Efficacy of belimumab combined with rituximab in severe systemic lupus erythematosus: study protocol for the phase 3, multicenter, randomized, open-label Synbiose 2 trial

[1]  C. Gordon,et al.  Effectiveness of Belimumab After Rituximab in Systemic Lupus Erythematosus , 2021, Annals of Internal Medicine.

[2]  B. Rovin,et al.  B-cell depletion with obinutuzumab for the treatment of proliferative lupus nephritis: a randomised, double-blind, placebo-controlled trial , 2021, Annals of the Rheumatic Diseases.

[3]  T. Rabelink,et al.  POS0680 BELIMUMAB ADD-ON THERAPY MOBILISES MEMORY B CELLS INTO THE CIRCULATION OF PATIENTS WITH SLE , 2021, Annals of the Rheumatic Diseases.

[4]  M. Tsang-A-Sjoe,et al.  Treatment targets in SLE: remission and low disease activity state , 2020, Rheumatology.

[5]  B. Rovin,et al.  Two-Year, Randomized, Controlled Trial of Belimumab in Lupus Nephritis. , 2020, The New England journal of medicine.

[6]  B. Diamond,et al.  Phase II Randomized Trial of Rituximab Plus Cyclophosphamide Followed by Belimumab for the Treatment of Lupus Nephritis , 2020, Arthritis & rheumatology.

[7]  T. Rabelink,et al.  Long-term effects of combined B-cell immunomodulation with rituximab and belimumab in severe, refractory systemic lupus erythematosus: 2-year results , 2020, Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association.

[8]  D. Bass,et al.  Systemic lupus erythematosus, lupus nephritis and end-stage renal disease: a pragmatic review mapping disease severity and progression , 2020, Lupus.

[9]  O. Jolobe,et al.  Systemic , 2020, Definitions.

[10]  D. Isenberg,et al.  A reverse translational study on the effect of rituximab, rituximab plus belimumab, or bortezomib on the humoral autoimmune response in SLE , 2020, Rheumatology.

[11]  A. Tincani,et al.  Association Between Changes in BLyS Levels and the Composition of B and T Cell Compartments in Patients With Refractory Systemic Lupus Erythematosus Treated With Belimumab , 2019, Front. Pharmacol..

[12]  D. Gladman,et al.  All-cause, cause-specific and age-specific standardised mortality ratios of patients with systemic lupus erythematosus in Ontario, Canada over 43 years (1971–2013) , 2019, Annals of the rheumatic diseases.

[13]  Yoshiya Tanaka,et al.  Efficacy and safety of intravenous belimumab in Japanese patients with systemic lupus erythematosus: A subgroup analysis of a phase 3 randomized placebo-controlled trial , 2018, Modern rheumatology.

[14]  B. Rovin,et al.  Peripheral Blood B Cell Depletion after Rituximab and Complete Response in Lupus Nephritis. , 2018, Clinical journal of the American Society of Nephrology : CJASN.

[15]  T. Rabelink,et al.  FRI0330 Rituximab therapy in sle: early retreatment is associated with lower disease activity and a reduction in corticosteroid use , 2018, Journal of autoimmunity.

[16]  I. Bruce,et al.  Short-term efficacy and safety of rituximab therapy in refractory systemic lupus erythematosus: results from the British Isles Lupus Assessment Group Biologics Register , 2017, Rheumatology.

[17]  D. Isenberg,et al.  Use of Rituximab in Systemic Lupus Erythematosus: A Single Center Experience Over 14 Years , 2017, Arthritis care & research.

[18]  E. Morand,et al.  Definition and initial validation of a Lupus Low Disease Activity State (LLDAS) , 2015, Annals of the rheumatic diseases.

[19]  C. Molta,et al.  Elevated BLyS levels in patients with systemic lupus erythematosus: Associated factors and responses to belimumab , 2015, Lupus.

[20]  L. Punzi,et al.  Prolonged remission in Caucasian patients with SLE: prevalence and outcomes , 2015, Annals of the rheumatic diseases.

[21]  D. Roccatello,et al.  Efficacy and safety of off-label use of rituximab in refractory lupus: data from the Italian Multicentre Registry , 2015 .

[22]  D. Gladman,et al.  Prolonged Clinical Remission in Patients with Systemic Lupus Erythematosus , 2014, The Journal of Rheumatology.

