SER Consensus statement on the use of biologic therapy for systemic lupus erythematosus;Consenso de la Sociedad Española de Reumatología sobre el uso de terapias biológicas en el lupus eritematoso sistémico

Reumatologia Clinica

Volumn 9, Issue 5, 2013, Pages 281-296

  Calvo Alén, Jaime ^a   Silva Fernández, Lucía ^b   Úcar Angulo, Eduardo ^c   Pego Reigosa, José María ^d   Olivé, Alejandro ^e   Martínez Fernández, Carmen ^f   Martínez Taboada, Víctor ^g   Luis Marenco, José ^h   Loza, Estíbaliz ⁱ   López Longo, Javier ^j   Gómez Reino, Juan Jesús ^k   Galindo Izquierdo, María ^l   Fernández Nebro, Antonio ^m   Cuadrado, María José ⁿ   Aguirre Zamorano, María Ángeles ^o   Zea Mendoza, Antonio ^p   Rúa Figueroa, Íñigo ^q  

^a Radiology Section   (Spain)

^b HOSPITAL UNIVERSITARIO DE GUADALAJARA   (Spain)

^c HOSPITAL DE BASURTO   (Spain)

^d UNIVERSITY HOSPITAL COMPLEX OF VIGO   (Spain)

^e HOSPITAL UNIVERSITARI GERMANS TRIAS I PUJOL   (Spain)

^f UNIDAD DE INVESTIGACIÓN   (Spain)

^g HOSPITAL UNIVERSITARIO MARQUÉS DE VALDECILLA   (Spain)

^h HOSPITAL UNIVERSITARIO DE VALME   (Spain)

ⁱ Instituto de Investigación Musculo esquelética inMusc   (Spain)

^j HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑÓN   (Spain)

^k UNIVERSITY OF SANTIAGO DE COMPOSTELA   (Spain)

^l HOSPITAL UNIVERSITARIO 12 DE OCTUBRE   (Spain)

^m HOSPITAL REGIONAL UNIVERSITARIO DE MÁLAGA   (Spain)

ⁿ ST THOMAS HOSPITAL   (United Kingdom)

^o HOSPITAL UNIVERSITARIO REINA SOFÍA   (Spain)

^p HOSPITAL RAMÓN Y CAJAL   (Spain)

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

more..

Author keywords

Biological therapy; Consensus; Guides; Recommendations; Systemic lupus erythematosus

Indexed keywords

BELIMUMAB;

ARTICLE; BIOLOGICAL THERAPY; CONSENSUS; DELPHI STUDY; DISEASE ACTIVITY; EVIDENCE BASED MEDICINE; FOLLOW UP; HUMAN; SYSTEMIC LUPUS ERYTHEMATOSUS;

BIOLOGICAL THERAPY; CONSENSO; CONSENSUS; GUIDES; GUÍAS; LUPUS ERITEMATOSO SISTÉMICO; RECOMENDACIONES; RECOMMENDATIONS; SYSTEMIC LUPUS ERYTHEMATOSUS; TERAPIAS BIOLÓGICAS;

BIOLOGICAL THERAPY; HUMANS; LUPUS ERYTHEMATOSUS, SYSTEMIC;

EID: 84881368578     PISSN: 1699258X     EISSN: 18851398     Source Type: Journal    
DOI: 10.1016/j.reuma.2013.04.001     Document Type: Article

References (164)

