Перспективы фармакотерапии системной красной волчанки
Аннотация
С.К. Соловьев – руководитель лаборатории интенсивных методов терапии ФБГУ «НИИР им. В.А. Насоновой» РАН, доктор мед наук, профессор
П р о г р е с с О р в и г р и е н в а м л а ь т н о ыл о е г и и с и с в л е Х д Х о I в а в н е и к я е
Перспективы фармакотерапии системной красной волчанки
Для лечения системной красной волчанки (СКВ) используется весь арсенал применяемых в ревматологии лекарственных средств, однако большинство из них не получили официального одобрения регулирующих органов и используются при СКВ по незарегистрированным (off-label) показаниям. Успешное применение генно-инженерного биологического препарата ритуксимаба (моноклональные антитела к CD20-антигену В-клеток) и регистрация белимумаба (моноклональные антитела к BLyS) для лечения СКВ стимулировали разработку новых подходов к лечению этого заболевания.
Об авторах
Е. Л. Насонов
ФГБУ «Научно- исследовательский институт ревматологии им. В.А. Насоновой» РАН, Москва, Россия
Россия
Россия
С. К. Соловьев
ФГБУ «Научно- исследовательский институт ревматологии им. В.А. Насоновой» РАН, Москва, Россия
Россия
Россия
Список литературы
1. Насонов ЕЛ, редактор. Системная красная волчанка. В кн.: Клинические рекомендации. Москва: ГЭОТАР-Медиа; 2010. С. 429–81. [Nasonov EL, editor. Systemic lupus erythe- matosus. In: Klinicheskie rekomendatsii [Clinical recommenda- tions]. Moscow: GEOTAR-Media; 2010. P. 429–81.]
2. Rahman A, Isenberg DA. Systemic lupus erythematosus. N Engl J Med. 2008;358(9):929–39. DOI: 10.1056/NEJMra071297.
3. Murphy G, Lisnevskaia L, Isenberg D. Systemic lupus erythe- matosus and other autoimmune rheumatic diseases: chalenges to treatment. Lancet. 2013;382(9894):808–18. DOI: 10.1016/S0140-6736(13)60889-2. Epub 2013 Aug 23.
4. Stohl W. Future prospects in biologic therapy for systemic lupus erythematosus. Nat Rev Rheumatol. 2013;9(12):705–20. DOI: 10.1038/nrrheum.2013.136. Epub 2013 Sep 10.
5. Thanou A, Merrill JT. Treatment of systemic lupus erythemato- sus: new therapeutic avenues and blind alleys. Nat Rev Rheumatol. 2014;10(1):23–34. DOI: 10.1038/nrrheum.2013.145. Epub 2013 Oct 8.
6. Насонов ЕЛ, редактор. Генно-инженерные биологические препараты в лечении ревматоидного артрита. Москва: ИМА-ПРЕСС; 2013. С. 549. [Nasonov EL, editor. Genetically engineered biological biological preparations in treatment of rheumatoid arthritis. Moscow: IMA-PRESS; 2013. P. 549]
7. Насонов ЕЛ, редактор. Анти-В-клеточная терапия в ревматологии: фокус на ритуксимаб. Москва: ИМА- ПРЕСС; 2012. С. 119–52. [Nasonov EL, editor. Anti-В-cellular therapy in rheumatology: focus on ritukximab. Moscow: IMA- PRESS; 2013. P. 119–52.]
8. Sanz I, Lee FE. B cells as therapeutic targets in SLE. Nat Rev Rheumatol. 2010;6(6):326–37. DOI: 10.1038/nrrheum.2010.68. 9. Левицки А, Линдер С, Ван Волленховен РФ. Ритуксимаб в терапии системной красной волчнки. Научно-практическая ревматология. 2013;51(3):223–39. [Levitsky A, Linder S, Vollenhoven RF. Rituximab in the management of systemic lupus erythematosus. Nauchno-prakticheskaya revmatologiya = Rheumatology Science and Practice. 2013;51(3):223–39. (In Russ.)]. DOI: http://dx.doi.org/10.14412/1995-4484-2013-1494.
9. Цанян МЭ, Соловьев СК, Торгашина АВ и др. Эффективность терапии ритуксимабом у больных системной красной волчанкой при длительном динамическом наблюдении. Научно-практическая ревматология. 2014;52(2):159–68. [Tsanyan ME, Soloviev SK, Torgashina AV. Rituximab treatment efficacy in patients with sys- temic lupus erythematosus refractory to standard therapy in the long-term follow-up. Nauchno-prakticheskaya revmatologiya = Rheumatology Science and Practice. 2014;52(2):159–68. (In Russ.)]. DOI: http://dx.doi.org/10.14412/1995-4484-2014-159- 168.
