Estudio multicéntrico no intervencional en pacientes con artritis reumatoidea tratados con tocilizumab
Palabras clave:
tocilizumab, artritis reumatoidea, anticuerpo monoclonal
Resumen
Introducción: Tocilizumab es un anticuerpo monoclonal humanizado anti-receptor de IL-6 que ha demostrado eficacia y seguridad en artritis reumatoidea (AR).Métodos y objetivos: Estudio observacional de cohorte en pacientes con AR moderada a severa tratados con tocilizumab con 6 meses de seguimiento. El objetivo primario fue establecer la adherencia al tratamiento y secundariamente estudiar la efectividad y seguridad.Resultados: Cincuenta pacientes fueron tratados con tocilizumab (86% asociados a DMAR y 14% a monoterapia). La adherencia fue 42/50 (84%; IC 95%: 71-93%) y el porcentaje de respuesta luego de 6 meses según criterios de la ACR20/50/70/90 fueron 68,2%, 40,9%, 13,6% y 9,1% respectivamente. El recuento de 28 articulaciones dolorosas (TJC28) e inflamadas (SJC28) se redujo significativamente de 12 y 8 en el momento basal a 5 y 2 a los 6 meses respectivamente (p <0,001). Se observó una reducción significativa en los parámetros de evaluación de actividad del médico y en las evaluaciones reportadas por el paciente. No se registraron eventos adversos de intensidad severa ni eventos adversos serios relacionados con la medicación.Citas
I. Grupo de estudio de artritis reumatoidea, guías de actualización de artritis reumatoidea. Sociedad Argentina de Reumatología 2013; 1-293.
II. Di WT, vergara F, Bertiller E, gallardo M de L, gandino I, Scolnik M, MartinezMJ, Schpilberg Mg, Rosa J, Soriano ER. Incidence and Prevalence of Rheumatoid Arthritis in a Health Management organization in Argentina: A 15-year Study. J Rheumatol. 2016 Jul;43(7):1306-11.
III. Scublinsky D, venarotti H, Citera G, Messina OD, Scheines E, Rillo o, Arturi A, Hofman J, Somma FF, Casado G, Iannantuono RF, gonzalez CD. The Prevalence of Rheumatoid Arthritis in Argentina. A CaptureRecapture Study in a City of Buenos Aires Province. Journal of Clinical Rheumatology. 2010 oct;16(7):317-321.
IV. Gibofsky A. Current therapeutic agents and treatment paradigms for the management of rheumatoid arthritis. Am J Manag Care. 2014 May;20(7Suppl):S136-44.
V. Avci AB, Feist E, Burmester GR. Biologicals in rheumatoid arthritis: current and future. RMD open. 2015 Aug 5; 1-8.
VI. Nam JL, Ramiro S, Gaujoux-viala C, Takase K, León-García M, Emery P, Gossec L, Landewe R, Smolen JS, Buch MH. Efficacy of biological disease-modifying antirheumatic drugs: a systematic literature review informing the 2013 update of the EULAR recommendations for the management of rheumatoid arthritis. Ann Rheum Dis. 2014 Mar;73(3):516-28.
VII. Boers M. Cost-effectiveness of biologics as first-line treatment of rheumatoid arthritis: case closed? Ann Intern Med. 2009 Nov 3;151(9):668-9.
VIII. Yoshida Y, Tanaka T. Interleukin 6 and rheumatoid arthritis. Biomed Res Int.2014; 1-12.
IX. Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, Healey LA, Kaplan SR, Liang MH, Luthra HS, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum1988 Mar;31(3):315-24.
X. Tanaka T, Kishimoto T. The biology and medical implications of interleukin-6. Cancer Immunol Res. 2014 Apr;2(4):288-94.
XI. Witte T. Methotrexate as combination partner of TNF inhibitors and tocilizumab. What is reasonable from an immunological viewpoint? Clin Rheumatol. 2015 Apr;34(4):629-34.
