Preview

Научно-практическая ревматология

Расширенный поиск

Генно-инженерная биологическая терапия ювенильного артрита

https://doi.org/10.14412/1995-4484-2011-873

Полный текст:

Аннотация

Механизмы действия используемых в настоящее время генно-инженерных биологических препаратов (ГИБП) включают ингибирова- ние цитокинов, интерлейкинов и Т-клеток, а также деплецию В-клеток. Первоначально ГИБП были доступны главным образом для лечения рефрактерных вариантов ювенильного идиопатического артрита (ЮИА), включая системный ЮИА (болезнь Стилла), что давало возможность отказаться от длительного использования высоких доз глюкокортикоидов или цитостатических препаратов. Начиная с 2000 г. ряд рандомизированных двойных слепых плацебоконтролируемых и открытых пилотных исследований убедительно продемонстрировал эффективность ГИБП у детей и подростков. Хотя ингибиторы фактора некроза опухоли a (ФНО a) этанерцепт и адалимумаб используются главным образом для лечения рефрактерного полиартикулярного варианта ЮИА, блокаторы интерлейкина 1 и 6 показали удовлетворительные результаты в лечении системного ЮИА. Абатацепт рассматривается как вариант лечения полиартикулярного ЮИА, когда болезнь-модифицирующие препараты и ингибиторы ФНО a неэффективны. Место ритуксимаба в лечении ЮИА до сих пор окончательно не определено.
Однако, несмотря на достигнутый прогресс, терапия ГИБП по-прежнему не способна вызвать полное излечение. ГИБП потенциально обладают рядом серьезных побочных эффектов, среди которых тяжелые инфекции, а также возможность развития злокачественных новообразований и аутоиммунных процессов. Их применение требует тщательного мониторирования для того, чтобы рано выявить развитие серьезных побочных реакций и таким образом предотвратить неблагоприятный исход.

