Belimumab for the treatment of pediatric patients with lupus nephritis

References

• Carreno L, Lopez-Longo FJ, Monteagudo I, et al. Immunological and clinical differences between juvenile and adult onset of systemic lupus erythematosus. Lupus. 1999;8(4):287–292.
   PubMed Web of Science ®Google Scholar
• Hiraki LT, Benseler SM, Tyrrell PN, et al. Clinical and laboratory characteristics and long-term outcome of pediatric systemic lupus erythematosus: a longitudinal study. J Paediatr. 2008;152(4):550–556.
   PubMed Web of Science ®Google Scholar
• Hersh AO, von Scheven E, Yazdany J, et al. Differences in long-term disease activity and treatment of adult patients with childhood- and adult-onset systemic lupus erythematosus. Arthritis & Rheumatism-Arthritis Care & Res. 2009;61(1):13–20.
   Web of Science ®Google Scholar
• Hui-Yuen JS, Imundo LF, Avitabile C, et al. Early versus later onset childhood-onset systemic lupus erythematosus: clinical features, treatment and outcome. Lupus. 2011;20(9):952–959.
   PubMed Web of Science ®Google Scholar
• Pineles D, Valente A, Warren B, et al. Worldwide incidence and prevalence of pediatric onset systemic lupus erythematosus. Lupus. 2011;20(11):1187–1192.
   PubMed Web of Science ®Google Scholar
• Massias JS, Smith EMD, Al-Abadi E, et al. Clinical and laboratory characteristics in juvenile-onset systemic lupus erythematosus across age groups. Lupus. 2020;29(5):474–481.
   PubMed Web of Science ®Google Scholar
• Fessel WJ. Systemic lupus erythematosus in the community: incidence, prevalence, outcome, and first symptoms; high prevalence in Black women. Arch Internal Med. 1974;134(6):1027–1035.
   PubMedGoogle Scholar
• Jacobson DL, Gange SJ, Rose NR, et al. Epidemiology and estimated population burden of selected autoimmune diseases in the United States. Clinical Immunol Immuno. 1997;84(3):223–243
   PubMedGoogle Scholar
• Fernandez M, Alarcon GS, Calvo-Alen J, et al. A multiethnic, multicenter cohort of patients with systemic lupus erythematosus (SLE) as a model for the study of ethnic disparities in SLE. Arthritis & Rheumatism-Arthritis Care & Res. 2007;57(4):576–584.
   Web of Science ®Google Scholar
• Chakravarty EF, Bush TM, Manzi S, et al. Prevalence of adult systemic lupus erythematosus in California and Pennsylvania in 2000: estimates obtained using hospitalization data. Arthritis Rheumatism. 2007;56(6):2092–2094.
   PubMed Web of Science ®Google Scholar
• Merola JF, Bermas B, Lu B, et al. Clinical manifestations and survival among adults with (SLE) according to age at diagnosis. Lupus. 2014;23(8):778–784.
   PubMed Web of Science ®Google Scholar
• Chanprapaph K, Tubtieng I, Pratumchat N, et al. Cutaneous, systemic features and laboratory characteristics of late- versus adult-onset systemic lupus erythematosus in 1006 Thai patients. Lupus. 2021;30(5):785–794.
   PubMed Web of Science ®Google Scholar
• Gheita TA, Noor RA, Abualfadl E, et al. Adult systemic lupus erythematosus in Egypt: the nation-wide spectrum of 3661 patients and world-wide standpoint. Lupus. 2021;30(9):1526–1535.
   PubMed Web of Science ®Google Scholar
• Schneider P, MacKay F, Steiner V, et al. BAFF, a novel ligand of the tumor necrosis factor family, stimulates B cell growth. J Exp Med. 1999;189(11):1747–1756.
   PubMed Web of Science ®Google Scholar
• Moore PA, Belvedere O, Orr A, et al. BLyS: member of the tumor necrosis factor family and B lymphocyte stimulator. Science. 1999;285(5425):260–263.
   PubMed Web of Science ®Google Scholar
• Nardelli B, Belvedere O, Roschke V, et al. Synthesis and release of B-lymphocyte stimulator from myeloid cells. Blood. 2001;97(1):198–204.