XII. Shetty A, Hanson R, Korsten P, Shawagfeh M, Arami S, volkov S, vila o, Swedler W, Shunaigat AN, Smadi S, Sawaqed R, Perkins D, Shahrara S, Sweiss NJ. Tocilizumab in treatment of rheumatoid arthritis and beyond. Drug Design, Development and Therapy2014, 8:349-364.
XIII. Souto A, Maneiro JR, gómez-Reino JJ. Rate of discontinuation and drug survival of biologic therapies in rheumatoid arthritis: a systematic review and metaanalysis of drug registries and health care databases. Rheumatology 2016 Mar;55(3):523-34.
XIV. Kremer JM, Blanco R, Brzosko M, et al. Tocilizumab inhibits structural joint damage in rheumatoid arthritis patients with inadequate responses to methotrexate: results from the double-blind treatment phase of a randomized placebo-controlled trial of tocilizumab safety and prevention of structural joint damage at one year. Arthritis Rheum. 2011;63(3):609-621.
XV. Maini RN, Taylor PC, Szechinski J, et al; CHARISMA Study group. Double-blind randomized controlled clinical trial of the interleukin-6 receptor antagonist, tocilizumab, in European patients with rheumatoid arthritis who had an incomplete response to methotrexate. Arthritis Rheum. 2006;54(9):2817-2829.
XVI. Smolen JS, Beaulieu A, Rubbert-Roth A, et al; OPTION Investigators. Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (OPTION study): a doubleblind, placebo-controlled, randomised trial. Lancet.2008;371(9617):987-997.
XVII. Genovese MC, McKay JD, Nasonov EL, et al. Interleukin-6 receptor inhibition with tocilizumab reduces disease activity in rheumatoid arthritis with inadequate response to disease-modifying antirheumatic drugs: the tocilizumab in combination with traditional disease-modifying antirheumatic drug therapy study. Arthritis Rheum. 2008;58(10):2968-2980.
XVIII. Yazici Y, Curtis JR, Ince A, et al. Early effects of tocilizumab in the treatment of moderate to severe active rheumatoid arthritis: a one-week sub-study of a randomised controlled trial (Rapid onset and Systemic Efficacy [ROSE] Study). Clin Exp Rheumatol. 2013;31(3):358-364.
XIX. Dougados M, Kissel K, Sheeran T, et al. Adding tocilizumab or switching to tocilizumab monotherapy in methotrexate inadequate responders: 24-week symptomatic and structural results of a 2-year randomised controlled strategy trial in rheumatoid arthritis (ACT-RAY). Ann Rheum Dis. 2013;72(1):43-50.
XX. Weinblatt ME, Kremer J, Cush J, et al. Tocilizumab as monotherapy or in combination with non biologic disease-modifying antirheumatic drugs: twenty-fourweek results of an open-label, clinical practice study. Arthritis Care Res. 2013;65(3):362-371.
XXI. Emery P, Keystone E, Tony HP, et al. IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumor necrosis factor biologicals: results from a 24-week multicentre randomized placebo-controlled trial. Ann Rheum Dis.2008;67(11):1516-1523.
XXII. Nishimoto N, Miyasaka N, Yamamoto K, et al. Study of active controlled tocilizumab monotherapy for rheumatoid arthritis patients with an inadequate response to methotrexate (SAToRI): significant reduction in disease activity and serum vascular endothelial growth factor by IL-6 receptor inhibition therapy. Mod Rheumatol. 2009;19(1):12-19.
XXIII. Nishimoto N, Hashimoto J, Miyasaka N, et al. Study of active controlled monotherapy used for rheumatoid arthritis, an IL-6 inhibitor (SAMuRAI): evidence of clinical and radiographic benefit from an x ray readerblinded randomised controlled trial of tocilizumab. Ann Rheum Dis. 2007;66(9):1162-1167.
XXIV. Jones g, Sebba A, gu J, et al. Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: the AMBITIoN study. Ann Rheum Dis. 2010;69(1):88-96.
