Meca-Lallana José Eustasio, Hernández-Clares Rocío, Carreón-Guarnizo Ester
Unidad de Esclerosis Múltiple, Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, España; Cátedra de Neuroinmunología Clínica y Esclerosis Múltiple, UCAM, Universidad Católica San Antonio de Murcia, Murcia, España.
Unidad de Esclerosis Múltiple, Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, España; Cátedra de Neuroinmunología Clínica y Esclerosis Múltiple, UCAM, Universidad Católica San Antonio de Murcia, Murcia, España.
Med Clin (Barc). 2014 Dec;143 Suppl 3:23-9. doi: 10.1016/S0025-7753(15)30006-3.
The development of new disease-modifying drugs (DMD) in relapsing-remitting multiple sclerosis (RRMS), which share the common denominator of oral administration, considerably improves patient expectations in terms of effectiveness, tolerability and treatment adherence compared with currently available drugs. However, the common route of administration of these drugs does not mean that they are equivalent, since the heading of "oral route" encompasses drugs with distinct indications and mechanisms of action, as well as heterogeneous results in terms of efficacy and safety, allowing treatment to be personalized according to the each patient' s characteristics. Currently, four oral DMD are available or in an advanced stage of clinical development: fingolimod, teriflunomide, dimethyl fumarate and laquinimod. In pivotal trials versus placebo, these molecules reduced the annualized rate of exacerbations versus placebo by 54%, 31%, 53% and 23%, respectively, the risk of progression of disability by 31%, 30%, 38% and 36%, and the number of active lesions showing contrast uptake on magnetic resonance imaging by 82%, 80%, 90% and 37%, respectively. Based on the risk/benefit ratio, fingolimod is indicated in patients with suboptimal response to initial DMD or in severe rapidly progressing RRMS, while the remaining drugs can be used as first-line options. Clinical experience with these treatments will provide new data on safety and effectiveness, which will be determinant when establishing therapeutic algorithms.
复发缓解型多发性硬化症（RRMS）中新型疾病修正药物（DMD）的研发，这些药物的共同特点是口服给药，与现有药物相比，在有效性、耐受性和治疗依从性方面显著提高了患者的期望。然而，这些药物的共同给药途径并不意味着它们是等效的，因为“口服途径”这一类别涵盖了具有不同适应症和作用机制的药物，以及在疗效和安全性方面的异质性结果，从而能够根据每个患者的特征进行个性化治疗。目前，有四种口服DMD已上市或处于临床开发的后期阶段：芬戈莫德、特立氟胺、富马酸二甲酯和拉喹莫德。在与安慰剂对照的关键试验中，这些药物使年化复发率与安慰剂相比分别降低了54%、31%、53%和23%，残疾进展风险降低了31%、30%、38%和36%，磁共振成像上显示有对比剂摄取的活动性病灶数量分别减少了82%、80%、90%和37%。基于风险/获益比，芬戈莫德适用于对初始DMD反应欠佳的患者或严重快速进展的RRMS患者，而其余药物可作为一线选择。这些治疗方法的临床经验将提供关于安全性和有效性的新数据，这在建立治疗算法时将起决定性作用。