Список литературы

1. <div><p>Wikipedia. Recombinant DNA. http://en.wikipedia.org/wiki/Recombinant_DNA</p><p>Wikipedia. Hybridoma Technology; http://en.wikipedia.org/wiki/Hybridoma_ &lt;http://en.wikipedia.org/wiki/Hybridoma_&gt; Technology</p><p>Nelson P.N., Reynolds G.M., Waldron E.E. et al. Monoclonal antibodies. Mol Pathol 2000; 53(3): 111-7.</p><p>Wikipedia. Fusion protein. http://en.wikipedia.org/wiki/Fusion_protein &lt;http://en.wikipedia.org/wiki/Fusion_protein&gt;</p><p>Woo P. Cytokines and juvenile idiopathic arthritis. Curr Rheumatol Rep 2002; 4(6): 452-7.</p><p>Bazzoni F., Beutler B. The tumor necrosis factor ligand and receptor families. N Engl J Med 1996; 334(26): 1717-25.</p><p>Scott D.L., Kingsley G.H. Tumor necrosis factor inhibitors for rheumatoid arthritis. N Engl J Med 2006; 355(7): 704-12.</p><p>Beutler B.A. The role of tumor necrosis factor in health and disease. J Rheumatol Suppl 1999; 57: 16-21.</p><p>McDevitt H., Munson S., Ettinger R., Wu A. Multiple roles for tumor necrosis factor-alpha and lymphotoxin alpha/beta in immunity and autoimmunity. Arthr Res 2002; 4(Suppl. 3): S141-S152.</p><p>Sfikakis P.P., Kollias G. Tumor necrosis factor biology in experimental and clinical arthritis. Curr Opin Rheumatol 2003; 15(4): 380-6.</p><p>Dekker L., Armbrust W., Rademaker C.M. et al. Safety of anti-TNFalpha therapy in children with juvenile idiopathic arthritis. Clin Exp Rheumatol 2004; 22(2): 252-8.</p><p>Wilkinson N., Jackson G., Gardner- Medwin J. Biologic therapies for juvenile arthritis. Arch Dis Child 2003; 88(3): 186-91.</p><p>Lovell D.J., Giannini E.H., Reiff A. et al. Etanercept in children with polyarticular juvenile rheumatoid arthritis. Pediatric Rheumatology Collaborative Study Group. N Engl J Med 2000; 342(11): 763-9.</p><p>Lovell D.J., Giannini E.H., Reiff A. et al. Long-term efficacy and safety of etanercept in children with polyarticular- course juvenile rheumatoid arthritis: interim results from an ongoing multicenter, open-label, extended-treatment trial. Arthr Rheum 2003; 48(1): 218-26.</p><p>Lovell D.J., ReiffA., Jones O.Y. et al. Long-term safety and efficacy of etanercept in children with polyarticular-course juvenile rheumatoid arthritis. Arthr Rheum 2006; 54(6): 1987-94.</p><p>Lovell D.J., Reiff A., Ilowite N.T. et al. Safety and efficacy of up to eight years of continuous etanercept therapy in patients with juvenile rheumatoid arthritis. Arthr Rheum 2008; 58(5): 1496-504.</p><p>Giannini E.H., Ilowite N.T., Lovell D.J. et al. Long-term safety and effectiveness of etanercept in children with selected categories of juvenile idiopathic arthritis. Arthr Rheum 2009; 60(9): 2794-804.</p><p>Horneff G., Schmeling H., Biedermann T. et al. The German etanercept registry for treatment of juvenile idiopathic arthritis. Ann Rheum Dis 2004; 63(12): 1638-44.</p><p>Horneff G., De Bock F., Foeldvari I. et al. Safety and efficacy of combination of etanercept and methotrexate compared to treatment with etanercept only in patients with juvenile idiopathic arthritis (JIA): preliminary data from the German JIA Registry. Ann Rheum Dis 2009; 68(4): 519-25.</p><p>Quartier P., Taupin P., Bourdeaut F. et al. Efficacy of etanercept for the treatment of juvenile idiopathic arthritis according to the onset type. Arthr Rheum 2003; 48(4): 1093-101.</p><p>Eberhard B.A., Ilowite N.T. Response of systemic onset juvenile rheumatoid arthritis to etanercept: is the glass half full or half empty? J Rheumatol 2005; 32(5): 763-5.</p><p>Kimura Y., Pinho P., Walco G. et al. Etanercept treatment in patients with refractory systemic onset juvenile rheumatoid arthritis. J Rheumatol 2005; 32(5): 935-42.</p><p>Russo R.A., Katsicas M.M., Zelazko M. Etanercept in systemic juvenile idiopathic arthritis. Clin Exp Rheumatol 2002; 20(5): 723-6.</p><p>Pascual V., Allantaz F., Arce E. et al. Role of interleukin-1 (IL-1) in the pathogenesis of systemic onset juvenile idiopathic arthritis and clinical response to IL-1 blockade. J Exp Med 2005; 201(9): 1479-86.</p><p>Lequerre T., Quartier P., Rosellini D. et al. Interleukin-1 receptor antagonist (anakinra) treatment in patients with systemic-onset juvenile idiopathic arthritis or adult onset Still disease: preliminary experience in France. Ann Rheum Dis 2008; 67(3): 302-8.</p><p>Gattorno M., Piccini A., Lasiglie D. et al. The pattern of response to antiinterleukin-1 treatment distinguishes two subsets of patients with systemic-onset juvenile idiopathic arthritis. Arthr Rheum 2008; 58(5): 1505-15.</p><p>Ohlsson V., Baildam E., Foster H. et al. Anakinra treatment for systemic-onset juvenile idiopathic arthritis (SOJIA). Rheumatology (Oxford) 2008; 47(4): 555-6.