Rates of, and risk factors for, severe infections in patients with systemic autoimmune diseases receiving biological agents off-label

Arthritis Research and Therapy

Volumn 13, Issue 4, 2011, Pages

  Díaz Lagares, Cándido ^a   Pérez Alvarez, Roberto ^b   García Hernández, Francisco J ^c   Ayala Gutiérrez, María M ^d   Callejas, José L ^e   Martínez Berriotxoa, Agustín ^f   Rascón, Javier ^g   Caminal Montero, Luis ^h   Selva O'Callaghan, Albert ⁱ   Oristrell, Joaquim ^j   Hidalgo, Carmen ^k   Gómez de la Torre, Ricardo ^l   Sáez, Luis ^m   Canora Lebrato, Jesús ⁿ   Camps, María Teresa ^d   Ortego Centeno, Norberto ^e   Castillo Palma, María Jesús ^c   Ramos Casals, Manuel ^a  

^a HOSPITAL CLÍNIC   (Spain)

^b HOSPITAL DO MEIXOEIRO   (Spain)

^c HOSPITAL UNIVERSITARIO VIRGEN DEL ROCÍO   (Spain)

^d HOSPITAL REGIONAL UNIVERSITARIO DE MÁLAGA   (Spain)

^e HOSPITAL UNIVERSITARIO SAN CECILIO   (Spain)

^f HOSPITAL DE CRUCES   (Spain)

^g HOSPITAL UNIVERSITARIO SON ESPASES   (Spain)

^h HOSPITAL UNIVERSITARIO CENTRAL DE ASTURIAS   (Spain)

ⁱ HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^j HOSPITAL DE SABADELL   (Spain)

^k HOSPITAL UNIVERSITARIO VIRGEN DE LAS NIEVES   (Spain)

^l Hospital de Avilés   (Spain)

^m Servicio de Medicina Interna   (Spain)

ⁿ HOSPITAL UNIVERSITARIO DE FUENLABRADA   (Spain)

more..

Author keywords

Adalimumab; Etanercept; Infection rate; Infliximab; Rituximab; Sj gren syndrome; Systemic lupus erythematosus; Vasculitis

Indexed keywords

ADALIMUMAB; ANTIBIOTIC AGENT; AZATHIOPRINE; BIOLOGICAL PRODUCT; CORTICOSTEROID; CYCLOPHOSPHAMIDE; CYCLOSPORIN A; ETANERCEPT; IMMUNOGLOBULIN; IMMUNOSUPPRESSIVE AGENT; INFLIXIMAB; METHOTREXATE; METHYLPREDNISOLONE; MYCOPHENOLIC ACID; RITUXIMAB; TACROLIMUS;

ADULT; AGE; ARTICLE; AUTOIMMUNE DISEASE; BACTEREMIA; BEHCET DISEASE; COHORT ANALYSIS; CRYOGLOBULINEMIA; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; FEMALE; FOLLOW UP; GENDER; HOSPITALIZATION; HUMAN; INFECTION; INFECTION RATE; INFECTION RISK; LOG RANK TEST; LOWER RESPIRATORY TRACT INFECTION; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTIPLE CYCLE TREATMENT; MYOSITIS; OBSERVATIONAL STUDY; OFF LABEL DRUG USE; PROPORTIONAL HAZARDS MODEL; PROSPECTIVE STUDY; RISK FACTOR; SEPSIS; SJOEGREN SYNDROME; SURVIVAL RATE; SYSTEMIC DISEASE; SYSTEMIC LUPUS ERYTHEMATOSUS; SYSTEMIC VASCULITIS; URINARY TRACT INFECTION; WEGENER GRANULOMATOSIS; ADOLESCENT; AGED; KAPLAN MEIER METHOD; MIDDLE AGED;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; AUTOIMMUNE DISEASES; BIOLOGICAL AGENTS; FEMALE; HUMANS; INFECTION; KAPLAN-MEIER ESTIMATE; MALE; MIDDLE AGED; OFF-LABEL USE; PROPORTIONAL HAZARDS MODELS; RISK FACTORS; YOUNG ADULT;

EID: 79960055269     PISSN: 14786354     EISSN: 14786362     Source Type: Journal    
DOI: 10.1186/ar3397     Document Type: Article

References (35)