1. Bernatsky S., Boivin J.F., Joseph L., Manzi S., Ginzler E., Gladman D.D., et al. Mortality in systemic lupus erythematosus. Arthritis Rheum 2006, 54:2550-2557.
2. Estudio EPISER. Prevalencia e impacto de las enfermedades reumáticas en la poblacion adulta española. Sociedad Española de Reumatología (Monografía). Ed. Merck, Sharp & Dohme, España. 2001.
3. Ponticelli C., Moroni G. Monoclonal antibodies for systemic lupus erythematosus. Pharmaceuticals 2010, 3:300-322.
4. EMA. Ficha técnica de Belimumab [consultado Abril 2012]. Disponible en: http://www.ema.europa.eu/docs/es_ES/document_library/EPAR_-_Product_Information/human/002015/WC500110150.pdf%3E;%5B.
5. Ramos-Casals M., Garcia-Hernandez F.J., de Ramon E., Callejas J.L., Martinez-Berriotxoa A., Pallares L., et al. Off-label use of rituximab in 196 patients with severe, refractory systemic autoimmune diseases. Clin Exp Rheumatol 2010, 28:468-476.
6. Fitch K, Bernstein SJ, Aguilar MS, Burnand B, LaCalle JR, Lazaro P, et al. The RAND/UCLA Appropriateness Method User's Manual. 2011 [consultado 7 Ene 2013]. Disponible en: http://www.rand.org/pubs/monograph_reports/MR1269.html.
7. Oxford Centre for Evidence-based Medicine. Levels of evidence. 2009 [consultado 27 Oct 2012]. Disponible en: http://www.cebm.net/index.aspx%3Fo=1025.
8. FitzGerald J.D., Grossman J.M. Validity and reliability of retrospective assessment of disease activity and flare in observational cohorts of lupus patients. Lupus 1999, 8:638-644.
9. Vitali C., Bencivelli W., Isenberg D.A., Smolen J.S., Snaith M.L., Sciuto M., et al. Disease activity in systemic lupus erythematosus: Report of the Consensus Study Group of the European Workshop for Rheumatology Research. II. Identification of the variables indicative of disease activity and their use in the development of an activity score. The European Consensus Study Group for Disease Activity in SLE. Clin Exp Rheumatol 1992, 10:541-547.
10. Isenberg D., Bacon P., Bombardier C., Gladman D., Goldsmith C.H., Kalunian K., et al. Criteria for assessing disease activity in systemic lupus erythematosus. J Rheumatol 1989, 16:1395-1396.
11. Smolen J.S., Strand V., Cardiel M., Edworthy S., Furst D., Gladman D., et al. Randomized clinical trials and longitudinal observational studies in systemic lupus erythematosus: Consensus on a preliminary core set of outcome domains. J Rheumatol 1999, 26:504-507.
12. Bertsias G.K., Ioannidis J.P., Aringer M., Bollen E., Bombardieri S., Bruce I.N., et al. EULAR recommendations for the management of systemic lupus erythematosus with neuropsychiatric manifestations: Report of a task force of the EULAR standing committee for clinical affairs. Ann Rheum Dis 2010, 69:2074-2082.
13. Hawker G., Gabriel S., Bombardier C., Goldsmith C., Caron D., Gladman D. A reliability study of SLEDAI: A disease activity index for systemic lupus erythematosus. J Rheumatol 1993, 20:657-660.
14. Arce-Salinas A., Cardiel M.H., Guzman J., Alcocer-Varela J. Validity of retrospective disease activity assessment in systemic lupus erythematosus. J Rheumatol 1996, 23:846-849.
15. Wollaston S.J., Farewell V.T., Isenberg D.A., Gordon C., Merrill J.T., Petri M.A., et al. Defining response in systemic lupus erythematosus: A study by the Systemic Lupus International Collaborating Clinics group. J Rheumatol 2004, 31:2390-2394.
16. Nikpour M., Urowitz M.B., Ibanez D., Gladman D.D. Frequency and determinants of flare and persistently active disease in systemic lupus erythematosus. Arthritis Rheum 2009, 61:1152-1158.
17. Petri M. Disease activity assessment in SLE: Do we have the right instruments?. Ann Rheum Dis 2007, 66(Suppl 3):iii61-iii64.
18. Ruperto N., Hanrahan L.M., Alarcon G.S., Belmont H.M., Brey R.L., Brunetta P., et al. International consensus for a definition of disease flare in lupus. Lupus 2011, 20:453-462.
19. Gladman D.D., Urowitz M.B., Kagal A., Hallett D. Accurately describing changes in disease activity in systemic lupus erythematosus. J Rheumatol 2000, 27:377-379.
20. Petri M., Kim M.Y., Kalunian K.C., Grossman J., Hahn B.H., Sammaritano L.R., et al. Combined oral contraceptives in women with systemic lupus erythematosus. N Engl J Med 2005, 353:2550-2558.
21. Buyon J.P., Petri M.A., Kim M.Y., Kalunian K.C., Grossman J., Hahn B.H., et al. The effect of combined estrogen and progesterone hormone replacement therapy on disease activity in systemic lupus erythematosus: A randomized trial. Ann Intern Med 2005, 142(12 Pt 1):953-962.
22. Chambers S.A., Allen E., Rahman A., Isenberg D. Damage and mortality in a group of British patients with systemic lupus erythematosus followed up for over 10 years. Rheumatology (Oxford) 2009, 48:673-675.
23. Ioannou Y., Isenberg D.A. Current concepts for the management of systemic lupus erythematosus in adults: A therapeutic challenge. Postgrad Med J 2002, 78:599-606.
24. King J.K., Hahn B.H. Systemic lupus erythematosus: Modern strategies for management: A moving target. Best Pract Res Clin Rheumatol 2007, 21:971-987.
