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

Blood

Volumn 113, Issue 20, 2009, Pages 4834-4840

  Carson, Kenneth R ^a   Evens, Andrew M ^b   Richey, Elizabeth A ^b   Habermann, Thomas M ^c   Focosi, Daniele ^d   Seymour, John F ^e   Laubach, Jacob ^f   Bawn, Susie D ^g   Gordon, Leo I ^b   Winter, Jane N ^b   Furman, Richard R ^h   Vose, Julie M ⁱ   Zelenetz, Andrew D ^h,j   Mamtani, Ronac ^h   Raisch, Dennis W ^k   Dorshimer, Gary W ^l   Rosen, Steven T ^b   Muro, Kenji ^b   Gottardi Littell, Numa R ^b   Talley, Robert L ^m   Sartor, Oliver ⁿ   Green, David ^b   Major, Eugene O ^o   Bennett, Charles L ^b,p   more..

^a USA   (United States)

^b NORTHWESTERN UNIVERSITY   (United States)

^c Mayo Clinic   (United States)

^d UNIVERSITY OF PISA   (Italy)

^e UNIVERSITY OF MELBOURNE   (Australia)

^f DANA FARBER CANCER INSTITUTE   (United States)

^g STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^h WEILL CORNELL MEDICAL CENTER   (United States)

ⁱ UNIVERSITY OF NEBRASKA MEDICAL CENTER   (United States)

^j MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^k UNIVERSITY OF NEW MEXICO   (United States)

^l PENNSYLVANIA HOSPITAL   (United States)

^m Kansas City Cancer Center   (United States)

ⁿ TULANE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^o NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE   (United States)

^p JESSE BROWN VA MEDICAL CENTER   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALKYLATING AGENT; ANTIVIRUS AGENT; AZATHIOPRINE; CIDOFOVIR; CORTICOSTEROID DERIVATIVE; CYTARABINE; DANAZOL; IMMUNOGLOBULIN; METHOTREXATE; MIRTAZAPINE; PLATINUM DERIVATIVE; PURINE DERIVATIVE; RISPERIDONE; RITUXIMAB; ROMIPLOSTIM; TUMOR NECROSIS FACTOR ALPHA INHIBITOR; ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY;

ADULT; AGED; ARTICLE; AUTOIMMUNE HEMOLYTIC ANEMIA; CLINICAL FEATURE; CONTROLLED STUDY; DONOR LYMPHOCYTE INFUSION; DRUG FATALITY; FEMALE; FOOD AND DRUG ADMINISTRATION; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS; HUMAN TISSUE; IDIOPATHIC THROMBOCYTOPENIC PURPURA; LYMPHOPROLIFERATIVE DISEASE; MAJOR CLINICAL STUDY; MALE; MEDICAL LITERATURE; PANCYTOPENIA; PRIORITY JOURNAL; PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY; RHEUMATOID ARTHRITIS; SYSTEMIC LUPUS ERYTHEMATOSUS; THROMBOCYTOPENIA; CHEMICALLY INDUCED DISORDER; CLINICAL TRIAL; DRUG MONITORING; DRUG SURVEILLANCE PROGRAM; DRUG TOXICITY; EVALUATION; METHODOLOGY; MIDDLE AGED; MULTICENTER STUDY; SERODIAGNOSIS;

ADULT; ADVERSE DRUG REACTION REPORTING SYSTEMS; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; DRUG MONITORING; DRUG TOXICITY; FEMALE; HIV SERONEGATIVITY; HUMANS; LEUKOENCEPHALOPATHY, PROGRESSIVE MULTIFOCAL; MALE; MIDDLE AGED;

EID: 66549130454     PISSN: 00064971     EISSN: 15280020     Source Type: Journal    
DOI: 10.1182/blood-2008-10-186999     Document Type: Article

References (68)