</p><p>Quartier P., Allantaz F., Cimaz R. et al. Efficacy, safety and effect on gene expression profiling of anakinra in systemic-onset juvenile idiopathic arthritis: final results of a randomised, placebo- controlled trial (ANAJIS). Ped Rheumatol 2008; 6(Suppl. I): 27.</p><p>Ruperto N., Quartier P., Wulffraat N. et al. A phase II trial with canakinumab (ACZ885), a new IL-1-beta blocking monoclonal antibody, to evaluate safety and preliminary efficacy in children with systemic juvenile idiopathic arthritis (SJIA). Ann Rheum Dis 2009; 68(Suppl. 3): 170.</p><p>Yokota S., Imagawa T., Mori M. et al. Efficacy and safety of tocilizumab in patients with systemic-onset juvenile idiopathic arthritis: a randomised, doubleblind, placebo-controlled, withdrawal phase III trial. Lancet 2008; 371(9617): 998-1006.</p><p>Reiff A., Takei S., Sadeghi S. et al. Etanercept therapy in children with treatment-resistant uveitis. Arthr Rheum 2001; 44(6): 1411-5.</p><p>Reddy A.R., Backhouse O.C. Does etanercept induce uveitis? Br J Ophthalmol 2003; 87(7): 925.</p><p>Schmeling H., Horneff G. Etanercept and uveitis in patients with juvenile idiopathic arthritis. Rheumatology (Oxford) 2005; 44(8): 1008-11.</p><p>Smith J.A., Thompson D.J., Whitcup S.M. et al. A randomized, placebo-controlled, double-masked clinical trial of etanercept for the treatment of uveitis associated with juvenile idiopathic arthritis. Arthr Rheum 2005; 53(1): 18-23.</p><p>Galor A., Perez V.L., Hammel J.P., Lowder C.Y. Differential effectiveness of etanercept and infliximab in the treatment of ocular inflammation. Ophthalmology 2006; 113(12): 2317-23.</p><p>Foeldvari I., Nielsen S., Kummerle- Deschner J. et al. Tumor necrosis factor- alpha blocker in treatment of juvenile idiopathic arthritis-associated uveitis refractory to second-line agents: results of a multinational survey. J Rheumatol 2007; 34(5): 1146-50.</p><p>Lim L.L., Fraunfelder F.W., Rosenbaum J.T. Do tumor necrosis factor inhibitors cause uveitis? A registry-based study. Arthr Rheum 2007; 56(10): 3248-52.</p><p>Tynjala P., Lindahl P., Honkanen V. et al. Infliximab and etanercept in the treatment of chronic uveitis associated with refractory juvenile idiopathic arthritis. Ann Rheum Dis 2007; 66(4): 548-50.</p><p>Lim L.L. Uveitis following the use of tumor necrosis factor alpha inhibitors: Reply on comments. Arthr Rheum 2008; 58: 1556-7.</p><p>Amgen. Amgen and Wyeth Statement on FDA Announcement About Tumor Necrosis Factor (TNF) Blockers. 2009. http://www.amgen.com/media_pr_detail.jsp &lt;http://www.amgen.com/media_pr_detail.jsp&gt;? ReleaseID=1316767.</p><p>Lovell D.J., Ruperto N., Goodman S. et al. Adalimumab with or without methotrexate in juvenile rheumatoid arthritis. N Engl J Med 2008; 359(8): 810-20.</p><p>Biester S., Deuter C., Michels H. et al. Adalimumab in the therapy of uveitis in childhood. Br J Ophthalmol 2007; 91(3): 319-24.</p><p>Tynjala P., Kotaniemi K., Lindahl P. et al. Adalimumab in juvenile idiopathic arthritis-associated chronic anterior uveitis. Rheumatology (Oxford) 2008; 47(3): 339-44.</p><p>Burmester G.R., Mease P., Dijkmans B.A. et al. Adalimumab safety and mortality rates from global clinical trials of six immune-mediated inflammatory diseases. Ann Rheum Dis 2009; 68(12): 1863-9.</p><p>Ruperto N., Lovell D.J., Cuttica R. et al. A randomized, placebo-controlled trial of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis. Arthr Rheum 2007; 56(9): 3096-106.</p><p>Ruperto N., Lovell D.J., Cuttica R. et al. Long-Term Efficacy and Safety of Infliximab plus Methotrexate for the Treatment of Polyarticular Course Juvenile Rheumatoid Arthritis: Findings from an Open-Label Treatment Extension. Ann Rheum Dis 2009[Epub. ahead of print].</p><p>Lahdenne P., Vahasalo P., Honkanen V. Infliximab or etanercept in the treatment of children with refractory juvenile idiopathic arthritis: an open label study. Ann Rheum Dis 2003; 62(3): 245-7.</p><p>Schreiber S., Rutgeerts P., Fedorak R.N. et al. A randomized, placebo-controlled trial of certolizumab pegol (CDP870) for treatment of Crohn's disease. Gastroenterology 2005; 129(3): 807-18.</p><p>Sandborn W.J., Feagan B.G., Stoinov S. et al. Certolizumab pegol for the treatment of Crohn's disease. N Engl J Med 2007; 357(3): 228-38.</p><p>Rutgeerts P., Schreiber S., Feagan B. et al. Certolizumab pegol, a monthly subcutaneously administered Fc-free anti- TNFalpha, improves health-related quality of life in patients with moderate to severe Crohn's disease. Int J Colorectal Dis 2008; 23(3): 289-96.</p><p>Smolen J.S., Landewe R.B., Mease P.J. et al. Efficacy and Safety of Certolizumab Pegol Plus Methotrexate in Active Rheumatoid Arthritis: The RAPID 2 Study. Ann Rheum Dis 2009; 68: 797-804.</p><p>Hutas G. Golimumab, a fully human monoclonal antibody against TNF-alpha. Curr Opin Mol Ther 2008; 10(4): 393-406.