Safety and efficacy of intravenous belimumab in children with systemic lupus erythematosus: results from a randomised, placebo-controlled trial
暂无分享,去创建一个
V. Chasnyk | A. Martini | H. Brunner | A. Hammer | H. Struemper | D. Lovell | J. Antón | C. Abud-Mendoza | B. Ji | D. Viola | I. Calvo Penadés | D. Levy | Julia E Calderon | M. Ferrandiz | V. Keltsev | M. E. Paz Gastañaga | M. Shishov | A. Boteanu | M. Henrickson | D. Bass | K. Clark | A. Nino | D. Roth | Mei-Lun Wang | N. Ruperto
[1] W. Koopman. Arthritis and allied conditions;: A textbook of rheumatology , 1972 .
[2] M. H. Gault,et al. Prediction of creatinine clearance from serum creatinine. , 1975, Nephron.
[3] B. Burke,et al. Systemic lupus erythematosus within the first two decades of life. , 1977, The American journal of medicine.
[4] J F Fries,et al. The 1982 revised criteria for the classification of systemic lupus erythematosus. , 1982, Arthritis and rheumatism.
[5] M. Hasper,et al. Thalidomide in the treatment of chronic discoid lupus erythematosus. , 1982, Acta dermato-venereologica.
[6] S. Garella,et al. Use of single voided urine samples to estimate quantitative proteinuria. , 1983, The New England journal of medicine.
[7] M. Cygler,et al. Antibodies to DNA , 1988, BioEssays : news and reviews in molecular, cellular and developmental biology.
[8] D. McCurdy,et al. Systemic lupus erythematosus in the first decade of life. , 1989, Pediatrics.
[9] K. Steinsson,et al. Systemic lupus erythematosus in Iceland 1975 through 1984. A nationwide epidemiological study in an unselected population. , 1990, The Journal of rheumatology.
[10] K. Hyllested,et al. Suicide and multiple sclerosis: an epidemiological investigation. , 1992, Journal of neurology, neurosurgery, and psychiatry.
[11] D. Sackett,et al. Derivation of the SLEDAI. A disease activity index for lupus patients. The Committee on Prognosis Studies in SLE. , 1992, Arthritis and rheumatism.
[12] D A Isenberg,et al. The BILAG index: a reliable and valid instrument for measuring clinical disease activity in systemic lupus erythematosus. , 1993, The Quarterly journal of medicine.
[13] M. Doherty,et al. The prevalence and incidence of systemic lupus erythematosus in Nottingham, UK, 1989-1990. , 1993, British journal of rheumatology.
[14] J. Reveille,et al. Clinical, serologic, and immunogenetic studies in childhood-onset systemic lupus erythematosus. , 1993, Arthritis and rheumatism.
[15] L. Costallat,et al. Systemic lupus erythematosus: clinical and laboratory aspects related to age at disease onset. , 1994, Clinical and experimental rheumatology.
[16] D. Symmons,et al. The development and initial validation of the Systemic Lupus International Collaborating Clinics/American College of Rheumatology damage index for systemic lupus erythematosus. , 1996, Arthritis and rheumatism.
[17] D. Isenberg,et al. SLICC/ACR Damage Index is valid, and renal and pulmonary organ scores are predictors of severe outcome in patients with systemic lupus erythematosus. , 1996, British journal of rheumatology.
[18] C. Patterson,et al. The Prevalence of Systemic Lupus Erythematosus in Northern Ireland , 1997, Lupus.
[19] Lehman Tj. Pediatric rheumatology in the 21st century--where's the common sense? , 1997 .
[20] M. Hochberg,et al. Updating the American College of Rheumatology revised criteria for the classification of systemic lupus erythematosus. , 1997, Arthritis and rheumatism.
[21] G. Remuzzi,et al. Cross sectional longitudinal study of spot morning urine protein:creatinine ratio, 24 hour urine protein excretion rate, glomerular filtration rate, and end stage renal failure in chronic renal disease in patients without diabetes , 1998, BMJ.