25. US Food and Drug Administration. Guidance for industry: systemic lupus erythematosus-developing medical products for treatment [consultado 12 Jun 2012]. Disponible en: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
26. Bertsias G.K., Ioannidis J.P., Boletis J., Bombardieri S., Cervera R., Dostal C., et al. EULAR points to consider for conducting clinical trials in systemic lupus erythematosus: Literature based evidence for the selection of endpoints. Ann Rheum Dis 2009, 68:477-483.
27. Urowitz M.B., Gladman D.D., Ibanez D., Fortin P.R., Bae S.C., Gordon C., et al. Evolution of disease burden over five years in a multicenter inception systemic lupus erythematosus cohort. Arthritis Care Res (Hoboken) 2012, 64:132-137.
28. Ruiz-Irastorza G., Olivares N., Ruiz-Arruza I., Martinez-Berriotxoa A., Egurbide M.V., Aguirre C. Predictors of major infections in systemic lupus erythematosus. Arthritis Res Ther 2009, 11:R109.
29. Urowitz M.B., Gladman D., Ibanez D., Fortin P., Sanchez-Guerrero J., Bae S., et al. Accumulation of coronary artery disease risk factors over three years: Data from an international inception cohort. Arthritis Rheum 2008, 59:176-180.
30. Roman M.J., Shanker B.A., Davis A., Lockshin M.D., Sammaritano L., Simantov R., et al. Prevalence and correlates of accelerated atherosclerosis in systemic lupus erythematosus. N Engl J Med 2003, 349:2399-2406.
31. Criteria for steroid-sparing ability of interventions in systemic lupus erythematosus: Report of a consensus meeting. Arthritis Rheum 2004, 50:3427-3431.
32. Gomez Reino J., Loza E., Andreu J.L., Balsa A., Batlle E., Canete J.D., et al. Consenso SER sobre la gestión de riesgo del tratamiento con terapias biológicas en pacientes con enfermedades reumáticas. Reumatol Clin 2011, 7:284-298.
33. Baker K.P., Edwards B.M., Main S.H., Choi G.H., Wager R.E., Halpern W.G., et al. Generation and characterization of LymphoStat-B, a human monoclonal antibody that antagonizes the bioactivities of B lymphocyte stimulator. Arthritis Rheum 2003, 48:3253-3265.
34. Halpern W.G., Lappin P., Zanardi T., Cai W., Corcoran M., Zhong J., et al. Chronic administration of belimumab, a BLyS antagonist, decreases tissue and peripheral blood B-lymphocyte populations in cynomolgus monkeys: Pharmacokinetic, pharmacodynamic, and toxicologic effects. Toxicol Sci 2006, 91:586-599.
35. Moore P.A., Belvedere O., Orr A., Pieri K., LaFleur D.W., Feng P., et al. BLyS: member of the tumor necrosis factor family and B lymphocyte stimulator. Science 1999, 285:260-263.
36. Cancro M.P., D'Cruz D.P., Khamashta M.A. The role of B lymphocyte stimulator (BLyS) in systemic lupus erythematosus. J Clin Invest 2009, 119:1066-1073.
37. Cheema G.S., Roschke V., Hilbert D.M., Stohl W. Elevated serum B lymphocyte stimulator levels in patients with systemic immune-based rheumatic diseases. Arthritis Rheum 2001, 44:1313-1319.
38. Zhang J., Roschke V., Baker K.P., Wang Z., Alarcon G.S., Fessler B.J., et al. Cutting edge: a role for B lymphocyte stimulator in systemic lupus erythematosus. J Immunol 2001, 166:6-10.
39. Petri M., Stohl W., Chatham W., McCune W.J., Chevrier M., Ryel J., et al. Association of plasma B lymphocyte stimulator levels and disease activity in systemic lupus erythematosus. Arthritis Rheum 2008, 58:2453-2459.
40. Wallace D.J., Stohl W., Furie R.A., Lisse J.R., McKay J.D., Merrill J.T., et al. A phase II, randomized, double-blind, placebo-controlled, dose-ranging study of belimumab in patients with active systemic lupus erythematosus. Arthritis Rheum 2009, 61:1168-1178.
41. Navarra S.V., Guzman R.M., Gallacher A.E., Hall S., Levy R.A., Jimenez R.E., et al. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: A randomised, placebo-controlled, phase 3 trial. Lancet 2011, 377:721-731.
42. Furie R., Petri M., Zamani O., Cervera R., Wallace D.J., Tegzova D., et al. A phase iii, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus. Arthritis Rheum 2011, 63:3918-3930.
43. Dooley M.A., Houssiau F., Aranow C., D'Cruz D.P., Askanase A.D., Roth D., et al. Effect of belimumab treatment on renal outcomes: Results from phase 3 belimumab clinical trials in patients with systemic lupus erythematosus. Arthritis Rheum 2011, 63(10 Suppl):S963.
44. Collins C.E., Narayanan S., Dall'Era M., Dennis G., Oglesby A., McGuire M.B. Outcomes associated with belimumab in black/African American patients with systemic lupus erythematous in clinical practice settings in the United States [abstract]. Arthritis Rheum 2011, 64(Suppl 10):2617.
45. Manzi S., Sanchez-Guerrero J., Merrill J.T., Furie R., Gladman D., Navarra S.V., et al. Effects of belimumab, a B lymphocyte stimulator-specific inhibitor, on disease activity across multiple organ domains in patients with systemic lupus erythematosus: combined results from two phase iii trials. Ann Rheum Dis 2012, 71:1833-1838.
46. Merrill J.T., Ginzler E.M., Wallace D.J., McKay J.D., Lisse J.R., Aranow C., et al. Long-term safety profile of belimumab plus standard therapy in patients with systemic lupus erythematosus. Arthritis Rheum 2012, 64:3364-3373.
47. Merrill J.T., Neuwelt C.M., Wallace D.J., Shanahan J.C., Latinis K.M., Oates J.C., et al. 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.
