Stronger association of drug-induced progressive multifocal leukoencephalopathy (PML) with biological immunomodulating agents

European Journal of Clinical Pharmacology

Volumn 66, Issue 2, 2010, Pages 199-206

  Piccinni, Carlo ^a   Sacripanti, Chiara ^a   Poluzzi, Elisabetta ^a   Motola, Domenico ^a   Magro, Lara ^b   Moretti, Ugo ^b   Conforti, Anita ^b   Montanaro, Nicola ^a  

^a UNIVERSITY OF BOLOGNA   (Italy)

^b UNIVERSITY OF VERONA   (Italy)

Author keywords

Adverse drug reaction; Database; Monoclonal antibody; Progressive multifocal leukoencephalopathy; Reporting system

Indexed keywords

ALEMTUZUMAB; ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; AZATHIOPRINE; CARMOFUR; CYCLOPHOSPHAMIDE; CYTARABINE; DOXORUBICIN; EFAVIRENZ; FLUDARABINE; FLUOROURACIL; FOLINATE CALCIUM; IMMUNOSUPPRESSIVE AGENT; INDINAVIR; LAMIVUDINE; LEVAMISOLE; LOPINAVIR; METHOTREXATE; MONOCLONAL ANTIBODY; MYCOPHENOLIC ACID; NATALIZUMAB; NEVIRAPINE; PEGINTERFERON ALPHA2A; PREDNISONE; RIBAVIRIN; RITONAVIR; RITUXIMAB; TACROLIMUS; TENOFOVIR; UNINDEXED DRUG; VINCRISTINE;

ARTICLE; AUTOIMMUNE DISEASE; DISEASE SEVERITY; DRUG INDUCED DISEASE; HUMAN; INFECTION; INFESTATION; LYMPHOPROLIFERATIVE DISEASE; NEOPLASM; PRIORITY JOURNAL; PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY; TRANSPLANTATION;

ADVERSE DRUG REACTION REPORTING SYSTEMS; ANTI-HIV AGENTS; ANTIBODIES, MONOCLONAL; ANTIBODIES, NEOPLASM; AUTOIMMUNE DISEASES; BIOLOGICAL PRODUCTS; BIOLOGICAL THERAPY; FEMALE; HUMANS; IMMUNOLOGIC FACTORS; IMMUNOMODULATION; IMMUNOSUPPRESSIVE AGENTS; LEUKOENCEPHALOPATHY, PROGRESSIVE MULTIFOCAL; LYMPHOPROLIFERATIVE DISORDERS; MALE; PRODUCT SURVEILLANCE, POSTMARKETING; RETROSPECTIVE STUDIES; TRANSPLANTATION;

EID: 76949087715     PISSN: 00316970     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00228-009-0739-z     Document Type: Article

References (38)

