2019, Number 2
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Rev Cubana Farm 2019; 52 (2)
Use of anti-TNF-α biotech drugs in rheumatoid arthritis and its immunogenicity
Santillán BJG, Filorio CY, Ortiz RM
Language: Spanish
References: 46
Page: 1-23
PDF size: 693.55 Kb.
ABSTRACT
Introduction: In the treatment of rheumatoid arthritis, biotechnological proteins are increasingly used as therapeutic agents. These proteins can induce a humoral and cellular immune response. The so-called biopharmaceuticals arrived to revolutionize the treatment of different diseases, in particular the rheumatic ones. Although there are effective biotechnological drugs to face those diseases, recent studies have shown that their consumption can lead to an immunogenic response in the patient, such as the formation of auto-antibodies, even inhibiting the sought therapeutic activity, and resulting in a null clinical response. Some researches claim to have found an answer in the immunogenic level after the consumption, and others point out that only self- antibodies of non-neutralizing nature are formed.
Objective: To establish the causality of immunogenicity associated with the use of anti-TNF-α biological drugs in rheumatoid arthritis.
Methods: It was carried out a compilation of bibliographic references from the search made in Redalyc, PubMed and from keywords as biopharmaceuticals and anti-TNF-α, and selecting as relevant the most recent and notable ones to the study.
Conclusions: The information available concerning immunogenicity by the use of anti -TNF-α biopharmaceuticals in rheumatoid arthritis establishes as a cause that if the molecule used is structurally more humanized, this will have a lesser immunogenicity compared with those that are not.
REFERENCES
McInnes I, Schett G. The Pathogenesis of Rheumatoid Arthritis. N. Engl. J. Med.2011;365(23):2205-19. DOI: 10.1056/NEJMra1004965
England BR, Thiele GM, Mikuls TR. Anticitrullinated protein antibodies: origin and rolein the pathogenesis of rheumatoid arthritis. Curr Opin Rheumatol. 2017;29(1):57-64.
Viatte S, Plant D, Raychaudhuri S. Genetics and epigenetics of rheumatoid artritis. Nat.Rev. Rheumatol. 2013;9:141-153. DOI:10.1038/nrrheum.2012.237
Tlaskalová H, Stěpánková R, Kozáková H, Hudcovic T, Vannucci L, Tučková L, et al.The role of gut microbiota (commensal bacteria) and the mucosal barrier in the pathogenesis of inflammatory and autoimmune diseases and cancer: contribution of germ-free and gnotobiotic animal models of human diseases. Cell Mol Immunol. 2011;8(2):110-20.
Thomas SS, Borazan N, Barroso N, Duan L, Taroumian S, Kretzmann B, Bardales R,Elashoff D, Vangala S, Furst DE. Comparative Immunogenicity of TNF Inhibitors: Impact on Clinical Efficacy and Tolerability in the Management of Autoimmune Diseases. A Systematic Review and Meta-Analysis. BioDrugs. 2015;29(4):241-58. DOI: 10.1007/s40259-015-0134-5
Willrich MA, Murray DL, Snyder MR. Tumor necrosis factor inhibitors: clinical utility inautoimmune diseases. Transl Res. 2015;165(2):270-82. DOI: 10.1016/j.trsl.2014.09.006
Mesquita D Jr, Cruvinel WM, Resende LS, Mesquita FV, Silva NP, Câmara NO, AndradeLE. Follicular helper T cell in immunity and autoimmunity. Braz J Med Biol Res. 2016;49(5):e5209. DOI: 10.1590/1414-431X20165209
Malmström V, Lundberg K, Padyukov L, Alfredsson L. Smoking, citrullination andgenetic variability in the immunopathogenesis of rheumatoid artritis. Seminars in Immunology. 2011;23(2):92-98.
Oka S, Furukawa H, Shimada K, Sugii S, Hashimoto A, Komiya A, et al. Association ofhuman leukocyte antigen alleles with chronic lung diseases in rheumatoid arthritis. Rheumatology (Oxford). 2016;55(7):1301-7. DOI: 10.1093/rheumatology/kew025
Ayral X, Pickering E, Woodworth T, Mackillop N, Dougados M. Synovitis: a potentialpredictive factor of structural progression of medial tibiofemoral knee osteoarthritis – results of a 1 year longitudinal arthroscopic study in 422 patients. Osteoarthritis Cartilage. 2005;13(5):361-7.
