Romatolojide Biyolojik Ajanların Kullanımı

Moleküler biyoloji alanında yaşanan gelişmeler romatolojik hastalıkların tedavisi için yeni yaklaşımların önünü açmıştır. Romatolojik hastalıkların patogenezlerinin daha iyi anlaşılması tedavide yeni hedefler ortaya çıkmasını sağlamıştır. Biyolojik ajanların kullanıma girmesi ile birçok romatolojik hastalığın tedavisinde remisyon artık daha gerçekçi bir hedef gibi görülmektedir. Biz bu yazıda, romatolojik hastalıklarda son yıllarda kullanımı giderek artan biyolojik ajanların etki mekanizmaları,klinik kullanımları, etkinlik ve güvenlik verilerini paylaşacağız.

Use of Biological Agents in Rheumatology

The advances in molecular biology have led to a variety of new treatment approaches for rheumatological diseases. The better understanding of the pathogenesis of rheumatological diseases has yielded new therapeutic targets. With the usage of biological agents in clinical practice the goal remission in rheumatic diseases has became a more realistic target. In this article we will share the mechanisms of action, clinical uses, efficacy and safety of biologic agents increasingly used in recent years in rheumatic diseases.

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  • 1. Grisar J. Biologicals and how they revolutionized rheumatology. Wiener Medizinische Wochenschrift 2015;165(1):1-2.
  • 2. Kohler G, Milstein C. Continuous cultures of fused cells secreting antibody of predefined specificity. Nature 1975;256(5517):495-7.
  • 3. Vivar N, van Vollenhoven RF. Advances in the treatment of rheumatoid arthritis. F1000Prime Rep 2014;6:31.
  • 4. Feldmann M, Steinman L. Design of effective immunotheraphy for human autoimmunity. Nature 2005;435(7042):612-9.
  • 5. Monaco C, Nanchahal J, Taylor P, Feldmann M. Anti-TNF therapy: past, present and future. Int Immunol 2015;27(1):55-62.
  • 6. Weir N, Athwal D, Brown D, Foulkes R, Kollias G, Nesbitt A, et al. A new generation of high affinity humanized PEGylated Fab fragment anti-tumor necrosis factor-alpha antibodies. Therapy 2006;3:535-45.
  • 7. Deeks ED. Certolizumab pegol. A review of its use in the management of rheumatoid arthritis. Drugs 2013;73(1):75-97.
  • 8. Tracey D, Klareskog L, Sasso EH, Salfeld GJ, Tak PP. Tumor necrosis factor antagonist mechanisms of action: a comprehensive review. Pharmacol Ther 2008;117(2):244- 79.
  • 9. Weir N, Athwal D, Brown D, Foulkes R, Kollias G, Nesbitt A, et al. A new generation of high affinity humanized PEGylated Fab fragment anti-tumor necrosis factor-alpha antibodies. Therapy 2006;3:535-45.
  • 10. Ertenli I, Kalyoncu U. Anti-TNF agents: Overview and basic differentiations. Turkiye Klinikleri J Immunol Rheumatol-Special Topics 2010;3(2):1-8.
  • 11. Nestorov I. Clinical pharmacokinetics of tumor necrosis factor antagonists: how do they differ? Semin Arthritis Rheum 2005;34(5 Suppl 1):12-8.
  • 12. St Clair EW, Wagner CL, Fasanmade AA, Wang B, Schaible T, Kavanaugh A, et al. The relationship of serum infliximab concentrations to clinical improvement in rheumatoid arthritis: results from ATTRACT, a multicenter, randomized, double-blind, placebo-controlledtrial. Arthritis Rheumatism 2002;46(6):1451-9.
  • 13. Meroni PL, Valesini G. Tumor nekrosis factor alpha antagonists in the treatment of rheumatoid arthritis: an immunological perspective. BioDrugs 2014;28(Suppl 1):5-13.
  • 14. Anderson PJ. Tumor necrosis factor inhibitors: clinical implications of their different immunogenicity profiles. Semin Arthritis Rheum 2005;34(5 Suppl 1):19-22.
  • 15. Lipsky PE, van der Heijde DM, St Clair EW, Furst DE, Breedweld FC, Kalden JR, et al. Infliximab and methotrexate in the treatment of rheumatoid arthritis. Anti-tumor necrosis factor trial in rheumatoid arthritis with concomitant therapy study group. N Engl J Med 2000;343(22):1594-602.
  • 16. Dore RK, Mathews S, Schechtman J, Surbeck W, Mandel D, Patel A, et al. The immunogenicity safety anf efficacy of etanercept liquid administrated once weekly in patients with rheumatoid arthritis. Clin Exp Rheumatol 2007;25(1):40-6.