1. Astrom KE, Mancall EL, Richardson EP Jr. Progressive multifocal leuko-encephalopathy: a hitherto unrecognized complication of chronic lymphatic leukemia and Hodgkin disease. Brain. 1958;81:93-111.
2. Major EO, Amemiya K, Tornatore CS, Houff SA, Berger JR. Pathogenesis and molecular biology of progressive multifocal leukoencephalopathy, the JC virus-induced demyelinating disease of the human brain. Clin Microbiol Rev. 1992;5:49-73.
3. Koralnik IJ, Schellingerhout D, Frosch MP. Case records of the Massachusetts General Hospital. Weekly clinicopathological exercises (Case 14-2004): a 66-year-old man with progressive neurologic deficits. N Engl J Med. 2004;350:1882-1893.
4. Gonzalez H, Bolgert F, Camporo P, Leblond V. Progressive multifocal leukoencephalitis (PML) in 3 patients treated with standard-dose fludarabine (FAMP). Hematol Cell Ther. 1999;41:183-186. (Pubitemid 29470750)
5. Power C, Gladden JG, Halliday W, et al. AIDS- and non-AIDS-related PML association with distinct p53 polymorphism. Neurology. 2000;54:743-746. (Pubitemid 30082951)
6. Kleinschmidt-DeMasters BK, Tyler KL. Progressive multifocal leukoencephalopathy complicating treatment with natalizumab and interferon beta-1a for multiple sclerosis. N Engl J Med. 2005;353:369-374. (Pubitemid 41132341)
7. Langer-Gould A, Atlas SW, Green AJ, Bollen AW, Pelletier D. Progressive multifocal leukoencephalopathy in a patient treated with natalizumab. N Engl J Med. 2005;353:375-381. (Pubitemid 41132342)
8. Van Assche G, Van Ranst M, Sciot R, et al. Progressive multifocal leukoencephalopathy after natalizumab therapy for Crohn disease. N Engl J Med. 2005;353:362-368. (Pubitemid 41132340)
9. Biogen. Tysabri update, February 2009. http://library.corporate-ir.net/ library/14/148/148682/ items/325387/50A3DDB4-521D-4A7A-AA57-5B35B92DD671- biibTysabri20Feb09.pdf. Accessed March 2, 2009.
10. Hartung HP. New cases of progressive multifocal leukoencephalopathy after treatment with natalizumab. Lancet Neurol. 2009;8:28-31.
11. Aksoy S, Harputluoglu H, Kilickap S, et al. Rituximab-related viral infections in lymphoma patients. Leuk Lymphoma. 2007;48:1307-1312. (Pubitemid 47079357)
12. FDA. Rituximab. FDAAlert: Information for Healthcare Professionals, Rockville, MD, December 2006. http://www.fda.gov/cder/drug/InfoSheets/HCP/ rituximab.pdf. Accessed March 2, 2009.
13. EMEA. European Public Assessment Report: Mabthera (revision), 2007. http://www.emea. europa.eu/humandocs/PDFs/EPAR/Mabthera/H-165-PI-en.pdf. Accessed March 2, 2009.
14. WHO. WHO Pharmaceuticals Newsletter, 2007. http://www.who.int/medicines/ publications/newsletter/PN-3-2007.pdf. Accessed March 2, 2009.
15. Rituximab (Rituxan) [package insert]. South San Francisco, CA: Genentech; 2006.
16. Rituximab (Rituxan) [package insert]. South San Francisco, CA: Genentech; 2008.
17. Genentech and Biogen. Important Drug Warning New Safety Information. 2008. http://www.fda.gov/medwAtch/safety/2008/rituxan-DHCP-Final%209411700.pdf. Accessed March 2, 2009.
18. Baehring JM, Vives K, Bannykh S. Progressive multifocal leukoencephalopathy in a patient with marginal zone B-cell lymphoma. J Neurooncol. 2007;85:289-290. (Pubitemid 350142518)
19. Brito-Babapulle F, Moule S, Stewart W, et al. Progressive multifocal leukoencephalopathy (PML) following rituximab-combination chemotherapy treatment: British Society for Haematology Annual Conference Abstract. Br J Haematol. 2006;133:36.