48. Rovin B.H., Furie R., Latinis K., Looney R.J., Fervenza F.C., Sanchez-Guerrero J., et al. Efficacy and safety of rituximab in patients with active proliferative lupus nephritis: the Lupus Nephritis Assessment with Rituximab study. Arthritis Rheum 2012, 64:1215-1226.
49. Coca A., Sanz I. Updates on B-cell immunotherapies for systemic lupus erythematosus and Sjogren's syndrome. Curr Opin Rheumatol 2012, 24:451-456.
50. Furie R., Looney R.J., Rovin B., Kevin M., Latinis K., Appel G., et al. Efficacy and safety of rituximab in subjects with active proliferative lupus nephritis (LN): Results from the Randomized, Double-Blind Phase III LUNAR Study. Arthritis Rheum 2009, 60(Suppl):S429.
51. Furie R., Rovin B.H., Kamen D.L., Latinis K.M., Appel G., Sanchez-Guerrero J., et al. Trial design and baseline characteristics of patients in the randomised double-blind, placebo controlled phase iii lupus nephritis assessment with rituximab study (LUNAR). Ann Rheum Dis 2009, 68(Suppl 3):253.
52. Merrill J., Buyon J., Furie R., Latinis K., Gordon C., Hsieh H.J., et al. Assessment of flares in lupus patients enrolled in a phase ii/iii study of rituximab (EXPLORER). Lupus 2011, 20:709-716.
53. Garcia Hernandez F.J., Ocana Medina C., Gonzalez Leon R., Garrido Rasco R., Colorado Bonilla R., Castillo Palma M.J., et al. [Rituximab for treatment of patients with systemic autoimmune diseases]. Med Clin (Barc) 2007, 128:458-462.
54. Garcia-Hernandez F.J., Diaz-Cobos C., Callejas-Rubio J.L., Ocana-Medina C., Ortego-Centeno N., Sanchez-Roman J., et al. [Experience with rituximab in the treatment of systemic erythematosus lupus]. Reumatol Clin 2006, 2:23-30.
55. Chen H., Zheng W., Su J., Xu D., Wang Q., Leng X., et al. Low-dose rituximab therapy for refractory thrombocytopenia in patients with systemic lupus erythematosus--a prospective pilot study. Rheumatology (Oxford) 2011, 50:1640-1644.
56. Li E.K., Tam L.S., Zhu T.Y., Li M., Kwok C.L., Li T.K., et al. Is combination rituximab with cyclophosphamide better than rituximab alone in the treatment of lupus nephritis?. Rheumatology (Oxford) 2009, 48:892-898.
57. Molloy E.S., Calabrese L.H. Progressive multifocal leukoencephalopathy associated with immunosuppressive therapy in rheumatic diseases: evolving role of biologic therapies. Arthritis Rheum 2012, 64:3043-3051.
58. Terrier B., Amoura Z., Ravaud P., Hachulla E., Jouenne R., Combe B., et al. 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.
59. Fernández-Nebro A., Marenco-de la Fuente J.L., Carreño L., Galindo-Izquierdo M., Tomero E., Hernández-Cruz B., et al. Multicenter longitudinal study of B-lymphocyte depletion in refractory systemic lupus erythematosus: The LESIMAB study. Lupus 2012, 21:1063-1076.
60. Vital E.M., Dass S., Emery P. Concomitant cyclophosphamide and oral immunosuppressants with rituximab for systemic lupus erythematosus. Rheumatology (Oxford) 2012, 51:1131-1132.
61. Turner-Stokes T., Lu T.Y., Ehrenstein M.R., Giles I., Rahman A., Isenberg D.A. The efficacy of repeated treatment with B-cell depletion therapy in systemic lupus erythematosus: An evaluation. Rheumatology (Oxford) 2011, 50:1401-1408.
62. Diaz-Lagares C., Croca S., Sangle S., Vital E.M., Catapano F., Martinez-Berriotxoa A., et al. Efficacy of rituximab in 164 patients with biopsy-proven lupus nephritis: Pooled data from European cohorts. Autoimmun Rev 2012, 11:357-364.
63. Murray E., Perry M. Off-label use of rituximab in systemic lupus erythematosus: A systematic review. Clin Rheumatol 2010, 29:707-716.
64. Sfikakis P.P., Boletis J.N., Tsokos G.C. Rituximab anti-B-cell therapy in systemic lupus erythematosus: Pointing to the future. Curr Opin Rheumatol 2005, 17:550-557.
65. Garcia-Carrasco M., Mendoza-Pinto C., Sandoval-Cruz M., Soto-Vega E., Beltran-Castillo A., Jimenez-Hernandez M., et al. Anti-CD20 therapy in patients with refractory systemic lupus erythematosus: A longitudinal analysis of 52 Hispanic patients. Lupus 2010, 19:213-219.
66. Tokunaga M., Saito K., Kawabata D., Imura Y., Fujii T., Nakayamada S., et al. Efficacy of rituximab (anti-CD20) for refractory systemic lupus erythematosus involving the central nervous system. Ann Rheum Dis 2007, 66:470-475.
67. Pinto L.F., Velasquez C.J., Prieto C., Mestra L., Forero E., Marquez J.D. Rituximab induces a rapid and sustained remission in Colombian patients with severe and refractory systemic lupus erythematosus. Lupus 2011, 20:1219-1226.
68. Lindholm C., Borjesson-Asp K., Zendjanchi K., Sundqvist A.C., Tarkowski A., Bokarewa M. Longterm clinical and immunological effects of anti-CD20 treatment in patients with refractory systemic lupus erythematosus. J Rheumatol 2008, 35:826-833.
69. Vesely S.K., Perdue J.J., Rizvi M.A., Terrell D.R., George J.N. Management of adult patients with persistent idiopathic thrombocytopenic purpura following splenectomy: A systematic review. Ann Intern Med 2004, 140:112-120.
70. Ng K.P., Leandro M.J., Edwards J.C., Ehrenstein M.R., Cambridge G., Isenberg D.A. Repeated B cell depletion in treatment of refractory systemic lupus erythematosus. Ann Rheum Dis 2006, 65:942-945.