1. Silverman GJ, Weisman S. Rituximab therapy and autoimmune disorders: prospects for anti-B cell therapy. Arthritis Rheum 2003, 48:1484-1492. 10.1002/art.10947, 12794814.
2. Ramos-Casals M, Brito-Zerón P, Muñoz S, Soto MJ, . BIOGEAS STUDY Group A systematic review of the off-label use of biological therapies in systemic autoimmune diseases. Medicine (Baltimore) 2008, 87:345-364. BIOGEAS STUDY Group.
3. Meijer JM, Meiners PM, Vissink A, Spijkervet FK, Abdulahad W, Kamminga N, Brouwer E, Kallenberg CG, Bootsma H. Effectiveness of rituximab treatment in primary Sjögren's syndrome: a randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2010, 62:960-968.
4. Dass S, Bowman SJ, Vital EM, Ikeda K, Pease CT, Hamburger J, Richards A, Rauz S, Emery P. Reduction of fatigue in Sjögren syndrome with rituximab: results of a randomised, double-blind, placebo-controlled pilot study. Ann Rheum Dis 2008, 67:1541-1544.
5. Merrill JT, Neuwelt CM, Wallace DJ, Shanahan JC, Latinis KM, Oates JC, Utset TO, Gordon C, Isenberg DA, Hsieh HJ, Zhang D, Brunetta PG. Efficacy and safety of rituximab in moderately-to-severely active systemic lupus erythematosus: the randomized, double-blind, phase II/III systemic lupus erythematosus evaluation of rituximab trial. Arthritis Rheum 2010, 62:222-233. 10.1002/art.27233, 20039413.
6. Stone JH, Merkel PA, Spiera R, Seo P, Langford CA, Hoffman GS, Kallenberg CG, St Clair EW, Turkiewicz A, Tchao NK, Webber L, Ding L, Sejismundo LP, Mieras K, Weitzenkamp D, Ikle D, Seyfert-Margolis V, Mueller M, Brunetta P, Allen NB, Fervenza FC, Geetha D, Keogh KA, Kissin EY, Monach PA, Peikert T, Stegeman C, Ytterberg SR, Specks U, . RAVE-ITN Research Group Rituximab versus cyclophosphamide for ANCA-associated vasculitis. N Engl J Med 2010, 363:221-232. 10.1056/NEJMoa0909905, 3137658, 20647199, RAVE-ITN Research Group.
7. Jones RB, Tervaert JW, Hauser T, Luqmani R, Morgan MD, Peh CA, Savage CO, Segelmark M, Tesar V, van Paassen P, Walsh D, Walsh M, Westman K, Jayne DR, . European Vasculitis Study Group Rituximab versus cyclophosphamide in ANCA-associated renal vasculitis. N Engl J Med 2010, 363:211-220. 10.1056/NEJMoa0909169, 20647198, European Vasculitis Study Group.
8. Hoffman GS, Cid MC, Rendt-Zagar KE, Merkel PA, Weyand CM, Stone JH, Salvarani C, Xu W, Visvanathan S, Rahman MU, . Infliximab-GCA Study Group Infliximab for maintenance of glucocorticosteroid-induced remission of giant cell arteritis: a randomized trial. Ann Intern Med 2007, 146:621-630. Infliximab-GCA Study Group.
9. Salvarani C, Macchioni P, Manzini C, Paolazzi G, Trotta A, Manganelli P, Cimmino M, Gerli R, Catanoso MG, Boiardi L, Cantini F, Klersy C, Hunder GG. Infliximab plus prednisone or placebo plus prednisone for the initial treatment of polymyalgia rheumatica: a randomized trial. Ann Intern Med 2007, 146:631-639.
10. Baughman RP, Lower EE, Bradley DA, Raymond LA, Kaufman A. Etanercept for refractory ocular sarcoidosis: results of a double-blind randomized trial. Chest 2005, 128:1062-1047. 10.1378/chest.128.2.1062, 16100213.
11. Mariette X, Ravaud P, Steinfeld S, Baron G, Goetz J, Hachulla E, Combe B, Puéchal X, Pennec Y, Sauvezie B, Perdriger A, Hayem G, Janin A, Sibilia J. Inefficacy of infliximab in primary Sjögren's syndrome: results of the randomized, controlled Trial of Remicade in Primary Sjögren's Syndrome (TRIPSS). Arthritis Rheum 2004, 50:1270-1276. 10.1002/art.20146, 15077311.
12. Melikoglu M, Fresko I, Mat C, Ozyazgan Y, Gogus F, Yurdakul S, Hamuryudan V, Yazici H. Short-term trial of etanercept in Behçet's disease: a double blind, placebo controlled study. J Rheumatol 2005, 32:98-105.
13. Rossman MD, Newman LS, Baughman RP, Teirstein A, Weinberger SE, Miller W, Sands BE. A double-blinded, randomized, placebo-controlled trial of infliximab in subjects with active pulmonary sarcoidosis. Sarcoidosis Vasc Diffuse Lung Dis 2006, 23:201-208.
