Safety of off-label biologicals in systemic lupus erythematosus

Bibliography

• Smolen JS, van der Heijde D, Machold KP, et al. Proposal for a new nomenclature of disease-modifying antirheumatic drugs. Ann Rheum Dis 2014;73(1):3–5
   PubMed Web of Science ®Google Scholar
• Navarra SV, Guzman RM, Gallacher AE, et al. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial. Lancet 2011;377(9767):721-31
   PubMed Web of Science ®Google Scholar
• Furie R, Petri M, Zamani O, 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(12):3918-30
   PubMed Web of Science ®Google Scholar
• Aringer M, Burkhardt H, Burmester GR, et al. Current state of evidence on off-label therapeutic options for systemic lupus erythematosus, including biological immunosuppressive agents, in Germany, Austria and Switzerland--a consensus report. Lupus 2012;21(4):386-401
   PubMed Web of Science ®Google Scholar
• Manzi S, Sanchez-Guerrero J, Merrill JT, 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(11):1833-8
   PubMed Web of Science ®Google Scholar
• Bertsias GK, Tektonidou M, Amoura Z, et al. Joint European League Against Rheumatism and European Renal Association-European Dialysis and Transplant Association (EULAR/ERA-EDTA) recommendations for the management of adult and paediatric lupus nephritis. Ann Rheum Dis 2012;71(11):1771-82
   PubMed Web of Science ®Google Scholar
• Terrier B, Amoura Z, Ravaud P, 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(8):2458-66
   PubMed Web of Science ®Google Scholar
• Lu TY, Ng KP, Cambridge G, et al. A retrospective seven-year analysis of the use of B cell depletion therapy in systemic lupus erythematosus at University College London Hospital: the first fifty patients. Arthritis Rheum 2009;61(4):482-7
   PubMed Web of Science ®Google Scholar
• Bauerle M, Grunke M, Tony HP, et al. Safety and efficacy of rituximab in patients with systemic lupus erythematosus: The German registry of autoimmune diseases (GRAID). Ann Rheum Dis 2010;69(Suppl 3):685
   Google Scholar
• Furst DE, Keystone EC, So AK, et al. Updated consensus statement on biological agents for the treatment of rheumatic diseases, 2012. Ann Rheum Dis 2013;72(Suppl 2):ii2-34
   PubMed Web of Science ®Google Scholar
• Ding HJ, Gordon C. New biologic therapy for systemic lupus erythematosus. Curr Opin Pharmacol 2013;13(3):405-12
   PubMed Web of Science ®Google Scholar
• Dall’Era M, Chakravarty EF. Treatment of mild, moderate, and severe lupus erythematosus: focus on new therapies. Curr Rheumatol Rep 2011;13(4):308-16
   PubMed Web of Science ®Google Scholar
• Ramos-Casals M, Diaz-Lagares C, Soto-Cardenas MJ, et al. Rituximab therapy in lupus nephritis: current clinical evidence. Clin Rev Allergy Immunol 2011;40(3):159-69
   PubMed Web of Science ®Google Scholar
• Witt M, Grunke M, Proft F, et al. Clinical outcomes and safety of rituximab treatment for patients with systemic lupus erythematosus (SLE) - results from a nationwide cohort in Germany (GRAID). Lupus 2013;22(11):1142-9
   PubMed Web of Science ®Google Scholar
• Rovin BH, Furie R, Latinis K, et al. Efficacy and safety of rituximab in patients with active proliferative lupus nephritis: the lupus nephritis assessment with rituximab (LUNAR) study. Arthritis Rheum 2012;64(4):1215-26
   PubMed Web of Science ®Google Scholar
• Merrill JT, Neuwelt CM, Wallace DJ, 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(1):222-33
   PubMed Web of Science ®Google Scholar
• Jones RB, Tervaert JW, Hauser T, et al. Rituximab versus cyclophosphamide in ANCA-associated renal vasculitis. N Engl J Med 2010;363(3):211-20
   PubMed Web of Science ®Google Scholar
• Stone JH, Merkel PA, Spiera R, et al. Rituximab versus cyclophosphamide for ANCA-associated vasculitis. N Engl J Med 2010;363(3):221-32
   PubMed Web of Science ®Google Scholar
• Emery P, Deodhar A, Rigby WF, et al. Efficacy and safety of different doses and retreatment of rituximab: a randomised, placebo-controlled trial in patients who are biological naive with active rheumatoid arthritis and an inadequate response to methotrexate (Study Evaluating Rituximab’s Efficacy in MTX iNadequate rEsponders (SERENE)). Ann Rheum Dis 2010;69(9):1629-35