XXV. Bykerk vP, Östör AJ, Alvaro-gracia J, Pavelka K, Román Ivorra JA, graninger W, Bensen W, Nurmohamed MT, Krause A, Bernasconi C, Aassi M, Sibilia J. Comparison of tocilizumab as monotherapy or with add-on disease-modifying antirheumatic drugs in patients with rheumatoid arthritis and inadequate responses to previous treatments: an open-label study close to clinical practice. Clin Rheumatol. 2015 Mar;34(3):563-71.
XXVI. Detert J, Klaus P. Biologic monotherapy in the treatment of rheumatoid arthritis. Biologics. 2015 May 14;9:35-43.
II. Di WT, vergara F, Bertiller E, gallardo M de L, gandino I, Scolnik M, MartinezMJ, Schpilberg Mg, Rosa J, Soriano ER. Incidence and Prevalence of Rheumatoid Arthritis in a Health Management organization in Argentina: A 15-year Study. J Rheumatol. 2016 Jul;43(7):1306-11.
III. Scublinsky D, venarotti H, Citera G, Messina OD, Scheines E, Rillo o, Arturi A, Hofman J, Somma FF, Casado G, Iannantuono RF, gonzalez CD. The Prevalence of Rheumatoid Arthritis in Argentina. A CaptureRecapture Study in a City of Buenos Aires Province. Journal of Clinical Rheumatology. 2010 oct;16(7):317-321.
IV. Gibofsky A. Current therapeutic agents and treatment paradigms for the management of rheumatoid arthritis. Am J Manag Care. 2014 May;20(7Suppl):S136-44.
V. Avci AB, Feist E, Burmester GR. Biologicals in rheumatoid arthritis: current and future. RMD open. 2015 Aug 5; 1-8.
VI. Nam JL, Ramiro S, Gaujoux-viala C, Takase K, León-García M, Emery P, Gossec L, Landewe R, Smolen JS, Buch MH. Efficacy of biological disease-modifying antirheumatic drugs: a systematic literature review informing the 2013 update of the EULAR recommendations for the management of rheumatoid arthritis. Ann Rheum Dis. 2014 Mar;73(3):516-28.
VII. Boers M. Cost-effectiveness of biologics as first-line treatment of rheumatoid arthritis: case closed? Ann Intern Med. 2009 Nov 3;151(9):668-9.
VIII. Yoshida Y, Tanaka T. Interleukin 6 and rheumatoid arthritis. Biomed Res Int.2014; 1-12.
IX. Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, Healey LA, Kaplan SR, Liang MH, Luthra HS, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum1988 Mar;31(3):315-24.
X. Tanaka T, Kishimoto T. The biology and medical implications of interleukin-6. Cancer Immunol Res. 2014 Apr;2(4):288-94.
XI. Witte T. Methotrexate as combination partner of TNF inhibitors and tocilizumab. What is reasonable from an immunological viewpoint? Clin Rheumatol. 2015 Apr;34(4):629-34.
XII. Shetty A, Hanson R, Korsten P, Shawagfeh M, Arami S, volkov S, vila o, Swedler W, Shunaigat AN, Smadi S, Sawaqed R, Perkins D, Shahrara S, Sweiss NJ. Tocilizumab in treatment of rheumatoid arthritis and beyond. Drug Design, Development and Therapy2014, 8:349-364.
XIII. Souto A, Maneiro JR, gómez-Reino JJ. Rate of discontinuation and drug survival of biologic therapies in rheumatoid arthritis: a systematic review and metaanalysis of drug registries and health care databases. Rheumatology 2016 Mar;55(3):523-34.
XIV. Kremer JM, Blanco R, Brzosko M, et al. Tocilizumab inhibits structural joint damage in rheumatoid arthritis patients with inadequate responses to methotrexate: results from the double-blind treatment phase of a randomized placebo-controlled trial of tocilizumab safety and prevention of structural joint damage at one year. Arthritis Rheum. 2011;63(3):609-621.
XV. Maini RN, Taylor PC, Szechinski J, et al; CHARISMA Study group. Double-blind randomized controlled clinical trial of the interleukin-6 receptor antagonist, tocilizumab, in European patients with rheumatoid arthritis who had an incomplete response to methotrexate. Arthritis Rheum. 2006;54(9):2817-2829.
