Serious infections in patients with rheumatoid arthritis and other immune-mediated connective tissue diseases exposed to anti-TNF or rituximab: Data from the Spanish registry BIOBADASER 2.0

Rheumatology International

Volumn 34, Issue 7, 2014, Pages 953-961

  Cobo Ibáñez, Tatiana ^a   Descalzo, Miguel Ángel ^b   Loza Santamaría, Estibaliz ^c   Carmona, Loreto ^c,d   Muñoz Fernández, Santiago ^a  

^a HOSPITAL UNIVERSITARIO INFANTA SOFÍA   (Spain)

^b UNIDAD DE INVESTIGACIÓN   (Spain)

^c Institute for Health   (Spain)

^d CAMILO JOSÉ CELA UNIVERSITY   (Spain)

Author keywords

Anti TNF; Immune mediated connective tissue diseases; Rheumatoid arthritis; Rituximab; Serious infections

Indexed keywords

ADALIMUMAB; AZATHIOPRINE; CORTICOSTEROID; CYCLOPHOSPHAMIDE; CYCLOSPORIN; ETANERCEPT; GLUCOCORTICOID; INFLIXIMAB; METHOTREXATE; RITUXIMAB; TUMOR NECROSIS FACTOR INHIBITOR; ANTIRHEUMATIC AGENT; MONOCLONAL ANTIBODY; TUMOR NECROSIS FACTOR ALPHA;

ARTICLE; ASPERGILLOSIS; CANDIDIASIS; CENTRAL NERVOUS SYSTEM INFECTION; CHICKENPOX; COMORBIDITY; CONNECTIVE TISSUE DISEASE; CORTICOSTEROID THERAPY; CYTOMEGALOVIRUS INFECTION; DISEASE DURATION; FEMALE; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; INFECTION; LEISHMANIASIS; LISTERIOSIS; LUNG TUBERCULOSIS; MAJOR CLINICAL STUDY; MALE; MILIARY TUBERCULOSIS; MIXED CONNECTIVE TISSUE DISEASE; MORTALITY; PRIORITY JOURNAL; RHEUMATOID ARTHRITIS; RISK FACTOR; SCLERODERMA; SYSTEMIC LUPUS ERYTHEMATOSUS; TUBERCULOSIS; URINARY TRACT INFECTION; ADULT; AGED; ANTAGONISTS AND INHIBITORS; ARTHRITIS, RHEUMATOID; BACTERIAL INFECTIONS; COMPLICATION; CONNECTIVE TISSUE DISEASES; INCIDENCE; MIDDLE AGED; OPPORTUNISTIC INFECTIONS; REGISTER; STATISTICS AND NUMERICAL DATA; VIRUS DISEASES;

ADULT; AGED; ANTIBODIES, MONOCLONAL, MURINE-DERIVED; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; BACTERIAL INFECTIONS; COMORBIDITY; CONNECTIVE TISSUE DISEASES; FEMALE; HUMANS; INCIDENCE; MALE; MIDDLE AGED; OPPORTUNISTIC INFECTIONS; REGISTRIES; RISK FACTORS; TUMOR NECROSIS FACTOR-ALPHA; VIRUS DISEASES;

EID: 84903184734     PISSN: 01728172     EISSN: 1437160X     Source Type: Journal    
DOI: 10.1007/s00296-014-2945-y     Document Type: Article

References (26)