</p><p>Inman R.D., Davis J.C. Jr., Heijde D. et al. Efficacy and safety of golimumab in patients with ankylosing spondylitis: results of a randomized, double-blind, placebo-controlled, phase III trial. Arthr Rheum 2008; 58(11): 3402-12.</p><p>Kay J., Matteson E.L., Dasgupta B. et al. Golimumab in patients with active rheumatoid arthritis despite treatment with methotrexate: a randomized, doubleblind, placebo-controlled, dose-ranging study. Arthr Rheum 2008; 58(4): 964-75.</p><p>Kavanaugh A., McInnes I., Mease P. et al. Golimumab, a new human tumor necrosis factor alpha antibody, administered every four weeks as a subcutaneous injection in psoriatic arthritis: Twenty-four-week efficacy and safety results of a randomized, placebo-controlled study. Arthr Rheum 2009; 60(4): 976-86.</p><p>Keystone E.C., Genovese M.C., Klareskog L. et al. Golimumab, a human antibody to tumour necrosis factor (alpha) given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy: the GO-FORWARD Study. Ann Rheum Dis 2009; 68(6): 789-96.</p><p>Dinarello C.A. Blocking IL-1 in systemic inflammation. J Exp Med 2005; 201(9): 1355-9.</p><p>Dinarello C.A. Interleukin-1β and the Autoinflammatory Diseases. N Engl J Med 2009; 360(23): 2467-70.</p><p>Shaikov A., Maximov A., Speranskij A.I. et al. Repetitive use of pulse therapy with methylprednisolone and cyclophosphamide in addition to oral methotrexate in children with systemic juvenile rheumatoid arthritis - preliminary results of a longterm study. J Rheumatol 1992; 19(4): 612-6.</p><p>Stoeber E. Prognosis in juvenile chronic arthritis. Follow-up of 433 chronic rheumatic children. Eur J Pediatr 1981; 135(3): 225-8.</p><p>Henrickson M. Efficacy of anakinra in refractory systemic arthritis. Arthr Rheum 2004; 50(Suppl. 9): S438.</p><p>Irigoyen P.I., Olson J., Horn C., Ilowite N.T. Treatment of systemic onset juvenile rheumatoid arthritis with anakinra. Arthr Rheum 2004; 50(Suppl. 9): S437-S438.</p><p>Verbsky J.W., White A.J. Effective use of the recombinant interleukin 1 receptor antagonist anakinra in therapy resistant systemic onset juvenile rheumatoid arthritis. J Rheumatol 2004; 31(10): 2071-5.</p><p>Adams A., Lehman T.J. Update on the pathogenesis and treatment of systemic onset juvenile rheumatoid arthritis. Curr Opin Rheumatol 2005; 17(5): 612-6.</p><p>Von Lorentz J., Kropp A., Michels H. Anakinra - eine neue therapeutische Option fü r die systemische juvenile idiopathische Arthritis. Akt Rheumatol 2007; 32(3): 137-40.</p><p>Woo P. Anakinra treatment for systemic juvenile idiopathic arthritis and adult onset Still disease. Ann Rheum Dis 2008; 67(3): 281-2.</p><p>Zeft A., Hollister R., LaFleur B. et al. Anakinra for systemic juvenile arthritis: the Rocky Mountain experience. J Clin Rheumatol 2009; 15(4): 161-4.</p><p>Ilowite N., Porras O., Reiff A. et al. Anakinra in the treatment of polyarticular-course juvenile rheumatoid arthritis: safety and preliminary efficacy results of a randomized multicenter study. Clin Rheumatol 2009; 28(2): 129-37.</p><p>Mertens M., Singh J.A. Anakinra for Rheumatoid Arthritis: A systematic Review. J Rheumatol 2009; 36(6): 1118-25.</p><p>Kalliolias G.D., Liossis S.N. The future of the IL-1 receptor antagonist anakinra: from rheumatoid arthritis to adult-onset Still's disease and systemiconset juvenile idiopathic arthritis. Expert Opin Investig Drugs 2008; 17(3): 349-59.</p><p>Hawkins P.N., Bybee A., Aganna E., McDermott M.F. Response to anakinra in a de novo case of neonatal-onset multisystem inflammatory disease. Arthr Rheum 2004; 50(8): 2708-9.</p><p>Hawkins P.N., Lachmann H.J., Aganna E., McDermott M.F. Spectrum of clinical features in Muckle-Wells syndrome and response to anakinra. Arthr Rheum 2004; 50(2): 607-12.</p><p>Lovell D.J., Bowyer S.L., Solinger A.M. Interleukin-1 blockade by anakinra improves clinical symptoms in patients with neonatal-onset multisystem inflammatory disease. Arthr Rheum 2005; 52(4): 1283-6.</p><p>Goldbach-Mansky R., Dailey N.J., Canna S.W. et al. Neonatal-onset multisystem inflammatory disease responsive to interleukin-1beta inhibition. N Engl J Med 2006; 355(6): 581-92.</p><p>Leslie K.S., Lachmann H.J., Bruning E. et al. Phenotype, genotype, and sustained response to anakinra in 22 patients with autoinflammatory disease associated with CIAS-1/NALP3 mutations. Arch Dermatol 2006; 142(12): 1591-7.</p><p>Mirault T., Launay D., Cuisset L. et al. Recovery from deafness in a patient with Muckle-Wells syndrome treated with anakinra. Arthr Rheum 2006; 54(5): 1697-700.</p><p>De Koning H.D., Bodar E.J., van der Meer J.W., Simon A. Schnitzler syndrome: beyond the case reports: review and follow-up of 94 patients with an emphasis on prognosis and treatment. Semin Arthr Rheum 2007; 37(3): 137-48.