mrjСовременная ревматологияModern Rheumatology Journal1996-70122310-158XIMA-PRESS, LLC10.14412/1996-7012-2013-2384mrj-482Research ArticleСтатьиArticlesОпыт длительного применения белимумаба у больного системной красной волчанкой (описание случая)Experience of long-term belimumab use in patients with systemic lupus erythematosus (a case report)КлюквинаН. Г.KlyukvinaNatalia Gennadyevnanataklykvina@yandex.ru20131506201372№2 (2013)6265Copyright © Клюквина Н.Г., 20132013Клюквина Н.Г.Klyukvina N.G.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://mrj.ima-press.net/mrj/article/view/482

За последние годы достигнуты значительные успехи в лечении системной красной волчанки (СКВ), однако решены далеко не все вопросы. Арсенал лекарственных средств существенно увеличился. В статье приводится описание случая длительного применения нового генно-инженерного биологического препарата (белимумаб) у пациента с СКВ.

In the past years considerable progress has been made in the treatment of systemic lupus erythe-matosus; however, not all questions have been answered. The range of medications has substan-tially increased. The paper describes a case of the long-term use of the new genetically engineered agent belimumab in a patient with systemic lupus erythematosus.

системная красная волчанкановые направления терапиибелимумабsystemic lupus erythematosusnew therapy areasbelimumabReferences<div><p>Системная красная волчанка. В кн.: Ревматология: Клинические рекомендации. Под ред. Е.Л.Насонова. М.: ГЭОТАР-Медиа, 2010:429-81.</p><p>Клюквина Н.Г. Системная красная волчанка. В кн.: Ревматология: Национальное руководство. Под ред. Е.Л. Насонова и В.А. Насоновой. М.: ГЭОТАР-Медиа, 2008;419—46.</p><p>Pons-Estel G.J., Alarcon G.S., Scofield L. et al. Understanding the epidemiology and progression of systemic lupus erythematosus. Semin Arthr Rheum 2010;39:257-68.</p><p>Насонов Е.Л., Решетняк Т.М., Денисов Л.Н. и др. Белимумаб: прогресс в лечении системной красной волчанки. Науч-практич ревматол 2012;5:13-9.</p><p>Houssiau F.A., D'Cruz D., Sangle S. et al. Azathioprine versus mycophenolate mofetil for long-term immunosupression in lupus nephritis: results from the MAINTAIN Nephritis Trial. Ann Rheum Dis 2010;69:2083-9.</p><p>Condon M.B., Griffith M.H., Cook H.T et al. Treatment of Class IY lupus nephritis with rituximab and mycophenolate mofetil with no oral steroids is effective and safe. J Am Soc Nephrol 2009;21:419A.</p><p>El Hashmi M., Jadoul M., Lefebre C. et al. Relapses of lupus nephritis: incidence, risk factors, serology and impact on outcome. Lupus 2003;12:692-6.</p><p>Moroni G., Gallelli B., Quaglini S. еt al. Withdrawal of therapy in patients with proliferative lupus nephritis: long-term follow-up. Nephrol Dial Transplant 2006;21:1541-648.</p><p>Hahn B.H., McManon M.A., Wilkinson A. et al. American College of Rheumatology guidelines for screening, treatment and management of lupus nephritis. Arthr Care Res 2012;64(6):797—808.</p><p>Rovin B.H., Zhang X. Biomarkers for lupus nephritis: the quest continues. Clin. J Am Soc Nephrol 2009;4:1858-65.</p><p>Steinman A.J., Gladman D.D., Ibanez D., Urowitz M.B. Prolonged serologically active clinically quiescent systemic lupus erythematosus: frequency and outcome. J Rheum 2010;37:1822-7.</p><p>Cervera R., Khamashta M.A., Font J. et al. The European Working Party on Systemic Lupus Erythematosus. Morbidity and mortality in systemic lupus erythematosus during a 10-year period: a comparison of early and late manifestations in a cohort of 1000 patients. Medicine (Baltimore) 2003;82:299-308.</p><p>Goldblatt F., Chambers S., Rahman A., Isenberg D.A. Serious infections in British patients with systemic lupus erythematosus: hospitalizations and mortality. Lupus 2009;18:682-9.</p><p>Bernatsky S., Boivin J.F., Joseph L. et al. Mortality in systemic lupus erythematosus. Arthr Rheum 2006;54:2550-7.</p><p>Moore P.A., Belvedere O., Orr A. et al. BLyS: member of the tumor necrosis factor family and B lymphocyte stimulator. Science 1999;285:260-3.</p><p>Baker K.P., Edwards B.M., Main S.H. et al. Generation and characterization of LymphoStat-B, aB lymphocyte stimulator. Arthr Rheum 2003;48:3253-65.</p><p>Halpern W.G., Lappin P., Zanardi T. et al. Chronic administration of belimumab, a BLyS antagonist, decreases tissue and peripheral blood B-lymphocyte populations in cynomolgus monkeys: pharmacokinetic, pharmacodynamic, and toxicologic effects. Toxicol Sci 2006;91:586-99.