14. Sankar V, Brennan MT, Kok MR, Leakan RA, Smith JA, Manny J, Baum BJ, Pillemer SR. Etanercept in Sjögren's syndrome: a twelve-week randomized, double-blind, placebo-controlled pilot clinical trial. Arthritis Rheum 2004, 50:2240-2245. 10.1002/art.20299, 15248223.
15. Wegener's Granulomatosis Etanercept Trial (WGET) Research Group Etanercept plus standard therapy for Wegener's granulomatosis. N Engl J Med 2005, 352:351-361. Wegener's Granulomatosis Etanercept Trial (WGET) Research Group.
16. Martínez-Taboada VM, Rodríguez-Valverde V, Carreño L, López-Longo J, Figueroa M, Belzunegui J, Mola EM, Bonilla G. A double-blind placebo controlled trial of etanercept in patients with giant cell arteritis and corticosteroid side effects. Ann Rheum Dis 2008, 67:625-630.
17. Ramos-Casals M, García-Hernández FJ, de Ramón E, Callejas JL, Martínez-Berriotxoa A, Pallarés L, Caminal-Montero L, Selva-O'Callaghan A, Oristrell J, Hidalgo C, Pérez-Alvarez R, Micó ML, Medrano F, Gómez de la Torre R, Díaz-Lagares C, Camps M, Ortego N, Sánchez-Román J, . BIOGEAS Study Group Off-label use of rituximab in 196 patients with severe, refractory systemic autoimmune diseases. Clin Exp Rheumatol 2010, 28:468-476. BIOGEAS Study Group.
18. Terrier B, Amoura Z, Ravaud P, Hachulla E, Jouenne R, Combe B, Bonnet C, Cacoub P, Cantagrel A, de Bandt M, Fain O, Fautrel B, Gaudin P, Godeau B, Harlé JR, Hot A, Kahn JE, Lambotte O, Larroche C, Léone J, Meyer O, Pallot-Prades B, Pertuiset E, Quartier P, Schaerverbeke T, Sibilia J, Somogyi A, Soubrier M, Vignon E, Bader-Meunier B, Mariette X, Gottenberg JE, . Club Rhumatismes et Inflammation Safety and efficacy of rituximab in systemic lupus erythematosus: results from 136 patients from the French AutoImmunity and Rituximab registry. Arthritis Rheum 2010, 62:2458-2466. 10.1002/art.27541, 20506527, Club Rhumatismes et Inflammation.
19. Dixon WG, Watson K, Lunt M, Hyrich KL, Silman AJ, Symmons DP, . British Society for Rheumatology Biologics Register Rates of serious infection, including site-specific and bacterial intracellular infection, in rheumatoid artritis patients receiving anti-tumor necrosis factor therapy: results from the British Society for Rheumatology Biologics Register. Arthritis Rheum 2006, 54:2368-2376. 10.1002/art.21978, 16868999, British Society for Rheumatology Biologics Register.
20. Galloway JB, Hyrich KL, Mercer LK, Dixon WG, Fu B, Ustianowski AP, Watson KD, Lunt M, Symmons DP, . BSRBR Control Centre Consortium, on behalf of the British Society for Rheumatology Biologics Register Anti-TNF therapy is associated with an increased risk of serious infections in patients with rheumatoid artritis 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) 2011, 50(1):124-131. BSRBR Control Centre Consortium, on behalf of the British Society for Rheumatology Biologics Register.
21. Dixon WG, Carmona L, Finckh A, Hetland ML, Kvien TK, Landewe R, Listing J, Nicola PJ, Tarp U, Zink A, Askling J. EULAR points to consider when establishing, analysing and reporting safety data of biologics registers in rheumatology. Ann Rheum Dis 2010, 69:1596-1602. 10.1136/ard.2009.125526, 20525843.
22. Gürcan HM, Keskin DB, Stern JN, Nitzberg MA, Shekhani H, Ahmed AR. A review of the current use of rituximab in autoimmune diseases. Int Immunopharmacol 2009, 9:10-25. 10.1016/j.intimp.2008.10.004, 19000786.
23. Nam JL, Winthrop KL, van Vollenhoven RF, Pavelka K, Valesini G, Hensor EM, Worthy G, Landewé R, Smolen JS, Emery P, Buch MH. Current evidence for the management of rheumatoid arthritis with biological disease-modifying antirheumatic drugs: a systematic literature review informing the EULAR recommendations for the management of RA. Ann Rheum Dis 2010, 69:976-986. 10.1136/ard.2009.126573, 20447957.
