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Blood, 14 May 2009, Vol. 113, No. 20, pp. 4834-4840.
Prepublished online as a Blood First Edition Paper on March 5, 2009; DOI 10.1182/blood-2008-10-186999.
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Submitted October 30, 2008
Accepted February 22, 2009
Progressive multifocal leukoencephalopathy following rituximab therapy in HIV negative patients: a report of 57 cases from the Research on Adverse Drug Event and Reports (RADAR) project
Kenneth R. Carson, Andrew M. Evens, Elizabeth A. Richey, Thomas M. Habermann, Daniele Focosi, John F. Seymour, Jacob Laubach, Susie D. Bawn, Leo I. Gordon, Jane N. Winter, Richard R. Furman, Julie M. Vose, Andrew D. Zelenetz, Ronac Mamtani, Dennis W. Raisch, Gary W. Dorshimer, Steven T. Rosen, Kenji Muro, Numa R. Gottardi-Littell, Robert L. Talley, Oliver Sartor, David Green, Eugene O. Major, and Charles L. Bennett*
Siteman Comprehensive Cancer Center, Washington University School of Medicine, St. Louis, MO, United States
Division of Hematology/Oncology, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States
Department of Hematology, Mayo Clinic College of Medicine, Rochester, MN, United States
Division of Hematology, University of Pisa, Pisa, Italy
Division of Haematology and Medical Oncology, Peter MacCallum Cancer Centre and University of Melbourne, East Melbourne, Victoria, Australia
Dana Farber Cancer Institute, Boston, MA, United States
Division of Hematology/Oncology, Stanford University School of Medicine, Stanford, CA, United States
Robert H. Lurie Comprehensive Cancer Center, Chicago, IL, United States
Division of Hematology/Oncology, New York Presbyterian Hospital-Cornell Medical Center, New York, NY, United States
Section of Hematology/Oncology, University of Nebraska Medical Center, Omaha, NE, United States
Division of Hematology/Oncology, Memorial Sloan-Kettering Cancer Center, New York, NY, United States
VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, University of New Mexico, Albuquerque, NM, United States
Pennsylvania Hospital, University of Pennsylvania Health System, Philadelphia, PA, United States
Department of Neurological Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States
Department of Pathology, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States
Kansas City Cancer Center, Kansas City, MO, United States
Tulane Medical School, New Orleans, LA, United States
Laboratory of Molecular Medicine and Neuroscience, National Institute of Neurological Disorders and Stroke, National Institutues of Health, Bethesda, MD, United States
VA Center for the Management of Complex Chronic Conditions, Jesse Brown VAMC, Chicago, IL, United States
* Corresponding author; email: cbenne{at}northwestern.edu.
Rituximab improves outcomes for persons with lymphoproliferative disorders and is increasingly used to treat immune-mediated illnesses. Recent reports describe two patients with systemic lupus erythematosus and one with rheumatoid arthritis, who developed progressive multifocal leukoencephalopathy (PML) following rituximab treatment. We reviewed PML case descriptions among patients treated with rituximab from the FDA, the manufacturer, physicians, and a literature review from 1997 to 2008. Overall, 52 patients with lymphoproliferative disorders, two patients with systemic lupus erythematosus, one patient with rheumatoid arthritis, one patient with an idiopathic autoimmune pancytopenia, and one patient with immune thrombocytopenia developed PML following treatment with rituximab and other agents. Other treatments included hematopoietic stem cell transplantation (7 patients), purine analogues (26 patients), or alkylating agents (39 patients). One patient with an autoimmune hemolytic anemia developed PML following treatment with corticosteroids and rituximab and one patient with an autoimmune pancytopenia developed PML following 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 individuals.
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