  • 17. Salliot C, Gossec L, Ruyssen- Witrand A, Luc M, Duclos M, Guignard S, et al. Infections during tumor necrosis factor- alpha blocker therapy for rheumatic diseases in daily practice: a systematic retrospective study of 709 patients. Rheumatology (Oxford) 2007;46(2):327- 34.
  • 18. Furst DE, Keystone EC, So AK, Braun J, Breedveld FC, Burmester GR, et al. Updated consensus statement on biological agents for treatment of rheumatic diseases, 2012. Annals of Rheumatic Disease 2013;72(Suppl 2):2- 34.
  • 19. Tubach F, Salmon D, Ravaud P, Allanore Y, Goupille P, Breban M, et al. Risk of tuberculosis is higher with anti-tumor necrosis factor monoclonal antibody therapy than with soluable tumor necrosis factor receptor therapy the three-year prospective French research axed on tolerance of biotherapies registry. Arthritis Rheumatism 2009;60(7):1884- 94.
  • 20. Li S, Kaur P, Chan V, Berney S. Use of tumor necrosis factor-alpha antagonists infliximab, etanercept and adalimumab in patients with concurrent rheumatoid arthritis and hepatitis B or hepatitis C: a retrospective record review of 11 patients. Clin Rheumatol 2009;28(7): 787-91.
  • 21. Leombruno JP, Einarson TR, Keystone EC. The safety of anti-tumor necrosis factor treatments in rheumatoid arthritis: meta and exposure adjusted pooled analyses of serious adverse events. Ann Rheum Dis 2009;68(7): 1136-45.
  • 22. Amari W, Zeringue AL, McDonald JR, Caplan L, Eisen SA, Ranganathan P. Risk of nonmelanoma skin cancer in a national cohort of veterans with rheumatoid arthritis. Rheumatology (Oxford) 2011;50(8):1431-9.
  • 23. Setoguchi S, Schneweiss S, Avom J, Katz JN, Weinblatt ME, Levin R, et al. Tumor necrosis factor-alpha antagonist use heart failure in elderly patients with rheumatoid arthritis. Am Heart J 2008;156(2):336-41.
  • 24. De Benedetti F, Rucci N, Del Fattore A, Peruzzi B, Paro R, Longo M, et al. Impaired iskeletal development in interleukin-6- transgenic mice: a model for the impact of chonic inflammation on the growing skeletal system. Arthritis Rheum 2006;54(11):3551-63.
  • 25. Kim GW, Lee NR, Pi RH, Lim YS, Lee YM, Lee JM, et al. IL-6 inhibitörs for treatment of RA: past, present, and future. Arch Pharm Res 2015;38(5):575-84.
  • 26. Dayer JM, Choy E. Therapeutic targets in rheumatoid arthritis: the interleukin-6 receptor. Rheumatology (Oxford) 2010;49(1):15-24.
  • 27. Shetty A, Hanson R, Korsten P, Shawagfeh M, Arami S, Volkov S, et al. Tocilizumab in the treatment of RA and beyond. Drug Desing, Drug Des Devel Ther 2014;8:349-64.
  • 28. Smolen JS, Schoels MM, Nishimoto N, Ferdinand CB, Burmester GR, Dougados M, et al. Consensus statement on blocking the effects of interleukin-6 and in particular by interleukin- 6 receptor inhibition in rheumatoid arthritis and other inflammatory conditions. Ann Rheum Dis 2013;72(4):482-92.
  • 29. Navarro-Millan I, Singh JA, Curtis JR. Systematic review of tocilizumab for rheumatoid arthritis: a new biologic agent targeting the interleukin- 6 receptor. Clin Ther 2012;34(4):788- 802.
  • 30. Schiff MH, Kremer JM, Jahreis A, Vernon E, Isaacs JD, Van Vollenhoven RF. Integrated safety in tocilizumab clinicl trials. Arthritis Res Ther 2011;13(5):R141.
  • 31. Koike T, Harigai M, Inokuma S, Ishiguro N, Ryu J, Takeuchi T, et al. Effectiveness and safety of tocilizumab: postmarketing surveillance of 7901 patients with RA in Japan. J Rheumatol 2014;41(1):15-23.
  • 32. Alvaro-Gracia JM, Fernandez-Nebro A, Garcia- Lopez A, Guzman M, Blanco FJ, Navarro FJ, et al. Tocilizumab in patients with active rheumatoid arthritis and inadequate response to disease-modifying antirheumatic drugs or tumor necrosis factor inhibitors: subanalysis of Spanish results of an open-label study close to clinical practice. Rheumatol Clin 2014; 10(2):94-100.
