Tratamientos biológicos en enfermedades reumatológicas y autoinmunes sistémicas

  1. Nieves, A. Turrión
  2. Holguera, R. Martín
  3. Atrio, A. Sánchez
  4. Bogado, M.L. Romero
  5. Soto, M. Álvarez de Mon
Revista:
Medicine: Programa de Formación Médica Continuada Acreditado

ISSN: 0304-5412

Año de publicación: 2015

Título del ejemplar: Actualidad clínico-terapéutica (IV)

Serie: 11

Número: 92

Páginas: 5496-5509

Tipo: Artículo

DOI: HTTPS://DOI.ORG/10.1016/J.MED.2015.12.003 DIALNET GOOGLE SCHOLAR

Otras publicaciones en: Medicine: Programa de Formación Médica Continuada Acreditado

Resumen

Resumen Los tratamientos biológicos constituyen un importante avance en el pronóstico clínico de las enfermedades reumatológicas y autoinmunes sistémicas. Los fármacos anti-TNF son los primeros que se desarrollaron para la artritis reumatoide (AR). Se han aprobado otras indicaciones para otras formas de enfermedad distintas a la AR. El conocimiento de la implicación patogénica de las distintas citoquinas ha llevado al desarrollo de fármacos dirigidos específicamente frente a esas moléculas (IL-6, IL-12/23, blys, IL-17…). En esta actualización se revisarán los fármacos de producción biotecnológica (biológicos), sus principales indicaciones, criterios de respuesta, uso fuera de guía clínica, sus contraindicaciones, dosis, vía de administración farmacocinética y efectos adversos, así como las peculiaridades en el manejo clínico. Las inmunoglobulinas, aunque no se obtengan por técnicas de biología molecular, en ocasiones son útiles como complemento terapéutico de algunas formas de enfermedad. Comentaremos la irrupción de los biosimilares en el mercado farmacológico que probablemente mejoren la eficiencia en el manejo de estas enfermedades. Biological treatments are an important advance clinical prognosis of systemic rheumatic and autoimmune diseases. Anti-TNF drugs are the first to be developed and approved for other indications different from other forms of rheumatoid arthritis disease. Knowledge of the pathogenic involvement of various cytokines has led to the development of drugs specifically directed against these molecules (IL-6, IL-12/23, BLyS, IL-17...). This update biotech drugs production (biological), its main indications, response criteria, use outside of clinical guidelines, contraindications, dosage, route of pharmacokinetics and major adverse effects and peculiarities in the clinical management board is reviewed. Immunoglobulins but not obtained by molecular biology techniques are sometimes useful as therapeutic supplement some forms of disease. Discuss the emergence of biosimilars in the drug market are likely to improve the efficiency in the management of these diseases.