   PubMed Web of Science ®Google Scholar
• Diaz-Lagares C, Perez-Alvarez R, Garcia-Hernandez FJ, et al. Rates of, and risk factors for, severe infections in patients with systemic autoimmune diseases receiving biological agents off-label. Arthritis Res Ther 2011;13(4):R112
   PubMed Web of Science ®Google Scholar
• Cobo-Ibanez T, Loza-Santamaria E, Pego-Reigosa JM, et al. Efficacy and safety of rituximab in the treatment of non-renal systemic lupus erythematosus: a systematic review. Semin Arthritis Rheum 2014. [Epub ahead of print]
   PubMed Web of Science ®Google Scholar
• van Vollenhoven RF, Emery P, Bingham CO, et al. Longterm safety of patients receiving rituximab in rheumatoid arthritis clinical trials. J Rheumatol 2010;37(3):558-67
   PubMed Web of Science ®Google Scholar
• Smith KG, Jones RB, Burns SM, et al. Long-term comparison of rituximab treatment for refractory systemic lupus erythematosus and vasculitis: remission, relapse, and re-treatment. Arthritis Rheum 2006;54(9):2970-82
   PubMed Web of Science ®Google Scholar
• Lim E, Tao Y, White AJ, et al. Hypogammaglobulinemia in pediatric systemic lupus erythematosus. Lupus 2013;22(13):1382-7
   PubMed Web of Science ®Google Scholar
• Lehman TJ, Singh C, Ramanathan A, et al. Prolonged improvement of childhood onset systemic lupus erythematosus following systematic administration of rituximab and cyclophosphamide. Pediatr Rheumatol Online J 2014;12(1):3
   PubMed Web of Science ®Google Scholar
• Ge S, Pao A, Vo A, et al. Immunologic parameters and viral infections in patients desensitized with intravenous immunoglobulin and rituximab. Transpl Immunol 2011;24(3):142-8
   PubMed Web of Science ®Google Scholar
• Beppu M, Kawamoto M, Nukuzuma S, et al. Mefloquine improved progressive multifocal leukoencephalopathy in a patient with systemic lupus erythematosus. Intern Med 2012;51(10):1245-7
   PubMed Web of Science ®Google Scholar
• Yoshida H, Ohshima K, Toda J, et al. Significant improvement following combination treatment with mefloquine and mirtazapine in a patient with progressive multifocal leukoencephalopathy after allogeneic peripheral blood stem cell transplantation. Int J Hematol 2014;99(1):95-9
   PubMed Web of Science ®Google Scholar
• Molloy ES, Calabrese LH. Progressive multifocal leukoencephalopathy in patients with rheumatic diseases: are patients with systemic lupus erythematosus at particular risk? Autoimmun Rev 2008;8(2):144-6
   PubMed Web of Science ®Google Scholar
• Petereit HF, Rubbert-Roth A. Rituximab levels in cerebrospinal fluid of patients with neurological autoimmune disorders. Mult Scler 2009;15(2):189-92
   PubMed Web of Science ®Google Scholar
• Carson KR, Evens AM, Richey EA, et al. Progressive multifocal leukoencephalopathy after rituximab therapy in HIV-negative patients: a report of 57 cases from the Research on Adverse Drug Events and Reports project. Blood 2009;113(20):4834-40
   PubMed Web of Science ®Google Scholar
• Clifford DB, Ances B, Costello C, et al. Rituximab-associated progressive multifocal leukoencephalopathy in rheumatoid arthritis. Arch Neurol 2011;68(9):1156-64
   PubMed Web of Science ®Google Scholar
• Heusele M, Clerson P, Guery B, et al. Risk factors for severe bacterial infections in patients with systemic autoimmune diseases receiving rituximab. Clin Rheumatol 2014;33(6):799-805
   PubMed Web of Science ®Google Scholar
• Witt M, Grunke M, Proft F, et al. Clinical outcomes and safety of rituximab treatment for patients with systemic lupus erythematosus (SLE) – results from a nationwide cohort in Germany (GRAID). Lupus 2013;22(11):1142-9
   PubMed Web of Science ®Google Scholar
• Hua C, Barnetche T, Combe B, et al. Effect of methotrexate, anti-TNFalpha and rituximab on the immune response to influenza and pneumococcal vaccines in patients with rheumatoid arthritis: a systematic review and meta-analysis. Arthritis Care Res (Hoboken) 2013;66(7):1016-26
   Web of Science ®Google Scholar
• Strangfeld A, Pattloch D, Herzer P, et al. Risk of cancer recurrence or new tumors in RA patients with prior malignancies treated with various biologic agents. Arthritis Rheum 2013;65(10 Supplement):S342