XVI. Smolen JS, Beaulieu A, Rubbert-Roth A, et al; OPTION Investigators. Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (OPTION study): a doubleblind, placebo-controlled, randomised trial. Lancet.2008;371(9617):987-997.
XVII. Genovese MC, McKay JD, Nasonov EL, et al. Interleukin-6 receptor inhibition with tocilizumab reduces disease activity in rheumatoid arthritis with inadequate response to disease-modifying antirheumatic drugs: the tocilizumab in combination with traditional disease-modifying antirheumatic drug therapy study. Arthritis Rheum. 2008;58(10):2968-2980.
XVIII. Yazici Y, Curtis JR, Ince A, et al. Early effects of tocilizumab in the treatment of moderate to severe active rheumatoid arthritis: a one-week sub-study of a randomised controlled trial (Rapid onset and Systemic Efficacy [ROSE] Study). Clin Exp Rheumatol. 2013;31(3):358-364.
XIX. Dougados M, Kissel K, Sheeran T, et al. Adding tocilizumab or switching to tocilizumab monotherapy in methotrexate inadequate responders: 24-week symptomatic and structural results of a 2-year randomised controlled strategy trial in rheumatoid arthritis (ACT-RAY). Ann Rheum Dis. 2013;72(1):43-50.
XX. Weinblatt ME, Kremer J, Cush J, et al. Tocilizumab as monotherapy or in combination with non biologic disease-modifying antirheumatic drugs: twenty-fourweek results of an open-label, clinical practice study. Arthritis Care Res. 2013;65(3):362-371.
XXI. Emery P, Keystone E, Tony HP, et al. IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumor necrosis factor biologicals: results from a 24-week multicentre randomized placebo-controlled trial. Ann Rheum Dis.2008;67(11):1516-1523.
XXII. Nishimoto N, Miyasaka N, Yamamoto K, et al. Study of active controlled tocilizumab monotherapy for rheumatoid arthritis patients with an inadequate response to methotrexate (SAToRI): significant reduction in disease activity and serum vascular endothelial growth factor by IL-6 receptor inhibition therapy. Mod Rheumatol. 2009;19(1):12-19.
XXIII. Nishimoto N, Hashimoto J, Miyasaka N, et al. Study of active controlled monotherapy used for rheumatoid arthritis, an IL-6 inhibitor (SAMuRAI): evidence of clinical and radiographic benefit from an x ray readerblinded randomised controlled trial of tocilizumab. Ann Rheum Dis. 2007;66(9):1162-1167.
XXIV. Jones g, Sebba A, gu J, et al. Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: the AMBITIoN study. Ann Rheum Dis. 2010;69(1):88-96.
XXV. Bykerk vP, Östör AJ, Alvaro-gracia J, Pavelka K, Román Ivorra JA, graninger W, Bensen W, Nurmohamed MT, Krause A, Bernasconi C, Aassi M, Sibilia J. Comparison of tocilizumab as monotherapy or with add-on disease-modifying antirheumatic drugs in patients with rheumatoid arthritis and inadequate responses to previous treatments: an open-label study close to clinical practice. Clin Rheumatol. 2015 Mar;34(3):563-71.
XXVI. Detert J, Klaus P. Biologic monotherapy in the treatment of rheumatoid arthritis. Biologics. 2015 May 14;9:35-43.
Publicado
2015-09-01
Cómo citar
1.
Montoya F. Estudio multicéntrico no intervencional en pacientes con artritis reumatoidea tratados con tocilizumab. Rev. Argent. Reumatol. [Internet]. 1 de septiembre de 2015 [citado 25 de abril de 2024];26(3):23 -28. Disponible en: https://ojs.reumatologia.org.ar/index.php/revistaSAR/article/view/637
Sección
Artículo Original
Derechos de autor 2015 A nombre de los autores. Derechos de reproducción: Sociedad Argentina de Reumatología
Esta obra está bajo licencia internacional Creative Commons Reconocimiento-NoComercial-SinObrasDerivadas 4.0.