10. Merrill JT, Neuwelt CM, Wallace DJ, et al. Efficacy and safety of rituximab in moderately-to-severely active systemic lupus erythe- matosus: The randomized, double-blind, phase II/III systemic lupus erythematosus evaluation of rituximab trial. Arthritis Rheum. 2010;62(1):222–33. DOI: 10.1002/art.27233.
11. Rovin BH, Furie R, Latinis K, et al.; LUNAR Investigator Group. Efficacy and safety of rituximab in patients with active proliferative lupus nephritis: the lupus nephritis assessment with rituximab study. Arthritis Rheum. 2012;64(4):1215–26. DOI: 10.1002/art.34359. Epub 2012 Jan 9.
12. Wofsy D. Recent progress in conventional and biologic therapy for systemic lupus erythematosus. Ann Rheum Dis. 2013;72 Suppl 2:ii66–8. DOI: 10.1136/annrheumdis-2012-202204. Epub 2012 Dec 19.
13. Tew GW, Rabbee N, Wolslegel K, et al. Baseline autoantibody profiles predict normalization of complement and anti-dsDNA autoantibody levels following Rituximab treatment in systemic lupus erythematosus. Lupus. 2010;19(2):146–57. DOI: 10.1177/0961203309350752. Epub 2009 Nov 27.
14. Murray E, Perry M. Off-label use of Rituximab in systemic lupus erythematosus: a systemic review. Clin Rheumatol. 2010;29(7):707–16. DOI: 10.1007/s10067-010-1387-5. Epub 2010 Feb 13.
15. Pepper R, Grifith M, Kirwan C, et al. Rituximab is an effective treatment for lupus nephritis and allows a reduction in mainte- nance steroids. Nephrol Dial Transplant. 2009;24(12):3717–23. DOI: 10.1093/ndt/gfp336. Epub 2009 Jul 17.
16. Ezeonyeji AN, Isenberg DA. Early treatment with rituximab in newly diagnosed systemic lupus erythematosus patients: a steroid-sparing regime. Rheumatology (Oxford). 2012;51(3):476–81. DOI: 10.1093/rheumatology/ker337. Epub 2011 Nov 16.
17. Gordon MB, Ashby D, Pepper RJ, et al. Prospective observa- tional single-centre cohort study to evaluate the effectiveness of treating lupus nephritis with rituximab and mycophenolate mofetil but no oral steroids. Ann Rheum Dis. 2013;72(8):1280–6. DOI: 10.1136/annrheumdis-2012-202844. Epub 2013 Jun 5.
18. Tedeschi B, Arnaud L, Hie M, et al. Successful treatment of combined proliferative and membranous lupus nephritis usind a full corticosteroid-free regimen. Ann Rheum Dis. 2012;73(2):474–5. DOI: 10.1136/annrheumdis-2013-204385.
19. Li EK, Tam LS, Zhu TY, et al. Is combination rituximab with cyclophosphamide better than Rituximab alone in the treatment of lupus nephritis? Rheumatology (Oxford). 2009;48(8):892–8. DOI: 10.1093/rheumatology/kep124. Epub 2009 May 28.
20. Chen H, Zheng W, Su J, et al. Low-dose rituximab therapy for refractory thrombocytopenia in patients with systemic lupus ery- thematosus – a prospective pilot study. Rheumatology (Oxford). 2011;50(9):1640–4. DOI: 10.1093/rheumatolofy/ker176.
21. Weidenbusch M, Rö mmele C, Schrö ttle A, Anders HJ. Beyond the LUNAR trial. Efficacy of rituximab in refractory lupus nephritis. Nephrol Dial Transplant. 2013;28(1):106–11. DOI: 10.1093/ndt/gfs285. Epub 2012 Jul 3.
22. 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 pae- diatric lupus nephritis. Ann Rheum Dis. 2012;71(11):1771–82. DOI: 10.1136/annrheumdis-2012-201940. Epub 2012 Jul 31.
23. Hanh BH, McMahon MA, Wilkinson A, et al.; American College of Rheumatology. American College of Rheumatology duidlines for screening, treatment, and management of lupus nephritis. Arthritis Care Res (Hoboken). 2012;64(6):797–808. DOI: 10.1002/acr.21664.
24. Guerry MJ, Brogan P, Bruce IN, et al. Recommendations for the use of Rituximab in anti-neutrophile cytoplasm antibody-associ- ated vasculitis. Rheumatology (Oxford). 2011;51(4):634–43. DOI: 10.1093/rheumatolofy/ker150. Epub 2011 May 25.
25. Mysler EF. Efficacy and safety of ocrelizumab, a humanized antiCD20 antibody, in patients with active proliferative lupus nephritis (LN): results from the randomized, double-blind phase III BELONG study. Arthritis Rheum. 2010;62:S606–7.
26. Tedder TF, Inaoki M, Sato S. The CD19–CD21 complex regu- lates signal transduction thresholds governing humoral immunity and autoimmunity. Immunity. 1997;6(2):107–18. DOI: http://dx.doi.org/10.1016/S1074-7613(00)80418-5.
