An evaluation of voclosporin for the treatment of lupus nephritis

References

• Tektonidou MG, Lewandowski LB, Hu J, et al. Survival in adults and children with systemic lupus erythematosus: a systematic review and bayesian meta-analysis of studies from 1950 to 2016. Annals of the Rheumatic Diseases. 2017;76:2009–2016. Annrheumdis-2017-211663.
   Google Scholar
• Merrell M, Shulman LE. Determination of prognosis in chronic disease, illustrated by systemic lupus erythematosus. J Chronic Dis. 1955;1(1):12–32.
   PubMedGoogle Scholar
• Almaani S, Meara A, Rovin BH. Update on lupus nephritis. Clin J Am Soc Nephrol. 2017;12(5):825–835.
   PubMed Web of Science ®Google Scholar
• Tektonidou MG, Dasgupta A, Ward MM. Risk of end‐stage renal disease in patients with lupus nephritis, 1971–2015: a systematic review and bayesian meta‐analysis. Arthritis Rheumatol. 2016;68(6):1432–1441.
   PubMed Web of Science ®Google Scholar
• Mok C, Kwok RC, Yip PS. Effect of renal disease on the standardized mortality ratio and life expectancy of patients with systemic lupus erythematosus. Arthritis Rheumatol. 2013;65(8):2154–2160.
   PubMed Web of Science ®Google Scholar
• Chen YE, Korbet SM, Katz RS, et al. Value of a complete or partial remission in severe lupus nephritis. Clin J Am Soc Nephrol. 2008;3(1):46–53.
   PubMed Web of Science ®Google Scholar
• Group KDIGO. Kdigo clinical practice guideline for glomerulonephritis. Kidney Int Suppl. 2012;2:139–274.
   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
• Houssiau FA, Vasconcelos C, D’cruz D, 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. Arthritis Rheumatol. 2004;50(12):3934–3940.
   PubMed Web of Science ®Google Scholar
• Dall’Era M, Cisternas MG, Smilek DE, et al. Predictors of long‐term renal outcome in lupus nephritis trials: lessons learned from the euro‐lupus nephritis cohort. Arthritis Rheumatol. 2015;67(5):1305–1313.
   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. 2012;64(6):797–808.
   PubMed Web of Science ®Google Scholar
• Ruiz-Irastorza G, Espinosa G, Frutos MA, et al. Diagnosis and treatment of lupus nephritis: consensus document from the systemic auto-immune disease group (geas) of the spanish society of internal medicine (semi) and the spanish society of nephrology (s.E.N.). Nefrologia. 2012;32(SUPPL. 1):1–45.
   PubMedGoogle Scholar
• Catapano F, Chaudhry AN, Jones RB, et al. Long-term efficacy and safety of rituximab in refractory and relapsing systemic lupus erythematosus. Nephrol Dial Transplant. 2010;25(11):3586–3592.
   PubMed Web of Science ®Google Scholar
• Pepper R, Griffith M, Kirwan C, et al. Rituximab is an effective treatment for lupus nephritis and allows a reduction in maintenance steroids. Nephrol Dial Transplant. 2009;24(12):3717–3723.
   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 Rheumatol. 2010;62(8):2458–2466.
   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 study. Arthritis Rheumatol. 2012;64(4):1215–1226.
   PubMed Web of Science ®Google Scholar
• Ramos L, Isenberg D. Rituximab: the lupus journey. Curr Treat Options Rheumatol. 2015;1(1):30–41.
   Google Scholar
• Houssiau FA, Vasconcelos C, D’Cruz D, et al. Immunosuppressive therapy in lupus nephritis: the euro-lupus nephritis trial, a randomized trial of low-dose versus high-dose intravenous cyclophosphamide. Arthritis Rheum. 2002;46(8):2121–2131.
   PubMed Web of Science ®Google Scholar
• Appel GB, Contreras G, Dooley MA, et al. Mycophenolate mofetil versus cyclophosphamide for induction treatment of lupus nephritis. J Am Soc Nephrol. 2009;20(5):1103–1112.