71. Grondal G., Gunnarsson I., Ronnelid J., Rogberg S., Klareskog L., Lundberg I. Cytokine production, serum levels and disease activity in systemic lupus erythematosus. Clin Exp Rheumatol 2000, 18:565-570.
72. Iwano M., Dohi K., Hirata E., Kurumatani N., Horii Y., Shiiki H., et al. Urinary levels of IL-6 in patients with active lupus nephritis. Clin Nephrol 1993, 40:16-21.
73. Linker-Israeli M., Deans R.J., Wallace D.J., Prehn J., Ozeri-Chen T., Klinenberg J.R. Elevated levels of endogenous IL-6 in systemic lupus erythematosus. A putative role in pathogenesis. J Immunol 1991, 147:117-123.
74. ClinicalTrials.gov. Etanercept for the treatment of lupus nephritis. 2012 [consultado 20 Feb 2012]. Disponible en: http://clinicaltrials.gov/ct2/show/NCT00447265%3Fterm=00447265%26rank=1.
75. ClinicalTrials.gov. TNF blockade with remicade in active lupus nephritisWHO class V. 2012 [consultado 20 Feb 2012]. Disponible en: http://clinicaltrials.gov/ct2/show/NCT00368264%3Fterm=00368264%26rank=1.
76. Aringer M., Houssiau F., Gordon C., Graninger W.B., Voll R.E., Rath E., et al. Adverse events and efficacy of TNF-alpha blockade with infliximab in patients with systemic lupus erythematosus: Long-term follow-up of 13 patients. Rheumatology (Oxford) 2009, 48:1451-1454.
77. Aringer M., Graninger W.B., Steiner G., Smolen J.S. Safety and efficacy of tumor necrosis factor alpha blockade in systemic lupus erythematosus: An open-label study. Arthritis Rheum 2004, 50:3161-3169.
78. Uppal S.S., Hayat S.J., Raghupathy R. Efficacy and safety of infliximab in active SLE: A pilot study. Lupus 2009, 18:690-697.
79. Matsumura R., Umemiya K., Sugiyama T., Sueishi M., Umibe T., Ichikawa K., et al. Anti-tumor necrosis factor therapy in patients with difficult-to-treat lupus nephritis: A prospective series of nine patients. Clin Exp Rheumatol 2009, 27:416-421.
80. Hayat S.J., Uppal S.S., Narayanan Nampoory M.R., Johny K.V., Gupta R., Al-Oun M. Safety and efficacy of infliximab in a patient with active WHO class iv lupus nephritis. Clin Rheumatol 2007, 26:973-975.
81. Ideguchi H., Ohno S., Takase K., Hattori H., Kirino Y., Takeno M., et al. Successful treatment of refractory lupus-associated haemophagocytic lymphohistiocytosis with infliximab. Rheumatology (Oxford) 2007, 46:1621-1622.
82. Hayat S.J., Uppal S.S. Therapeutic efficacy and safety profile of infliximab in active systemic lupus erythematosus. Mod Rheumatol 2007, 17:174-177.
83. Kikuchi H., Yamamoto T., Asako K., Takayama M., Shirasaki R., Ono Y. Etanercept for the treatment of intractable hemophagocytic syndrome with systemic lupus erythematosus. Mod Rheumatol 2012, 22:308-311.
84. Micheloud D., Nuno L., Rodriguez-Mahou M., Sanchez-Ramon S., Ortega M.C., Aguaron A., et al. Efficacy and safety of Etanercept, high-dose intravenous gammaglobulin and plasmapheresis combined therapy for lupus diffuse proliferative nephritis complicating pregnancy. Lupus 2006, 15:881-885.
85. Takahashi N., Naniwa T., Banno S. Successful use of etanercept in the treatment of acute lupus hemophagocytic syndrome. Mod Rheumatol 2008, 18:72-75.
86. Atreya R., Mudter J., Finotto S., Mullberg J., Jostock T., Wirtz S., et al. Blockade of interleukin 6 trans signaling suppresses T-cell resistance against apoptosis in chronic intestinal inflammation: evidence in crohn disease and experimental colitis in vivo. Nat Med 2000, 6:583-588.
87. Najafian N., Sayegh M.H. CTLA4-Ig: A novel immunosuppressive agent. Expert Opin Investig Drugs 2000, 9:2147-2157.
88. Merrill J.T., Burgos-Vargas R., Westhovens R., Chalmers A., D'Cruz D., Wallace D.J., et al. The efficacy and safety of abatacept in patients with non-life-threatening manifestations of systemic lupus erythematosus: Results of a twelve-month, multicenter, exploratory, phase iib, randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2010, 62:3077-3087.
89. Furie R., Nicholls K., Cheng T.T., Houssiau F., Burgos-Vargas R., Chen S.L., et al. Efficacy and safety of abatacept over 12 months in patients with lupus nephritis: Results from a multicenter, randomized, double-blind, placebo-controlled phase ii/iii study. Arthritis Rheum 2011, 63(10 Suppl):S971.
90. Coca A., Anolik J.H. Two negative randomized controlled trials in lupus: now what? F1000. Med Rep 2009, 1:28.
91. Lateef A., Petri M. Biologics in the treatment of systemic lupus erythematosus. Curr Opin Rheumatol 2010, 22:504-509.
92. Wofsy D., Hillson J.L., Diamond B. Abatacept for lupus nephritis: Alternative definitions of complete response support conflicting conclusions. Arthritis Rheum 2012, 64:3660-3665.
93. Nishimoto N., Kishimoto T. Humanized antihuman IL-6 receptor antibody, tocilizumab. Handb Exp Pharmacol 2008, 181:151-160.
94. Chun H.Y., Chung J.W., Kim H.A., Yun J.M., Jeon J.Y., Ye Y.M., et al. Cytokine IL-6 and IL-10 as biomarkers in systemic lupus erythematosus. J Clin Immunol 2007, 27:461-466.
95. Peterson E., Robertson A.D., Emlen W. Serum and urinary interleukin-6 in systemic lupus erythematosus. Lupus 1996, 5:571-575.