</p><p>Ryan J.G., de Koning H.D., Beck L.A. et al. IL-1 blockade in Schnitzler syndrome: ex vivo findings correlate with clinical remission. J Allergy Clin Immunol 2008; 121(1): 260-2.</p><p>Aksentijevich I., Masters S.L., Ferguson P.J. et al. An Autoinflammatory Disease with Deficiency of the Interleukin-1-Receptor Antagonist. N Engl J Med 2009; 360(23): 2426-37.</p><p>Goldbach-Mansky R., Shroff S.D., Wilson M. et al. A pilot study to evaluate the safety and efficacy of the long-acting interleukin-1 inhibitor rilonacept (interleukin-1 Trap) in patients with familial cold autoinflammatory syndrome. Arthr Rheum 2008; 58(8): 2432-42.</p><p>Hoffman H.M., Throne M.L., Amar N.J. et al. Efficacy and safety of rilonacept (interleukin-1 Trap) in patients with cryopyrin-associated periodic syndromes: results from two sequential placebo-controlled studies. Arthr Rheum 2008; 58(8): 2443-52.</p><p>Church L.D., McDermott M.F. Rilonacept in cryopyrin-associated periodic syndromes: the beginning of longer-acting interleukin-1 antagonism. Nat Clin Pract Rheumatol 2009; 5(1): 14-5.</p><p>Hoffman H.M. Rilonacept for the treatment of cryopyrin-associated periodic syndromes (CAPS). Expert Opin Biol Ther 2009; 9(4): 519-31.</p><p>Lachmann H.J., Kone-Paut I., Kuemmerle-Deschner J.B. et al. Use of Canakinumab in the Cryopyrin-Associated Periodic Syndrome. N Engl J Med 2009; 360(23): 2416-25.</p><p>Nishimoto N., Kishimoto T. Interleukin 6: from bench to bedside. Nat Clin Pract Rheumatol 2006; 2(11): 619-26.</p><p>De Benedetti F., Massa M., Robbioni P. et al. Correlation of serum interleukin-6 levels with joint involvement and thrombocytosis in systemic juvenile rheumatoid arthritis. Arthr Rheum 1991; 34(9): 1158-63.</p><p>De Benedetti F., Martini A. Targeting the interleukin-6 receptor: a new treatment for systemic juvenile idiopathic arthritis? Arthr Rheum 2005; 52(3): 687-93.</p><p>Boulanger M.J., Chow D.C., Brevnova E.E., Garcia K.C. Hexameric structure and assembly of the interleukin- 6/IL-6 alpha-receptor/gp130 complex. Science 2003; 300(5628): 2101-4.</p><p>Heinrich P.C., Behrmann I., Haan S. et al. Principles of interleukin (IL)-6-type cytokine signalling and its regulation. Biochem J 2003; 374(Pt 1): 1-20.</p><p>Rose-John S., Scheller J., Elson G., Jones S.A. Interleukin-6 biology is coordinated by membrane-bound and soluble receptors: role in inflammation and cancer. J Leukoc Biol 2006; 80(2): 227-36.</p><p>Nishimoto N., Kishimoto T. Humanized antihuman IL-6 receptor antibody, tocilizumab. Handb Exp Pharmacol 2008; 181: 151-60.</p><p>Woo P., Wilkinson N., Prieur A.M. et al. Open label phase II trial of single, ascending doses of MRA in Caucasian children with severe systemic juvenile idiopathic arthritis: proof of principle of the efficacy of IL-6 receptor blockade in this type of arthritis and demonstration of prolonged clinical improvement. Arthr Res Ther 2005; 7(6): R1281-R1288.</p><p>Yokota S., Miyamae T., Imagawa T. et al. Therapeutic efficacy of humanized recombinant anti-interleukin-6 receptor antibody in children with systemic-onset juvenile idiopathic arthritis. Arthr Rheum 2005; 52(3): 818-25.</p><p>Grom A.A., Hirsch R. T-cell and T- cell receptor abnormalities in the immunopathogenesis of juvenile rheumatoid arthritis. Curr Opin Rheumatol 2000; 12(5): 420-4.</p><p>Alegre M.L., Frauwirth K.A., Thompson C.B. T-cell regulation by CD28 and CTLA-4. Nat Rev Immunol 2001; 1(3): 220-8.</p><p>Ruperto N., Lovell D.J., Quartier P. et al. Abatacept in children with juvenile idiopathic arthritis: a randomized, double-blind, placebo-controlled withdrawal trial. Lancet 2008; 372(9636): 383-91.</p><p>Ruperto N., Lovell D., Quartier P. et al. Long-term safety and efficacy of abatacept in children with juvenile idiopathic arthritis. Arthr Rheum 2010; 62(6): 1792-1802.DOI 10.1002/art.27431.</p><p>Angeles-Han S., Flynn T., Lehman T. Abatacept for refractory juvenile idiopathic arthritis-associated uveitis - a case report. J Rheumatol 2008; 35(9): 1897-8.</p><p>Mei H., Dö rner T. Translationale Aspekte zur Rolle von B-Zellen bei Autoimmunerkrankungen. «From bench to bedside» and «from bed to benchside». Z Rheumatol 2009; 68(5): 364-9.</p><p>Morbach H., Girschick H.J. Do B cells play a role in the pathogenesis of juvenile idiopathic arthritis? Autoimmunity 2009; 42(4): 373-5.</p><p>Tsokos G.C. B cells, be gone - B- cell depletion in the treatment of rheumatoid arthritis. N Engl J Med 2004; 350(25): 2546-8.</p><p>Youinou P., Jamin C., Saraux A. B- cell: a logical target for treatment of rheumatoid arthritis. Clin Exp Rheumatol 2007; 25(2): 318-28.</p><p>Roll P., Tony H.P. Anti-CD20- Therapie bei rheumatoider Arthritis. Z Rheumatol 2009; 68(5): 370-9.