   PubMed Web of Science ®Google Scholar
• Laabi Y, Gras MP, Brouet JC, et al. TheBCMA gene, preferentially expressed during B lymphoid maturation, is bidirectionally transcribed. Nucleic Acids Res. 1994;22(7):1147–1154.
   PubMed Web of Science ®Google Scholar
• von Bülow GU, Bram RJ. NF-AT activation induced by a CAML-interacting member of the tumor necrosis factor receptor superfamily. Science. 1997;278(5335):138–141.
   PubMed Web of Science ®Google Scholar
• Thompson JS, Bixler SA, Qian F, et al. BAFF-R, a newly identified TNF receptor that specifically interacts with BAFF. Science. 2001;293(5537):2108–2111.
   PubMed Web of Science ®Google Scholar
• Yan MH, Brady JR, Chan B, et al. Identification of a novel receptor for B lymphocyte stimulator that is mutated in a mouse strain with severe B cell deficiency. Curr Biol. 2001;11(19):1547–1552.
   PubMed Web of Science ®Google Scholar
• Kreuzaler M, Rauch M, Salzer U, et al. Soluble BAFF levels inversely correlate with peripheral B cell numbers and the expression of BAFF receptors. J Iimmunol. 2012;188(1):497–503.
   PubMed Web of Science ®Google Scholar
• Jacob CO, Pricop L, Putterman C, et al. Paucity of clinical disease despite serological autoimmunity and kidney pathology in lupus-prone New Zealand Mixed 2328 mice deficient in BAFF. J Iimmunol. 2006;177(4):2671–2680.
   PubMed Web of Science ®Google Scholar
• Gross JA, Johnston J, Mudri S, et al. TACI and BCMA are receptors for a TNF homologue implicated in B-cell autoimmune disease. Nature. 2000;404(6781):995–999.
   PubMed Web of Science ®Google Scholar
• Kayagaki N, Yan MH, Seshasayee D, et al. BAFF/BLyS receptor 3 binds the B cell survival factor BAFF ligand through a discrete surface loop and promotes processing of NF-κB2. Immunity. 2002;17(4):515–524.
   PubMed Web of Science ®Google Scholar
• Ramanujam M, Wang XB, Huang WQ, et al. Mechanism of action of transmembrane activator and calcium modulator ligand interactor-Ig in murine systemic lupus erythematosus. J Iimmunol. 2004;173(5):3524–3534.
   PubMed Web of Science ®Google Scholar
• Mackay F, Woodcock SA, Lawton P, et al. Mice transgenic for BAFF develop lymphocytic disorders along with autoimmune manifestations. J Exp Med. 1999;190(11):1697–1710.
   PubMed Web of Science ®Google Scholar
• Khare SD, Sarosi I, Xia XZ, et al. Severe B cell hyperplasia and autoimmune disease in TALL-1 transgenic mice. Proc Natl Acad Sci U S A. 2000;97(7),3370–3375.
   PubMed Web of Science ®Google Scholar
• Stohl W, Xu D, Kim KS, et al. BAFF overexpression and accelerated glomerular disease in mice with an incomplete genetic predisposition to systemic lupus erythematosus. Arthritis Rheumatism. 2005;52(7):2080–2091.
   PubMed Web of Science ®Google Scholar
• Steri M, Orru V, Idda ML, et al. Overexpression of the cytokine BAFF and autoimmunity risk. N Engl J Med. 2017;376(17):1615–1626.
   PubMed Web of Science ®Google Scholar
• Cheema GS, Roschke V, Hilbert DA, et al. Elevated serum B lymphocyte stimulator levels in patients with systemic immune-based rheumatic diseases. Arthritis Rheumatism. 2001;44(6):1313–1319.
   PubMed Web of Science ®Google Scholar
• Zhang J, Roschke V, Baker KP, et al. Cutting edge: a role for B lymphocyte stimulator in systemic lupus erythematosus. J Iimmunol. 2001;166(1):6–10.
