Progressive multifocal leukoencephalopathy after rituximab therapy in HIV-negative patients: A report of 57 cases from the Research on Adverse Drug Events and Reports project Journal Article
| Authors: | Carson, K. R.; Evens, A. M.; Richey, E. A.; Habermann, T. M.; Focosi, D.; Seymour, J. F.; Laubach, J.; Bawn, S. D.; Gordon, L. I.; Winter, J. N.; Furman, R. R.; Vose, J. M.; Zelenetz, A. D.; Mamtani, R.; Raisch, D. W.; Dorshimer, G. W.; Rosen, S. T.; Muro, K.; Gottardi-Littell, N. R.; Talley, R. L.; Sartor, O.; Green, D.; Major, E. O.; Bennett, C. L. |
| Article Title: | Progressive multifocal leukoencephalopathy after rituximab therapy in HIV-negative patients: A report of 57 cases from the Research on Adverse Drug Events and Reports project |
| Abstract: | Rituximab improves outcomes for persons with lymphoproliferative disorders and is increasingly used to treat immune-mediated illnesses. Recent reports describe 2 patients with systemic lupus erythematosus and 1 with rheumatoid arthritis who developed progressive multifocal leukoencephalopathy (PML) after rituximab treatment. We reviewed PML case descriptions among patients treated with rituximab from the Food and Drug Administration, the manufacturer, physicians, and a literature review from 1997 to 2008. Overall, 52 patients with lymphoproliferative disorders, 2 patients with systemic lupus erythematosus, 1 patient with rheumatoid arthritis, 1 patient with an idiopathic autoimmune pancytopenia, and 1 patient with immune thrombocytopenia developed PMLafter treatment with rituximab and other agents. Other treatments included hematopoietic stem cell transplantation (7 patients), purine analogs (26 patients), or alkylating agents (39 patients). One patient with an autoimmune hemolytic anemia developed PMLafter treatment with corticosteroids and rituximab, and 1 patient with an autoimmune pancytopenia developed PML after treatment with corticosteroids, azathioprine, and rituximab. Median time from last rituximab dose to PML diagnosis was 5.5 months. Median time to death after PML diagnosis was 2.0 months. The case-fatality rate was 90%. Awareness is needed of the potential for PML among rituximab-treated persons. |
| Keywords: | adult; controlled study; human tissue; aged; aged, 80 and over; middle aged; major clinical study; danazol; clinical feature; clinical trial; antineoplastic agents; cytarabine; methotrexate; rituximab; methodology; antineoplastic agent; thrombocytopenia; risperidone; alkylating agent; immunoglobulin; hematopoietic stem cell transplantation; food and drug administration; monoclonal antibody; drug fatality; antibodies, monoclonal; drug surveillance program; adverse drug reaction reporting systems; evaluation; multicenter study; chemically induced disorder; corticosteroid derivative; donor lymphocyte infusion; medical literature; antivirus agent; azathioprine; cidofovir; mirtazapine; platinum derivative; purine derivative; romiplostim; tumor necrosis factor alpha inhibitor; autoimmune hemolytic anemia; human immunodeficiency virus; idiopathic thrombocytopenic purpura; lymphoproliferative disease; pancytopenia; progressive multifocal leukoencephalopathy; rheumatoid arthritis; systemic lupus erythematosus; drug monitoring; drug toxicity; serodiagnosis; hiv seronegativity; leukoencephalopathy, progressive multifocal |
| Journal Title: | Blood |
| Volume: | 113 |
| Issue: | 20 |
| ISSN: | 0006-4971 |
| Publisher: | American Society of Hematology |
| Date Published: | 2009-05-14 |
| Start Page: | 4834 |
| End Page: | 4840 |
| Language: | English |
| DOI: | 10.1182/blood-2008-10-186999 |
| PUBMED: | 19264918 |
| PROVIDER: | scopus |
| PMCID: | PMC2686134 |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 111" - "Export Date: 30 November 2010" - "CODEN: BLOOA" - "Source: Scopus" |
