Yamout Bassem, Alroughani Raed, Inshasi Jihad, Farouk Samar, Abdulla Fatema, Al-Jarki Namareq Y, Alasmi Abdulla, Al Fahad Sarmad, Alkhabouri Jaber, Al-Saffar Khalid, Benedetti Beatrice, Canibano Beatriz, Deleu Dirk, Hassan Ali, Sarathchandran Pournamy, Shatila Ahmed, Abouelnaga Mohammad, Thakre Mona, Szolics Miklos, Boshra Amir
Neurology Institute and Multiple Sclerosis Center, Harley Street Medical Center, Abu Dhabi, United Arab Emirates.
Division of Neurological, Department of Medicine, Amiri Hospital, Arabian Gulf Street, 13001, Sharq, Kuwait.
Neurol Ther. 2024 Oct;13(5):1321-1335. doi: 10.1007/s40120-024-00650-5. Epub 2024 Aug 3.
Cladribine tablets (CladT), like alemtuzumab, acts as an immune reconstitution therapy. However, CladT is administered orally (alemtuzumab is given by infusion) and without the potential for serious side effects that limit the therapeutic use of alemtuzumab in multiple sclerosis (MS). Treatment with CladT, given initially as short courses of treatment 1 year apart, provides years of freedom from MS disease activity in responders to treatment. The appearance of mild or moderate MS disease activity after the initial 2 years of treatment may prompt careful follow-up or a further course of CladT, depending on the nature of the activity and individual circumstances. The appearance of severe MS disease activity requires a switch to an alternative high-efficacy disease-modifying treatment (DMT). The accumulating data from CladT-treated people with MS in real-world studies, including those with follow-up durations extending for years beyond the initial treatment, have demonstrated long-term freedom from MS disease activity in a good proportion of patients. This clinical experience has also confirmed that treatment with CladT is generally safe and well tolerated. The best time to prescribe a high-efficacy DMT is the subject of debate, with evidence that earlier versus later use of such agents may provide more effective long-term protection from disability progression. High-efficacy DMTs have traditionally been reserved for use in people with MS and high disease activity on presentation or breakthrough disease on one or more DMTs, as per the current product labels. The latest evidence from real-world studies suggests that CladT is effective and safe in DMT-naïve patients, including those with shorter disease duration.
克拉屈滨片（CladT）与阿仑单抗一样，可作为一种免疫重建疗法。然而，CladT通过口服给药（阿仑单抗通过静脉输注给药），且不存在限制阿仑单抗在多发性硬化症（MS）中治疗应用的严重副作用风险。CladT最初以每年间隔的短疗程给药，可使治疗有反应者多年无MS疾病活动。在最初2年治疗后出现轻度或中度MS疾病活动，可能需要根据活动性质和个体情况进行仔细随访或进一步使用CladT疗程。出现严重MS疾病活动则需要换用另一种高效疾病修饰治疗（DMT）。在现实世界研究中，接受CladT治疗的MS患者积累的数据，包括那些随访时间在初始治疗后延长数年的数据，已表明很大一部分患者长期无MS疾病活动。这一临床经验也证实，CladT治疗总体上是安全且耐受性良好的。开具高效DMT的最佳时机存在争议，有证据表明早期与晚期使用此类药物可能为预防残疾进展提供更有效的长期保护。根据当前产品标签，高效DMT传统上仅用于初诊时MS疾病活动度高或在一种或多种DMT治疗中出现突破性疾病的患者。现实世界研究的最新证据表明，CladT在未接受过DMT治疗的患者中，包括疾病病程较短的患者中，是有效且安全的。
