Ciron Jonathan, Bourre Bertrand, Castelnovo Giovanni, Guennoc Anne Marie, De Sèze Jérôme, Ben-Amor Ali Frederic, Savarin Carine, Vermersch Patrick
Department of Neurology, Centre de Ressources et de Compétences Sclérose en Plaques (CRC-SEP), Toulouse University Hospital, Hôpital Pierre-Paul Riquet, Toulouse, France.
INSERM UMR1291, CNRS UMR5051, Institut Toulousain des Maladies Infectieuses et Inflammatoires (Infinity), Université Toulouse III, Toulouse, France.
Neurol Ther. 2024 Jun;13(3):503-518. doi: 10.1007/s40120-024-00589-7. Epub 2024 Mar 15.
Cladribine tablets (CladT) has been available for therapeutic use in France since March 2021 for the management of highly active relapsing multiple sclerosis (RMS). This high-efficacy disease-modifying therapy (DMT) acts as an immune reconstitution therapy. In contrast to most high-efficacy DMTs, which act via continuous immunosuppression, two short courses of oral treatment with CladT at the beginning of years 1 and 2 of treatment provide long-term control of MS disease activity in responders to treatment, without the need for any further pharmacological treatment for several years. Although the labelling for CladT does not provide guidance beyond the initial treatment courses, real-world data on the therapeutic use of CladT from registries of previous clinical trial participants and patients treated in routine practice indicate that MS disease activity is controlled for a period of years beyond this time for a substantial proportion of patients. Moreover, this clinical experience has provided useful information on how to initiate and manage treatment with CladT. In this article we, a group of expert neurologists from France, provide recommendations on the initiation of CladT in DMT-naïve patients, how to switch from existing DMTs to CladT for patients with continuing MS disease activity, how to manage patients during the first 2 years of treatment and finally, how to manage patients with or without MS disease activity in years 3, 4 and beyond after initiating treatment with CladT. We believe that optimisation of the use of CladT beyond its initial courses of treatment will maximise the benefits of this treatment, especially early in the course of MS when suppression of focal inflammation in the CNS is a clinical priority to limit MS disease progression.
自2021年3月起，克拉屈滨片（CladT）已在法国用于治疗高度活动性复发型多发性硬化症（RMS）。这种高效疾病修正疗法（DMT）作为一种免疫重建疗法。与大多数通过持续免疫抑制起作用的高效DMT不同，在治疗的第1年和第2年初，用CladT进行两个短疗程的口服治疗可为治疗反应者提供MS疾病活动的长期控制，无需在数年内进行任何进一步的药物治疗。尽管CladT的药品说明书在初始治疗疗程之外未提供指导，但来自先前临床试验参与者登记处和常规实践中治疗患者的CladT治疗用途的真实世界数据表明，对于相当一部分患者，MS疾病活动在这段时间之后的数年里都得到了控制。此外，这一临床经验为如何启动和管理CladT治疗提供了有用信息。在本文中，我们一群来自法国的神经科专家就初治DMT患者启动CladT治疗、对于疾病仍有活动的患者如何从现有DMT转换为CladT治疗、在治疗的前两年如何管理患者，以及最后在开始使用CladT治疗后的第3年、第4年及以后如何管理有或无MS疾病活动的患者提供建议。我们认为，在CladT初始治疗疗程之外优化其使用将使这种治疗的益处最大化，尤其是在MS病程早期，此时抑制中枢神经系统局灶性炎症是限制MS疾病进展的临床重点。