   PubMed Web of Science ®Google Scholar
• Askanase A, Byron M, Keyes-Elstein L, et al. Treatment of lupus nephritis with abatacept: the abatacept and cyclophosphamide combination efficacy and safety study. Arthritis Rheumat. 2014;66(11):3096.
   PubMed Web of Science ®Google Scholar
• Houssiau F. Thirty years of cyclophosphamide: assessing the evidence. Lupus. 2007;16(3):212–216.
   PubMed Web of Science ®Google Scholar
• Kuglstatter A, Mueller F, Kusznir E, et al. Structural basis for the cyclophilin a binding affinity and immunosuppressive potency of e-isa247 (voclosporin). Acta Crystallogr Sec D. 2011;67(2):119–123.
   PubMedGoogle Scholar
• Faul C, Donnelly M, Merscher-Gomez S, et al. The actin cytoskeleton of kidney podocytes is a direct target of the antiproteinuric effect of cyclosporine a. Nat Med. 2008;14(9):931.
   PubMed Web of Science ®Google Scholar
• Isenberg D, Snaith M, Morrow W, et al. Cyclosporin a for the treatment of systemic lupus erythematosus. Int J Immunopharmacol. 1981;3(2):163–169.
   PubMed Web of Science ®Google Scholar
• Griffiths B, Emery P, Ryan V, et al. The bilag multi-centre open randomized controlled trial comparing ciclosporin vs azathioprine in patients with severe sle. Rheumatol. 2010;49(4):723–732.
   PubMed Web of Science ®Google Scholar
• Hannah J, Casian A, D’Cruz D. Tacrolimus use in lupus nephritis: a systematic review and meta-analysis. Autoimmun Rev. 2016;15(1):93–101.
   PubMed Web of Science ®Google Scholar
• Zavada J, Pešickova S, Ryšavá R, et al. Cyclosporine a or intravenous cyclophosphamide for lupus nephritis: the cyclofa-lune study. Lupus. 2010;19(11):1281–1289.
   PubMed Web of Science ®Google Scholar
• Mok CC, Ying KY, Yim CW, et al. Tacrolimus versus mycophenolate mofetil for induction therapy of lupus nephritis: a randomised controlled trial and long-term follow-up. Ann Rheum Dis. 2014;75(1):30–36.
   PubMed Web of Science ®Google Scholar
• Zavada J, Pešičková SS, Ryšavá R, et al. Extended follow-up of the cyclofa-lune trial comparing two sequential induction and maintenance treatment regimens for proliferative lupus nephritis based either on cyclophosphamide or on cyclosporine a. Lupus. 2014;23(1):69–74.
   PubMed Web of Science ®Google Scholar
• Tunnicliffe DJ, Palmer SC, Henderson L, et al. Immunosuppressive treatment for proliferative lupus nephritis. Cochrane Database Syst Rev. 2018;6. Available from: https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD002922.pub4/full#CD002922-sec1-0005
   Web of Science ®Google Scholar
• Liu Z, Zhang H, Liu Z, et al. Multitarget therapy for induction treatment of lupus nephritis: a randomized trial. Ann Intern Med. 2015;162(1):18–26.
   PubMed Web of Science ®Google Scholar
• Zhang H, Liu Z, Zhou M, et al. Multitarget therapy for maintenance treatment of lupus nephritis. J Am Soc Nephrol. 2017;28(12):3671–3678.
   PubMed Web of Science ®Google Scholar
• Naesens M, Kuypers DR, Sarwal M. Calcineurin inhibitor nephrotoxicity. Clin J Am Soc Nephrol. 2009;4(2):481–508.
   PubMed Web of Science ®Google Scholar
• Moroni G, Doria A, Mosca M, et al. A randomized pilot trial comparing cyclosporine and azathioprine for maintenance therapy in diffuse lupus nephritis over four years. Clin J Am Soc Nephrol. 2006;1(5):925–932.
   PubMed Web of Science ®Google Scholar
• Birsan T, Dambrin C, Freitag DG, et al. The novel calcineurin inhibitor isa247: a more potent immunosuppressant than cyclosporine in vitro. Transpl Int. 2005;17(12):767–771.