[22] M. Reichlin,et al. Evidence for the participation of anti-ribosomal P antibodies in lupus nephritis. , 1999, Arthritis and rheumatism.
[23] Mimi Y. Kim,et al. Classification and definition of major flares in SLE clinical trials , 1999, Lupus.
[24] D A Isenberg,et al. From BILAG to BLIPS—disease activity assessment in lupus past, present and future , 2000, Lupus.
[25] V. Roschke,et al. Elevated serum B lymphocyte stimulator levels in patients with systemic immune-based rheumatic diseases. , 2001, Arthritis and rheumatism.
[26] R. Kimberly,et al. Treatment of lupus with corticosteroids , 2001, Lupus.
[27] P. Lipsky,et al. Autoantibodies as predictors of disease. , 2001, The Journal of clinical investigation.
[28] D. Isenberg,et al. An analysis of clinical disease activity and nephritis-associated serum autoantibody profiles in patients with systemic lupus erythematosus: a cross-sectional study. , 2001, Rheumatology.
[29] C. Moore,et al. Association between presence of HLA-B*5701, HLA-DR7, and HLA-DQ3 and hypersensitivity to HIV-1 reverse-transcriptase inhibitor abacavir , 2002, The Lancet.
[30] J. Varni,et al. The PedsQL in pediatric rheumatology: reliability, validity, and responsiveness of the Pediatric Quality of Life Inventory Generic Core Scales and Rheumatology Module. , 2002, Arthritis and rheumatism.
[31] C. Bombardier,et al. Risk factors for damage in childhood-onset systemic lupus erythematosus: cumulative disease activity and medication use predict disease damage. , 2002, Arthritis and rheumatism.
[32] Clive E. Bowman,et al. Genetic variations in HLA-B region and hypersensitivity reactions to abacavir , 2002, The Lancet.
[33] C. Gordon,et al. Definition and treatment of lupus flares measured by the BILAG index. , 2003, Rheumatology.
[34] W. Kuis,et al. Preliminary core sets of measures for disease activity and damage assessment in juvenile systemic lupus erythematosus and juvenile dermatomyositis. , 2003, Rheumatology.
[35] V. Roschke,et al. Generation and characterization of LymphoStat-B, a human monoclonal antibody that antagonizes the bioactivities of B lymphocyte stimulator. , 2003, Arthritis and rheumatism.
[36] C. Gutiérrez,et al. Epidemiology of systemic lupus erythematosus in a northern Spanish population: gender and age influence on immunological features , 2003, Lupus.
[37] R. Baldassano,et al. Infliximab (REMICADE) Therapy in the Treatment of Pediatric Crohn's Disease , 2003, American Journal of Gastroenterology.
[38] Y. Matsukawa. Suicides in persons suffering from rheumatoid arthritis. , 2003, Rheumatology.
[39] M. Liang. Criteria for steroid-sparing ability of interventions in systemic lupus erythematosus: report of a consensus meeting. , 2004, Arthritis and rheumatism.
[40] J. Varni,et al. The PedsQL Multidimensional Fatigue Scale in pediatric rheumatology: reliability and validity. , 2004, The Journal of rheumatology.
[41] Y. Levy,et al. Early response to immunosuppressive therapy predicts good renal outcome in lupus nephritis: lessons from long-term followup of patients in the Euro-Lupus Nephritis Trial. , 2004, Arthritis and rheumatism.
[42] A. Martini,et al. International research networks in pediatric rheumatology: the PRINTO perspective , 2004, Current opinion in rheumatology.
[43] D. Mccarty,et al. Epidemiology of systemic lupus erythematosus in rural Wisconsin , 2005, Lupus.
[44] K. Kalunian,et al. Combined oral contraceptives in women with systemic lupus erythematosus. , 2005, The New England journal of medicine.
[45] K. Minden,et al. The Pediatric Rheumatology International Trials Organization criteria for the evaluation of response to therapy in juvenile systemic lupus erythematosus: prospective validation of the disease activity core set. , 2005, Arthritis and rheumatism.