Referencias bibliográficas

  • Listing J, Kekow J, Manger B, Burmester GR, Pattloch D, Zink A, et al. Mortality in rheumatoid arthritis: the impact of disease activity, treatment with glucocorticoids, TNFalpha inhibitors and rituximab. Ann Rheum Dis. 2015;74(2):415-21.
  • Gabay C, Emery P, van Vollenhoven R, Dikranian A, Alten R, Pavelka K, et al. Tocilizumab monotherapy versus adalimumab monotherapy for treatment of rheumatoid arthritis (ADACTA): a randomised, double-blind, controlled phase 4 trial. Lancet. 2013; 381(9877):1541-50.
  • Schiff M, Weinblatt ME, Valente R, van der Heijde D, Citera G, Elegbe A, et al. Head-to-head comparison of subcutaneous abatacept versus adalimumab for rheumatoid arthritis: two-year efficacy and safety findings from AMPLE trial. Ann Rheum Dis. 2014;73(1):86-94.
  • Favalli EG, Bugatti S, Biggioggero M, Caporali R. Treatment comparison in rheumatoid arthritis: head-to-head trials and innovative study designs. Biomed Res Int. 2014;2014:831603.
  • Jones G, Sebba A, Gu J, Lowenstein MB, Calvo A, Goómez-Reino JJ, et al. Comparison of tocilizumab monotherapy versus methotrexate mo-notherapy in patients with moderate to severe rheumatoid arthritis: the AMBITION study. Ann Rheum Dis. 2010;69(1):88-96.
  • Sanmarti R, García-Rodríguez S, Álvaro-Gracía JM, Andreu JL, Balsa A, Caliz R, et al. 2014 update of the Consensus Statementof the Spanish Society of Rheumatology on the use of biological therapies in rheumatoid arthritis. Reumatol Clin. 2015;11(5): 279-94.
  • Schur PH, Moreland LW. General principles of management of rheuma-toid arthritis. 2012. Disponible en: www.uptodate.com. [Consultado 4 de Septiembre de 2012].
  • Sociedad Española de Reumatología. Guía de práctica clínica para el manejo de la artritis reumatoide 2007.Actualización 2011. 2011; Disponible en: http://www.ser.es/practicaClinica/GUIPCAR_ 2007/T_Farmacologico/Menu5_TFarmacologico.php. [Consultado el 4 de Septiembre de 2015].
  • Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38(6):727-35.
  • Van den Bosch F, Deodhar A. Treatment of spondyloarthritis beyond TNF-alpha blockade. Best Pract Res Clin Rheumatol. 2014;28(5):819-27.
  • Lie E, Kristensen LE, Forsblad-d’Elia H, Zverkova-Sandstrom T, Askling J, Jacobsson LT, et al. The effect of comedication with conventional synthetic disease modifying antirheumatic drugs on TNF inhibitor drug survival in patients with ankylosing spondylitis and undifferentiated spondyloarthritis: results from a nationwide prospective study. Ann Rheum Dis. 2015;74(6):970-8.
  • Park JH, Seo GY, Lee JS, Kim TH, Yoo DH. Positive conver-sion of tuberculin skin test and performance of interferon release assay to detect hidden tuberculosis infection during anti-tumor ne-crosis factor agent trial. J Rheumatol. 2009;36(10):2158-63.
  • Bernal JA, Andres M, Jovani V, Garcia Sevila R, Begazo A, Vela P. Primary tuberculosis infection in patients treated with tumor necrosis factor-alpha antagonists and a negative initial screening. Reumatol Clin. En prensa 2015.
  • Cobeta García JC, Medrano M. Reactivation of hepatitis B in a patient with spondyloarthritis after the suspension of methotrexate and efficacy of treatment with antivirals in association to adalimumab. Reumatol Clin. 2011;7(3):200-2.
  • Ibanez Bosch R. Management of difficult clinical situations in rheumatoid arthritis: hepatitis. Reumatol Clin. 2009;5S1:53-60.
  • Zein NN, Etanercept Study Group. Etanercept as an adjuvant to interfe-ron and ribavirin in treatment-naive patients with chronic hepatitis C virus infection: a phase 2 randomized, double-blind, placebo-controlled study. J Hepatol. 2005;42(3):315-22.