  • 33. Cohen SB, Emery P, Greenwald MW, Dougados M, Furie RA, Genovese MC, et al; REFLEX Trial Group. Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy: results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks. Arthritis Rheum 2006;54(9):2793-806.
  • 34. Keystone E, Emery P, Peterfy CG, Tak PP, Cohen S, Genovese MC, et al. Rituximab inhibits structural joint damage in patients with rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitor therapies. Ann Rheum Dis 2009;68(2):216-21.
  • 35. Lipsky PE. Systemic lupus erythematosus: an autoimmune disease of B cell hyperactivity Nat Immunol 2001;2(9):764-6.
  • 36. Dörner T, Egerer K, Feist E, Burmester GR. Rheumatoid factor revisited. Curr Opin Rheumatol 2004;16(3):246-53.
  • 37. Nielen MM, van Schaardenburg D, Reesink HW, van de Stadt RJ, van der Horst-Bruinsma IE, de Koning MH et al. Specific autoantibodies precede the symptoms of rheumatoid arthritis: a study of serial measurements in blood donors. Arthritis Rheum 2004;50(2): 380-6.
  • 38. van Vollenhoven RF, Fleischmann RM, Furst DE, Lacey S, Lehane PB Longterm Safety of Rituximab: Final Report of the Rheumatoid Arthritis Global Clinical Trial Program over 11 Years. J Rheumatol 2015;42(10):1761-6.
  • 39. Loveless J, Olech E, Pritchard CH, Chai A, Kelman A, Klearman M. An open-label, prospective study (SUNDIAL) of the safety of rituximab in combination with disease-modifying anti-rheumatic drugs in patients with active rheumatoid arthritis (SUNDIAL). Arthritis Rheum 2009;60 Suppl 10 :1660.
  • 40. Bouldouyre MA, Cohen P, Guillevin L. Severe bronchospasm associated with rituximab for refractory Churg-Strauss syndrome. Ann Rheum Dis 2009;68(4):606.
  • 41. Lowndes S, Darby A, Mead G, Lister A. Stevens-Johnson syndrome after treatment with rituximab. Ann Oncol 2002;13(12):1948- 50.
  • 42. Stone JH, Merkel PA, Spiera R, Seo P, Langford CA, Hoffman GS, et al. Rituximab versus cyclophosphamide for ANCA-associated vasculitis. N Engl J Med 2010;363(3):221 32.
  • 43. Jones RB, Tervaert JW, Hauser T, Walsh M, Westman K, Jayne DR, et al. Rituximab versus cyclophosphamidein ANCA-associated renal vasculitis. N Engl J Med 2010;363(3): 211-20.
  • 44. Molloy ES, Calabrese LH. Progressive multifocal leukoencephalopathy associated with immunosuppressive therapy in rheumatic diseases: evolving role of biologic therapies. Arthritis Rheum 2012;64(9):3043-51.
  • 45. Sagnelli E, Pisaturo M, Sagnelli, Coppala N. Rituximab-based treatment, HCV replication, and hepatic flares. Clin Dev Immunol 2012;2012:945950.
  • 46. Wang YH, Fan L, Wang L, Zhang R, Xu J, Fang C et al. Efficacy of prophylactic lamivudine to prevent hepatitis B virus reactivation in B-cell lymphoma treated with rituximab- containing chemotherapy. Support Care Cancer 2013;21(5):1265-71.
  • 47. Tsai MJ, Chou CW, Lin FC, Chang SC. Pneumocystis jiroveci pneumonia in patients with systemic lupus erythematosus after rituximab therapy. Lupus 2012;21(8):914-8.
  • 48. Smith RM, Jones RB, Guerry MJ, Laurino S, Catapano F, Chaudhry A, et al. Rituximab for remission maintenance in relapsing antineutrophil cytoplasmic antibody-associated vasculitis. Arthritis Rheum 2012;64(11):3760-9.
  • 49. Roubaud-Baudron C, Pagnoux C, Meaux-Ruault N, Grasland A, Zoulim A, LE Guen J, et al. Rituximab maintenance therapy for granulomatosis with polyangiitis and microscopic polyangiitis. J Rheumatol 2012;39(1):125-30.
  • 50. Cartin-Ceba R, Golbin JM, Keogh KA, Peikert T, Sanchez-Menendez M, Ytterberg SR, et al. Rituximab for remission induction and maintenance in refractory granulomatosis with polyangiitis (Wegener’s): ten-year experience at a single center. Arthritis Rheum 2012;64(11):3770-8.
  • 51. Venhoff N, Effelsberg NM, Salzer U, Warnatz K, Peter HH, Lebrecht D, et al. Impact of rituximab on immünoglobulin concentrations and B cell numbers after cyclophosphamide treatment in patients with ANCA-associated vasculitides. PLoS One 2012;7(5):e37626.