[46] C. Härtel,et al. Cytokine responses correlate differentially with age in infancy and early childhood , 2005, Clinical and experimental immunology.
[47] Christopher P Price,et al. Use of protein:creatinine ratio measurements on random urine samples for prediction of significant proteinuria: a systematic review. , 2005, Clinical chemistry.
[48] C. Alloui,et al. Quantification of Hepatitis Delta Virus RNA in Serum by Consensus Real-Time PCR Indicates Different Patterns of Virological Response to Interferon Therapy in Chronically Infected Patients , 2005, Journal of Clinical Microbiology.
[49] E. Haddad,et al. Initial presentation of childhood-onset systemic lupus erythematosus: a French multicenter study. , 2005, The Journal of pediatrics.
[50] Mimi Y. Kim,et al. Outcomes of planned home births with certified professional midwives: large prospective study in North America , 2005, BMJ : British Medical Journal.
[51] R. Wilke,et al. Cytochrome P450 gene-based drug prescribing and factors impacting translation into routine clinical practice. , 2005, Personalized medicine.
[52] L. Pasquier,et al. Orphanet Journal of Rare Diseases , 2006 .
[53] S. Bae,et al. The Pediatric Rheumatology International Trials Organization/American College of Rheumatology provisional criteria for the evaluation of response to therapy in juvenile systemic lupus erythematosus: prospective validation of the definition of improvement. , 2006, Arthritis and rheumatism.
[54] D. D'cruz. Systemic lupus erythematosus , 2006, BMJ : British Medical Journal.
[55] C. Gasparini,et al. Relationship between Damage Accrual, Disease Flares and Cumulative Drug Therapies in Juvenile-Onset Systemic Lupus Erythematosus , 2006, Lupus.
[56] J. Dadonienė,et al. The Prevalence of Systemic Lupus Erythematosus in Lithuania: The Lowest Rate in Northern Europe , 2006, Lupus.
[57] A. Martini,et al. A proposal for a pediatric version of the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index based on the analysis of 1,015 patients with juvenile-onset systemic lupus erythematosus. , 2006, Arthritis and rheumatism.
[58] D. Mevorach,et al. Outcome of a national Israeli cohort of pediatric systemic lupus erythematosus. , 2007, Lupus.
[59] F. Pluchinotta,et al. Distinctive clinical features of pediatric systemic lupus erythematosus in three different age classes , 2007, Lupus.
[60] T. Lehman. The future of pediatric rheumatology: many questions remain. , 2007, Arthritis and rheumatism.
[61] C. D. de Vries,et al. Systemic lupus erythematosus prevalence in the U.K.: methodological issues when using the General Practice Research Database to estimate frequency of chronic relapsing‐remitting disease , 2007, Pharmacoepidemiology and drug safety.
[62] Barbara Stanley,et al. Columbia Classification Algorithm of Suicide Assessment (C-CASA): classification of suicidal events in the FDA's pediatric suicidal risk analysis of antidepressants. , 2007, The American journal of psychiatry.
[63] L. Smeeth,et al. Incidence of systemic lupus erythematosus in the United Kingdom, 1990-1999. , 2007, Arthritis and rheumatism.
[64] M. Petri,et al. Association of plasma B lymphocyte stimulator levels and disease activity in systemic lupus erythematosus. , 2008, Arthritis and rheumatism.
[65] A. Martini,et al. Abatacept in children with juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled withdrawal trial , 2008, The Lancet.
[66] M. Pescovitz,et al. Safety and pharmacokinetics of daclizumab in pediatric renal transplant recipients , 2008, Pediatric transplantation.
[67] Agustín R. Uribe,et al. Adolescent onset of lupus results in more aggressive disease and worse outcomes: results of a nested matched case–control study within LUMINA, a multiethnic US cohort (LUMINA LVII) , 2008, Lupus.
[68] D. Gladman,et al. Difference in disease features between childhood-onset and adult-onset systemic lupus erythematosus. , 2008, Arthritis and rheumatism.