  • Anolik JH, Ravikumar R, Barnard J, Owen T, Almudevar A, Milner EC, et al. Cutting edge: anti-tumor necrosis factor therapy in rheumatoid arthri-tis inhibits memory B lymphocytes via effects on lymphoid germinal centers and follicular dendritic cell networks. J Immunol. 2008;180(2):688-92.
  • Steel L, Khan A, Dasgupta B. Giant cell arteritis: beyond corticosteroids. Drugs Aging. 2015;32(8):591-9.
  • Wils P, Bouhnik Y, Michetti P, Flourie B, Brixi H, Bourrier A, et al. Sub-cutaneous ustekinumab provides clinical benefit for two-thirds of patients with Crohn’s disease refractory to anti-tumor necrosis factor agents. Clin Gastroenterol Hepatol. En prensa 2015.
  • Cragg MS, Walshe CA, Ivanov AO, Glennie MJ. The biology of CD20 and its potential as a target for mAb therapy. Curr Dir Autoimmun. 2005;8:140-74.
  • Jayne D. What place for the new biologics in the treatment of necrotising vasculitides. Clin Exp Rheumatol. 2006;24(2)Suppl 41:S1-5.
  • Kaushik VV, Reddy HV, Bucknall RC. Successful use of rituximab in a patient with recalcitrant Churg-Strauss syndrome. Ann Rheum Dis. 2006;65(8):1116-7.
  • Bhatia A, Ell PJ, Edwards JC. Anti-CD20 monoclonal antibody (rituxi-mab) as an adjunct in the treatment of giant cell arteritis. Ann Rheum Dis. 2005;64(7):1099-100.
  • Edwards JC, Cambridge G. Sustained improvement in rheumatoid ar-thritis following a protocol designed to deplete B lymphocytes. Rheuma-tology (Oxford). 2001;40(2):205-11.
  • Merrill JT, Neuwelt CM, Wallace DJ, Shanahan JC, Latinis KM, Oates JC, et al. Efficacy and safety of rituximab in moderately-to-severely active systemic lupus erythematosus: the randomized, double-blind, phase II/III systemic lupus erythematosus evaluation of rituximab trial. Arthritis Rheum. 2010;62(1):222-33.
  • Furie R, Stohl W, Ginzler EM, Becker M, Mishra N, Chatham W, et al. Biologic activity and safety of belimumab, a neutralizing anti-B-lympho-cyte stimulator (BLyS) monoclonal antibody: a phase I trial in patients with systemic lupus erythematosus. Arthritis Res Ther. 2008;10(5):R109.
  • Seror R, Nocturne G, Lazure T, Hendel-Chavez H, Desmoulins F, Be-lkhir R, et al. Low numbers of blood and salivary natural killer cells are associated with a better response to belimumab in primary Sjogren’s syn-drome: results of the BELISS study. Arthritis Res Ther. 2015;17:241.
  • Lutalo PM, D’Cruz DP. Biological drugs in ANCA-associated vasculitis. Int Immunopharmacol. 2015;27(2):209-12.
  • Orange JS, Hossny EM, Weiler CR, Ballow M, Berger M, Bonilla FA, et al. Use of intravenous immunoglobulin in human disease: a review of evidence by members of the Primary Immunodeficiency Committee of the American Academy of Allergy, Asthma and Immunology. J Allergy Clin Immunol. 2006;117(4)Suppl:S525-53.
  • Silva Fernández L, Andreu Sanchez JL. Agentes biológicos usados en en-fermedades inflamatorias. En: Silva Fernández L, Andreu Sanchez JL, editors. Órdenes de tratamiento en reumatología 2012. Madrid: Farmalia Comunicación; 2012. p. 90-142.
  • Michalopoulos G, Vrakas S, Makris K, Tzathas C. Systemic lupus erythe-matosus in Crohn’s disease: drug-induced or idiopathic? Ann Gastroen-terol. 2015;28(3):408-9.
  • Curtis JR, Xie F, Yun H, Saag KG, Chen L, Delzell E. Risk of hospitalized infection among rheumatoid arthritis patients concu-rrently treated with a biologic agent and denosumab. Arthritis Rheumatol. 2015;67(6):1456-64.
  • Chiricozzi A, Krueger JG. IL-17 targeted therapies for psoria-sis. Expert Opin Investig Drugs. 2013;22(8):993-1005.
  • Mease PJ, Genovese MC, Greenwald MW, Ritchlin CT, Beaulieu AD, Deodhar A, et al. Brodalumab, an anti-IL17RA monoclonal an-tibody, in psoriatic arthritis. N Engl J Med. 2014;370(24):2295-306.
Fuente de los datos: Dialnet