Demyelinating Disease in Patients Treated with TNF Antagonists in Rheumatology: Data from BIOBADASER, a Pharmacovigilance Database, and a Systematic Review

Seminars in Arthritis and Rheumatism

Volumn 40, Issue 4, 2011, Pages 330-337

  Fernández Espartero, María Cruz ^a   Pérez Zafrilla, Beatriz ^b   Naranjo, Antonio ^c   Esteban, Carmen ^d   Ortiz, Ana M ^e   Gómez Reino, Juan J ^f   Carmona, Loreto ^g  

^a HOSPITAL DE MÓSTOLES   (Spain)

^b HOSPITAL GENERAL UNIVERSITARIO DE ALBACETE   (Spain)

^c HOSPITAL UNIVERSITARIO DE GRAN CANARIA DR NEGRÍN   (Spain)

^d Pharmacovigilance Unit   (Spain)

^e HOSPITAL UNIVERSITARIO DE LA PRINCESA   (Spain)

^f Pediatric Nutrition Research Group Health Research Institute of Santiago de Compostela   (Spain)

^g UNIDAD DE INVESTIGACIÓN   (Spain)

Author keywords

Demyelinating disease; Demyelination; Multiple sclerosis; Optic neuritis; TNF antagonists

Indexed keywords

ADALIMUMAB; AMITRIPTYLINE; BETA INTERFERON; ETANERCEPT; GABAPENTIN; GLUCOCORTICOID; IMMUNOGLOBULIN; INFLIXIMAB; INTERFERON; METHOTREXATE; MITOXANTRONE; TUMOR NECROSIS FACTOR ANTIBODY;

ADULT; AGED; ANKYLOSING SPONDYLITIS; ARTICLE; COCHRANE LIBRARY; CONTROLLED STUDY; DEMYELINATING DISEASE; DRUG SURVEILLANCE PROGRAM; DRUG WITHDRAWAL; DYSESTHESIA; EMBASE; FACIAL NERVE PARALYSIS; FEMALE; GUILLAIN BARRE SYNDROME; HUMAN; INCIDENCE; MAJOR CLINICAL STUDY; MALE; MEDLINE; MULTIPLE SCLEROSIS; OPTIC NEURITIS; PARESTHESIA; POLYNEUROPATHY; PRIORITY JOURNAL; PSORIATIC ARTHRITIS; REFERENCE DATABASE; REGISTER; RHEUMATIC DISEASE; RHEUMATOID ARTHRITIS; RHEUMATOLOGY; SPAIN; SYSTEMATIC REVIEW; VOCAL CORD PARALYSIS;

EID: 78751704873     PISSN: 00490172     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.semarthrit.2010.06.004     Document Type: Article

References (44)

