RESUMEN
Resumen La enfermedad inflamatoria intestinal (EII) es un término con el que se conocen varias entidades, las 2 más importantes son: la colitis ulcerativa idiopática (CUI) y la enfermedad de Crohn (EC), cuyo origen es multifactorial y se caracterizan por un fenómeno inflamatorio, crónico, recurrente con diferentes grados de severidad del tubo digestivo; pero además con afectación potencial de otros órganos. En la última década ha habido un renovado interés en dichas entidades, debido a una incidencia creciente de estas, pero también debido al desarrollo de medicamentos que por primera vez están cambiando la historia natural de estas enfermedades: son los medicamentos llamados biológicos, que son aquellos producidos o derivados de organismos vivos y representan el sector de mayor crecimiento en la industria farmacéutica mundial. Debido al interés comercial, se han desarrollado y sometido a las autoridades reguladoras productos no originadores; similares, pero no idénticos a los productos de referencia. La Agencia Europea de Medicamentos (EMA) aprobó el primer biosimilar del infliximab para todas las indicaciones en las cuales este estaba aprobado, incluidas: colitis ulcerativa moderada a severa en todas las edades, EC moderada a severa en todas las edades, al igual que EC fistulizante, artritis psoriásica (AP), psoriasis, espondilitis anquilosante (EA) y artritis reumatoide (AR) (1). En esta revisión nos proponemos definir lo que son estos productos al igual que algunos conceptos relacionados (extrapolación, sustitución e intercambiabilidad), además hacer una revisión histórica de su desarrollo, sus indicaciones actuales, las posiciones de las diferentes asociaciones científicas al respecto y, lo más importante, brindar datos de la vida real en cuanto a su efectividad, seguridad y costos en los diferentes países donde se han estado usando.
Abstract The term Inflammatory Bowel Disease (IBD) is used to identify several entities, the two most important of which are Idiopathic Ulcerative Colitis (IUC) and Crohn's Disease (EC). Both are multifactorial in origin, are chronic and recurrent, are characterized by inflammation, have varying degrees of severity, and potentially involve other organs. In the last decade there has been renewed interest in these entities due to growing incidence and to the development of drugs called biologicals. For the first time, these drugs have changed the natural history of these diseases. They are produced or derived from living organisms and represent the fastest growing sector in the global pharmaceutical industry. Due to commercial interest, products similar but not identical to the original products have been developed and submitted to regulatory authorities. The European Medicines Agency has approved the first biosimilar for infliximab for all indications for which it has been approved. These include moderate to severe ulcerative colitis (UC) at all ages, moderate to severe Crohn's disease (CD) at all ages, fistulizing Crohn's disease, Psoriasic arthritis, Psoriasis, Ankylosing Spondylitis, and Rheumatoid Arthritis. 1 In this review, we define what these products are, as well as some concepts coined for their usage including extrapolation, substitution and interchangeability. We also make a historical review of their development, current indications, the positions of various scientific associations with respect to them, and - most importantly - provide real-life data regarding their effectiveness, safety and costs in countries where they have been used.
Asunto(s)
Factores Biológicos , Biosimilares Farmacéuticos , Intercambiabilidad de MedicamentosRESUMEN
Crohn's disease (CD) is often very difficult to treat. Almost ten years ago "biologic" agents were introduced in the armamentarium to control CD. Although there are many new drugs in the pipeline, only two antiTNF agents have been released to the market (infliximab and, recently, adalimumab) and probably in 2008 certolizumab will be approved. A review of available evidence suggests that the three antibodies are effective in the induction and maintenance of response, and (to a lesser extent) remission. Infliximab has been very useful in fistulizing disease, and preliminary data do suggest that adalimumab and certolizumab will be also. Cost and long-term safety limit the use of these agents in daily practice. To maximize benefits and minimize risks, good patient selection and strict adherence to Clinical Guidelines seem the key points. It has been suggested that these drugs should be used in early disease to avoid progression, but current data are very scarce to generalize this recommendation. In anycase, we think that the use of "biologics" will provoke a dramatic change in CD treatment in the next 10 years.
Crohns disesae (CD) is often very difficult to treat. Almost ten years ago "biologic" agents were introduced inthe armamentarium to control CD. Although there are many new drugs in the pipeline, only two antiTNF agents have been released to the market (infliximab and, recently, adalimumab) and probably in 2008 certolizumabwill be approved. A review of available evidence suggests that the three antibodies are effective in the induction and maintenance of response, and (to alesser extent) remission. Infliximab has been very useful in fistulizing disease, and preliminary data do suggest that adalimumab and certolizumab will be also. Cost and long-term safety limit the use of these agents in daily practice. To maximize benefits and minimize risks, good patient selection and strict adherence to Clinical Guidelines seem the key points. It has been suggestedthat these drugs should be used in early disease to avoid progression, but current data are very scarce to generalize this recommendation. In anycase, we think that the use of "biologics" will provoke a dramaticchange in CD treatment in the next 10 years.