27. Herbst R, Wang Y, Gallagher S, et al. B-cell depletion in vitro and in vivo with an afucosylated anti-CD19 antibody. J Pharmacol Exp Ther. 2010;335(1):213–22. DOI: 10.1124/jpet.110.168062. Epub 2010 Jul 6.
28. Cardarelli PM, Rao-Naik C, Chen S, et al. A nonfucosylated human antibody to CD19 with potent B-cell depletive activity for therapy of B-cell malignancies. Cancer Immunol Immunother. 2010;59(2):257–65. DOI: 10.1007/s00262-009-0746-z.
29. Carnahan J, Stein R, Qu Z, et al. Epratuzumab, a CD22-target- ing recombinant humanized antibody with a different mode of action from rituximab. Mol Immunol. 2007;44(6):1331–41. DOI: http://dx.doi.org/10.1016/j.molimm.2006.05.007. Epub 2006 Jun 30.
30. Traczewski P, Rudnicka L. Treatment of systemic lupus erythe- matosus with epratuzumab. Br J Clin Pharmacol. 2011;71(2):175–82. DOI: 10.1111/j.1365-2125.2010.03767.x.
31. Sieger N, Fleischer SJ, Mei HE, et al. CD22 ligation inhibits downstream B-cell receptor signaling ava Ca2+ flux upon activa- tion. Arthritis Rheum. 2013;65(3):770–9. DOI: 10.1002/art.37818.
32. Wallace DJ, Kalunian K, Petri MA, et al. Efficacy and safety of epratuzumab in patients with moderate/severe active systemic lupus erythematosus: results from EMBLEM, a phase IIb, ran- domised, double-blind, placebo-controlled, multicentre study. Ann Rheum Dis. 2014;73(1):183–90. DOI: 10.1136/annrheumdis-2012-202760. Epub 2013 Jan 12.
33. Wallace DJ, Gordon C, Strand V, et al. Efficacy and safety of epratuzumab in patients with moderate/severe flaring systemic lupus erythematosus: results from two randomized, double-blind, placebo-controlled, multicentre studies (ALLEVIATE) and fol- low-up. Rheumatology (Oxford). 2013;52(7):1313–22. DOI: 10.1093/rheumatology/ket129. Epub 2013 Mar 28.
34. FDA approves Benlysta to treat lupus. [Last accessed on 2011 Mar 28]. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncemen ts/ucm246489.htm
35. European Medicines Agency. Benlysta: belimumab. (cited August 8, 2011). Available from: www.ema.ruropa.eu/ema/index/jsp?curl=pages/medicines/huma n/medicines.002015/human_med_001466.jsp&mid=WC0bac058 001d124
36. Merrill JT. Ending the 50-year drought of FDA drug approval for SLE. Bull NYU Hosp Joint Dis. 2011;69(3):238–42.
37. Stohl W, Hilbert DM. The discovery and development of beli- mumab: the anti-BlyS-lupus connection. Nature Biotechnol. 2012;30(1):69–77. DOI: 10.1038/nbt.2076.
38. Насонов ЕЛ, Решетняк ТМ, Денисов ЛН и др. Белимумаб: прогресс в лечении системной красной волчанки. Научно- практическая ревматология. 2012;51(5):13–9. [Nasonov EL, Reshetnyak TM, Denisov LN, et al. Belimumab: advances in drug therapy for systemic lupus erythematosus. Nauchno-prak- ticheskaya revmatologiya = Rheumatology Science and Practice. 2012;51(5):13–9. (In Russ.)]. DOI: http://dx.doi.org/10.14412/1995-4484-2012-1174.
39. Furie R, Stohl W, Ginzler EM, et al. Biologic activity and safety of belimumab, a neutralizing anti-B-lymphocyte stimulator (BLyS) monoclonal antibody: a phase I trial in patients with sys- temic lupus erythematosus. Arthritis Res Ther. 2008;10(5):R109. DOI: 10.1186/ar2506. Epub 2008 Sep 11.
40. Wallace DJ, Stohl W, Ginzler EM, et al. A phase II, randomized, double-blind, placebo-controlled, dose-ranging study of beli- mumab in patients with active systemic lupus erythematosus. Arthritis Rheum. 2009;61(9):1168–78. DOI: 10.1002/art.24699.
41. Navarra SV, Guzman RM, Gallacher AE, et al.; BLISS-52 Study Group. 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. DOI: 10.1016/S0140-6736(10)61354-2. Epub 2011 Feb 4.
42. Furie, R, Petri M, Zamani E, 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 Rheum. 2011;63(12):3918–30.
43. DOI: 10.1002/art.30613.
44. Ginzler EM, Wallace DJ, Merrill JT, et al. Disease control and safety of belimumab plus standart therapy over 7 years in patients with systemic lupus erythematosus. J Rheumatology. 2014;41(2):300–9. DOI: 10.3899/jrheum.121368. Epub 2013 Nov 1.