1. Selmaj K., Raine C.S., Cross A.H. Anti-tumor necrosis factor therapy abrogates autoimmune demyelination. Ann Neurol 1991, 30(5):694-700.
2. Baker D., Butler D., Scallon B.J., O'Neill J.K., Turk J.L., Feldmann M. Control of established experimental allergic encephalomyelitis by inhibition of tumor necrosis factor (TNF) activity within the central nervous system using monoclonal antibodies and TNF receptor-immunoglobulin fusion proteins. Eur J Immunol 1994, 24(9):2040-2048.
3. Hofman F.M., Hinton D.R., Johnson K., Merrill J.E. Tumor necrosis factor identified in multiple sclerosis brain. J Exp Med 1989, 170(2):607-612.
4. Sharief M.K., Hentges R. Association between tumor necrosis factor-alpha and disease progression in patients with multiple sclerosis. N Engl J Med 1991, 325(7):467-472.
5. Maimone D., Gregory S., Arnason B.G., Reder A.T. Cytokine levels in the cerebrospinal fluid and serum of patients with multiple sclerosis. J Neuroimmunol 1991, 32(1):67-74.
6. Selmaj K., Raine C.S., Cannella B., Brosnan C.F. Identification of lymphotoxin and tumor necrosis factor in multiple sclerosis lesions. J Clin Invest 1991, 87(3):949-954.
7. Selmaj K.W., Raine C.S. Experimental autoimmune encephalomyelitis: immunotherapy with anti-tumor necrosis factor antibodies and soluble tumor necrosis factor receptors. Neurology 1995, 45(6 Suppl 6):S44-S49.
8. Mohan N., Edwards E.T., Cupps T.R., Oliverio P.J., Sandberg G., Crayton H., et al. Demyelination occurring during anti-tumor necrosis factor alpha therapy for inflammatory arthritides. Arthritis Rheum 2001, 44(12):2862-2869.
9. Sicotte N.L., Voskuhl R.R. Onset of multiple sclerosis associated with anti-TNF therapy. Neurology 2001, 57(10):1885-1888.
10. Foroozan R., Buono L.M., Sergott R.C., Savino P.J. Retrobulbar optic neuritis associated with infliximab. Arch Ophthalmol 2002, 120(7):985-987.
11. Attout H., Toussirot E., Auge B., Chavot D., Wendling D. Rheumatoid arthritis and multiple sclerosis in the same patient. Two case-reports. Rev Rhum Engl Ed 1999, 66(3):169-172.
12. Brinar V.V., Petelin Z., Brinar M., Djakovic V., Zadro I., Vranjes D. CNS demyelination in autoimmune diseases. Clin Neurol Neurosurg 2006, 108(3):318-326.
13. Midgard R., Gronning M., Riise T., Kvale G., Nyland H. Multiple sclerosis and chronic inflammatory diseases. A case-control study. Acta Neurol Scand 1996, 93(5):322-328.
14. Toussirot E., Pertuiset E., Martin A., Melac-Ducamp S., Alcalay M., Grardel B., et al. Association of rheumatoid arthritis with multiple sclerosis: report of 14 cases and discussion of its significance. J Rheumatol 2006, 33(5):1027-1028.
15. Nasir A., Greenberg J.D. TNF antagonist safety in rheumatoid arthritis: updated evidence from observational registries. Bull NYU Hosp Jt Dis 2007, 65(3):178-181.
16. Carmona L., Gomez-Reino J.J., Rodriguez-Valverde V., Montero D., Pascual-Gomez E., Mola E.M., et al. Effectiveness of recommendations to prevent reactivation of latent tuberculosis infection in patients treated with tumor necrosis factor antagonists. Arthritis Rheum 2005, 52(6):1766-1772.
17. Gomez-Reino J.J., Carmona L., Valverde V.R., Mola E.M., Montero M.D. Treatment of rheumatoid arthritis with tumor necrosis factor inhibitors may predispose to significant increase in tuberculosis risk: a multicenter active-surveillance report. Arthritis Rheum 2003, 48(8):2122-2127.
18. BIOBADASER: Spanish Registry for Adverse Events of Biological Therapies in Rheumatic Diseases Spanish Society of Rheumatology, [19/10/2008]. http://biobadaser.ser.es/biobadaser/eng/index.html.
19. Cervera A., Maymo A.C., Martinez-Pardo R., Garcera M.D. Vitellogenin polypeptide levels in one susceptible and one cadmium-resistant strain of Oncopeltus fasciatus (Heteroptera: Lygaeidae), and its role in cadmium resistance. J Insect Physiol 2006, 52(2):158-168.
20. [database on the Internet] [cited 19/10/2008]. Available from: http://www.meddramsso.org.
21. Brown E.G. Using MedDRA: implications for risk management. Drug Saf 2004, 27(8):591-602.
22. Casquero P., Villoslada P., Montalban X., Torrent M. Frequency of multiple sclerosis in Menorca, Balearic islands, Spain. Neuroepidemiology 2001, 20(2):129-133.
23. Benito-Leon J., Martin E., Vela L., Villar M.E., Felgueroso B., Marrero C., et al. Multiple sclerosis in Mostoles, central Spain. Acta Neurol Scand 1998, 98(4):238-242.
