab Female business Adverse drug reaction medicine.drug |
| Zdroj: | Clinical Pharmacology & Therapeutics, 98(5), 542-550. Wiley-Blackwell Clinical Pharmacology and Therapeutics, 98(5), 542. Nature Publishing Group Europe PubMed Central Clinical Pharmacology & Therapeutics, 98(5), 542. Nature Publishing Group |
| ISSN: | 0009-9236 |
| Popis: | Progressive multifocal leukoencephalopathy (PML) has been identified as a serious adverse drug reaction (ADR) of several immunomodulatory biologicals. In this study, we contrasted the reporting patterns of PML for two biologicals for which the risk was identified at different points in their lifecycle: natalizumab (before reapproval) and rituximab (nine years postapproval). We found that, apart from the differences in clinical characteristics (age, gender, indication, time to event, fatality), which reflect the diversity in context of use, PML reports for natalizumab were more complete and were received sooner after occurrence. This study serves as an important reminder that spontaneous reports should only be used with great caution to quantify and compare safety profiles across products over time. The observed variability in reporting patterns and heterogeneity of PML cases presents challenges to such comparisons. Lumping uncharacterized PML reports together without taking these differences into account may result in biased comparisons and flawed conclusions about differential safety. |
| Databáze: | OpenAIRE |
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