45. Furie RA, Petri MA, Wallace DJ, et al. Novel evidence-based systemic lupus erythematosus responder index. Arthritis Rheum.
46. ;61(9):1143–51. DOI: 10.1002/art.24698.
47. Furie RA, Leon G, Thomas M, et al. A phase 2, randomized, placebo-controlled clinical trial of blisibimod, an inhibitor of B cell activating factor, in patients with moderate-to-severe sys- temic lupus erythematosus, the PEARL-SC study. Arthritis Rheum. 2014 Apr 19. DOI: 10.1136/annrheumdis-2013-205144.
48. Genovese MC, Bojin S, Biagini IM, et al. Tabalumab in rheuma- toid arthritis patients with an inadequate response to methotrex- ate and naive to biologic therapy: a phase II, randomized, place- bo-controlled trial. Arthritis Rheum. 2013;65(4):880–9. DOI: 10.1002/art.37820.
49. Genovese MC, Fleischmann RM, Greenwald M, et al. Tabalumab, an anti-BAFF monoclonal antibody, in patients with active rheumatoid arthritis with an inadequate response to TNF inhibitors. Ann Rheum Dis. 2013 Sep 1;72(9):1461–8. DOI: http://dx.doi.org/10.1136/annrheumdis-2012-202775.
50. Dall'Era M, Chakravarty E, Wallace D, et al. Reduced B lym- phocyte and immunoglobulin levels after atacicept treatment in patients with systemic lupus erythematosus: results of a multicen- ter, phase Ib, double-blind, placebo-controlled, dose-escalating trial. Arthritis Rheum. 2007;56(12):4142–50. DOI: http://dx.doi.org/10.1002/art.23047.
51. Ginzler EM, Wax S, Rajeswaran A, et al. Atacicept in combina- tion with MMF and corticosteroids in lupus nephritis: results of a prematurely terminated trial. Arthritis Res Ther. 2012;14(1):R33. DOI: 10.1186/ar3738.
52. Baechler EC, Batliwalla FM, Karypis G, et al. Interferon- inducible gene expression signature in peripheral blood cells of patients with severe lupus. Proc Natl Acad Sci USA. 2003;100(5):2610–5. DOI: http://dx.doi.org/10.1073/pnas.0337679100. Epub 2003 Feb 25.
53. Bennett L, Palucka AK, Arce E. et al. Interferon and granu- lopoiesis signatures in systemic lupus erythematosus blood. J Exp Med. 2003;197(6):711–23. DOI: http://dx.doi.org/10.1084/jem.20021553.
54. Kirou KA, Lee C, George S, et al. Activation of the interferon-α pathway identifies a subgroup of systemic lupus erythematosus patients with distinct serologic features and active disease. Arthritis Rheum. 2005;52(5):1491–503. DOI: http://dx.doi.org/10.1002/art.21031.
55. Peterson KS, Huang JF, Zhu J, et al. Characterization of hetero- geneity in the molecular pathogenesis of lupus nephritis from transcriptional profiles of laser-captured glomeruli. J Clin Invest. 2004;113(12):1722–33. DOI: http://dx.doi.org/10.1172/JCI200419139.
56. Nzeusseu Toukap A, Galant C, Theate I, et al. Identification of distinct gene expression profiles in the synovium of patients with systemic lupus erythematosus. Arthritis Rheum. 2007;56(5):1579–88. DOI: http://dx.doi.org/10.1002/art.22578.
57. Rö nnblom LE, Alm GV, Oberg KE. Possible induction of sys- temic lupus erythematosus by interferon-α treatment in a patient with a malignant carcinoid tumor. J Intern Med. 1990;227(3):207–10. DOI: http://dx.doi.org/10.1111/j.1365- 2796.1990.tb00144.x.
58. Niewold TB, Swedler WI. Systemic lupus erythematosus arising during interferon-α therapy for cryoglobulinemic vasculitis asso- ciated with hepatitis C. Clin Rheumatol. 2005;24(2):178–81. DOI: http://dx.doi.org/10.1007/s10067-004-1024-2. Epub 2004 Nov 24.
59. Thacker SG, Zhao W, Smith CK, et al. Type I interferons modulate vascular function, repair, thrombosis, and plaque progression in murine models of lupus and atherosclerosis. Arthritis Rheum. 2012;64(9):2975–85. DOI: 10.1002/art.34504.
60. Denny MF, Thacker S, Mehta H, et al. Interferon-α promotes abnormal vasculogenesis in lupus: a potential pathway for prema- ture atherosclerosis. Blood. 2007;110(8):2907–915. DOI: http://dx.doi.org/10.1182/blood-2007-05-089086. Epub 2007 Jul 16.