   PubMed Web of Science ®Google Scholar
• Stohl W, Metyas S, Tan SM, et al. B lymphocyte stimulator overexpression in patients with systemic lupus erythematosus: longitudinal observations. Arthritis Rheumatism. 2003;48(12):3475–3486.
   PubMed Web of Science ®Google Scholar
• Collins CE, Gavin AL, Migone TS, et al. B lymphocyte stimulator (BLyS) isoforms in systemic lupus erythematosus: disease activity correlates better with blood leukocyte BLyS mRNA levels than with plasma BLyS protein levels. Arthritis Res Ther. 2006;8(1):R6.
   PubMed Web of Science ®Google Scholar
• Becker-Merok A, Nikolaisen C, Nossent HC. B-lymphocyte activating factor in systemic lupus erythematosus and rheumatoid arthritis in relation to autoantibody levels, disease measures and time. Lupus. 2006;15(9):570–576.
   PubMed Web of Science ®Google Scholar
• Ju SQ, Zhang DL, Wang YG, et al. Correlation of the expression levels of BLyS and its receptors mRNA in patients with systemic lupus erythematosus. Clin Biochem. 2006;39(12):1131–1137.
   PubMed Web of Science ®Google Scholar
• Petri M, Stohl W, Chatham W, et al. Association of plasma B lymphocyte stimulator levels and disease activity in systemic lupus erythematosus. Arthritis Rheumatism. 2008;58(8):2453–2459.
   PubMed Web of Science ®Google Scholar
• Petri MA, van Vollenhoven RF, Buyon J, et al. Baseline predictors of systemic lupus erythematosus flares: data from the combined placebo groups in the phase III belimumab trials. Arthritis Rheumatism. 2013;65(8):2143–2153.
   PubMed Web of Science ®Google Scholar
• McCarthy EM, Lee RZ, Gabhann JN, et al. Elevated B lymphocyte stimulator levels are associated with increased damage in an Irish systemic lupus erythematosus cohort. Rheumatology. 2013;52(7):1279–1284.
   PubMed Web of Science ®Google Scholar
• Hong SD, Reiff A, Yang HT, et al. B lymphocyte stimulator expression in pediatric systemic lupus erythematosus and juvenile idiopathic arthritis patients. Arthritis Rheumatism. 2009;60(11):3400–3409.
   PubMedGoogle Scholar
• Edelbauer M, Kshirsagar S, Riedl M, et al. Markers of childhood lupus nephritis indicating disease activity. Pediatr Nephrol. 2011;26(3):401–410.
   PubMed Web of Science ®Google Scholar
• Baker KP, Edwards BM, Main SH, et al. Generation and characterization of LymphoStat-B, a human monoclonal antibody that antagonizes the bioactivities of B lymphocyte stimulator. Arthritis Rheumatism. 2003;48(11):3253–3265.
   PubMed Web of Science ®Google Scholar
• Stohl W, Hilbert DM. The discovery and development of belimumab: the anti-BLyS–lupus connection. Nat Biotechnol. 2012;30(1):69–77.
   PubMed Web of Science ®Google Scholar
• Wallace DJ, Stohl W, Furie RA, et al. A phase II, randomized, double-blind, placebo-controlled, dose-ranging study of belimumab in patients with active systemic lupus erythematosus. Arthritis & Rheumatism-Arthritis Care & Res. 2009;61(9):1168–1178.
   Web of Science ®Google Scholar
• Furie RA, Petri MA, Wallace DJ, et al. Novel evidence-based systemic lupus erythematosus responder index. Arthritis & Rheumatism-Arthritis Care & Res. 2009;61(9):1143–1151.
   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):721–731.
   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 Rheumatism. 2011;63(12):3918–3930.
   PubMed Web of Science ®Google Scholar
• Stohl W, Schwarting A, Okada M, et al. Efficacy and safety of subcutaneous belimumab in systemic lupus erythematosus: a fifty-two-week randomized, double-blind, placebo-controlled study. Arthritis Rheumatol. 2017;69(5):1016–1027.
   PubMed Web of Science ®Google Scholar
• Zhang FC, Bae SC, Bass D, 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. Ann Rheum Dis. 2018;77:3.