[69] N. Yuen,et al. Drug-induced liver injury following positive drug rechallenge. , 2009, Regulatory toxicology and pharmacology : RTP.
[70] Susan L Furth,et al. New equations to estimate GFR in children with CKD. , 2009, Journal of the American Society of Nephrology : JASN.
[71] L. Criswell,et al. Prevalence of mood and anxiety disorders in women with systemic lupus erythematosus. , 2009, Arthritis and rheumatism.
[72] M. Petri,et al. Novel evidence-based systemic lupus erythematosus responder index. , 2009, Arthritis and rheumatism.
[73] R. Andrade,et al. Rechallenge in drug-induced liver injury: the attractive hazard , 2009, Expert opinion on drug safety.
[74] A. Martini,et al. Evaluation of 21-Numbered Circle and 10-Centimeter Horizontal Line Visual Analog Scales for Physician and Parent Subjective Ratings in Juvenile Idiopathic Arthritis , 2010, The Journal of Rheumatology.
[75] C. Hunt. Mitochondrial and immunoallergic injury increase risk of positive drug rechallenge after drug‐induced liver injury: A systematic review , 2010, Hepatology.
[76] D. Moher,et al. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials , 2010, BMC medicine.
[77] S. Kamphuis,et al. Prevalence and burden of pediatric-onset systemic lupus erythematosus , 2010, Nature Reviews Rheumatology.
[78] 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.
[79] 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.
[80] G. Antes,et al. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials , 2011 .
[81] A. Martini,et al. Networking in paediatrics: the example of the Paediatric Rheumatology International Trials Organisation (PRINTO) , 2011, Archives of Disease in Childhood.
[82] C. Wouters,et al. Two randomized trials of canakinumab in systemic juvenile idiopathic arthritis. , 2012, The New England journal of medicine.
[83] S. Kamphuis,et al. Systemic lupus erythematosus in children and adolescents. , 2012, Pediatric clinics of North America.
[84] H. Brunner,et al. Taxonomy for systemic lupus erythematosus with onset before adulthood , 2012, Arthritis care & research.
[85] C. Wouters,et al. Randomized trial of tocilizumab in systemic juvenile idiopathic arthritis. , 2012, The New England journal of medicine.
[86] 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.
[87] H. Struemper,et al. Population Pharmacokinetics of Belimumab Following Intravenous Administration in Patients With Systemic Lupus Erythematosus , 2013, Journal of clinical pharmacology.
[88] M. Punaro,et al. Validation of the systemic lupus erythematosus responder index for use in juvenile-onset systemic lupus erythematosus , 2013, Annals of the rheumatic diseases.
[89] Anthony O'Hagan,et al. Robust meta‐analytic‐predictive priors in clinical trials with historical control information , 2014, Biometrics.
[90] D. Jayne,et al. SUMMARY OF PRODUCT CHARACTERISTICS , 2014 .
[91] Bradley P Carlin,et al. Statistical modeling for Bayesian extrapolation of adult clinical trial information in pediatric drug evaluation , 2017, Pharmaceutical statistics.
[92] A. Schwarting,et al. Efficacy and Safety of Subcutaneous Belimumab in Systemic Lupus Erythematosus: A Fifty‐Two–Week Randomized, Double‐Blind, Placebo‐Controlled Study , 2017, Arthritis & rheumatology.
[93] S. Bae,et al. A pivotal phase III, randomised, placebo-controlled study of belimumab in patients with systemic lupus erythematosus located in China, Japan and South Korea , 2018, Annals of the rheumatic diseases.
[94] R. Schneider,et al. Pediatric Rheumatology Collaborative Study Group – over four decades of pivotal clinical drug research in pediatric rheumatology , 2018, Pediatric Rheumatology.
[95] A. Hammer,et al. P128 Efficacy of intravenous belimumab in children with systemic lupus erythematosus with markers of high disease activity: across-trial comparison with adult belimumab studies , 2020 .