61. Somers EC, Zhao W, Lewis EE, et al. Type I interferons are asso- ciated with subclinical markers of cardiovascular disease in a cohort of systemic lupus erythematosus patients. PLoS ONE. 2012;7(5):e37000. DOI: 10.1371/journal.pone.0037000. Epub 2012 May 14.
62. Morimoto AM, Flesher DT, Yang J, et al. Association of endoge- nous anti-interferon-α autoantibodies with decreased interferon- pathway and disease activity in patients with systemic lupus ery- thematosus. Arthritis Rheum. 2011;63(8):2407–15. DOI: http://dx.doi.org/10.1002/art.30399.
63. Yao Y, Richman L, Higgs BW, et al. Neutralization of interferon- α/β-inducible genes and downstream effect in a phase I trial of an anti-interferon-α monoclonal antibody in systemic lupus ery- thematosus. Arthritis Rheum. 2009;60(6):1785–96. DOI: http://dx.doi.org/10.1002/art.24557.
64. Merrill JT, Wallace DJ, Petri M, et al. Safety profile and clinical activity of sifalimumab, a fully human anti-interferon α mono- clonal antibody, in systemic lupus erythematosus: a phase I, muticentre, double-blind randomised study. Ann Rheum Dis. 2011;70(11):1905–13. DOI: http://dx.doi.org/10.1136/ard.2010.144485.
65. Petri M, Wallace DJ, Spindler A, et al. Sifalimumab, a human anti-interferon-α monoclonal antibody, in systemic lupus erythe- matosus: a phase I randomized, controlled, dose-escalation study. Arthritis Rheum. 2013;65(4):1011–21. DOI: 10.1002/art.37824.
66. Tcherepanova I, Curtis M, Sale M, et al. Results of a randomized placebo controlled phase IA study of AGS-009, a humanized anti-interferon-α monoclonal antibody in subjects with systemic lupus erythematosus. Ann Rheum Dis. 2012;71 Suppl 3:536.
67. McBride JM, Jiang J, Abbas AR , et al. Safety and pharmacody- namics of rontalizumab in patients with systemic lupus erythe- matosus: results of a phase I, placebo-controlled, double-blind, dose-escalation study. Arthritis Rheum. 2012;64(11):3666–76. DOI: 10.1002/art.34632.
68. Kalunian K. Efficacy and safety of rontalizumab (anti-interferon α) in SLE subjects with restricted immunosuppressant use: results of a randomized, double-blind placebo-controlled phase 2 study. Arthritis Rheum. 2012;64:S1111.
69. Santiago-Raber ML, Baccala R, Haraldsson KM, et al. Type-I interferon receptor deficiency reduces lupus-like disease in NZB mice. J Exp Med. 2003;197:777–88. DOI: http://dx.doi.org/10.1084/jem.20021996.
70. Agrawal, H. et al. Deficiency of type I IFN receptor in lupus- prone New Zealand Mixed 2328 mice decreases dendritic cell numbers and activation and protects from disease. J Immunol. 2009; 183, 6021–6029. DOI: http://dx.doi.org/10.4049/jim- munol.0803872.
71. Goronzy JJ, Weyand CM. T-cell co-stimulatory pathways in autoimmunity. Arthritis Res Ther. 2008;10 Suppl 1:S3. DOI: http://dx.doi.org/10.1186/ar2414.
72. Yamada A, Salama AD, Sayegh MH. The role of novel T cell costimulatory pathways in autoimmunity and transplantation. J Am Soc Nephrol. 2002;13(2):559–75.
73. Finck BK, Linsley PS, Wofsy D. Treatment of murine lupus with CTLA4Ig. Science. 1994;265(5176):1225–7. DOI: http://dx.doi.org/10.1126/science.7520604.
74. Merrill JT, Burgos-Vargas R, Westhovens R, et al. The efficacy and safety of abatacept in patients with non-life-threatening manifestations of systemic lupus erythematosus: results of a twelve-month, multicenter, exploratory, phase IIb, randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2010;62(10):3077–87. DOI: http://dx.doi.org/10.1002/art.27601.
75. Furie R. Efficacy and safety of abatacept over 12 months in
76. patients with lupus nephritis: results from a multicenter, random- ized, double-blind, placebo-controlled phase II/III study. Arthritis Rheum. 2011;63:S962–3.
77. Wofsy D, Hillson JL, Diamond B. Abatacept for lupus nephritis: alternative definitions of complete response support conflicting conclusions. Arthritis Rheum. 2012;64(11):3660–5. DOI: http://dx.doi.org/10.1002/art.34624.
78. Daikh DI, Wofsy D. Cutting edge: reversal of murine lupus nephritis with CTLA-4Ig and cyclophosphamide. J Immunol. 2001;166(5):2913–6. DOI: http://dx.doi.org/10.4049/jim- munol.166.5.2913.
79. Desai-Mehta A, Lu L, Ramsey-Goldman R, Datta K. Hyperexpression of CD40 ligand by B and T cells in human lupus and its role in pathogenic autoantibody production. J Clin Invest. 1996;97(9):2063–73. DOI: http://dx.doi.org/10.1172/JCI118643.