   PubMedGoogle Scholar
• van Vollenhoven RF, Petri M, Wallace DJ, et al. Cumulative corticosteroid dose over fifty-two weeks in patients with systemic lupus erythematosus: pooled analyses from the phase III belimumab trials. Arthritis Rheumatol. 2016;68(9):2184–2192.
   PubMed Web of Science ®Google Scholar
• Ginzler E, Barbosa LSG, D’Cruz D, et al. Phase III/IV, randomized, fifty-two-week study of the efficacy and safety of belimumab in patients of Black African ancestry with systemic lupus erythematosus. Arthritis Rheumatol. 2022;74(1):112–123.
   PubMed Web of Science ®Google Scholar
• Ginzler EM, Wallace DJ, Merrill JT, et al. Disease control and safety of belimumab plus standard therapy over 7 years in patients with systemic lupus erythematosus. J Rheumatol. 2014;41(2):300–309.
   PubMed Web of Science ®Google Scholar
• Collins CE, Dall’Era M, Kan H, et al. Response to belimumab among patients with systemic lupus erythematosus in clinical practice settings: 24-month results from the OBSErve study in the USA. Lupus Sci Med. 2016;3(1):e000118.
   PubMed Web of Science ®Google Scholar
• Schwarting A, Schroeder JO, Alexander T, et al. First real-world insights into belimumab use and outcomes in routine clinical care of systemic lupus erythematosus in Germany: results from the OBSErve Germany Study. Rheumatol Ther. 2016;3(2):271–290.
   PubMed Web of Science ®Google Scholar
• Scheinberg M, de Melo FFN, Bueno AN, et al. Belimumab for the treatment of corticosteroid-dependent systemic lupus erythematosus: from clinical trials to real-life experience after 1 year of use in 48 Brazilian patients. Clin Rheumatol. 2016;35(7):1719–1723.
   PubMed Web of Science ®Google Scholar
• Touma Z, Sayani A, Pineau CA, et al. Belimumab use, clinical outcomes and glucocorticoid reduction in patients with systemic lupus erythematosus receiving belimumab in clinical practice settings: results from the OBSErve Canada Study. Rheumatol Int. 2017;37(6):865–873.
   PubMed Web of Science ®Google Scholar
• Iaccarino L, Bettio S, Reggia R, et al. Effects of belimumab on flare rate and expected damage progression in patients with active systemic lupus erythematosus. Arthritis Care Res (Hoboken). 2017;69(1):115–123.
   PubMed Web of Science ®Google Scholar
• Sthoeger Z, Lorber M, Tal Y, et al. Anti-BLyS treatment of 36 Israeli systemic lupus erythematosus patients. Israel Med Associ J. 2017;19(1): 44–48
   PubMed Web of Science ®Google Scholar
• Fanouriakis A, Adamichou C, Koutsoviti S, et al. Low disease activity-irrespective of serologic status at baseline-associated with reduction of corticosteroid dose and number of flares in patients with systemic lupus erythematosus treated with belimumab: a real-life observational study. Semin Arthritis Rheum. 2018;48(3):467–474.
   PubMed Web of Science ®Google Scholar
• Iaccarino L, Andreoli L, Bocci EB, et al. Clinical predictors of response and discontinuation of belimumab in patients with systemic lupus erythematosus in real life setting: results of a large, multicentric, nationwide study. J Autoimmun. 2018;86:1–8.
   PubMed Web of Science ®Google Scholar
• Anjo C, Mascaro JM, Espinosa G, et al. Effectiveness and safety of belimumab in patients with systemic lupus erythematosus in a real-world setting. Scand J Rheumatol. 2019;48(6):469–473.
   PubMed Web of Science ®Google Scholar
• Wallace DJ, Ginzler EM, Merrill JT, et al. Safety and efficacy of belimumab plus standard therapy for up to thirteen years in patients with systemic lupus erythematosus. Arthritis Rheumatol. 2019;71(7):1125–1134.
   PubMed Web of Science ®Google Scholar
• Hammam N, Evans M, Bell CF, et al. Evaluating the use of glucocorticoids among belimumab-treated patients with systemic lupus erythematosus in real-world settings using the Rheumatology Informatics System for Effectiveness registry. ACR Open Rheumatol. 2022;4(10):883–889.