</p><p>Cheema G.S., Roschke V., Hilbert D.M., Stohl W. Elevated serum B lymphocyte stimulator levels in patients with systemic immunebased rheumatic diseases. Arthr Rheum 2001;44:1313-9.</p><p>Petri M., Stohl W., Chatham W. et al. Association of plasma B lymphocyte stimulator levels and disease activity in systemic lupus erythematosus. Arthr Rheum 2008;58:2453-9.</p><p>Zhang J., Roschke V., Baker K.P. et al. A role for B lymphocyte stimulator in systemic lupus erythematosus. J Immunol 2001;166:6-10.</p><p>Wallace D.J., Stohl W., Furie R.A. et al. A phase II, randomized, double-blind, placebo-controlled, dose-ranging study of belimumab in patients with active systemic lupus erythematosus. Arthr Rheum 2009;61:1168-78.</p><p>Furie R., Petri M., Zamani O. et al, for the BLISS-76 Study Group. A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus. Arthr Rheum 2011;63:3918-30.</p><p>Navarra S.V., Guzman R.M., Gallacher A.E. et al. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebocontrolled, phase 3 trial. Lancet 2011;377:721-31.</p><p>Chiche L., Jourde N., Thomas G. et al. New treatment options for lupus a focus on belimumab. Therap Clin Risk Management 2012;8:33-43.</p><p>Van Vollenhoven R.F., Petri M.A., Cervera R. et al. Belimumab in the treatment of systemic lupus erythematosus: high disease activity predictors of response. Ann Rheum Dis 2012;71:1343-9.</p><p>Stohl W., Hiepe F., Latinis K.M. et al. Belimumab reduces autoantibodies, normalizes low complement levels, and reduced select B cell populations in patients with systemic lupus erythematosus. Arthr Rheum 2012;64(7):2328-37.</p><p>Merrill J.T., Ginzler E.M., Wallace D.J. et al. Long-term safety profile of Belimumab plus standard therapy in patients with systemic lupus erythematosus. Arthr Rheum 2012;64(10):3364-79.</p><p>Lutalo P., D'Cruz D. Belimumab for the management of systemic lupus erythematosus. Exp Opin Biol Ther 2012;12(7):957—63.</p><p>Wallace D.J., Navarra S., Petri M.A. et al. Safety profile of belimumab: pooled data from placebo-controlled phase 2 and 3 studies in patients with systemic lupus erythematosus. Lupus 2013;22:144-54.</p><p>Furie R., Stohl W., Ginzler E.M. et al. Biologic activity and safety of belimumab — a neutralizing anti-B-lymphocyte stimulator (BlyS) monoclonal antibody: a phase 1 trial in patients with systemic lupus erythematosus. Arthr Res Ther 2008;10(5):109.</p><p>Stohl W., Hilbert D.M. The discovery and development of belimumab: the anti-BLyS-lupus connection. Nat Biotechnol 2012;30(1):69-77.</p><p>Van Vollenhoven R.F., Petri M.A., Cervera R. Et al. Belimumab in the treatment of systemic lupus erythematosus: high disease activity predictors of response. Ann Rheum Dis 2012;71:1343-9</p></div><br /><div><p>Системная красная волчанка. В кн.: Ревматология: Клинические рекомендации. Под ред. Е.Л.Насонова. М.: ГЭОТАР-Медиа, 2010:429-81.</p><p>Клюквина Н.Г. Системная красная волчанка. В кн.: Ревматология: Национальное руководство. Под ред. Е.Л. Насонова и В.А. Насоновой. М.: ГЭОТАР-Медиа, 2008;419—46.</p><p>Pons-Estel G.J., Alarcon G.S., Scofield L. et al. Understanding the epidemiology and progression of systemic lupus erythematosus. Semin Arthr Rheum 2010;39:257-68.</p><p>Насонов Е.Л., Решетняк Т.М., Денисов Л.Н. и др. Белимумаб: прогресс в лечении системной красной волчанки. Науч-практич ревматол 2012;5:13-9.</p><p>Houssiau F.A., D'Cruz D., Sangle S. et al. Azathioprine versus mycophenolate mofetil for long-term immunosupression in lupus nephritis: results from the MAINTAIN Nephritis Trial. Ann Rheum Dis 2010;69:2083-9.</p><p>Condon M.B., Griffith M.H., Cook H.T et al. Treatment of Class IY lupus nephritis with rituximab and mycophenolate mofetil with no oral steroids is effective and safe. J Am Soc Nephrol 2009;21:419A.</p><p>El Hashmi M., Jadoul M., Lefebre C. et al. Relapses of lupus nephritis: incidence, risk factors, serology and impact on outcome. Lupus 2003;12:692-6.</p><p>Moroni G., Gallelli B., Quaglini S. еt al. Withdrawal of therapy in patients with proliferative lupus nephritis: long-term follow-up. Nephrol Dial Transplant 2006;21:1541-648.</p><p>Hahn B.H., McManon M.A., Wilkinson A. et al. American College of Rheumatology guidelines for screening, treatment and management of lupus nephritis. Arthr Care Res 2012;64(6):797—808.