20. Darbesio A, Bertoldo E, Guana R, Geda C. Progressive mutlifocal leukoencephalopathy complicating follicular lymphoma: a possible role for chemotherapy and anti-CD20 treatment. 4th National Conference of Medical Oncology Abstract. Ann Oncol. 2002;13:94.
21. Freim Wahl SG, Folvik MR, Torp SH. Progressive multifocal leukoencephalopathy in a lymphoma patient with complete remission after treatment with cytostatics and rituximab: case report and review of the literature. Clin Neuropathol. 2007;26:68-73.
22. Goldberg SL, Pecora AL, Alter RS, et al. Unusual viral infections (progressive multifocal leukoencephalopathy and cytomegalovirus disease) after high-dose chemotherapy with autologous blood stem cell rescue and peritransplantation rituximab. Blood. 2002;99:1486-1488.
23. Harris HE. Progressive multifocal leucoencephalopathy in a patient with systemic lupus erythematosus treated with rituximab. Rheumatology (Oxf). 2008;47:224-225. (Pubitemid 351168240)
24. Hasan MM, Taylor P. Progressive multifocal leucoencephalopathy in a case of chronic lymphocytic leukemia. Br J Haematol. 2005;130:808. (Pubitemid 43899721)
25. Kranick SM, Mowry EM, Rosenfeld MR. Progressive multifocal leukoencephalopathy after rituximab in a case of non-Hodgkin lymphoma. Neurology. 2007;69:704-706. (Pubitemid 47256017)
26. Ng C, Slavin MA, Seymour JF. Progressive multifocal leukoencephalopathy complicating Waldenstrom macroglobulinaemia. Leuk Lymphoma. 2003;44:1819-1821. (Pubitemid 37221061)
27. Pelosini M, Focosi D, Rita F, et al. Progressive multifocal leukoencephalopathy: report of 3 cases in HIV-negative hematological patients and review of literature. Ann Hematol. 2007;87:405-412.
28. Rey J, Belmecheri N, Bouayed N, et al. JC papovavirus leukoencephalopathy after first line treatment with CHOP and rituximab. Haematologica. 2007;92:e101.
29. Steurer M, Clausen J, Gotwald T, et al. Progressive multifocal leukoencephalopathy after allogeneic stem cell transplantation and posttransplantation rituximab. Transplantation. 2003;76:435-436. (Pubitemid 36928014)
30. Yokoyama H, Watanabe T, Maruyama D, Kim SW, Kobayashi Y, Tobinai K. Progressive multifocal leukoencephalopathy in a patient with B-cell lymphoma during rituximab-containing chemotherapy: case report and review of the literature. Int J Hematol. 2008;88:443-447.
31. Hopfinger G, Plessl A, Grisold W, et al. Progressive multifocal leukoencephalopathy after rituximab in a patient with relapsed follicular lymphoma and low IgG levels and a low CD4+ lymphocyte count. Leuk Lymphoma. 2008;49:2367-2369.
32. Cinque P, Koralnik IJ, Clifford DB. The evolving face of human immunodeficiency virus-related progressive multifocal leukoencephalopathy: defining a consensus terminology. J Neurovirol. 2003;9[suppl 1]:88-92. (Pubitemid 36656477)
33. Weber F, Goldmann C, Kramer M, et al. Cellular and humoral immune response in progressive multifocal leukoencephalopathy. Ann Neurol. 2001;49:636-642. (Pubitemid 32429790)
34. Houff SA, Major EO, Katz DA, et al. Involvement of JC virus-infected mononuclear cells from the bone marrow and spleen in the pathogenesis of progressive multifocal leukoencephalopathy. N Engl J Med. 1988;318:301-305.
35. Stasi R, Del Poeta G, Stipa E, et al. Response to B-cell depleting therapy with rituximab reverts the abnormalities of T-cell subsets in patients with idiopathic thrombocytopenic purpura. Blood. 2007;110:2924-2930. (Pubitemid 350006946)