24. Hernandez M.A. Epidemiology of multiple sclerosis in the Canary Islands (Spain): a study on the island of La Palma. J Neurol 2002, 249(10):1378-1381.
25. Modrego Pardo P.J., Latorre M.A., Lopez A., Errea J.M. Prevalence of multiple sclerosis in the province of Teruel, Spain. J Neurol 1997, 244(3):182-185.
26. Chang V., McCurdy D., Gordon L.K. Etanercept associated optic neuropathy. Clin Exp Ophthalmol 2007, 35(7):680-682.
27. Shin I.S., Baer A.N., Kwon H.J., Papadopoulos E.J., Siegel J.N. Guillain-Barre and Miller Fisher syndromes occurring with tumor necrosis factor alpha antagonist therapy. Arthritis Rheum 2006, 54(5):1429-1434.
28. Simsek I., Erdem H., Pay S., Sobaci G., Dinc A. Optic neuritis occurring with anti-tumour necrosis factor alpha therapy. Ann Rheum Dis 2007, 66(9):1255-1258.
29. Richette P., Dieude P., Damiano J., Liote F., Orcel P., Bardin T. Sensory neuropathy revealing necrotizing vasculitis during infliximab therapy for rheumatoid arthritis. J Rheumatol 2004, 31(10):2079-2081.
30. Cisternas M., Gutierrez M., Jacobelli S. Successful rechallenge with anti-tumor necrosis factor alpha for psoriatic arthritis after development of demyelinating nervous system disease during initial treatment: comment on the article by Mohan et al. Arthritis Rheum 2002, 46(11):3107-3108. [author reply 8-9].
31. Cay H.F., Gungor H.A., Sezer I., Kacar C., Balci N. Adverse effect of TNF-alpha blocker?. Demyelination in an ankylosing spondylitis patient: a case report. J Clin Pharm Ther 2006, 31(6):645-648.
32. Ruiz-Jimeno T., Carvajal A., Mata C., Aurrecoechea E. Demyelinating disease in a patient with psoriatic arthritis and family history of multiple sclerosis treated with infliximab. J Rheumatol 2006, 33(7):1457-1458.
33. Enayati P.J., Papadakis K.A. Association of anti-tumor necrosis factor therapy with the development of multiple sclerosis. J Clin Gastroenterol 2005, 39(4):303-306.
34. Rovira A., Swanton J., Tintore M., Huerga E., Barkhof F., Filippi M., et al. A single, early magnetic resonance imaging study in the diagnosis of multiple sclerosis. Arch Neurol 2009, 66(5):587-592.
35. Suissa S., Renoux C., Bernatsky S. Demyelinating events in rheumatoid arthritis after drug exposures. Ann Rheum Dis 2010 Jun 22, Epub ahead of print.
36. Carmona L., Villaverde V., Hernandez-Garcia C., Ballina J., Gabriel R., Laffon A. The prevalence of rheumatoid arthritis in the general population of Spain. Rheumatology (Oxford) 2002, 41(1):88-95.
37. Martin R., McFarland H.F., McFarlin D.E. Immunological aspects of demyelinating diseases. Annu Rev Immunol 1992, 10:153-187.
38. Hafler D.A., Slavik J.M., Anderson D.E., O'Connor K.C., De Jager P., Baecher-Allan C. Multiple sclerosis. Immunol Rev 2005, 204:208-231.
39. Gonzalez-Alvaro I., Descalzo M.A., Carmona L. Trends towards an improved disease state in rheumatoid arthritis over time: influence of new therapies and changes in management approach: analysis of the EMECAR cohort. Arthritis Res Ther 2008, 10(6):R138.
40. TNF neutralization in MS: results of a randomized, placebo-controlled multicenter study. The Lenercept Multiple Sclerosis Study Group and the University of British Columbia MS/MRI Analysis Group. Neurology 1999, 53(3):457-465.
41. van Oosten B.W., Barkhof F., Truyen L., Boringa J.B., Bertelsmann F.W., von Blomberg B.M., et al. Increased MRI activity and immune activation in two multiple sclerosis patients treated with the monoclonal anti-tumor necrosis factor antibody cA2. Neurology 1996, 47(6):1531-1534.
42. Robinson W.H., Genovese M.C., Moreland L.W. Demyelinating and neurologic events reported in association with tumor necrosis factor alpha antagonism: by what mechanisms could tumor necrosis factor alpha antagonists improve rheumatoid arthritis but exacerbate multiple sclerosis?. Arthritis Rheum 2001, 44(9):1977-1983.
43. Sotgiu S., Pugliatti M., Fois M.L., Arru G., Sanna A., Sotgiu M.A., et al. Genes, environment, and susceptibility to multiple sclerosis. Neurobiol Dis 2004, 17(2):131-143.
44. van Boxel-Dezaire A.H., Hoff S.C., van Oosten B.W., Verweij C.L., Drager A.M., Ader H.J., et al. Decreased interleukin-10 and increased interleukin-12p40 mRNA are associated with disease activity and characterize different disease stages in multiple sclerosis. Ann Neurol 1999, 45(6):695-703.