</p><p>Kuek A., Hazleman B.L., Gaston J.H., Ostor A.J. Successful treatment of refractory polyarticular juvenile idiopathic arthritis with rituximab. Rheumatology (Oxford) 2006; 45(11): 1448-9.</p><p>Denisova R.V., Alexeyeva E.I., Bzarova T.M. et al. Efficacy and safety of rituximab in patients with juvenile idiopathic arthritis. EULAR 2008, OP-0063.</p><p>Kasher-Meron M., Uziel Y., Amital H. Successful treatment with B-cell depleting therapy for refractory systemic onset juvenile idiopathic arthritis: a case report. Rheumatology (Oxford) 2009; 48(4): 445-6.</p><p>Narvaez J., Diaz-Torne C., Juanola X. et al. Rituximab therapy for refractory systemic-onset juvenile idiopathic arthritis. Ann Rheum Dis 2009; 68(4): 607-8.</p><p>MacDermott E.J., Lehman T.J. Prospective, open-label trial of rituximab in childhood systemic lupus erythematosus. Curr Rheumatol Rep 2006; 8(6): 439-41.</p><p>Marks S.D., Tullus K. Successful outcomes with rituximab therapy for refractory childhood systemic lupus erythematosus. Pediatr Nephrol 2006; 21(4): 598-9.</p><p>Noss E.H., Hausner-Sypek D.L., Weinblatt M.E. Rituximab as therapy for refractory polymyositis and dermatomyositis. J Rheumatol 2006; 33(5): 1021-6.</p><p>Willems M., Haddad E., Niaudet P. et al. Rituximab therapy for childhood- onset systemic lupus erythematosus. J Pediatr 2006; 148(5): 623-7.</p><p>Cooper M.A., Willingham D.L., Brown D.E. et al. Rituximab for the treatment of juvenile dermatomyositis: a report of four pediatric patients. Arthr Rheum 2007; 56(9): 3107-11.</p><p>Jansson A.F., Wintergerst U., Renner E.D., Belohradsky B.H. Rituximab-induced long-term remission in two children with SLE. Eur J Pediatr 2007; 166(2): 177-81.</p><p>Nwobi O., Abitbol C.L., Chandar J. et al. Rituximab therapy for juvenile-onset systemic lupus erythematosus. Pediatr Nephrol 2008; 23(3): 413-9.</p><p>Dorner T., Radbruch A., Burmester G.R. B-cell-directed therapies for autoimmune disease. Nat Rev Rheumatol 2009; 5(8): 433-41.</p><p>Cheifetz A., Mayer L. Monoclonal antibodies, immunogenicity, and associated infusion reactions. Mt Sinai J Med 2005; 72(4): 250-6.</p><p>Kapetanovic M.C., Larsson L., Truedsson L. et al. Predictors of infusion reactions during infliximab treatment in patients with arthritis. Arthr Res Ther 2006; 8(4): R131.</p><p>Gartlehner G., Hansen R.A., Jonas B.L. et al. Biologics for the treatment of juvenile idiopathic arthritis: a systematic review and critical analysis of the evidence. Clin Rheumatol 2008; 27(1): 67-76.</p><p>Horneff G., Augustin S. Evidenz- basierte Therapie der juvenilen idiopathischen Arthritis. Med Monatsschr Pharm 2008; 31(9): 326-36.</p><p>Pichlmeier E., Böhm H., Graf B. et al. Eitrige Spondylodiszitis bei juveniler chronischer Arthritis: Komplikation unter Etanercept-Therapie. Akt Rheumatol 2003; 28(5): 275-6.</p><p>Wallis R.S., Ehlers S. Tumor necrosis factor and granuloma biology: explaining the differential infection risk of etanercept and infliximab. Semin Arthr Rheum 2005; 34(5 Suppl. 1): 34-8.</p><p>Keane J., Bresnihan B. Tuberculosis reactivation during immunosuppressive therapy in rheumatic diseases: diagnostic and therapeutic strategies. Curr Opin Rheumatol 2008; 20(4): 443-9.</p><p>Diel R., Hauer B., Loddenkemper R. et al. Empfehlungen fü r das Tuberkulose- Screening vor Gabe von TNF-α- Inhibitoren bei rheumatischen Erkrankungen. Z Rheumatol 2009; 68(5): 411-6.</p><p>Ayaz N.A., Demirkaya E., Bilginer Y.N. et al. Preventing tuberculosis in children receiving anti-tnf treatment. Clin Rheumatol 2010; 29: 389-92.</p><p>U.S. Food and Drug Administration. Tumor necrosis factor-alpha blockers (TNF blockers), Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab). Sept 2008. http://www.fda.gov/Safety/MedWatch/Sa &lt;http://www.fda.gov/Safety/MedWatch/Sa&gt; fetyInformation/SafetyAlertsforHumanM edicalProducts/ucm163195.htm</p><p>U.S. Food and Drug Administration. Simponi (golimumab). http://www.fda.gov/Safety/MedWatch/Sa &lt;http://www.fda.gov/Safety/MedWatch/Sa&gt; fetyInformation/SafetyAlertsforHumanM edicalProducts/ucm162802.htm</p><p>Bader-Meunier B., Quartier P., Wouters C. Safety of rituximab in children with auto-immune diseases. Pediatr Rheumatol 2008; 6(Suppl. I): P255.</p><p>Ebert A., Horneff G. Rituximab bei einem 7-jährigen Mädchen mit seronegativer polyartikulärer juveniler idiopathischer Arthritis. Z Rheumatol 2009; 68(Suppl. 1): KR15.</p><p>U.S. Food and Drug Administration. Rituxan (rituximab) - PML. http://www.fda.gov/Safety/MedWatch/Sa &lt;http://www.fda.gov/Safety/MedWatch/Sa&gt; fetyInformation/SafetyAlertsforHumanM edicalProducts/ucm187791.htm</p><p>Camussi G., Lupia E. The future role of anti-tumour necrosis factor (TNF) products in the treatment of rheumatoid arthritis. Drugs 1998; 55(5): 613-20.