36. Narula S, LaRosa DF, Kamoun M, Dalmau J, Levinson AI. Progressive multifocal leukoencephalopathy in a patient with common variable immunodeficiency and abnormal CD8+ T-cell subset distribution. Ann Allergy Asthma Immunol. 2007;98:483-489. (Pubitemid 46752643)
37. Teramoto T, Kaneko H, Funato M, et al. Progressive multifocal leukoencephalopathy in a patient with X-linked agammaglobulinemia. Scand J Infect Dis. 2003;35:909-910. (Pubitemid 38028943)
38. Sabath BF, Major EO. Traffic of JC virus from sites of initial infection to the brain: the path to progressive multifocal leukoencephalopathy. J Infect Dis. 2002;186[suppl 2]:S180-S186.
39. Bonig H, Wundes A, Chang KH, Lucas S, Papayannopoulou T. Increased numbers of circulating hematopoietic stem/progenitor cells are chronically maintained in patients treated with the CD49d blocking antibody natalizumab. Blood. 2008;111:3439-3441.
40. Lindberg RL, Achtnichts L, Hoffmann F, Kuhle J, Kappos L. Natalizumab alters transcriptional expression profiles of blood cell subpopulations of multiple sclerosis patients. J Neuroimmunol. 2008;194:153-164.
41. Zohren F, Toutzaris D, Klarner V, Hartung HP, Kieseier B, Haas R. The monoclonal anti-VLA-4 antibody natalizumab mobilizes CD34+ hematopoietic progenitor cells in humans. Blood. 2008;111:3893-3895.
42. Gibson PE, Gardner SD, Field AM. Use of a molecular probe for detecting JCV DNA directly in human brain material. J Med Virol. 1986;18:87-95.
43. Fong IW, Britton CB, Luinstra KE, Toma E, Mahony JB. Diagnostic value of detecting JC virus DNA in cerebrospinal fluid of patients with progressive multifocal leukoencephalopathy. J Clin Microbiol. 1995;33:484-486.
44. Dubois V, Moret H, Lafon ME, et al. Prevalence of JC virus viraemia in HIV-infected patients with or without neurological disorders: a prospective study. J Neurovirol. 1998;4:539-544. (Pubitemid 28499349)
45. Delbue S, Guerini FR, Mancuso R, et al. JC virus viremia in interferon-beta-treated and untreated Italian multiple sclerosis patients and healthy controls. J Neurovirol. 2007;13:73-77. (Pubitemid 46510147)
46. Engsig FN, Hansen AB, Omland LH, et al. Incidence, clinical presentation, and outcome of progressive multifocal leukoencephalopathy in HIV-infected patients during the highly active antiretroviral therapy era: a nationwide cohort study. J Infect Dis. 2009;199:77-83.
47. Berger JR, Major EO. Progressive multifocal leukoencephalopathy. Semin Neurol. 1999;19:193-200.
48. Laszlo D, Bassi S, Andreola G, et al. Peripheral T-lymphocyte subsets in patients treated with rituximab-chlorambucil combination therapy for indolent NHL. Ann Hematol. 2006;85:813-814. (Pubitemid 44377880)
49. Brooks BR, Walker DL. Progressive multifocal leukoencephalopathy. Neurol Clin. 1984;2:299-313.
50. Garcia-Suarez J, de Miguel D, Krsnik I, Banas H, Arribas I, Burgaleta C. Changes in the natural history of progressive multifocal leukoencephalopathy in HIV-negative lymphoproliferative disorders: impact of novel therapies. Am J Hematol. 2005;80:271-281. (Pubitemid 41746174)
51. Winstein K. Biogen Cites New Setback for MS Drug. Wall Street Journal. December 16, 2008:D2.
52. Kappos L, Bates D, Hartung HP, et al. Natalizumab treatment for multiple sclerosis: recommendations for patient selection and monitoring. Lancet Neurol. 2007;6:431-441. (Pubitemid 46551850)
53. Wysowski D, Bozic C. Natalizumab's Risk Minimization Action Plan and Risk Management Plan: Food and Drug Administration's Peripheral and Central Nervous System Drug Advisory Committee meeting. Gaithersburg, MD, 2006.