24. Tubach F, Salmon D, Ravaud P, Allanore Y, Goupille P, Bréban M, Pallot-Prades B, Pouplin S, Sacchi A, Chichemanian RM, Bretagne S, Emilie D, Lemann M, Lortholary O, Mariette X, . Research Axed on Tolerance of Biotherapies Group Risk of tuberculosis is higher with anti-tumor necrosis factor monoclonal antibody therapy than with soluble tumor necrosis factor receptor therapy: The three-year prospective French Research Axed on Tolerance of Biotherapies registry. Arthritis Rheum 2009, 60:1884-1894. 10.1002/art.24632, 2921546, 19565495, Research Axed on Tolerance of Biotherapies Group.
25. Askling J, Fored CM, Brandt L, Baecklund E, Bertilsson L, Feltelius N, Cöster L, Geborek P, Jacobsson LT, Lindblad S, Lysholm J, Rantapää-Dahlqvist S, Saxne T, van Vollenhoven RF, Klareskog L. Time-dependent increase in risk of hospitalisation with infection among Swedish RA patients treated with TNF antagonists. Ann Rheum Dis 2007, 66:1339-1344. 10.1136/ard.2006.062760, 1994293, 17261532.
26. Dixon WG, Symmons DP, Lunt M, Watson KD, Hyrich KL, . British Society for Rheumatology Biologics Register Control Centre Consortium, on behalf of the British Society for Rheumatology Biologics Register Serious infection following anti-tumor necrosis factor _ therapy in patients with rheumatoid arthritis: lessons from interpreting data from observational studies. Arthritis Rheum 2007, 56:2896-2904. 10.1002/art.22808, 2435418, 17763441, British Society for Rheumatology Biologics Register Control Centre Consortium, on behalf of the British Society for Rheumatology Biologics Register.
27. Carmona L, Descalzo MA, Perez-Pampin E, Ruiz-Montesinos D, Erra A, Cobo T, Gómez-Reino JJ, . BIOBADASER and EMECAR Groups All-cause and cause-specific mortality in rheumatoid arthritis are not greater than expected when treated with tumour necrosis factor antagonists. Ann Rheum Dis 2007, 66:880-885. 10.1136/ard.2006.067660, 1955107, 17324968, BIOBADASER and EMECAR Groups.
28. Bongartz T, Sutton AJ, Sweeting MJ, Buchan I, Matteson EL, Montori V. Anti-TNF antibody therapy in rheumatoid artritis and the risk of serious infections and malignancies: systematic review and meta-analysis of rare harmful effects in randomized controlled trials. JAMA 2006, 295:2275-2285. 10.1001/jama.295.19.2275, 16705109.
29. Listing J, Strangfeld A, Kary S, Rau R, von Hinueber U, Stoyanova-Scholz M, Gromnica-Ihle E, Antoni C, Herzer P, Kekow J, Schneider M, Zink A. Infections in patients with rheumatoid arthritis treated with biologic agents. Arthritis Rheum 2005, 52:3403-3412. 10.1002/art.21386, 16255017.
30. Curtis JR, Patkar N, Xie A, Martin C, Allison JJ, Saag M, Shatin D, Saag KG. Risk of serious bacterial infections among rheumatoid artritis patients exposed to tumor necrosis factor antagonists. Arthritis Rheum 2007, 56:1125-1133. 10.1002/art.22504, 17393394.
31. Doran MF, Crowson CS, Pond GR, O'Fallon WM, Gabriel SE. Frequency of infection in patients with rheumatoid arthritis compared with controls: a population-based study. Arthritis Rheum 2002, 46:2287-2293. 10.1002/art.10524, 12355475.
32. Doran MF, Crowson CS, Pond GR, O'Fallon WM, Gabriel SE. Predictors of infection in rheumatoid arthritis. Arthritis Rheum 2002, 46:2294-2300. 10.1002/art.10529, 12355476.
33. Lacaille D, Guh DP, Abrahamowicz M, Anis AH, Esdaile JM. Use of nonbiologic disease-modifying antirheumatic drugs and risk of infection in patients with rheumatoid arthritis. Arthritis Rheum 2008, 59:1074-1081. 10.1002/art.23913, 18668604.
34. Gottenberg JE, Ravaud P, Bardin T, Cacoub P, Cantagrel A, Combe B, Dougados M, Flipo RM, Godeau B, Guillevin L, Le Loët X, Hachulla E, Schaeverbeke T, Sibilia J, Baron G, Mariette X, . AutoImmunity and Rituximab registry and French Society of Rheumatology Risk factors for severe infections in patients with rheumatoid arthritis treated with rituximab in the autoimmunity and rituximab registry. Arthritis Rheum 2010, 62:2625-2632. 10.1002/art.27555, 20506353, AutoImmunity and Rituximab registry and French Society of Rheumatology.
35. BIOGEAS. , http://www.biogeas.es