دورية أكاديمية
Progressive multifocal leukoencephalopathy with natalizumab extended or standard interval dosing in the United States and the rest of the world.
| العنوان: | Progressive multifocal leukoencephalopathy with natalizumab extended or standard interval dosing in the United States and the rest of the world. |
|---|---|
| المؤلفون: | Dsilva L; Global Medical Safety, Biogen, Cambridge, MA, USA., McCarthy K; Drug Safety, Pharmacovigilance & Systems & Data Analytics, Biogen, Cambridge, MA, USA., Lyons J; Global Medical Safety, Biogen, Cambridge, MA, USA., Cabigas B; Global Medical Safety, Biogen, Cambridge, MA, USA., Campbell N; Global Medical, Biogen, Cambridge, MA, USA., Kong G; Biostatistics, Biogen, Cambridge, MA, USA., Adams B; Biostatistics, Biogen, Cambridge, MA, USA., Kuhelj R; Global Medical, Biogen, Baar, Switzerland., Singhal P; Development, Biogen, Cambridge, MA, USA., Smirnakis K; Safety and Benefit Risk Management, Biogen, Cambridge, MA, USA. |
| المصدر: | Expert opinion on drug safety [Expert Opin Drug Saf] 2023 Jul-Dec; Vol. 22 (10), pp. 995-1002. Date of Electronic Publication: 2023 Jun 10. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Taylor & Francis Country of Publication: England NLM ID: 101163027 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1744-764X (Electronic) Linking ISSN: 14740338 NLM ISO Abbreviation: Expert Opin Drug Saf Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2015- : Abingdon, Oxford : Taylor & Francis Original Publication: London : Ashley Publications, c2002- |
| مواضيع طبية MeSH: | Leukoencephalopathy, Progressive Multifocal*/chemically induced , Leukoencephalopathy, Progressive Multifocal*/epidemiology , Leukoencephalopathy, Progressive Multifocal*/diagnosis , Multiple Sclerosis*/drug therapy , Multiple Sclerosis*/chemically induced , JC Virus*, Humans ; United States/epidemiology ; Natalizumab/adverse effects ; Retrospective Studies ; Immunosuppressive Agents ; Risk Factors ; Immunologic Factors/adverse effects |
| مستخلص: | Background: Progressive multifocal leukoencephalopathy (PML), an important identified risk for natalizumab, has been described for standard interval dosing (SID; dosing interval every-4-weeks). Information on PML with natalizumab extended interval dosing (EID; dosing interval >every-4-weeks) in the US and the rest of the world (ROW) is limited. Research Design and Methods: A retrospective analysis of patient demographics, risk factors, clinical characteristics, and clinical outcomes was conducted on confirmed natalizumab EID and SID PML cases evaluated from Biogen pharmacovigilance systems. Results: Of 857 confirmed natalizumab PML cases, EID and SID accounted for 7.5% and 92.5%, respectively (US: 12.9% and 87.1%; ROW: 5.4% and 94.6%). PML risk factors included anti-JCV index > 1.5 (US: EID, 56.7% and SID, 12.8%; ROW: EID, 44.1% and SID, 21.0%), mean duration of natalizumab treatment (US: 90.0 and 70.2 months; ROW: 54.1 and 49.8 months), and prior immunosuppressive therapy (US: 20.0% and 21.7%; ROW:11.8% and 18.0%). In the EID and SID groups, 68.8% and 76.0% of patients, respectively, were alive at up to 2 years after diagnosis. Conclusions: This analysis provides insights on PML in patients receiving natalizumab that extend current knowledge, particularly regarding PML in patients receiving natalizumab EID, which can be built upon in the future. |
| فهرسة مساهمة: | Keywords: extended interval dosing; multiple sclerosis; natalizumab; progressive multifocal leukoencephalopathy; standard interval dosing |
| المشرفين على المادة: | 0 (Natalizumab) 0 (Immunosuppressive Agents) 0 (Immunologic Factors) |
| تواريخ الأحداث: | Date Created: 20230605 Date Completed: 20231102 Latest Revision: 20231102 |
| رمز التحديث: | 20231215 |
| DOI: | 10.1080/14740338.2023.2221027 |
| PMID: | 37272350 |
| قاعدة البيانات: | MEDLINE |
PDF full text from Publisher | تدمد: | 1744-764X |
|---|---|
| DOI: | 10.1080/14740338.2023.2221027 |