1. Clinical practice guideline for the management of rheumatoid arthritis in Spain (2007) http://www.ser.es/practicaClinica/Guias-practica-clinica/Guias- finalizadas.php. Accessed 2 Nov 2013
2. Furst DE, Keystone EC, Braun J et al (2011) Updated consensus statement on biological agents for the treatment of rheumatic diseases, 2010. Ann Rheum Dis 70(Suppl 1):2-36
3. Gomez Reino J, Loza E, Andreu JL et al (2011) Consensus statement of the Spanish Society of Rheumatology on risk management of biologic therapy in rheumatic patients. Reumatol Clin 7:284-298
4. Conti F, Ceccarelli F, Perricone C et al (2011) Rituximab infusion-related adverse event rates are lower in patients with systemic lupus erythematosus than in those with rheumatoid arthritis. Rheumatology (Oxford) 50:1148-1152
5. Carmona L, Descalzo MA, Ruiz-Montesinos D et al (2011) Safety and retention rate of off-label uses of TNF antagonists in rheumatic conditions: data from the Spanish registry BIOBADASER 2.0. Rheumatology (Oxford) 50:85-92
6. MedDRA (Meddra maintenance and support services organization. http://www.Meddramsso.Org/)
7. Dixon WG, Carmona L, Finckh A et al (2010) EULAR points to consider when establishing, analysing and reporting safety data of biologics registers in rheumatology. Ann Rheum Dis 69:1596-1602
8. Ramos-Casals M, Brito-Zeron P, Munoz S et al (2008) A systematic review of the off-label use of biological therapies in systemic autoimmune diseases. Medicine 87:345-364
9. Galloway JB, Hyrich KL, Mercer LK et al (2011) Anti-TNF therapy is associated with an increased risk of serious infections in patients with rheumatoid arthritis especially in the first 6 months of treatment: updated results from the British Society for Rheumatology Biologics Register with special emphasis on risks in the elderly. Rheumatology (Oxford) 50:124-131
10. Curtis JR, Xie F, Chen L et al (2011) The comparative risk of serious infections among rheumatoid arthritis patients starting or switching biological agents. Ann Rheum Dis 70:1401-1406
11. Diaz-Lagares C, Perez-Alvarez R, Garcia-Hernandez FJ et al (2011) Rates of, and risk factors for, severe infections in patients with systemic autoimmune diseases receiving biological agents off-label. Arthritis Res Ther 13:R112. doi:10.1186/ar3397
12. Terrier B, Amoura Z, Ravaud P et al (2010) Safety and efficacy of rituximab in systemic lupus erythematosus: results from 136 patients from the French auto immunity and rituximab registry. Arthritis Rheum 62:2458-2466
13. Tony HP, Burmester G, Schulze-Koops H et al (2011) Safety and clinical outcomes of rituximab therapy in patients with different autoimmune diseases: experience from a national registry (GRAID. Arthritis Res Ther 13:R75. doi:10.1186/ar3337
14. Alamanos Y, Tsifetaki N, Voulgari PV et al (2006) Epidemiology of primary Sjogren's syndrome in north-west Greece, 1982-2003. Rheumatology (Oxford) 45:187-191 (Pubitemid 43160081)
15. Carmona L, Descalzo MA, Perez-Pampin E et al (2007) All-cause and cause-specific mortality in rheumatoid arthritis are not greater than expected when treated with tumour necrosis factor antagonists. Ann Rheum Dis 66:880-885 (Pubitemid 46999787)
16. Toledano E, Candelas G, Rosales Z et al (2012) A meta-analysis of mortality in rheumatic diseases. Reumatol Clin 8:334-341
17. Carmona L, Gomez-Reino JJ, Rodriguez-Valverde V et al (2005) Effectiveness of recommendations to prevent reactivation of latent tuberculosis infection in patients treated with tumor necrosis factor antagonists. Arthritis Rheum 52:1766-1772 (Pubitemid 40852885)
18. Peña-Sagredo JLHM, Fernandez-Llanio N, Giménez-Ubeda E et al (2008) Listeria monocytogenes infection in patients with rheumatic diseases on TNF-alpha antagonist therapy: the Spanish Study Group experience. Clin Exp Rheumatol 26:854-859
19. Schmedt NAF, Garbe E (2012) 9 Signals of progressive multifocal leukoencephalopathy for immunosuppressants: a disproportionality analysis of spontaneous reports within the US Adverse Event Reporting System (AERS). Pharmacoepidemiol Drug Saf 21:1216-1220
20. Molloy ES, Calabrese LH (2012) Progressive multifocal leukoencephalopathy associated with immunosuppressive therapy in rheumatic diseases: evolving role of biologic therapies. Arthritis Rheum 64:3043-3051
21. Atzeni F, Sarzi-Puttini P, Botsios C et al (2012) Long-term anti-TNF therapy and the risk of serious infections in a cohort of patients with rheumatoid arthritis: comparison of adalimumab, etanercept and infliximab in the GISEA registry. Autoimmun Rev 12:225-229
22. Doran MF, Crowson CS, Pond GR (2002) Predictors of infection in rheumatoid arthritis. Arthritis Rheum 46:2294-2300
23. Gottenberg JE, Ravaud P, Bardin T (2010) Risk factors for severe infections in patients with rheumatoid arthritis treated with rituximab in the autoimmunity and rituximab registry. Arthritis Rheum 62:2625-2632
24. Bj F (2002) Infectious disease in systemic lupus erythematosus: risk factors, management and prophylaxis. Best Pract Res Clin Rheumatol 16:281-291
25. Chen IJ, Tsai WP, Wu YJ (2010) Infections in polymyositis and dermatomyositis: analysis of 192 cases. Rheumatology (Oxford) 49:2429-2437
26. Ruiz-Irastorza G, Olivares N, Ruiz-Arruza I (2009) Predictors of major infections in systemic lupus erythematosus. Arthritis Res Ther 11:R109. doi:10.1186/ar2764