80. Koshy M, Berger D, Crow MK. Increased expression of CD40 ligand on systemic lupus erythematosus lymphocytes. J Clin Invest. 1996;98(3):826–37. DOI: http://dx.doi.org/10.1172/JCI118855.
81. Mohan C, Shi Y, Laman JD, Datta SK. Interaction between CD40 and its ligand gp39 in the development of murine lupus nephritis. J Immunol. 1995;154(3):1470–80.
82. Early GS, Zhao W, Burns CM. Anti-CD40 ligand antibody treat- ment prevents the development of lupus-like nephritis in a subset of New Zealand Black X New Zealand White mice. J Immunol. 1996;157(7):3159–64.
83. Russell JQ, Mooney T, Cohen PL, et al. Anti-CD40L accelerates renal disease and adenopathy in MRL-lpr mice in parallel with decreased thymocyte apoptosis. J Immunol. 1998;161(2):729–39.
84. Kalunian KC, Davis JC Jr, Merrill JT, et al. Treatment of sys- temic lupus erythematosus by inhibition of T cell costimulation with anti-CD154. Arthritis Rheum. 2002;46(12):3251–8. DOI: http://dx.doi.org/10.1002/art.10681.
85. Boumpas DT, Furie R, Manzi D, et al.; BG9588 Lupus Nephritis Trial Group. A short course of BG9588 (anti-CD40 ligand anti- body) improves serologic activity and decreases hematuria in patients with proliferative lupus glomerulonephritis. Arthritis Rheum. 2003;48(3):719–27. DOI: http://dx.doi.org/10.1002/art.10856.
86. Jones SA, Richards PJ, Scheller J, Rose-John S. IL-6 transsig- naling: the in vivo consequences. J Interferon Cytokine Res. 2005;25(5):241–53. DOI: http://dx.doi.org/10.1089/jir.2005.25.241.
87. Mihara M, Hashizume M, Yoshida H, et al. IL6/IL-6 receptor system and its role in physiological and pathological conditions. Clin Sci (Lond). 2012;122(4):143–59. DOI: 10.1042/CS20110340.
88. Tackey E, Lipsky PE, Illei GG. Rationale for interleukin-6 blockade in systemic lupus erythematosus. Lupus. 2004;13(5):339–43. DOI: http://dx.doi.org/10.1191/0961203304lu1023oa.
89. Linker-Israeli M, Deans RJ, Wallace DJ, et al. Elevated levels of endogenous IL-6 in systemic lupus erythematosus: a putative role in pathogenesis. J Immunol. 1991;147(1):117–23.
90. Peterson E, Robertson AD, Emlen W. Serum and urinary inter- leukin-6 in systemic lupus erythematosus. Lupus. 1996;5(6):571–5. DOI: http://dx.doi.org/10.1177/096120339600500603.
91. Grondal G, Gunnarsson I, Ronnelid J, et al. Cytokine produc- tion, serum levels and disease activity in systemic lupus erythe- matosus. Clin Exp Rheumatol. 2000;18(5):565–70.
92. Peterson E, Robertson AD, Emlen W. Serum and urinary inter- leukin-6 in systemic lupus erythematosus. Lupus. 1996;5(6):571–5. DOI: http://dx.doi.org/10.1177/096120339600500603.
93. Grondal G, Gunnarsson I, Ronnelid J, et al. Cytokine production, serum levels and disease activity in systemic lupus erythe-
94. matosus. Clin Exp Rheumatol. 2000;18(5):565–70.
95. Iwano M, Dohi K, Hirata E, et al. Urinary levels of IL-6 in patients with active lupus nephritis. Clinical Nephrology. 1993;40(1):16–21.
96. Malide D, Russo P, Bendayan M. Presence of tumor necrosis factor alpha and interleukin-6 in renal mesangial cells of lupus nephritis patients. Human Pathology. 1995;26(5):558–64. DOI: http://dx.doi.org/10.1016/0046-8177(95)90253-8.
97. Herrera-Esparza R, Barbosa-Cisneros O, Villalobos-Hurtado R, Avalos-DТaz E. Renal expression of IL-6 and TNFα genes in lupus nephritis. Lupus. 1998;7(3):154–8. DOI: http://dx.doi.org/10.1191/096120398678919949.
98. Tsai GY, Wu TH, Yu CL, et al. Increased excretions of β2- microglobulin, IL-6, and IL-8 and decreased excretion of Tamm-Horsfall glycoprotein in urine of patients with active lupus nephritis. Nephron. 2000;85(3):207–14. DOI: http://dx.doi.org/10.3109/03009749609069992.