   PubMedGoogle Scholar
• Urowitz MB, Ohsfeldt RL, Wielage RC, et al. Organ damage in patients treated with belimumab versus standard of care: a propensity score-matched comparative analysis. Ann Rheum Dis. 2019;78(3):372–379.
   PubMed Web of Science ®Google Scholar
• Urowitz MB, Ohsfeldt RL, Wielage RC, et al. Comparative analysis of long-term organ damage in patients with systemic lupus erythematosus using belimumab versus standard therapy: a post hoc longitudinal study. Lupus Sci Med. 2020;7(1). DOI:10.1136/lupus-2020-000412.
   PubMed Web of Science ®Google Scholar
• Brunner HI, Abud-Mendoza C, Viola DO, et al. Safety and efficacy of intravenous belimumab in children with systemic lupus erythematosus: results from a randomised, placebo-controlled trial. Ann Rheum Dis. 2020;79(10):1340–1348.
   PubMed Web of Science ®Google Scholar
• Brunner HI, Abud-Mendoza C, Mori M, et al. Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison. Rmd Open. 2021;7(3):e001747.
   PubMed Web of Science ®Google Scholar
• Hui-Yuen JS, Reddy A, Taylor J, et al. Safety and efficacy of belimumab to treat systemic lupus erythematosus in academic clinical practices. J Rheumatol. 2015;42(12):2288–2295.
   PubMed Web of Science ®Google Scholar
• Akbar L, Alsagheir R, Al-Mayouf SM. Efficacy of a sequential treatment by belimumab in monogenic systemic lupus erythematosus. Eur J Rheumatol. 2020;7(4):184–189.
   PubMed Web of Science ®Google Scholar
• Ferreira J, Trindade VC, Espada G, et al. Epidemiology and management practices for childhood-onset systemic lupus erythematosus patients: a survey in Latin America. Clin Rheumatol. 2018;37(12):3299–3307.
   PubMed Web of Science ®Google Scholar
• Feldman CH, Hiraki LT, Liu J, et al. Epidemiology and sociodemographics of systemic lupus erythematosus and lupus nephritis among US adults with Medicaid coverage, 2000-2004. Arthritis Rheumatism. 2013;65(3):753–763.
   PubMedGoogle Scholar
• Feldman CH, Broder A, Guan HS, et al. Sex differences in health care utilization, end-stage renal disease, and mortality among Medicaid beneficiaries with incident lupus nephritis. Arthritis Rheumatol. 2018;70(3):417–426.
   PubMed Web of Science ®Google Scholar
• Houghton KM, Page J, Cabral DA, et al. Systemic lupus erythematosus in the pediatric North American Native population of British Columbia. J Rheumatol. 2006;33(1):161–163.
   PubMed Web of Science ®Google Scholar
• Kamphuis S, Silverman ED. Prevalence and burden of pediatric-onset systemic lupus erythematosus. Nat Rev Rheumatol. 2010;6(9):538–546.
   PubMed Web of Science ®Google Scholar
• Demir S, Gulhan B, Ozen S, et al. Long-term renal survival of paediatric patients with lupus nephritis. Nephrol Dialysis Transplantation. 2022;37(6):1069–1077.
   PubMed Web of Science ®Google Scholar
• Furie R, Rovin BH, Houssiau F, et al. Two-year, randomized, controlled trial of belimumab in lupus nephritis. N Engl J Med. 2020;383(12):1117–1128.
   PubMed Web of Science ®Google Scholar
• Furie R, Rovin BH, Houssiau F, et al. Safety and efficacy of belimumab in patients with lupus nephritis open-label extension of BLISS-LN study. Clin J Am Soc Nephrol. 2022;17(1620–1630):1620–1630.
   PubMedGoogle Scholar
• Dooley MA, Houssiau F, Aranow C, et al. Effect of belimumab treatment on renal outcomes: results from the phase 3 belimumab clinical trials in patients with SLE. Lupus. 2013;22(1):63–72.