   PubMedGoogle Scholar
• Weinblatt ME, Schiff M, Valente R, et al. Head-to-head comparison of subcutaneous abatacept versus adalimumab for rheumatoid arthritis: findings of a phase IIIb, multinational, prospective, randomized study. Arthritis Rheum 2013;65(1):28-38
   PubMed Web of Science ®Google Scholar
• Smolen JS, Aletaha D. Forget personalised medicine and focus on abating disease activity. Ann Rheum Dis 2013;72(1):3-6
   PubMed Web of Science ®Google Scholar
• Bonelli M, Ferner E, Goschl L, et al. Abatacept (CTLA-4IG) treatment reduces the migratory capacity of monocytes in patients with rheumatoid arthritis. Arthritis Rheum 2013;65(3):599-607
   PubMed Web of Science ®Google Scholar
• Merrill JT, Burgos-Vargas R, Westhovens R, 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(10):3077-87
   PubMed Web of Science ®Google Scholar
• Furie R, Nicholls K, Cheng TT, et al. Efficacy and safety of abatacept in lupus nephritis: a twelve-month, randomized, double-blind study. Arthritis Rheumatol 2014;66(2):379-89
   PubMed Web of Science ®Google Scholar
• Wofsy DA, Askanase A, Cagnoli PC, et al. Treatment of lupus nephritis with abatacept plus low-dose pulse cyclophosphamide followed by azathioprine (the Euro-Lupus regimen): twenty-four week data from a double-blind controlled trial. Arthritis Rheum 2013;65(10 Supplement):S884-5
   Google Scholar
• Genovese MC, Becker JC, Schiff M, et al. Abatacept for rheumatoid arthritis refractory to tumor necrosis factor alpha inhibition. N Engl J Med 2005;353(11):1114-23
   PubMed Web of Science ®Google Scholar
• Westhovens R, Robles M, Ximenes AC, et al. Clinical efficacy and safety of abatacept in methotrexate-naive patients with early rheumatoid arthritis and poor prognostic factors. Ann Rheum Dis 2009;68(12):1870-7
   PubMed Web of Science ®Google Scholar
• Konsta M, Rallis E, Karameris A, et al. Psoriasiform lesions appearing in three patients with rheumatoid arthritis during therapeutic administration of abatacept, a selective inhibitor of T-cell costimulation. J Eur Acad Dermatol Venereol 2012;26(2):257-8
   PubMed Web of Science ®Google Scholar
• Jost C, Hermann J, Caelen-Lel S, et al. New onset psoriasis in a patient receiving abatacept for rheumatoid arthritis. BMJ Case Rep 2009. [Epub ahead of print]
   Google Scholar
• Takase K, Horton SC, Ganesha A, et al. What is the utility of routine ANA testing in predicting development of biological DMARD-induced lupus and vasculitis in patients with rheumatoid arthritis? Data from a single-centre cohort. Ann Rheum Dis 2014;73(9):1695-9
   PubMed Web of Science ®Google Scholar
• Simon TA, Smitten AL, Franklin J, et al. Malignancies in the rheumatoid arthritis abatacept clinical development programme: an epidemiological assessment. Ann Rheum Dis 2009;68(12):1819-26
   PubMed Web of Science ®Google Scholar
• Mohan N, Edwards ET, Cupps TR, et al. Demyelination occurring during anti-tumor necrosis factor alpha therapy for inflammatory arthritides. Arthritis Rheum 2001;44(12):2862-9
   PubMed Web of Science ®Google Scholar
• Aringer M, Smolen JS. The role of tumor necrosis factor-alpha in systemic lupus erythematosus. Arthritis Res Ther 2008;10(1):202
   PubMed Web of Science ®Google Scholar
• Jacob CO, McDevitt HO. Tumour necrosis factor-alpha in murine autoimmune ’lupus’ nephritis. Nature 1988;331(6154):356-8
   PubMed Web of Science ®Google Scholar
• Jacob N, Yang H, Pricop L, et al. Accelerated pathological and clinical nephritis in systemic lupus erythematosus-prone New Zealand Mixed 2328 mice doubly deficient in TNF receptor 1 and TNF receptor 2 via a Th17-associated pathway. J Immunol 2009;182(4):2532-41
   PubMed Web of Science ®Google Scholar
• Bethunaickan R, Sahu R, Liu Z, et al. Anti-tumor necrosis factor alpha treatment of interferon-alpha-induced murine lupus nephritis reduces the renal macrophage response but does not alter glomerular immune complex formation. Arthritis Rheum 2012;64(10):3399-408
   PubMed Web of Science ®Google Scholar