96. Mihara M., Nishimoto N., Ohsugi Y. The therapy of autoimmune diseases by anti-interleukin-6 receptor antibody. Expert Opin Biol Ther 2005, 5:683-690.
97. Shirota Y., Yarboro C.H., Sims G. The impact of in vivo anti IL-6 receptor blockade on circulating T and B cell subsets in patients with systemic lupus erythematosus. Arthritis Rheum 2005, 52(Suppl):S697.
98. Illei G.G., Shirota Y., Yarboro C.H., Daruwalla J., Tackey E., Takada K., et al. Tocilizumab in systemic lupus erythematosus: Data on safety, preliminary efficacy, and impact on circulating plasma cells from an open-label phase I dosage-escalation study. Arthritis Rheum 2010, 62:542-552.
99. Smolen J.S., Beaulieu A., Rubbert-Roth A., Ramos-Remus C., Rovensky J., Alecock E., et al. Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (OPTION study): A double-blind, placebo-controlled, randomised trial. Lancet 2008, 371:987-997.
100. Choy E.H., Isenberg D.A., Garrood T., Farrow S., Ioannou Y., Bird H., et al. Therapeutic benefit of blocking interleukin-6 activity with an anti-interleukin-6 receptor monoclonal antibody in rheumatoid arthritis: A randomized, double-blind, placebo-controlled, dose-escalation trial. Arthritis Rheum 2002, 46:3143-3150.
101. Tedder T.F., Tuscano J., Sato S., Kehrl J.H. CD22, a B lymphocyte-specific adhesion molecule that regulates antigen receptor signaling. Annu Rev Immunol 1997, 15:481-504.
102. Grammer A.C., Slota R., Fischer R., Gur H., Girschick H., Yarboro C., et al. Abnormal germinal center reactions in systemic lupus erythematosus demonstrated by blockade of CD154-CD40 interactions. J Clin Invest 2003, 112:1506-1520.
103. Kalunian K.C., Davis J.C., Merrill J.T., Totoritis M.C., Wofsy D. Treatment of systemic lupus erythematosus by inhibition of T cell costimulation with anti-CD154: A randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2002, 46:3251-3258.
104. Davis J.C., Totoritis M.C., Rosenberg J., Sklenar T.A., Wofsy D. Phase I clinical trial of a monoclonal antibody against CD40-ligand (IDEC-131) in patients with systemic lupus erythematosus. J Rheumatol 2001, 28:95-101.
105. Sidiropoulos P.I., Boumpas D.T. Lessons learned from anti-CD40L treatment in systemic lupus erythematosus patients. Lupus 2004, 13:391-397.
106. Iwai H., Abe M., Hirose S., Tsushima F., Tezuka K., Akiba H., et al. Involvement of inducible costimulator-B7 homologous protein costimulatory pathway in murine lupus nephritis. J Immunol 2003, 171:2848-2854.
107. Llorente L., Richaud-Patin Y., Garcia-Padilla C., Claret E., Jakez-Ocampo J., Cardiel M.H., et al. Clinical and biologic effects of anti-interleukin-10 monoclonal antibody administration in systemic lupus erythematosus. Arthritis Rheum 2000, 43:1790-1800.
108. Lee P.Y., Reeves W.H. Type I interferon as a target of treatment in SLE. Endocr Metab Immune Disord Drug Targets 2006, 6:323-330.
109. Kalunian K., Merrill J.T., Maciuca R., Wenjun Ouyang J.M., McBride J.M., TM J., et al. Efficacy and safety of rontalizumab (anti-interferon alpha) in SLE subjects with restricted immunosuppressant use: Results of a randomized, double-blind, placebo-controlled phase 2 study [abstract]. Arthritis Rheum 2012, 64(10 Suppl):S1111.
110. Rother R.P., Mojcik C.F., McCroskery E.W. Inhibition of terminal complement: A novel therapeutic approach for the treatment of systemic lupus erythematosus. Lupus 2004, 13:328-334.
111. Isenberg D.A., Rahman A., Allen E., Farewell V., Akil M., Bruce I.N., et al. BILAG 2004. Development and initial validation of an updated version of the British Isles Lupus Assessment Group's disease activity index for patients with systemic lupus erythematosus. Rheumatology (Oxford) 2005, 44:902-906.
112. Stoll T., Stucki G., Malik J., Pyke S., Isenberg D.A. Further validation of the BILAG disease activity index in patients with systemic lupus erythematosus. Ann Rheum Dis 1996, 55:756-760.
113. Hay E.M., Bacon P.A., Gordon C., Isenberg D.A., Maddison P., Snaith M.L., et al. The BILAG index: a reliable and valid instrument for measuring clinical disease activity in systemic lupus erythematosus. Q J Med 1993, 86:447-458.
114. Isenberg D.A., Allen E., Farewell V., D'Cruz D., Alarcon G.S., Aranow C., et al. An assessment of disease flare in patients with systemic lupus erythematosus: A comparison of BILAG 2004 and the flare version of SELENA. Ann Rheum Dis 2011, 70:54-59.
115. Symmons D.P., Coppock J.S., Bacon P.A., Bresnihan B., Isenberg D.A., Maddison P., et al. Development and assessment of a computerized index of clinical disease activity in systemic lupus erythematosus. Members of the British Isles Lupus Assessment Group (BILAG). Q J Med 1988, 69:927-937.
116. Nasiri S., Karimifar M., Bonakdar Z.S., Salesi M. Correlation of ESR, C3, C4, anti-DNA and lupus activity based on British Isles Lupus Assessment Group Index in patients of rheumatology clinic. Rheumatol Int 2010, 30:1605-1609.
117. Yee C.S., Farewell V., Isenberg D.A., Rahman A., Teh L.S., Griffiths B., et al. British Isles Lupus Assessment Group 2004 index is valid for assessment of disease activity in systemic lupus erythematosus. Arthritis Rheum 2007, 56:4113-4119.