</p><p>Rovin B.H., Zhang X. Biomarkers for lupus nephritis: the quest continues. Clin. J Am Soc Nephrol 2009;4:1858-65.</p><p>Steinman A.J., Gladman D.D., Ibanez D., Urowitz M.B. Prolonged serologically active clinically quiescent systemic lupus erythematosus: frequency and outcome. J Rheum 2010;37:1822-7.</p><p>Cervera R., Khamashta M.A., Font J. et al. The European Working Party on Systemic Lupus Erythematosus. Morbidity and mortality in systemic lupus erythematosus during a 10-year period: a comparison of early and late manifestations in a cohort of 1000 patients. Medicine (Baltimore) 2003;82:299-308.</p><p>Goldblatt F., Chambers S., Rahman A., Isenberg D.A. Serious infections in British patients with systemic lupus erythematosus: hospitalizations and mortality. Lupus 2009;18:682-9.</p><p>Bernatsky S., Boivin J.F., Joseph L. et al. Mortality in systemic lupus erythematosus. Arthr Rheum 2006;54:2550-7.</p><p>Moore P.A., Belvedere O., Orr A. et al. BLyS: member of the tumor necrosis factor family and B lymphocyte stimulator. Science 1999;285:260-3.</p><p>Baker K.P., Edwards B.M., Main S.H. et al. Generation and characterization of LymphoStat-B, aB lymphocyte stimulator. Arthr Rheum 2003;48:3253-65.</p><p>Halpern W.G., Lappin P., Zanardi T. et al. Chronic administration of belimumab, a BLyS antagonist, decreases tissue and peripheral blood B-lymphocyte populations in cynomolgus monkeys: pharmacokinetic, pharmacodynamic, and toxicologic effects. Toxicol Sci 2006;91:586-99.</p><p>Cheema G.S., Roschke V., Hilbert D.M., Stohl W. Elevated serum B lymphocyte stimulator levels in patients with systemic immunebased rheumatic diseases. Arthr Rheum 2001;44:1313-9.</p><p>Petri M., Stohl W., Chatham W. et al. Association of plasma B lymphocyte stimulator levels and disease activity in systemic lupus erythematosus. Arthr Rheum 2008;58:2453-9.</p><p>Zhang J., Roschke V., Baker K.P. et al. A role for B lymphocyte stimulator in systemic lupus erythematosus. J Immunol 2001;166:6-10.</p><p>Wallace D.J., Stohl W., Furie R.A. et al. A phase II, randomized, double-blind, placebo-controlled, dose-ranging study of belimumab in patients with active systemic lupus erythematosus. Arthr Rheum 2009;61:1168-78.</p><p>Furie R., Petri M., Zamani O. et al, for the BLISS-76 Study Group. A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus. Arthr Rheum 2011;63:3918-30.</p><p>Navarra S.V., Guzman R.M., Gallacher A.E. et al. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebocontrolled, phase 3 trial. Lancet 2011;377:721-31.</p><p>Chiche L., Jourde N., Thomas G. et al. New treatment options for lupus a focus on belimumab. Therap Clin Risk Management 2012;8:33-43.</p><p>Van Vollenhoven R.F., Petri M.A., Cervera R. et al. Belimumab in the treatment of systemic lupus erythematosus: high disease activity predictors of response. Ann Rheum Dis 2012;71:1343-9.</p><p>Stohl W., Hiepe F., Latinis K.M. et al. Belimumab reduces autoantibodies, normalizes low complement levels, and reduced select B cell populations in patients with systemic lupus erythematosus. Arthr Rheum 2012;64(7):2328-37.</p><p>Merrill J.T., Ginzler E.M., Wallace D.J. et al. Long-term safety profile of Belimumab plus standard therapy in patients with systemic lupus erythematosus. Arthr Rheum 2012;64(10):3364-79.</p><p>Lutalo P., D'Cruz D. Belimumab for the management of systemic lupus erythematosus. Exp Opin Biol Ther 2012;12(7):957—63.</p><p>Wallace D.J., Navarra S., Petri M.A. et al. Safety profile of belimumab: pooled data from placebo-controlled phase 2 and 3 studies in patients with systemic lupus erythematosus. Lupus 2013;22:144-54.</p><p>Furie R., Stohl W., Ginzler E.M. et al. Biologic activity and safety of belimumab — a neutralizing anti-B-lymphocyte stimulator (BlyS) monoclonal antibody: a phase 1 trial in patients with systemic lupus erythematosus. Arthr Res Ther 2008;10(5):109.</p><p>Stohl W., Hilbert D.M. The discovery and development of belimumab: the anti-BLyS-lupus connection. Nat Biotechnol 2012;30(1):69-77.</p><p>Van Vollenhoven R.F., Petri M.A., Cervera R. Et al. Belimumab in the treatment of systemic lupus erythematosus: high disease activity predictors of response. Ann Rheum Dis 2012;71:1343-9</p></div><br />

The authors declare that there are no conflicts of interest present.