   PubMed Web of Science ®Google Scholar
• Gatto M, Saccon F, Andreoli L, et al. Durable renal response and safety with add-on belimumab in patients with lupus nephritis in real-life setting (BeRLiSS-LN): results from a large, nationwide, multicentric cohort. J Autoimmun. 2021;124:102729.
   PubMed Web of Science ®Google Scholar
• Zhang CN, Zeng M, Ge YF, et al. Effectiveness and safety of belimumab combined with standard therapy in severe active lupus nephritis requiring kidney replacement therapy: a case report and literature review. Front Immunol. 2022;13:977377.
   PubMed Web of Science ®Google Scholar
• Mina R, von Scheven E, Ardoin SP, et al. Consensus treatment plans for induction therapy of newly diagnosed proliferative lupus nephritis in juvenile systemic lupus erythematosus. Arthritis Care Res (Hoboken). 2012;64(3):375–383.
   PubMed Web of Science ®Google Scholar
• Groot N, de Graeff N, Marks SD, et al. European evidence-based recommendations for the diagnosis and treatment of childhood-onset lupus nephritis: the SHARE initiative. Ann Rheum Dis. 2017;76(12):1965–1973.
   PubMed Web of Science ®Google Scholar
• Kleinmann JF, Tubach F, Le Guern V, et al. International and multidisciplinary expert recommendations for the use of biologics in systemic lupus erythematosus. Autoimmun Rev. 2017;16(6):650–657.
   PubMed Web of Science ®Google Scholar
• Mosca M, Tani C, Aringer M, et al. European League Against Rheumatism recommendations for monitoring patients with systemic lupus erythematosus in clinical practice and in observational studies. Ann Rheum Dis. 2010;69(7):1269–1274.
   PubMed Web of Science ®Google Scholar
• Hahn BH, McMahon MA, Wilkinson A, et al. American College of Rheumatology guidelines for screening, treatment, and management of lupus nephritis. Arthritis Care Res (Hoboken). 2012;64(6):797–808.
   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):1771–1782.
   PubMed Web of Science ®Google Scholar
• Groot N, de Graeff N, Avcin T, et al. European evidence-based recommendations for diagnosis and treatment of childhood-onset systemic lupus erythematosus: the SHARE initiative. Ann Rheum Dis. 2017;76(11):1788–1796.
   PubMed Web of Science ®Google Scholar
• Pons-Estel BA, Bonfa E, Soriano ER, et al. First latin American clinical practice guidelines for the treatment of systemic lupus erythematosus: latin American Group for the Study of Lupus (GLADEL, Grupo Latino Americano de Estudio del Lupus)-Pan-American League of Associations of Rheumatology (PANLAR). Ann Rheum Dis. 2018;77(11):1549–1557.
   PubMed Web of Science ®Google Scholar
• Fanouriakis A, Kostopoulou M, Alunno A. update of the EULAR recommendations for the management of systemic lupus erythematosus. Ann Rheum Dis. 2019;78(6):736–745.
   PubMed Web of Science ®Google Scholar
• Fanouriakis A, Kostopoulou M, Cheema K, et al. 2019 update of the joint European League Against Rheumatism and European Renal Association-European Dialysis and Transplant Association (EULAR/ERA-EDTA) recommendations for the management of lupus nephritis. Ann Rheum Dis. 2020;79(6):713–723.
   PubMed Web of Science ®Google Scholar
• Basu B, Roy B, Babu BG. Efficacy and safety of rituximab in comparison with common induction therapies in pediatric active lupus nephritis. Pediatr Nephrol. 2017;32(6):1013–1021.
   PubMed Web of Science ®Google Scholar
• Balevic SJ, Niu J, Chen JM, et al. Extrapolation of adult efficacy data to pediatric systemic lupus erythematosus: evaluating similarities in exposure-response. J Clin Pharmacol. 2022;63(1):105–118.
   PubMed Web of Science ®Google Scholar
• Dimelow R, Ji B, Struemper H. Pharmacokinetics of belimumab in children with systemic lupus erythematosus. Clin Pharmacol Drug Dev. 2021;10(6):622–633.
   PubMed Web of Science ®Google Scholar
• Servick K. Doubts persist for claimed Alzheimer’s drug. Science. 2019;366(6471):1298.
