Department of Neurogeriatric Medicine, Hospital Sisters of Charity, Seilerstaette 4, Linz, Austria.
J Neurol. 2013 Jul;260(7):1838-45. doi: 10.1007/s00415-013-6888-0. Epub 2013 Mar 17.
Evidence of a significant improvement of IFNB-1b in clinical severity in the older population with RRMS has not been established so far. The aim of this exploratory post hoc analysis of the 250 mcg IFNB-1b group of the BEYOND study is to compare the efficacy and safety of older versus younger patients using a cut-off at the age of 50 and at the age of 40, respectively. There was no difference between age groups in adjusted relapse risk (age 50 cut-off: P = 0.482, age 40 cut-off: P = 0.073) nor in adjusted time to confirmed EDSS progression (age 50 cut-off: P = 0.096, age 40 cut-off: P = 0.189). There were no significant differences between patients <50 and ≥ 50 years in the adjusted annualized relapse rate (P = 0.285), whereas relapse rate was higher in the <40 as compared to the ≥ 40 group (P = 0.024). The proportion of patients with confirmed disability progression was not significantly different for the 50 cutoff (P = 0.148), whereas significantly fewer <40 than ≥ 40 patients had disability progression (P = 0.047). Only minor differences in adverse event frequencies between the age groups for the two cut-offs were seen. These results indicate that IFNB-1b is as efficacious and safe in patients ≥ 50 years as <50 years of age.
目前尚无证据表明 IFNB-1b 可显著改善 RRMS 老年患者的临床严重程度。本研究旨在对 BEYOND 研究中 250μg IFNB-1b 组进行探索性事后分析，比较年龄≥50 岁与<50 岁患者的疗效和安全性，分别以 50 岁和 40 岁为年龄界限。调整后的复发风险在年龄组间无差异（年龄 50 岁界限：P=0.482；年龄 40 岁界限：P=0.073），调整后的 EDSS 进展时间也无差异（年龄 50 岁界限：P=0.096；年龄 40 岁界限：P=0.189）。年龄<50 岁和≥50 岁的患者间，调整后的年复发率无显著差异（P=0.285），而<40 岁患者的复发率高于≥40 岁患者（P=0.024）。在 50 岁界限处，残疾进展的患者比例在两组间无显著差异（P=0.148），而在 40 岁界限处，<40 岁患者的残疾进展比例显著低于≥40 岁患者（P=0.047）。仅在两个界限处，年龄组间的不良事件频率存在细微差异。这些结果表明，IFNB-1b 对≥50 岁与<50 岁的患者同样有效且安全。