Maciejewska H, Jüngel A, Gay R, Gay S. Innate immunity, epigenetics andautoimmunity in rheumatoid artritis. Mol. Immunol. 2009;47(1):12-8.
Ronninger M, Guo Y, Shchetynsky K, Hill A, Khademi M, Olsson T, et al. Theexpression of splice forms for the rheumatoid arthritis risk associated gene PTPN22 is significantly different for patients compared to controls. Ann. Rheum. Dis. 2012;71:A56.
Taylor P, Mehta P, Tull T. Aetiopathology of rheumatoid artritis. Medicine.2010;38(4):163-166.
Klareskog L, Lundberg K, Malmström V. Chapter Three - Autoimmunity in RheumatoidArthritis: Citrulline Immunity and Beyond. Advances in Immunology. 2013;118:129-158.
Levy RA, Guzman R, Castañeda-Hernández G, Martinez-Vazquez M, Damian G, CaraC. Biology of anti-TNF agents in immune-mediated inflammatory diseases: therapeutic implications. Immunotherapy. 2016;8(12):1427-1436. DOI: 10.2217/imt-2016-0067
Mok CC, Tsai WC, Chen DY, Wei JC. Immunogenicity of anti-TNF biologic agents inthe treatment of rheumatoid arthritis. Expert Opin Biol Ther. 2016;16(2):201-11. DOI: 10.1517/14712598.2016.1118457
Baumgart DC, Sandborn WJ. Crohn's disease. Lancet 2012;380(9853):1590–605.
Atzeni F, Talotta R, Salaffi F, Cassinott A, Varisco V, Battellino M, et al.Immunogenicity and autoimmunity during anti-TNF therapy. Autoimmun. Rev. 2013;12:703-708.
Eng G, Stoltenberg M, Szkudlarek M, Bouchelouche P, Christensen R, Bliddal H, et al.Efficacy of treatment intensification with adalimumab, etanercept and infliximab in rheumatoid arthritis: A systematic review of cohort studies with focus on dose. Semin. Arthritis. Rheum. 2013;43(2):144-51.
Romas E, Gillespie M, Martin T. Involvement of receptor activator of NFκB ligandand tumor necrosis factor-α in bone destruction in rheumatoid arthritis Bone. 2002;30(2):340-346.
Emery P, Vencovský J, Ghil J, Kang JW. Response to: 'Comparing the immunogenicityof the etanercept biosimilar SB4 with the innovator etanercept: another consideration' by Marshall et al. Ann Rheum Dis. 2016 Jul;75(7):e38. DOI: 10.1136/annrheumdis-2016-209517
Murdaca G, Spanò F, Contatore M, Guastalla A, Penza E, Magnani O, Puppo F.Immunogenicity of infliximab and adalimumab: what is its role in hypersensitivity and modulation of therapeutic efficacy and safety? Expert Opin Drug Saf. 2016;15(1):43-52. DOI: 10.1517/14740338.2016.1112375
Rákóczi É, Perge B, Végh E, Csomor P, Pusztai A, Szamosi S, Bodnár N, Szántó S,Szücs G, Szekanecz Z. Evaluation of the immunogenicity of the 13-valent conjugated pneumococcal vaccine in rheumatoid arthritis patients treated with etanercept. Joint Bone Spine. 2016; pii: S1297-319X(16)00043-9. DOI: 10.1016/j.jbspin.2015.10.017
Marshall L, Hickling T, Bill D, Mahgoub E. Comparing the immunogenicity of theetanercept biosimilar SB4 with the innovator etanercept: another consideration. Ann Rheum Dis. 2016;75(7):e37. DOI: 10.1136/annrheumdis-2016-209502
Chen DY, Chen YM, Hung WT, Chen HH, Hsieh CW, Chen YH, Huang WN, HsiehTY. Immunogenicity, drug trough levels and therapeutic response in patients with rheumatoid arthritis or ankylosing spondylitis after 24-week golimumab treatment. Ann Rheum Dis. 2015;74(12):2261-4. DOI: 10.1136/annrheumdis-2015-207978
Tun GS, Lobo AJ. Evaluation of pharmacokinetics and pharmacodynamics and clinicalefficacy of certolizumab pegol for Crohn's disease. Expert Opin Drug Metab Toxicol. 2015;11(2):317-27. DOI: 10.1517/17425255.2015.995166
Ferrero E, Zocchi MR, Magni E, Panzeri MC, Curnis F, Rugarli C, et al. Roles of tumornecrosis factor p55 and p75 receptors in TNF-alpha-induced vascular permeability. Am. J. Physiol. Cell Physiol. 2001;281(4):C1173-9.