99. Hirohata S, Miyamoto T. Elevated levels of interleukin-6 in cere- brospinal fluid from patients with systemic lupus erythematosus and central nervous system involvement. Arthritis Rheum. 1990;33(5):644–9. DOI: http://dx.doi.org/10.1002/art.1780330506.
100. Hagiwara E, Gourley MF, Lee S, Klinman DM. Disease severity in patients with systemic lupus erythematosus correlates with an increased ratio of interleukin-10: interferon-α-secreting cells in the peripheral blood. Arthritis Rheum. 1996;39(3):379–85. DOI: http://dx.doi.org/10.1002/art.1780390305.
101. Swaak G, van den Brink HG, Aarden LA. Cytokine production (IL-6 and TNFα) in whole blood cell cultures of patients with systemic lupus erythematosus. Scand J Rheumatol. 1996;25(4):233–8. DOI: http://dx.doi.org/10.3109/03009749609069992.
102. Klashman DJ, Martin RA, Martinez-Maza O, Stevens RH.
103. In vitro regulation of B cell differentiation by interleukin-6 and soluble CD23 in systemic lupus erythematosus B cell subpopula- tions and antigen-induced normal B cells. Arthritis Rheum. 1991;34(3):276–86. DOI: http://dx.doi.org/10.1002/art.1780340305.
104. Kitani A, Hara M, Hirose T, et al. Autostimulatory effects of IL- 6 on excessive B cell differentiation in patients with systemic lupus erythematosus: analysis of IL-6 production and IL-6R expression. Clin Exp Immunol. 1992;88(1):75–83. DOI: http://dx.doi.org/10.1111/j.1365-2249.1992.tb03042.x.
105. Suzuki H, Yasukawa K, Saito T, et al. Serum soluble interleukin- 6 receptor in MRL/lpr mice is elevated with age and mediates the interleukin-6 signal. Eur J Immunol. 1993;23(5):1078–82. DOI: http://dx.doi.org/10.1002/eji.1830230515.
106. Tang B, Matsuda T, Akira S, et al. Age-associated increase in interleukin 6 in MRL/lpr mice. Int Immunol. 1991;31(3):273–8. DOI: http://dx.doi.org/10.1093/intimm/3.3.273.
107. Alarcon-Riquelme ME, Moller G, Fernandez C. Age-dependent responsiveness to interleukin-6 in B lymphocytes from a systemic lupus erythematosus-prone (NZB x NZW)F1 hybrid. Clin Immunol Immunopath. 1992;62(3):264–9. DOI: http://dx.doi.org/10.1016/0090-1229(92)90101-S.
108. Mihara M, Fukui H, Koishihara Y, et al. Immunologic abnor- mality in NZB/W F1 mice. Thymus-independent expansion of B cells responding to interleukin-6. Clin Exp Immunol. 1990;82(3):533–7. DOI: http://dx.doi.org/10.1111/j.1365- 2249.1990.tb05485.x.
109. Mihara M, Ohsug Y. Possible role of IL-6 in pathogenesis of immune complex-mediated glomerulonephritis in NZB/W F1 mice: induction of IgG class anti-DNA autoantibody production. Intern. Arch Allergy Appl Immunol. 1990;93(1):89–92. DOI: http://dx.doi.org/10.1159/000235285.
110. Ryffel B, Car BD, Gunn H, et al. Interleukin-6 exacerbates glomerulonephritis in (NZBxNZW)F1 mice. Am J Pathol. 1994;144(5):927–37.
111. Finck BK, Chan B, Wofsy D. Interleukin 6 promotes murine lupus in NZB/NZW F1 mice. J Clin Inves. 1994;94(2):585–91. DOI: http://dx.doi.org/10.1172/JCI117373.
112. Mihara M, Takagi N, Takeda Y, Ohsugi Y. IL-6 receptor blockage inhibits the onset of autoimmune kidney disease in NZB/WF1 mice. Clin Exp Immunol. 1998;112(3):397–402. DOI: http://dx.doi.org/10.1046/j.1365-2249.1998.00612.x.
113. Liang B, Gardner DB, Griswold DE, et al. Anti-interleukin-6 monoclonal antibody inhibits autoimmune responses in a murine model of systemic lupus erythematosus. Immunology. 2006;119(3):296–305. DOI: http://dx.doi.org/10.1111/j.1365- 2567.2006.02433.x.
114. Pflegerl P, Vesely P, Hantusch B, et al. Epidermal loss of JunB leads to a SLE phenotype due to hyper IL-6 signaling. Proc Nat Acad Sci USA. 2009;106(48):20423–8. DOI: http://dx.doi.org/10.1073/pnas.0910371106.
115. Illei GG, Shirota Y, Yarboro CH, et al. Tocilizumab in systemic lupus erythematosus: data on safety, preliminary efficacy, and impact on circulating plasma cells from an open-label phase I dosage-escalation study. Arthritis Rheum. 2010;62(2):542–52. DOI: http://dx.doi.org/10.1002/art.27221.
