Barbero P, Bergui M, Versino E, Ricci A, Zhong J J, Ferrero B, Clerico M, Pipieri A, Verdun E, Giordano L, Durelli L
Clinica Neurologica I, Dipartimento di Neuroscienze, Università degli Studi di Torino, Italy.
Mult Scler. 2006 Feb;12(1):72-6. doi: 10.1191/135248506ms1247oa.
In RRMS, clinical exacerbations are usually associated with different types of active lesions at MRI, including: hyperintense lesions on T1-weighted post-gadolinium sequences; new hyperintense lesions or enlarging old lesions on PD/T2-weighted scans; or new hypointense lesions on T1-weighted pre-Gd sequences.
OBJECTIVE/METHODS: Primary outcome was the occurrence of patients with at least one active MRI lesion of the different types indicated above during treatment with 250 microg every other day (EOD) interferon beta (IFNbeta)-1b or 30 microg once weekly (OW) IFNbeta-1a in outpatients with RRMS (INCOMIN Trial).
The number of patients with at least one 'active' lesion, evaluated over the two-year follow-up, was significantly (P = 0.014) lower in the EOD IFNbeta-1 b arm (1 3/76, 17%) then in the OW IFNbeta-1a arm (25/73, 34%). NAb frequency over two-year follow-up was 22/65 (33.8%) in the EOD IFNbeta-1b arm and 4/62 (6.5%) in the OW IFNbeta-1a arm, significantly greater in the EOD IFNbeta-1b arm.
The development of MRI active lesions is strongly reduced by EOD-IFNbeta-1b compared with OW-IFNbeta-1a, indicating that EOD-IFNbeta-1b is more effective than OW-IFNbeta-1a in reducing ongoing inflammation and demyelination in MS. Logistic regression showed that NAb status did not affect the risk of MRI activity.
在复发缓解型多发性硬化症(RRMS)中,临床病情加重通常与MRI上不同类型的活动性病灶相关,包括:钆增强T1加权序列上的高信号病灶;质子密度加权/ T2加权扫描上的新的高信号病灶或扩大的陈旧病灶;或T1加权钆增强前序列上的新的低信号病灶。
目的/方法:主要结局是RRMS门诊患者在接受隔日(EOD)250微克β-1b干扰素(IFNβ)或每周一次(OW)30微克α-1a干扰素治疗期间出现至少一个上述不同类型的MRI活动性病灶(INCOMIN试验)。
在两年的随访中,EOD IFNβ-1b组(13/76,17%)至少有一个“活动性”病灶的患者数量显著低于OW IFNβ-1a组(25/73,34%)(P = 0.014)。在两年的随访中,EOD IFNβ-1b组的中和抗体(NAb)频率为22/65(33.8%),OW IFNβ-1a组为4/62(6.5%),EOD IFNβ-1b组显著更高。
与OW IFNβ-1a相比,EOD IFNβ-1b可显著减少MRI活动性病灶的出现,表明EOD IFNβ-1b在减轻MS中持续的炎症和脱髓鞘方面比OW IFNβ-1a更有效。逻辑回归显示,NAb状态不影响MRI活动的风险。