54. FDA. FDAAlert: Information for Healthcare Professionals: Natalizumab Injection for Intraveneous Use; August 2008. http://www.fda.gov/cder/drug/ InfoSheets/HCP/natalizumab 2008HCP.htm. Accessed March 2, 2009.
55. Genentech. Medication Guide Rituxan (rituximab); 2008. http://www.gene.com/gene/products/information/pdf/rituxan-med-guide.pdf. Accessed March 2, 2009.
56. Coiffier B, Lepage E, Briere J, et al. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med. 2002;346:235-242. (Pubitemid 34438862)
57. Feugier P, Van Hoof A, Sebban C, et al. Long-term results of the R-CHOP study in the treatment of elderly patients with diffuse large B-cell lymphoma: a study by the Groupe d'Etude des Lymphomes de l'Adulte. J Clin Oncol. 2005;23:4117-4126. (Pubitemid 46211317)
58. Marcus R, Imrie K, Solal-Celigny P, et al. Phase III study of R-CVP compared with cyclophosphamide, vincristine, and prednisone alone in patients with previously untreated advanced follicular lymphoma. J Clin Oncol. 2008;26:4579-4586.
59. Pfreundschuh M, Trumper L, Osterborg A, et al. CHOP-like chemotherapy plus rituximab versus CHOP-like chemotherapy alone in young patients with good-prognosis diffuse large-B-cell lymphoma: a randomised controlled trial by the Mab-Thera International Trial (MInT) Group. Lancet Oncol. 2006;7:379-391.
60. Fu K, Weisenburger DD, Choi WW, et al. Addition of rituximab to standard chemotherapy improves the survival of both the germinal center B-cell-like and non-germinal center B-cell-like subtypes of diffuse large B-cell lymphoma. J Clin Oncol. 2008;26:4587-4594.
61. Arnold DM, Dentali F, Crowther MA, et al. Systematic review: efficacy and safety of rituximab for adults with idiopathic thrombocytopenic purpura. Ann Intern Med. 2007;146:25-33. (Pubitemid 351650318)
62. Cohen SB, Emery P, Greenwald MW, et al. Rituximab for rheumatoid arthritis refractory to antitumor necrosis factor therapy: results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at 24 weeks. Arthritis Rheum. 2006;54:2793-2806. (Pubitemid 44497758)
63. Hauser SL, Waubant E, Arnold DL, et al. B-cell depletion with rituximab in relapsing-remitting multiple sclerosis. N Engl J Med. 2008;358:676-688. (Pubitemid 351240747)
64. Ng KP, Cambridge G, Leandro MJ, Edwards JC, Ehrenstein M, Isenberg DA. B cell depletion therapy in systemic lupus erythematosus: long-term follow-up and predictors of response. Ann Rheum Dis. 2007;66:1259-1262. (Pubitemid 47309748)
65. Bennett CL, Nebeker JR, Lyons EA, et al. The Research on Adverse Drug Events and Reports (RADAR) project. JAMA. 2005;293:2131-2140. (Pubitemid 40617066)
66. Bennett CL, Nebeker JR, Yarnold PR, et al. Evaluation of serious adverse drug reactions: a proactive pharmacovigilance program (RADAR) vs safety activities conducted by the Food and Drug Administration and pharmaceutical manufacturers. Arch Intern Med. 2007;167:1041-1049.
67. Holman RC, Torok TJ, Belay ED, Janssen RS, Schonberger LB. Progressive multifocal leukoencephalopathy in the United States, 1979-1994: increased mortality associated with HIV infection. Neuroepidemiology. 1998;17:303-309.
68. Kavanaugh A, Matteson E. Hotline: Rituximab and Progressive Multifocal Leukoencephalopathy. American College of Rheumatology; 2008. http://www.rheumatology.org/publications/hotline/0107leuko.asp. Accessed March 2, 2009.