116. Garcia-Hernandez FJ, Gonzalez-Leon R, Castillo-Palma MJ, et al. Tocilizumab for treating refractory haemolytic anaemia in a patient with systemic lupus erythematosus. Rheumatology (Oxford). 2012;51(10):1918–9. DOI: http://dx.doi.org/10.1093/rheumatology/kes072. Epub 2012 Apr 17.
117. Kamata Y, Minota S. Successful treatment of massive intractable pericardial effusion in a patient with systemic lupus erythemato- sus with tocilizumab. BMJ Case Rep. 2012 Dec 21;2012. pii: bcr2012007834. DOI: http://dx.doi.org/10.1136/bcr-2012- 007834.
118. Jacob CO, McDevitt HO. Tumour necrosis factor-α in murine autoimmune «lupus» nephritis. Nature. 1988;331(6154):356–8. DOI: http://dx.doi.org/10.1038/331356a0.
119. Gordon C, Ranges GE, Greenspan JS, Wofsy D. Chronic thera- py with recombinant tumor necrosis factor-α in autoimmune NZB/NZW F1 mice. Clin Immunol Immunopathol. 1989;52(3):421–34. DOI: http://dx.doi.org/10.1016/0090- 1229(89)90157-8.
120. Kontoyiannis D, Kollias G. Accelerated autoimmunity and lupus nephritis in NZB mice with an engineered heterozygous deficiency in tumor necrosis factor. Eur J Immunol. 2000;30(7):2038–47. DOI: http://dx.doi.org/10.1002/1521- 4141(200007)30:7%3C2038::AID-IMMU2038%3E3.0.CO;2-K.
121. Jacob N, et al. Accelerated pathological and clinical nephritis in systemic lupus erythematosus-prone New Zealand Mixed 2328 mice doubly deficient in TNF receptor 1 and TNF receptor 2 via a Th17-associated pathway. J Immunol. 2009;182(4):2532–41. DOI: http://dx.doi.org/10.4049/jim- munol.0802948.
122. Studnicka-Benke A, Steiner G, Petera P, Smolen JS. Tumour necrosis factor α and its soluble receptors parallel clinical dis- ease and autoimmune activity in systemic lupus erythematosus. Br J Rheumatol. 1996;35(11):1067–74. DOI: http://dx.doi.org/10.1093/rheumatology/35.11.1067.
123. Zhu LJ, Landolt-Marticorena C, Li T, et al. Altered expression of TNF-α signaling pathway proteins in systemic lupus erythemato- sus. J Rheumatol. 2010;37(8):1658–66. DOI: http://dx.doi.org/10.3899/jrheum.091123.
124. Soforno E, Baumgartner M, Francis L, et al. Induction of sys- temic lupus erythematosus with tumor necrosis factor blockers. J Rheumatol. 2010;37(1):204–5. DOI: http://dx.doi.org/10.3899/jrheum.081312.
125. Aringer M, Graninger WB, Steiner G, Smolen JS. Safety and efficacy of tumor necrosis factor α blockade in systemic lupus erythematosus: an open-label study. Arthritis Rheum. 2004;50(10):3161–9. DOI: http://dx.doi.org/10.1002/art.20576.
126. Uppal SS, Hayat SJ, Raghupathy R. Efficacy and safety of inflix- imab in active SLE: a pilot study. Lupus. 2009;18(8):690–7. http://dx.doi.org/10.1177/0961203309102557.
127. Matsumura R, Umemiya K, Sugiyama T, et al. Anti-tumor necrosis factor therapy in patients with difficult-to-treat lupus nephritis: a prospective series of nine patients. Clin Exp Rheumatol. 2009;27(3):416–21.
128. Aringer M, Houssiau F, Gordon C, et al. Adverse events and effi- cacy of TNF-α blockade with infliximab in patients with sys- temic lupus erythematosus: long-term follow-up of 13 patients. Rheumatology (Oxford). 2009;48(11):1451–4. DOI: http://dx.doi.org/10.1093/rheumatology/kep270.
129. Runkel L, Stacey J. Lupus clinical development: will belimum- ab`s approval catalase a new paradigm for SLE drug develop- ment? Expert Opin Biol Ther. 2014;14(4):491–501. DOI: http://dx.doi.org/10.1517/14712598.2014.884065.
Для цитирования:
Насонов Е.Л., Соловьев С.К. Перспективы фармакотерапии системной красной волчанки. Научно-практическая ревматология. 2014;52(3):311-321. https://doi.org/10.14412/1995-4484-2014-311-321
For citation:
Nasonov E.L., Solovyev S.K. PROSPECTS FOR PHARMACOTHERAPY OF SYSTEMIC LUPUS ERYTHEMATOSUS. Rheumatology Science and Practice. 2014;52(3):311-321. (In Russ.) https://doi.org/10.14412/1995-4484-2014-311-321
Просмотров: 1237
Послать статью по эл. почте 