</p><p>Demirkaya E., Cok I., Durmaz E. et al. Genotoxicity of anti-tumor necrosis factor therapy in patients with juvenile idiopathic arthritis. Arthr Care Res 2010; 62(1): 73-7.</p><p>Thomas E., Brewster D.H., Black R.J.,Macfarlane G.J. Risk of malignancy among patients with rheumatic conditions. Int J Cancer 2000; 88(3): 497-502.</p><p>Baecklund E., Iliadou A., Askling J. Association of chronic inflammation, not its treatment, with increased lymphoma risk in rheumatoid arthritis. Arthr Rheum 2006; 54(3): 692-701.</p><p>Franklin J., Lunt M., Bunn D. et al. Incidence of lymphoma in a large primary care derived cohort of cases of inflammatory polyarthritis. Ann Rheum Dis 2006; 65(5): 617-22.</p><p>Smedby K.E., Askling J., Mariette X., Baecklund E. Autoimmune and inflammatory disorders and risk of malignant lymphomas - an update. J Intern Med 2008; 264(6): 514-27.</p><p>Bernatsky S., Rosenberg A., Oen K.G. et al. Malignancy in Juvenile Idiopathic Arthritis. Arthr Rheum 2009; 60(Suppl.), Abstract 250.</p><p>U.S. Food and Drug Administration. Information for Healthcare Professionals: Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi). http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatient sandProviders/DrugSafetyInformationfor HeathcareProfessionals/ucm174474.htm</p><p>U.S. Food and Drug Administration. Early Communication About an Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia). CDER Homepage. http://www.fda.gov/cder/drug/early_com &lt;http://www.fda.gov/cder/drug/early_com&gt; m/TNF_blockers.htm</p><p>U.S. Food and Drug Administration. Follow-up to the June 4, 2008 Early Communication about the Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi). http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationfor PatientsandProviders/DrugSafetyInform ationforHeathcareProfessionals/ucm174 449.htm</p><p>Diak P. Pediatric malignancies with TNF blocking agents. Philadelphia, 2009, American College of Rheumatology. http://www.rheumatology.org/practice/dr &lt;http://www.rheumatology.org/practice/dr&gt; ugalerts/pediatricmalignancies.pdf</p><p>U.S. Food and Drug Administration. Questions and Answers - TNF Blockers 8/25/2009. http://www.fda.gov/Drugs/DrugSafety/ &lt;http://www.fda.gov/Drugs/DrugSafety/&gt; PostmarketDrugSafetyInformationfor PatientsandProviders/DrugSafetyInformatio nforHeathcareProfessionals/ucm180694.htm</p><p>Hyrich K.L., Silman A.J., Watson K.D., Symmons D.P. Anti-tumour necrosis factor alpha therapy in rheumatoid arthritis: an update on safety. Ann Rheum Dis 2004; 63(12): 1538-43.</p><p>Oh J., Arkfeld D.G., Horwitz D.A. Development of Crohn's disease in a patient taking etanercept. J Rheumatol 2005; 32(4): 752-3.</p><p>Ramos-Casals M., Brito-Zeron P., Soto M.J. et al. Autoimmune diseases induced by TNF-targeted therapies. Best Pract Res Clin Rheumatol 2008; 22(5): 847-61.</p><p>Westhovens R., Kremer J.M., Moreland L.W. et al. Safety and efficacy of the selective costimulation modulator abatacept in patients with rheumatoid arthritis receiving background methotrexate: a 5-year extended phase IIB study. J Rheumatol 2009; 36(4): 736-42.</p><p>Gerloni V., Pontikaki I., Gattinara M., Fantini F. Focus on adverse events of tumour necrosis factor alpha blockade in juvenile idiopathic arthritis in an open monocentric long-term prospective study of 163 patients. Ann Rheum Dis 2008; 67(8): 1145-52.</p><p>Van Dijken G.D., Gerloni V.M., Linnemann K. et al. Development of inflammatory bowel disease in patients with juvenile idiopathic arthritis while using etanercept. EULAR 2009 Abstracts, Abstract OP-0267.</p><p>Wiegering V., Morbach H., Dick A., Girschick H.J. Crohn's disease during etanercept therapy in juvenile idiopathic arthritis: a case report and review of the literature. Rheumatol Int 2010; 30(6): 801-4.</p><p>Ruemmele F.M., Prieur A.M., Talbotec C. et al. Development of Crohn disease during anti-TNF-alpha therapy in a child with juvenile idiopathic arthritis. J Pediatr Gastroenterol Nutr 2004; 39(2): 203-6.</p><p>Pontikaki I., Gerloni V., Gattinara M. et al. Effetti collaterali del trattamento con inibitori del TNF-α nell'artrite idiopatica giovanile. Side effects of anti-TNF-α therapy in juvenile idiopathic arthritis. Reumatismo 2006; 58(1): 31-8.</p><p>Mohan N., Edwards E.T., Cupps T.R. et al. Demyelination occurring during anti-tumor necrosis factor alpha therapy for inflammatory arthritides. Arthr Rheum 2001; 44(12): 2862-9.</p><p>Sicotte N.L., Voskuhl R.R. Onset of multiple sclerosis associated with anti-TNF therapy. Neurology 2001; 57(10): 1885-8.</p><p>Tauber T., Daniel D., Barash J. et al. Optic neuritis associated with etanercept therapy in two patients with extended oligoarticular juvenile idiopathic arthritis. Rheumatology (Oxford) 2005; 44(3): 405.