UCSF, Weill Institute for Neurosciences, San Francisco, United States.
University of Utah, Department of Pediatrics, Salt Lake City, United States.
Mult Scler Relat Disord. 2024 Jul;87:105647. doi: 10.1016/j.msard.2024.105647. Epub 2024 Apr 26.
Observational studies looking at clinical a++nd MRI outcomes of treatments in pediatric MS, could assess current treatment algorithms, and provide insights for designing future clinical trials.
To describe baseline characteristics and clinical and MRI outcomes in MS patients initiating ocrelizumab and fingolimod under 18 years of age.
MS patients seen at 12 centers of US Network of Pediatric MS were included in this study if they had clinical and MRI follow-up and started treatment with either ocrelizumab or fingolimod prior to the age of 18.
Eighty-seven patients initiating fingolimod and 52 initiating ocrelizumab met the inclusion criteria. Before starting fingolimod, mean annualized relapse rate was 0.43 (95 % CI: 0.29 - 0.65) and 78 % developed new T2 lesions while during treatment it was 0.12 (95 % CI: 0.08 - 1.9) and 47 % developed new T2 lesions. In the ocrelizumab group, the mean annualized relapse rate prior to initiation of treatment was 0.64 (95 % CI: 0.38-1.09) and a total of 83 % of patients developed new T2 lesions while during treatment it was 0.09 (95 % CI: 0.04-0.21) and none developed new T2 lesions.
This study highlights the importance of evaluating current treatment methods and provides insights about the agents in the ongoing phase III trial comparing fingolimod and ocrelizumab.
观察性研究着眼于儿科多发性硬化症治疗的临床和 MRI 结果,可以评估当前的治疗方案,并为设计未来的临床试验提供见解。
描述在 18 岁以下开始使用奥瑞珠单抗和芬戈利莫德治疗的多发性硬化症患者的基线特征、临床和 MRI 结局。
如果在 18 岁之前开始使用奥瑞珠单抗或芬戈利莫德治疗的多发性硬化症患者在 12 个美国儿科多发性硬化症网络中心具有临床和 MRI 随访资料,则将其纳入本研究。
符合纳入标准的开始使用芬戈利莫德的患者有 87 例,开始使用奥瑞珠单抗的患者有 52 例。在开始使用芬戈利莫德之前,年平均复发率为 0.43(95%CI:0.29-0.65),78%的患者出现新的 T2 病变,而在治疗期间,年平均复发率为 0.12(95%CI:0.08-1.9),47%的患者出现新的 T2 病变。在奥瑞珠单抗组中,在开始治疗之前,年平均复发率为 0.64(95%CI:0.38-1.09),83%的患者出现新的 T2 病变,而在治疗期间,年平均复发率为 0.09(95%CI:0.04-0.21),无一例患者出现新的 T2 病变。
本研究强调了评估当前治疗方法的重要性,并为正在进行的比较芬戈利莫德和奥瑞珠单抗的 III 期试验中的药物提供了见解。