[23]  J. Aviña-Zubieta,et al.  Overall and Cause‐Specific Mortality in Patients With Systemic Lupus Erythematosus: A Meta‐Analysis of Observational Studies , 2014, Arthritis care & research.

[24]  R. Fischer-Betz,et al.  Clinical outcomes and safety of rituximab treatment for patients with systemic lupus erythematosus (SLE) – results from a nationwide cohort in Germany (GRAID) , 2013, Lupus.

[25]  J. Levy,et al.  Prospective observational single-centre cohort study to evaluate the effectiveness of treating lupus nephritis with rituximab and mycophenolate mofetil but no oral steroids , 2013, Annals of the rheumatic diseases.

[26]  David Moher,et al.  SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials , 2013, BMJ.

[27]  K. Latinis,et al.  Belimumab reduces autoantibodies, normalizes low complement levels, and reduces select B cell populations in patients with systemic lupus erythematosus. , 2012, Arthritis and rheumatism.

[28]  R. Maciuca,et al.  Efficacy and safety of rituximab in patients with active proliferative lupus nephritis: the Lupus Nephritis Assessment with Rituximab study. , 2012, Arthritis and rheumatism.

[29]  T. Huizinga,et al.  Induction of long-term B-cell depletion in refractory rheumatoid arthritis patients preferentially affects autoreactive more than protective humoral immunity , 2012, Arthritis Research & Therapy.

[30]  M. Petri,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. , 2011, Arthritis and rheumatism.

[31]  P. Emery,et al.  B cell biomarkers of rituximab responses in systemic lupus erythematosus. , 2011, Arthritis and rheumatism.

[32]  M. Petri,et al.  Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial , 2011, The Lancet.

[33]  E. Vignon,et al.  Safety and efficacy of rituximab in systemic lupus erythematosus: results from 136 patients from the French AutoImmunity and Rituximab registry. , 2010, Arthritis and rheumatism.

[34]  C. Gordon,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. , 2010, Arthritis and rheumatism.

[35]  J. Levy,et al.  Rituximab is an effective treatment for lupus nephritis and allows a reduction in maintenance steroids. , 2009, Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association.

[36]  A. Vissink,et al.  Clinical and histologic evidence of salivary gland restoration supports the efficacy of rituximab treatment in Sjögren's syndrome. , 2009, Arthritis and rheumatism.

[37]  M. Petri,et al.  A phase II, randomized, double-blind, placebo-controlled, dose-ranging study of belimumab in patients with active systemic lupus erythematosus. , 2009, Arthritis and rheumatism.

[38]  M. Bokarewa,et al.  Short- and long-term effects of anti-CD20 treatment on B cell ontogeny in bone marrow of patients with rheumatoid arthritis , 2009, Arthritis research & therapy.

[39]  D. Isenberg,et al.  Mycophenolate mofetil versus cyclophosphamide for induction treatment of lupus nephritis. , 2009, Journal of the American Society of Nephrology : JASN.

[40]  D. Isenberg,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. , 2008, Arthritis and rheumatism.

[41]  M. Petri,et al.  Association of plasma B lymphocyte stimulator levels and disease activity in systemic lupus erythematosus. , 2008, Arthritis and rheumatism.

[42]  E. L. Prak,et al.  Variability in the biological response to anti-CD20 B cell depletion in systemic lupus erythaematosus , 2008, Annals of the rheumatic diseases.

[43]  T. Huizinga,et al.  Immunohistochemical analysis as a means to predict responsiveness to rituximab treatment. , 2007, Arthritis and rheumatism.

[44]  I. Bruce,et al.  Prolonged remission in systemic lupus erythematosus. , 2005, The Journal of rheumatology.

[45]  Hilde van der Togt,et al.  Publisher's Note , 2003, J. Netw. Comput. Appl..

[46]  V. Roschke,et al.  Elevated serum B lymphocyte stimulator levels in patients with systemic immune-based rheumatic diseases. , 2001, Arthritis and rheumatism.

[47]  G. Alarcón,et al.  Cutting Edge: A Role for B Lymphocyte Stimulator in Systemic Lupus Erythematosus1 , 2001, The Journal of Immunology.

[48]  N. Aaronson,et al.  Translation, validation, and norming of the Dutch language version of the SF-36 Health Survey in community and chronic disease populations. , 1998, Journal of clinical epidemiology.