• Aringer M, Steiner G, Graninger WB, et al. Effects of short-term infliximab therapy on autoantibodies in systemic lupus erythematosus. Arthritis Rheum 2006;56(1):274-9
   Web of Science ®Google Scholar
• Aringer M, Graninger WB, Steiner G, et al. Safety and efficacy of TNF blockade in systemic lupus erythematosus - an open label study. Arthritis Rheum 2004;50(10):3161-9
   PubMed Web of Science ®Google Scholar
• Aringer M, Houssiau F, Gordon C, 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(11):1451-4
   PubMed Web of Science ®Google Scholar
• Cortes-Hernandez J, Egri N, Vilardell-Tarres M, et al. Safety and efficacy of etanercept in systemic lupus erythematosus. Arthritis Rheum 2012;64(10 Supplement):S616
   Google Scholar
• Slifman NR, Gershon SK, Lee JH, et al. Listeria monocytogenes infection as a complication of treatment with tumor necrosis factor alpha-neutralizing agents. Arthritis Rheum 2003;48(2):319-24
   PubMed Web of Science ®Google Scholar
• Lee JH, Slifman NR, Gershon SK, et al. Life-threatening histoplasmosis complicating immunotherapy with tumor necrosis factor alpha antagonists infliximab and etanercept. Arthritis Rheum 2002;46(10):2565-70
   PubMed Web of Science ®Google Scholar
• Keane J, Gershon S, Wise RP, et al. Tuberculosis associated with infliximab, a tumor necrosis factor alpha-neutralizing agent. N Engl J Med 2001;345(15):1098-104
   PubMed Web of Science ®Google Scholar
• Listing J, Gerhold K, Zink A. The risk of infections associated with rheumatoid arthritis, with its comorbidity and treatment. Rheumatology (Oxford) 2013;52(1):53-61
   PubMed Web of Science ®Google Scholar
• Askling J, Fahrbach K, Nordstrom B, et al. Cancer risk with tumor necrosis factor alpha (TNF) inhibitors: meta-analysis of randomized controlled trials of adalimumab, etanercept, and infliximab using patient level data. Pharmacoepidemiol Drug Saf 2011;20(2):119-30
   PubMed Web of Science ®Google Scholar
• Raaschou P, Simard JF, Holmqvist M, et al. Rheumatoid arthritis, anti-tumour necrosis factor therapy, and risk of malignant melanoma: nationwide population based prospective cohort study from Sweden. BMJ 2013;346:f1939
   PubMed Web of Science ®Google Scholar
• Deepak P, Sifuentes H, Sherid M, et al. T-cell non-Hodgkin’s lymphomas reported to the FDA AERS with tumor necrosis factor-alpha (TNF-alpha) inhibitors: results of the REFURBISH study. Am J Gastroenterol 2013;108(1):99-105
   PubMed Web of Science ®Google Scholar
• Wegener’s Granulomatosis Etanercept Trial (WGET) Research Group. Etanercept plus standard therapy for Wegener’s granulomatosis. N Engl J Med 2005;352(4):351-61
   PubMed Web of Science ®Google Scholar
• Silva F, Seo P, Schroeder DR, et al. Solid malignancies among etanercept-treated patients with granulomatosis with polyangiitis (Wegener’s): long-term followup of a multicenter longitudinal cohort. Arthritis Rheum 2011;63(8):2495-503
   PubMed Web of Science ®Google Scholar
• Illei GG, Shirota Y, Yarboro CH, 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(2):542-52
   PubMed Web of Science ®Google Scholar
• Ostendorf B, Iking-Konert C, Kurz K, et al. Preliminary results of safety and efficacy of the interleukin-1 receptor antagonist anakinra in patients with severe lupus arthritis. Ann Rheum Dis 2005;64(4):630-3
   PubMed Web of Science ®Google Scholar
• Moosig F, Zeuner R, Renk C, et al. IL-1RA in refractory systemic lupus erythematosus. Lupus 2004;13(8):605-6
   PubMed Web of Science ®Google Scholar
• Singh JA, Wells GA, Christensen R, et al. Adverse effects of biologics: a network meta-analysis and Cochrane overview. Cochrane Database Syst Rev 2011(2):CD008794
   PubMed Web of Science ®Google Scholar
• Strangfeld A, Eveslage M, Schneider M, et al. Treatment benefit or survival of the fittest: what drives the time-dependent decrease in serious infection rates under TNF inhibition and what does this imply for the individual patient? Ann Rheum Dis 2011;70(11):1914-20
   PubMed Web of Science ®Google Scholar
• van Vollenhoven RF, Mosca M, Bertsias G, et al. Treat-to-target in systemic lupus erythematosus: recommendations from an international task force. Ann Rheum Dis 2014;73(6):958-67
   PubMed Web of Science ®Google Scholar