Department of Radiology and Nuclear Medicine, Amsterdam UMC, Location VUmc, Amsterdam, The Netherlands.
Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy.
J Neurol. 2023 Apr;270(4):2271-2282. doi: 10.1007/s00415-022-11554-5. Epub 2023 Feb 1.
Evaluate the effect of subcutaneous interferon β-1a (sc IFN β-1a) versus placebo on the evolution of T1-weighted MRI lesions and central brain atrophy in in patients with a first clinical demyelinating event (FCDE).
Post hoc analysis of baseline-to-24 month MRI data from patients with an FCDE who received sc IFN β-1a 44 μg once- (qw) or three-times-weekly (tiw), or placebo, in REFLEX. Patients were grouped according to treatment regimen or conversion to clinically definite MS (CDMS) status. The intensity of new lesions on unenhanced T1-weighted images was classified as T1 iso- or hypo-intense (black holes) and percentage ventricular volume change (PVVC) was assessed throughout the study.
In patients not converting to CDMS, sc IFN β-1a tiw or qw, versus placebo, reduced the overall number of new lesions (P < 0.001 and P = 0.005) and new T1 iso-intense lesions (P < 0.001 and P = 0.002) after 24 months; only sc IFN β-1a tiw was associated with fewer T1 hypo-intense lesions versus placebo (P < 0.001). PVVC findings in patients treated with sc IFN β-1a suggested pseudo-atrophy that was ~ fivefold greater versus placebo in the first year of treatment (placebo 1.11%; qw 4.28%; tiw 6.76%; P < 001); similar findings were apparent for non-converting patients.
In patients with an FCDE, treatment with sc IFN β-1a tiw for 24 months reduced the number of new lesions evolving into black holes.
评估皮下注射干扰素β-1a（sc IFN β-1a）与安慰剂对首次临床脱髓鞘事件（FCDE）患者 T1 加权 MRI 病变和中枢性脑萎缩进展的影响。
REFLEX 研究中 FCDE 患者基线至 24 个月 MRI 数据的事后分析，患者接受 sc IFN β-1a 44μg 每周一次（qw）或每周三次（tiw）皮下注射，或安慰剂治疗。根据治疗方案或转化为临床确诊多发性硬化症（CDMS）的状态将患者分组。未转化为 CDMS 的患者中，与安慰剂相比，sc IFN β-1a tiw 或 qw 治疗降低了新病变的总数（P<0.001 和 P=0.005）和新 T1 等信号病变的数量（P<0.001 和 P=0.002）在 24 个月后；只有 sc IFN β-1a tiw 与安慰剂相比，新 T1 低信号病变更少（P<0.001）。接受 sc IFN β-1a 治疗的患者的 PVVC 结果提示假性萎缩，与安慰剂相比，第一年的治疗中约为 5 倍（安慰剂 1.11%；qw 4.28%；tiw 6.76%；P<0.001）；在未转化的患者中也有类似的发现。
在 FCDE 患者中，sc IFN β-1a tiw 治疗 24 个月可减少新病变发展为黑洞的数量。