118. Ward M.M., Marx A.S., Barry N.N. Comparison of the validity and sensitivity to change of 5 activity indices in systemic lupus erythematosus. J Rheumatol 2000, 27:664-670.
119. Yee C.S., Farewell V., Isenberg D.A., Griffiths B., Teh L.S., Bruce I.N., et al. The BILAG-2004 index is sensitive to change for assessment of SLE disease activity. Rheumatology (Oxford) 2009, 48:691-695.
120. Mosca M., Bencivelli W., Vitali C., Carrai P., Neri R., Bombardieri S. The validity of the ECLAM index for the retrospective evaluation of disease activity in systemic lupus erythematosus. Lupus 2000, 9:445-450.
121. Liang M.H., Socher S.A., Larson M.G., Schur P.H. Reliability and validity of six systems for the clinical assessment of disease activity in systemic lupus erythematosus. Arthritis Rheum 1989, 32:1107-1118.
122. Bae S.C., Koh H.K., Chang D.K., Kim M.H., Park J.K., Kim S.Y. Reliability and validity of systemic lupus activity measure-revised (SLAM-R) for measuring clinical disease activity in systemic lupus erythematosus. Lupus 2001, 10:405-409.
123. Gladman D.D., Goldsmith C.H., Urowitz M.B., Bacon P., Bombardier C., Isenberg D., et al. Sensitivity to change of 3 Systemic Lupus Erythematosus Disease Activity Indices: International validation. J Rheumatol 1994, 21:1468-1471.
124. Fortin P.R., Abrahamowicz M., Clarke A.E., Neville C., Du Berger R., Fraenkel L., et al. Do lupus disease activity measures detect clinically important change?. J Rheumatol 2000, 27:1421-1428.
125. Gladman D.D., Goldsmith C.H., Urowitz M.B., Bacon P., Bombardier C., Isenberg D., et al. Crosscultural validation and reliability of 3 disease activity indices in systemic lupus erythematosus. J Rheumatol 1992, 19:608-611.
126. Uribe A.G., Vila L.M., McGwin G., Sanchez M.L., Reveille J.D., Alarcon G.S. The Systemic Lupus Activity Measure-revised, the Mexican Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), and a modified SLEDAI-2K are adequate instruments to measure disease activity in systemic lupus erythematosus. J Rheumatol 2004, 31:1934-1940.
127. Chang E., Abrahamowicz M., Ferland D., Fortin P.R. Comparison of the responsiveness of lupus disease activity measures to changes in systemic lupus erythematosus activity relevant to patients and physicians. J Clin Epidemiol 2002, 55:488-497.
128. Bombardier C., Gladman D.D., Urowitz M.B., Caron D., Chang C.H. Derivation of the SLEDAI. A disease activity index for lupus patients. The Committee on Prognosis Studies in SLE. Arthritis Rheum 1992, 35:630-640.
129. Petri M., Hellmann D., Hochberg M. Validity and reliability of lupus activity measures in the routine clinic setting. J Rheumatol 1992, 19:53-59.
130. Gladman D.D., Ibanez D., Urowitz M.B. Systemic lupus erythematosus disease activity index 2000. J Rheumatol 2002, 29:288-291.
131. Guzman J., Cardiel M.H., Arce-Salinas A., Sanchez-Guerrero J., Alarcon-Segovia D. Measurement of disease activity in systemic lupus erythematosus. Prospective validation of 3 clinical indices. J Rheumatol 1992, 19:1551-1558.
132. Yazdany J., Yelin E.H., Panopalis P., Trupin L., Julian L., Katz P.P. Validation of the systemic lupus erythematosus activity questionnaire in a large observational cohort. Arthritis Rheum 2008, 59:136-143.
133. Karlson E.W., Daltroy L.H., Rivest C., Ramsey-Goldman R., Wright E.A., Partridge A.J., et al. Validation of a Systemic Lupus Activity Questionnaire (SLAQ) for population studies. Lupus 2003, 12:280-286.
134. Gladman D., Ginzler E., Goldsmith C., Fortin P., Liang M., Urowitz M., et al. The development and initial validation of the Systemic Lupus International Collaborating Clinics/American College of Rheumatology damage index for systemic lupus erythematosus. Arthritis Rheum 1996, 39:363-369.
135. Stoll T., Seifert B., Isenberg D.A. SLICC/ACR Damage Index is valid, and renal and pulmonary organ scores are predictors of severe outcome in patients with systemic lupus erythematosus. Br J Rheumatol 1996, 35:248-254.
136. Gladman D.D., Goldsmith C.H., Urowitz M.B., Bacon P., Fortin P., Ginzler E., et al. The Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index for Systemic Lupus Erythematosus International Comparison. J Rheumatol 2000, 27:373-376.
137. Gladman D.D., Urowitz M.B., Goldsmith C.H., Fortin P., Ginzler E., Gordon C., et al. The reliability of the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index in patients with systemic lupus erythematosus. Arthritis Rheum 1997, 40:809-813.
138. Stoll T., Stucki G., Malik J., Pyke S., Isenberg D.A. Association of the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index with measures of disease activity and health status in patients with systemic lupus erythematosus. J Rheumatol 1997, 24:309-313.
139. Costenbader K.H., Khamashta M., Ruiz-Garcia S., Perez-Rodriguez M.T., Petri M., Elliott J., et al. Development and initial validation of a self-assessed lupus organ damage instrument. Arthritis Care Res (Hoboken) 2010, 62:559-568.
