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PID: 23136242, This was a pooled observed case analysis of long-term safety data of patients with rheumatoid arthritis treated with rituximab from eight randomised trials and two open-label extension studies. The data showed that the rates of infections and serious infections were similar to placebo group, and remained stable over time as well as with multiple courses of rituximab
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van Vollenhoven RF, Emery P, Bingham 3rd CO, Keystone EC, Fleischmann RM, Furst DE, et al. Long-term safety of rituximab in rheumatoid arthritis: 9.5-year follow-up of the global clinical trial programme with a focus on adverse events of interest in RA patients. Ann Rheum Dis. 2013;72(9):1496–502. This was a pooled observed case analysis of long-term safety data of patients with rheumatoid arthritis treated with rituximab from eight randomised trials and two open-label extension studies. The data showed that the rates of infections and serious infections were similar to placebo group, and remained stable over time as well as with multiple courses of rituximab.
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Westhovens R, Kremer JM, Moreland LW, Emery P, Russell AS, Li T, et al. Safety and efficacy of the selective costimulation modulator abatacept in patients with rheumatoid arthritis receiving background methotrexate: a 5-year extended phase IIB study. J Rheumatol. 2009;36(4):736–42.
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Assessment of long-term safety and efficacy of etanercept in a 5-year extension study in patients with rheumatoid arthritis
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Galloway JB, Hyrich KL, Mercer LK, Dixon WG, Fu B, Ustianowski AP, et al. 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. 2011;50(1):124–31.
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Rigby W, Tony HP, Oelke K, Combe B, Laster A, von Muhlen CA, et al. Safety and efficacy of ocrelizumab in patients with rheumatoid arthritis and an inadequate response to methotrexate: results of a forty-eight-week randomized, double-blind, placebo-controlled, parallel-group phase III trial. Arthritis Rheum. 2012;64(2):350–9.
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Tak PP, Mease PJ, Genovese MC, Kremer J, Haraoui B, Tanaka Y, et al. Safety and efficacy of ocrelizumab in patients with rheumatoid arthritis and an inadequate response to at least one tumor necrosis factor inhibitor: results of a forty-eight-week randomized, double-blind, placebo-controlled, parallel-group phase III trial. Arthritis Rheum. 2012;64(2):360–70.
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Efficacy and safety of ocrelizumab in active proliferative lupus nephritis: results from a randomized, double-blind, phase III study
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Mysler EF, Spindler AJ, Guzman R, Bijl M, Jayne D, Furie RA, et al. Efficacy and safety of ocrelizumab in active proliferative lupus nephritis: results from a randomized, double-blind, phase III study. Arthritis Rheum. 2013;65(9):2368–79.
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PID: 24498318, This meta-analysis of four ocrelizumab phase III trials highlighted the difference in rates of serious infections between the two ocrelizumab (OCR) dosages. Higher ocrelizumab dosage; OCR500 + MTX as opposed to the lower dosage; OCR 200 + MTX was associated with an increased risk of serious infection compared with placebo + MTX
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Emery P, Rigby W, Tak PP, Dorner T, Olech E, Martin C, et al. Safety with ocrelizumab in rheumatoid arthritis: results from the ocrelizumab phase III program. PLoS One. 2014;9(2):e87379. This meta-analysis of four ocrelizumab phase III trials highlighted the difference in rates of serious infections between the two ocrelizumab (OCR) dosages. Higher ocrelizumab dosage; OCR500 + MTX as opposed to the lower dosage; OCR 200 + MTX was associated with an increased risk of serious infection compared with placebo + MTX.
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Risk factors for severe infections in patients with rheumatoid arthritis treated with rituximab in the autoimmunity and rituximab registry
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COI: 1:CAS:528:DC%2BC3cXht1ClurbP, PID: 20506353, This French Registry identified risk factors for severe infections in patients with rheumatoid arthritis who were treated with rituximab included chronic lung and/or cardiac disease, extraarticular involvement, and low IgG levels before therapy
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Gottenberg JE, Ravaud P, Bardin T, Cacoub P, Cantagrel A, Combe B, et al. Risk factors for severe infections in patients with rheumatoid arthritis treated with rituximab in the autoimmunity and rituximab registry. Arthritis Rheum. 2010;62(9):2625–32. This French Registry identified risk factors for severe infections in patients with rheumatoid arthritis who were treated with rituximab included chronic lung and/or cardiac disease, extraarticular involvement, and low IgG levels before therapy.
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COI: 1:CAS:528:DC%2BC3MXotFyks7o%3D, PID: 21378402, This consensus statement of the use of rituximab in rheumatoid arthritis provided recommendations on a wide range of clinical issues included appropriate screening for hepatitis, monitoring for immunoglobulin levels and strategies to minimise infection risk with therapy
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Buch MH, Smolen JS, Betteridge N, Breedveld FC, Burmester G, Dorner T, et al. Updated consensus statement on the use of rituximab in patients with rheumatoid arthritis. Ann Rheum Dis. 2011;70(6):909–20. This consensus statement of the use of rituximab in rheumatoid arthritis provided recommendations on a wide range of clinical issues included appropriate screening for hepatitis, monitoring for immunoglobulin levels and strategies to minimise infection risk with therapy.
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Venhoff N, Effelsberg NM, Salzer U, Warnatz K, Peter HH, Lebrecht D, et al. Impact of rituximab on immunoglobulin concentrations and B cell numbers after cyclophosphamide treatment in patients with ANCA-associated vasculitides. PLoS One. 2012;7(5):e37626.
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COI: 1:CAS:528:DC%2BC2cXotlSrsQ%3D%3D, PID: 24414744, This Spanish Registry reported that patients with connective tissue diseases other than rheumatoid arthritis had increased risk for serious infection when treated with either TNF-inhibitor or rituximab
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Cobo-Ibanez T, Descalzo MA, Loza-Santamaria E, Carmona L, Munoz-Fernandez S. 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. Rheumatol Int. 2014;34(7):953–61. This Spanish Registry reported that patients with connective tissue diseases other than rheumatoid arthritis had increased risk for serious infection when treated with either TNF-inhibitor or rituximab.
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Initiation of rheumatoid arthritis treatments and the risk of serious infections
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Grijalva CG, Kaltenbach L, Arbogast PG, Mitchel Jr EF, Griffin MR. Initiation of rheumatoid arthritis treatments and the risk of serious infections. Rheumatology. 2010;49(1):82–90.
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