   PubMed Web of Science ®Google Scholar
• Pendergraft WF, Tumlin J, Rovin BH, et al. Aura-lv: successful treatment of active lupus nephritis with voclosporin. Chicago, IL: American Society of Nephrology Kidney Week 2016; 2016.
   Google Scholar
• Busque S, Cantarovich M, Mulgaonkar S, et al. The promise study: a phase 2b multicenter study of voclosporin (isa247) versus tacrolimus in de novo kidney transplantation. Am J Transplant. 2011;11(12):2675–2684.
   PubMed Web of Science ®Google Scholar
• Dooley M, Pendergraft W III, Ginzler EM, et al.: Speed of remission with the use of voclosporin, mmf and low dose steroids: results of a global lupus nephritis study. American College of Rheumatology (ACR) 2016 Annual Meeting, Washington D.C. (2016).
   Google Scholar
• Ling SY, Huizinga RB, Mayo PR, et al. Cytochrome p450 3a and p-glycoprotein drug–drug interactions with voclosporin. Br J Clin Pharmacol. 2014;77(6):1039–1050.
   PubMed Web of Science ®Google Scholar
• Papp K, Bissonnette R, Rosoph L, et al. Efficacy of isa247 in plaque psoriasis: a randomised, multicentre, double-blind, placebo-controlled phase iii study. The Lancet. 2008;371(9621):1337–1342.
   PubMed Web of Science ®Google Scholar
• Mayo PR, Ling SY, Huizinga RB, et al. Population pkpd of voclosporin in renal allograft patients. J Clin Pharmacol. 2014;54(5):537–545.
   PubMed Web of Science ®Google Scholar
• Ling S, Huizinga R, Mayo P, et al. Pharmacokinetics of voclosporin in renal impairment and hepatic impairment. J Clin Pharmacol. 2013;53(12):1303–1312.
   PubMed Web of Science ®Google Scholar
• Bissonnette R, Papp K, Poulin Y, et al. A randomized, multicenter, double-blind, placebo-controlled phase 2 trial of isa247 in patients with chronic plaque psoriasis. J Am Acad Dermatol. 2006;54(3):472–478.
   PubMed Web of Science ®Google Scholar
• Yatscoff RW, Abel MD, Aspeslet LJ, et al. Phase 2, randomized, multicenter, open-label study of isa247 and neoral® in post-renal transplant patients. Am J Transplant Suppl. 2003;3:463 (abstract number 1215).
   Google Scholar
• Huizinga R, Yahya R, Gafor A, et al. Aurion study: 24-week data of multi-target therapy with voclosporin, mmf and steroids for active lupus nephritis. Lupus. 2017;4(Suppl 1):A10.
   Google Scholar
• Yahya R, Gafor A, Huizinga R, et al. Ab0419 aurion study: preliminary results of voclosporin in lupus nephritis. Ann Rheum Dis. 2016;75(Suppl 2):1049–1050.
   Google Scholar
• Dobronravov V, Dooley M, Haq S, et al. Lb0002 48 week complete remission of active lupus nephritis with voclosporin. Ann Rheum Dis. 2017;76(Suppl 2):153.
   PubMedGoogle Scholar
• Tumlin J, Rovin BH, Rahman M, et al. Steroid sparing efficacy of voclosporin in active lupus nephritis: stable kidney function and blood pressure without electrolyte complications at 48 weeks. Madrid: European Renal Association-European Dialysis and Transplant Association Congress; 2017.
   Google Scholar
• Wasel N, Lynde C, Langley R, et al. Long term safety of isa247 in plaque psoriasis after 60 weeks of dosing. Proceedings of the Canadian Dermatology Association Annual Conference 2007, p. 50.
   Google Scholar
• Wofsy D, Isenberg DA, Houssiau FA, et al. 48-week complete remission by ethnic, sex and age subgroups in patients with active lupus nephritis treated with voclosporin. Arthritis & Rheumatology. 2017 Oct;69 Suppl 10:1299.
   Google Scholar