140. Fortin P.R., Abrahamowicz M., Ferland D., Lacaille D., Smith C.D., Zummer M. Steroid-sparing effects of methotrexate in systemic lupus erythematosus: A double-blind, randomized, placebo-controlled trial. Arthritis Rheum 2008, 59:1796-1804.
141. Rahman P., Humphrey-Murto S., Gladman D.D., Urowitz M.B. Efficacy and tolerability of methotrexate in antimalarial resistant lupus arthritis. J Rheumatol 1998, 25:243-246.
142. Chang A.Y., Piette E.W., Foering K.P., Tenhave T.R., Okawa J., Werth V.P. Response to antimalarial agents in cutaneous lupus erythematosus: a prospective analysis. Arch Dermatol 2011, 147:1261-1267.
143. Callen J.P. Management of «refractory» skin disease in patients with lupus erythematosus. Best Pract Res Clin Rheumatol 2005, 19:767-784.
144. Man B.L., Mok C.C. Serositis related to systemic lupus erythematosus: Prevalence and outcome. Lupus 2005, 14:822-826.
145. Appel G.B., Contreras G., Dooley M.A., Ginzler E.M., Isenberg D., Jayne D., et al. Mycophenolate mofetil versus cyclophosphamide for induction treatment of lupus nephritis. J Am Soc Nephrol 2009, 20:1103-1112.
146. Houssiau F.A., D'Cruz D., Sangle S., Remy P., Vasconcelos C., Petrovic R., et al. Azathioprine versus mycophenolate mofetil for long-term immunosuppression in lupus nephritis: Results from the MAINTAIN Nephritis Trial. Ann Rheum Dis 2010, 69:2083-2089.
147. Houssiau F.A. Therapy of lupus nephritis: Lessons learned from clinical research and daily care of patients. Arthritis Res Ther 2012, 14:202.
148. Houssiau F.A., Vasconcelos C., D'Cruz D., Sebastiani G.D., de Ramon Garrido E., Danieli M.G., et al. The 10-year follow-up data of the Euro-Lupus Nephritis Trial comparing low-dose and high-dose intravenous cyclophosphamide. Ann Rheum Dis 2010, 69:61-64.
149. Dooley M.A., Jayne D., Ginzler E.M., Isenberg D., Olsen N.J., Wofsy D., et al. Mycophenolate versus azathioprine as maintenance therapy for lupus nephritis. N Engl J Med 2011, 365:1886-1895.
150. Hahn B.H., McMahon M.A., Wilkinson A., Wallace W.D., Daikh D.I., Fitzgerald J.D., et al. American college of rheumatology guidelines for screening, treatment, and management of lupus nephritis. Arthritis Care Res (Hoboken) 2012, 64:797-808.
151. Austin H.A., Illei G.G., Braun M.J., Balow J.E. Randomized, controlled trial of prednisone, cyclophosphamide, and cyclosporine in lupus membranous nephropathy. J Am Soc Nephrol 2009, 20:901-911.
152. Postal M., Costallat L.T., Appenzeller S. Neuropsychiatric manifestations in systemic lupus erythematosus: Epidemiology, pathophysiology and management. CNS Drugs 2011, 25:721-736.
153. Pego-Reigosa J.M., Medeiros D.A., Isenberg D.A. Respiratory manifestations of systemic lupus erythematosus: Old and new concepts. Best Pract Res Clin Rheumatol 2009, 23:469-480.
154. Neunert C., Lim W., Crowther M., Cohen A., Solberg L., Crowther M.A. The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia. Blood 2011, 117:4190-4207.
155. Provan D., Stasi R., Newland A.C., Blanchette V.S., Bolton-Maggs P., Bussel J.B., et al. International consensus report on the investigation and management of primary immune thrombocytopenia. Blood 2010, 115:168-186.
156. Hepburn A.L., Narat S., Mason J.C. The management of peripheral blood cytopenias in systemic lupus erythematosus. Rheumatology (Oxford) 2010, 49:2243-2254.
157. Olivé A., Monreal M. Manifestaciones hematológicas. Lupus eritematoso sistémico 2009, Caduceo Multimedia, Barcelona. 3.a ed. M. Khamastha, M. Vilardell (Eds.).
158. Dorner T., Kaufmann J., Wegener W.A., Teoh N., Goldenberg D.M., Burmester G.R. Initial clinical trial of epratuzumab (humanized anti-CD22 antibody) for immunotherapy of systemic lupus erythematosus. Arthritis Res Ther 2006, 8:R74.
159. Daridon C., Blassfeld D., Reiter K., Mei H.E., Giesecke C., Goldenberg D.M., et al. Epratuzumab targeting of CD22 affects adhesion molecule expression and migration of B-cells in systemic lupus erythematosus. Arthritis Res Ther 2010, 12:R204.
160. The efficacy and safety of atacicept in combination with mycophenolate mofetil used to treat lupus nephritis. 2009 [consultado 20 Feb 2012]. Disponible en: http://clinicaltrials.gov/.
161. Atacicept phase II/III in generalized systemic lupus erythematosus (April SLE). 2010 [consultado 20 Feb 2012]. Disponible en: http://clinicaltrials.gov/.
162. Boumpas D.T., Furie R., Manzi S., Illei G.G., Wallace D.J., Balow J.E., et al. A short course of BG9588 (anti-CD40 ligand antibody) improves serologic activity and decreases hematuria in patients with proliferative lupus glomerulonephritis. Arthritis Rheum 2003, 48:719-727.
163. Yao Y., Richman L., Higgs B.W., Morehouse C.A., de los Reyes M., Brohawn P., et al. Neutralization of interferon-alpha/beta-inducible genes and downstream effect in a phase I trial of an anti-interferon-alpha monoclonal antibody in systemic lupus erythematosus. Arthritis Rheum 2009, 60:1785-1796.
164. McBride JM, Morimoto A, Drappa J. Genentech's rontalizumab is well-tolerated by lupus patients in a phase i clinical trial. Lupus Foundation of America Website [consultado 3 Jun 2012]. Disponible en:.