1. IJ Koralnik 2004 New insights into progressive multifocal leukoencephalopathy Curr Opin Neurol 17 365 370 10.1097/00019052-200406000-00019 15167073 (Pubitemid 38720991)
2. IJ Koralnik 2006 Progressive multifocal leukoencephalopathy revisited: has the disease outgrown its name? Ann Neurol 60 162 173 10.1002/ana.20933 16862584 (Pubitemid 44182391)
3. A Langer-Gould SW Atlas AJ Green AW Bollen D Pelletier 2005 Progressive multifocal leukoencephalopathy in a patient treated with natalizumab N Engl J Med 353 375 381 10.1056/NEJMoa051847 1:CAS:528:DC%2BD2MXms1Kntrc%3D 15947078 (Pubitemid 41132342)
4. BK Kleinschmidt-DeMasters KL Tyler 2005 Progressive multifocal leukoencephalopathy complicating treatment with natalizumab and interferon beta-1a for multiple sclerosis N Engl J Med 353 369 374 10.1056/NEJMoa051782 1:CAS:528:DC%2BD2MXms1KntrY%3D 15947079 (Pubitemid 41132341)
5. G Van Assche M Van Ranst R Sciot B Dubois S Vermeire M Noman J Verbeeck K Geboes W Robberecht P Rutgeerts 2005 Progressive multifocal leukoencephalopathy after natalizumab therapy for Crohn's disease N Engl J Med 353 362 368 10.1056/NEJMoa051586 15947080 (Pubitemid 41132340)
6. TA Yousry EO Major C Ryschkewitsch G Fahle S Fischer J Hou B Curfman K Miszkiel N Mueller-Lenke E Sanchez F Barkhof EW Radue HR Jager DB Clifford 2006 Evaluation of patients treated with natalizumab for progressive multifocal leukoencephalopathy N Engl J Med 354 924 933 10.1056/NEJMoa054693 1:CAS:528:DC%2BD28XitVertLs%3D 16510746 (Pubitemid 43313659)
7. CH Polman PW O'Connor E Havrdova M Hutchinson L Kappos DH Miller JT Phillips FD Lublin G Giovannoni A Wajgt M Toal F Lynn MA Panzara AW Sandrock 2006 A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis N Engl J Med 354 899 910 10.1056/NEJMoa044397 1:CAS:528:DC%2BD28XitVertL4%3D 16510744 (Pubitemid 43313657)
8. JR Berger 2007 Progressive multifocal leukoencephalopathy Curr Neurol Neurosci Rep 7 461 469 10.1007/s11910-007-0072-9 1:CAS:528:DC%2BD2sXhtlOls77E 17999891 (Pubitemid 350090305)
9. U.S. Food and Drug Administration (FDA) (2009) FDA-AERS Adverse Event Reporting System. http://www.fda.gov/cder/aers/default.htm. Accessed 23 Feb 2009
10. Northrup Grumman (2009) The Medical Dictionary for Regulatory Activities (MedDRA). Available via http://www.meddramsso.com/MSSOWeb/index.htm. Accessed 23 Feb 2009
11. World Health Organization (WHO) (2009) WHO-VigiBase.Uppsala Monitoring Centre. http://www.umc-products.com/DynPage.aspx?id=4910&mn=1107. Accessed 23 Feb 2009
12. World Health Organization (WHO) (2009) WHO Collaborating Centre for Drug Statistics Methodology. http://www.whocc.no/atcddd/. Accessed 23 Feb 2009
13. IW Hammond TG Gibbs HA Seifert DS Rich 2007 Database size and power to detect safety signals in pharmacovigilance Expert Opin Drug Saf 6 713 721 10.1517/14740338.6.6.713 1:CAS:528:DC%2BD2sXht1anu7%2FK 17967160 (Pubitemid 351308283)
14. CD Furberg AA Levin PA Gross RS Shapiro BL Strom 2006 The FDA and drug safety: a proposal for sweeping changes Arch Intern Med 166 1938 1942 10.1001/archinte.166.18.1938 17030825 (Pubitemid 44537173)
15. A Pariente F Gregoire A Fourrier-Reglat F Haramburu N Moore 2007 Impact of safety alerts on measures of disproportionality in spontaneous reporting databases: the notoriety bias Drug Saf 30 891 898 10.2165/00002018-200730100- 00007 17867726
16. D Motola A Vargiu R Leone A Conforti U Moretti A Vaccheri G Velo N Montanaro 2008 Influence of regulatory measures on the rate of spontaneous adverse drug reaction reporting in Italy Drug Saf 31 609 616 10.2165/00002018-200831070-00006 1:CAS:528:DC%2BD1cXpslKms7o%3D 18558794 (Pubitemid 351861953)
17. NR Hartnell JP Wilson 2004 Replication of the Weber effect using postmarketing adverse event reports voluntarily submitted to the United States Food and Drug Administration Pharmacotherapy 24 743 749 10.1592/phco.24.8.743. 36068 15222664 (Pubitemid 38747859)
18. M Hauben L Reich J DeMicco K Kim 2007 'Extreme duplication' in the US FDA Adverse Events Reporting System database Drug Saf 30 551 554 10.2165/00002018-200730060-00009 17536881 (Pubitemid 46873080)
19. V Falco M Olmo SV del Saz A Guelar JR Santos M Gutierrez D Colomer E Deig G Mateo M Montero E Pedrol D Podzamczer P Domingo JM Llibre 2008 Influence of HAART on the clinical course of HIV-1-infected patients with progressive multifocal leukoencephalopathy: results of an observational multicenter study J Acquir Immune Defic Syndr 49 26 31 10.1097/QAI.0b013e31817bec64 18667930
20. AJ Aksamit 2006 Review of progressive multifocal leukoencephalopathy and natalizumab Neurologist 12 293 298 10.1097/01.nrl.0000250948.04681.96 17122725 (Pubitemid 44813665)