Quintana M, Apezteguía I. Las Buenas Prácticas en la Producción de Biológicos y losSistemas de Gestión de la Calidad. Rev Cubana Farmacia. 2010;44(4):547-557.
Chaparro M, Guerra I, Muñoz P, Gisbert J. Systematic review: antibodies and anti-TNF-α levels in inflammatory bowel disease. Aliment. Pharmacol. Ther. 2012;35:971-986.
Katzung G, Masters S, Trevor A. Farmacología básica y clínica. 12aed. México:McGraw-Hill; 2012.
Atzeni F, Sarzi P. Autoantibody production in patients treated with anti-TNF-alpha.Expert. Rev. Clin. Immunol. 2008;4:275-80.
Ramos M, Brito P, Munoz S, Soria N, Galiana D, Bertolaccini L, et al. Autoimmunediseases induced by TNF-targeted therapies: analysis of 233 cases. Medicine. 2007;86:242-51.
Rosenblum H, Amital H. Anti-TNF therapy: safety aspects of taking the risk.Autoimmun. Rev. 2011;10:563-8.
O’Dell J, Mikuls T, Taylor T, Ahluwalia V, Brophy M, Warren S, Lew R, et al.Therapies for Active Rheumatoid Arthritis after Methotrexate Failure. N. Engl. J. Med. 2013;369:307-18.
Seung J, Hyun K, Hae K, Na Young K, Jung L, Juryun K, et al. Immunogenicity of anti-tumour necrosis factor therapy in Korean patients with rheumatoid arthritis and ankylosing spondylitis. Int Immunopharmacol. 2014;21(1):20-5.
Marits P, Landucci L, Sundin U, Davidsdottir L, Nilsson J, Befrits R, et al. Trough s-infliximab and antibodies towards infliximab in a cohort of 79 IBD patients with maintenance infliximab treatment. J. Crohns. Colitis. 2014. pii: S1873-9946(14)00013-0.
Carrascosa J. Inmunogenicidad en terapia biológica. Implicaciones en Dermatología.Actas Dermosifiliogr. 2013;104(6):471-479.
Jawa V, Cousens L, Awwad M, Wakshull E, Kropshofer H. T-cell dependentimmunogenicity of protein therapeutics: Preclinical assessment and mitigation. Clinical Immunology. 2013;149(3PB):534-555.
Data Analysis for Promonitor® Kits. [acceso 22/04/2019] Disponible en:https://www.myassays.com/promonitor.html
Plasencia C, Pascual D, Nuño L, Bonilla G, Villalba A, Peiteado D, et al. Influence ofimmunogenicity on the efficacy of long-term treatment of spondyloarthritis with infliximab. Ann. Rheum Dis. 2012;71(12):1955-60.
Finckh A, Dudler J, Wermelinger F, Ciurea A, Kyburz D, Gabay C, et al. Influence ofanti-infliximab antibodies and residual infliximab concentrations on the occurrence of acquired drug resistance to infliximab in rheumatoid arthritis patients. Joint Bone Spine. 2010;77(4):313-8.
Llinares F, de Salazar J, Gallego J, Soler G, Ramírez C, Heredia E, et al. Analytical andclinical evaluation of a new immunoassay for therapeutic drug monitoring of infliximab and adalimumab. Clin. Chem. Lab. Med. 2012;50(10):1845-7.
Bendtzen K, Ainsworth M, Steenholdt C, Thomsen O, Brynskov J. Individual medicinein inflammatory bowel disease: monitoring bioavailability, pharmacokinetics and immunogenicity of antitumour necrosis factor alpha antibodies. Scand. J. Gastroenterol. 2009;44:774-81.
Chen J, Nag S, Vidi PA, Irudayaraj J. Single molecule in vivo analysis of toll-likereceptor 9 and CpG DNA interaction. PLoS One. 2011 Apr 4;6(4):e17991. DOI: 10.1371/journal.pone.0017991
Ramos M, Perez R, Diaz C, Cuadrado M, Khamashta M, BIOGEAS Study Group.Autoimmune diseases induced by biological agents: a double-edged sword? Autoimmun. Rev. 2010;9:188-93.
Anderson P. Tumor Necrosis Factor Inhibitors: Clinical Implications of Their DifferentImmunogenicity Profiles. Semin. Arthritis Rheum. 2005;34(5 Suppl 1):19-22.