</p><p>Kunzmann S., Warmuth-Metz M., Girschick H.J. Cerebral demyelination in association with TNF-inhibition therapy in a 5-year-old girl with aseptic meningitis as the first symptom of Still's disease. Scand J Rheumatol 2004; 33: 76-8.</p><p>Kobayashi K., Okamoto Y., Inoue H. et al. Leukoencephalopathy with cognitive impairment following tocilizumab for the treatment of rheumatoid arthritis (RA). Intern Med 2009; 48(15): 1307-9.</p><p>Lepore L., Marchetti F., Facchini S. et al. Drug-induced systemic lupus erythematosus associated with etanercept therapy in a child with juvenile idiopathic arthritis. Clin Exp Rheumatol 2003; 21(2): 276-7.</p><p>Mor A., Bingham C. III, Barisoni L. et al. Proliferative lupus nephritis and leukocytoclastic vasculitis during treatment with etanercept. J Rheumatol 2005; 32(4): 740-3.</p><p>Costa M.F., Said N.R., Zimmermann B. Drug-induced lupus due to anti-tumor necrosis factor alpha agents. Semin Arthr Rheum 2008; 37(6): 381-7.</p><p>Bloom B.J. Development of diabetes mellitus during etanercept therapy in a child with systemic-onset juvenile rheumatoid arthritis. Arthr Rheum 2000; 43(11): 2606-8.</p><p>Wollina U., Hansel G., Koch A. et al. Tumor necrosis factor-alpha inhibitor-induced psoriasis or psoriasi- form exanthemata: first 120 cases from the literature including a series of six new patients. Am J Clin Dermatol 2008; 9(1): 1-14.</p><p>Ko J.M., Gottlieb A.B., Kerbleski J.F. Induction and exacerbation of psoriasis with TNF-blockade therapy: a review and analysis of 127 cases. J Dermatolog Treat 2009; 20(2): 100-8.</p><p>Stone J.H., Furst D.E., Romain P.L. Tumor necrosis factor-alpha inhibitors: An overview of adverse effects. UpToDate[17.2]. Waltham, MA 02453, UpToDate, Inc., 2009.</p><p>Haapasaari J., Kautiainen H.J., Isomaki H.A., Hakala M. Etanercept does not essentially increase the total costs of the treatment of refractory juvenile idiopathic arthritis. J Rheumatol 2004; 31(11): 2286-9.</p><p>Cummins C., Connock M., Fry-Smith A., Burls A. A systematic review of effectiveness and economic evaluation of new drug treatments for juvenile idiopathic arthritis: etanercept. Health Technol Assess 2002; 6(17): 1-43.</p><p>Chen Y.F., Jobanputra P., Barton P. et al. A systematic review of the effectiveness of adalimumab, etanercept and infliximab for the treatment of rheumatoid arthritis in adults and an economic evaluation of their cost-effectiveness. Health Technol Assess 2006; 10(42): iii-xiii, 1.</p><p>Doan Q.V., Chiou C.F., Dubois R.W. Review of eight pharmacoeconomic studies of the value of biologic DMARDs (adalimumab, etanercept, and infliximab) in the management of rheumatoid arthritis. J Manag Care Pharm 2006; 12(7): 555-69.</p><p>Brennan A., Bansback N., Nixon R. et al. Modelling the cost effectiveness of TNF-alpha antagonists in the management of rheumatoid arthritis: results from the British Society for Rheumatology Biologics Registry. Rheumatology (Oxford) 2007; 46(8): 1345-54.</p><p>Furst D.E., Keystone E.C., Kirkham B. et al. Updated consensus statement on biological agents for the treatment of rheumatic diseases, 2008. Ann Rheum Dis 2008; 67(Suppl. 3): iii2-25.</p><p>Coombs J.H., Bloom B.J., Breedveld F.C. et al. Improved pain, physical functioning, and health status in rheumatoid arthritis patients treated with CP-690,550, an orally active Janus kinase (JAK) inhibitor: results from a randomized, double-blind, placebo-controlled trial. Ann Rheum Dis 2010; 69: 413-6.</p><p>Kremer J.M., Bloom B.J., Breedveld F.C. et al. The safety and efficacy of a JAK inhibitor in patients with active rheumatoid arthritis: Results of a doubleblind, placebo-controlled phase IIa trial of three dosage levels of CP-690,550 versus placebo. Arthr Rheum 2009; 60(7): 1895-905.</p><p>Ruperto N., Quartier P., Wulffraat N. et al. A phase II trial with canakinumab, a new IL-1beta blocking monoclonal antibody (ACZ885), to evaluate preliminary dosing, safety and efficacy profile in children with systemic Juvenile Idiopathic arthritis (sJIA). Pediatric Rheumatology 2009; 6(Suppl. I): S2.</p></div><br />


Для цитирования:


Mikhel's K., Nikishina I.P., Федоров Е.С., Салугина С.О., Michels H., Nikishina I.P., Федоров Е.С., Салугина С.О. Генно-инженерная биологическая терапия ювенильного артрита. Научно-практическая ревматология. 2011;49(1):78-93. https://doi.org/10.14412/1995-4484-2011-873

For citation:


Mikhel's K., Nikishina I.P., Fedorov E.S., Salugina S.O., Michels H., Nikishina I.P., Fedorov E.S., Salugina S.O. Gene engineering biological therapy for juvenile arthritis. Rheumatology Science and Practice. 2011;49(1):78-93. (In Russ.) https://doi.org/10.14412/1995-4484-2011-873

Просмотров: 1547


Creative Commons License
Контент доступен под лицензией Creative Commons Attribution 4.0 License.


ISSN 1995-4484 (Print)
ISSN 1995-4492 (Online)