21. EJ Boren GS Cheema SM Naguwa AA Ansari ME Gershwin 2008 The emergence of progressive multifocal leukoencephalopathy (PML) in rheumatic diseases J Autoimmun 30 90 98 10.1016/j.jaut.2007.11.013 1:CAS:528:DC%2BD1cXlvFSisQ%3D%3D 18191544
22. U.S. Food and Drug Administration (FDA) (2006) Tysabri - FDA approval letter. http://www.fda.gov/cder/foi/appletter/2006/125104s015LTR.pdf. Accessed 23 Feb 2009
23. U.S. Food and Drug Administration (FDA) (2006) Tysabri - risk minimization action plan. http://www.fda.gov/cder/foi/appletter/2006/ 125104s015LTR.pdf. Accessed 23 Feb 2009
24. GL Mancardi MP Amato R D'Alessandro F Drago C Milanese P Popoli L Provinciali P Rossi G Savettieri G Tedeschi MR Tola N Vanacore A Covezzoli M De Rosa C Piccinni N Montanaro L Periotto A Addis N Martini 2008 Natalizumab: a country-based surveillance program Neurol Sci 29 Suppl 2 S235 S237 10.1007/s10072-008-0948-8 18690503
25. TJ Giezen AK Mantel-Teeuwisse SM Straus H Schellekens HG Leufkens AC Egberts 2008 Safety-related regulatory actions for biologicals approved in the United States and the European Union JAMA 300 1887 1896 10.1001/jama.300.16.1887 1:CAS:528:DC%2BD1cXht12iur%2FN 18940975
26. KR Carson D Focosi EO Major M Petrini EA Richey DP West CL Bennett 2009 Monoclonal antibody-associated progressive multifocal leucoencephalopathy in patients treated with rituximab, natalizumab, and efalizumab: a review from the Research on Adverse Drug Events and Reports (RADAR) project Lancet Oncol 10 816 824 10.1016/S1470-2045(09)70161-5 1:CAS:528:DC%2BD1MXptlals7o%3D 19647202
27. J Uetrecht 2009 Immune-mediated adverse drug reactions Chem Res Toxicol 22 24 34 10.1021/tx800389u 1:CAS:528:DC%2BD1cXhsV2hurvJ 19149477
28. CD Hamilton 2004 Infectious complications of treatment with biologic agents Curr Opin Rheumatol 16 393 398 10.1097/01.bor.0000127594.92432.7c 15201602 (Pubitemid 38803140)
29. T Bongartz AJ Sutton MJ Sweeting I Buchan EL Matteson V Montori 2006 Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: systematic review and meta-analysis of rare harmful effects in randomized controlled trials JAMA 295 2275 2285 10.1001/jama.295.19. 2275 1:CAS:528:DC%2BD28Xksl2ktrk%3D 16705109 (Pubitemid 43736578)
30. A Strangfeld J Listing P Herzer A Liebhaber K Rockwitz C Richter A Zink 2009 Risk of herpes zoster in patients with rheumatoid arthritis treated with anti-TNF-alpha agents JAMA 301 737 744 10.1001/jama.2009.146 1:CAS:528:DC%2BD1MXit1anu7Y%3D 19224750
31. RA Rudick WH Stuart PA Calabresi C Confavreux SL Galetta EW Radue FD Lublin B Weinstock-Guttman DR Wynn F Lynn MA Panzara AW Sandrock 2006 Natalizumab plus interferon beta-1a for relapsing multiple sclerosis N Engl J Med 354 911 923 10.1056/NEJMoa044396 1:CAS:528:DC%2BD28XitVertLw%3D 16510745 (Pubitemid 43313658)
32. WJ Sandborn JF Colombel R Enns BG Feagan SB Hanauer IC Lawrance R Panaccione M Sanders S Schreiber S Targan S van Deventer R Goldblum D Despain GS Hogge P Rutgeerts 2005 Natalizumab induction and maintenance therapy for Crohn's disease N Engl J Med 353 1912 1925 10.1056/NEJMoa043335 1:CAS:528:DC%2BD2MXhtF2rsbzF 16267322 (Pubitemid 41565956)
33. HP Hartung 2009 New cases of progressive multifocal leukoencephalopathy after treatment with natalizumab Lancet Neurol 8 28 31 10.1016/S1474-4422(08) 70281-3 19081511
34. European Agency for the Evaluation of Medicinal Products (EMEA) (2009) European Medicines Agency recommends suspension of the marketing authorisation ofRaptiva (efalizumab). EMEA/CHMP/20857/2009. http://www.emea.europa.eu/ humandocs/PDFs/EPAR/raptiva/2085709en.pdf. Accessed 1 Apr 2009
35. VC Wu JW Huang HC Lien ST Hsieh HM Liu CC Yang YH Lin JJ Hwang KD Wu 2006 Levamisole-induced multifocal inflammatory leukoencephalopathy: clinical characteristics, outcome, and impact of treatment in 31 patients Medicine (Baltimore) 85 203 213 10.1097/01.md.0000230250.95281.60 1:CAS:528: DC%2BD28XntFyqtrc%3D (Pubitemid 44107178)
36. National Institute for Health and Clinical Excellence (NICE) (2007) Natalizumab for the treatment of adults with highly active relapsing- remitting multiple sclerosis. www.nice.org.uk
37. L Naldi A Addis S Chimenti A Giannetti M Picardo C Tomino M Maccarone L Chatenoud P Bertuccio E Maggese R Cuscito 2008 Impact of body mass index and obesity on clinical response to systemic treatment for psoriasis. Evidence from the Psocare project Dermatology 217 365 373 10.1159/000156599 18810241
38. T Nijsten M Wakkee 2008 Psocare: Italy shows the way in postmarketing studies Dermatology 217 362 364 10.1159/000156598 18810240