   PubMed Web of Science ®Google Scholar
• Howard R, Liu KY. Questions EMERGE as Biogen claims aducanumab turnaround. Nat Rev Neurol. 2020;16(2):63–64.
   PubMed Web of Science ®Google Scholar
• Mullard A. Landmark Alzheimer’s drug approval confounds research community. Nature. 2021;594(7863):309–310.
   PubMed Web of Science ®Google Scholar
• Largent EA, Peterson A, Lynch HF. FDA drug approval and the ethics of desperation. JAMA Intern Med. 2021;181(12):1555–1556.
   PubMed Web of Science ®Google Scholar
• Rubin R. Recently approved Alzheimer drug raises questions that might never be answered. JAMA J Am Med Assoc. 2021;326(6):469–472.
   PubMed Web of Science ®Google Scholar
• Knopman DS, Jones DT, Greicius MD. Failure to demonstrate efficacy of aducanumab: an analysis of the EMERGE and ENGAGE trials as reported by Biogen, December 2019. Alzheimers & Dementia. 2021;17(4):696–701
   PubMed Web of Science ®Google Scholar
• Haeberlein SB, Aisen PS, Barkhof F, et al. Two randomized phase 3 studies of aducanumab in early Alzheimer’s disease. Jpad J Preven of Alzheimers Disease. 2022;9(2): 197–210
   PubMed Web of Science ®Google Scholar
• Costa T, Cauda F. A Bayesian reanalysis of the phase III aducanumab (ADU) trial. J Alzheimers Dis. 2022;87(3):1009–1012.
   PubMed Web of Science ®Google Scholar
• Spinner CD, Gottlieb RL, Criner GJ, et al. Effect of remdesivir vs standard care on clinical status at 11 days in patients with moderate COVID-19: a randomized clinical trial. JAMA J Am Med Assoc. 2020;324(11):1048–1057.
   PubMed Web of Science ®Google Scholar
• Cohen J, Kupferschmidt K. ‘A very, very bad look’ for remdesivir. Science. 2020;370(6517):642–643.
   PubMed Web of Science ®Google Scholar
• Wang YM, Zhang DY, Du GH, et al. Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial. Lancet. 2020;395(10236):1569–1578.
   PubMed Web of Science ®Google Scholar
• Beigel JH, Tomashek KM, Dodd LE, et al. Remdesivir for the treatment of Covid-19-final report. N Engl J Med. 2020;383(19):1813–1826.
   PubMed Web of Science ®Google Scholar
• Goldman JD, Lye DCB, Hui DS, et al. Remdesivir for 5 or 10 days in patients with severe Covid-19. N Engl J Med. 2020;383(19):1827–1837.
   PubMed Web of Science ®Google Scholar
• WHO-Solidarity-Trial-Consortium. Repurposed antiviral drugs for Covid-19-interim WHO Solidarity trial results. N Engl J Med. 2021;384(6):497–511.
   PubMed Web of Science ®Google Scholar
• Tambralli A, Beukelman T, Cron RQ, et al. Safety and efficacy of rituximab in childhood-onset systemic lupus erythematosus and other rheumatic diseases. J Rheumatol. 2015;42(3):541–546.
   PubMed Web of Science ®Google Scholar
• Shipa M, Embleton-Thirsk A, Parvaz M, et al. Effectiveness of belimumab after rituximab in systemic lupus erythematosus: a randomized controlled trial. Ann Intern Med. 2021;174(12):1647–1657.
   PubMed Web of Science ®Google Scholar
• Atisha-Fregoso Y, Malkiel S, Harris KM, et al. Phase II randomized trial of rituximab plus cyclophosphamide followed by belimumab for the treatment of lupus nephritis. Arthritis Rheumatol. 2021;73(1):121–131.
   PubMed Web of Science ®Google Scholar
• Ahmed HMA, Abohamad S, Elfishawi M, et al. Subcutaneous formulation of belimumab in treatment of systemic lupus erythematosus: a critical review with focus on safety and satisfaction. Patient Prefer Adherence. 2018;12:2475–2479.
   PubMed Web of Science ®Google Scholar