Scott Thomas F, Su Ray, Xiong Kuangnan, Altincatal Arman, Castrillo-Viguera Carmen, Naylor Maria L
Neurology and Neuroscience Institute, Allegheny General Hospital, Allegheny Health Network, Pittsburgh, PA 15212, USA.
Biogen, Cambridge, MA, USA, at the time of this analysis.
Ther Adv Neurol Disord. 2021 Jan 12;14:1756286420975916. doi: 10.1177/1756286420975916. eCollection 2021.
Peginterferon beta-1a and glatiramer acetate (GA) are approved first-line therapies for the treatment of relapsing forms of multiple sclerosis, but their therapeutic efficacy has not been compared directly.
Clinical outcomes at 2 years, including no evidence of disease activity (NEDA), for patients receiving peginterferon beta-1a 125 mcg every 2 weeks (Q2W) or GA 20 mg/ml once daily (QD) were compared by propensity score matching analysis using individual patient data from ADVANCE and CONFIRM phase III clinical trials. In addition, clinical outcomes at 1-3 years for patients receiving peginterferon beta-1a Q2W or GA 40 mg/ml three times a week (TIW) were evaluated using a matching-adjusted comparison analysis of individual patient data from ADVANCE and the ADVANCE extension study, ATTAIN, and aggregate patient data from the phase III GALA and the GALA extension studies.
Propensity-score-matched peginterferon beta-1a patients ( = 336) had a significantly lower annualized relapse rate [ARR (0.204 0.282); rate ratio = 0.724; = 0.045], a significantly lower probability of 12-week confirmed disability worsening (10.0% 14.6%; hazard ratio = 0.625; = 0.048), and a significantly higher rate of NEDA (20.3% 11.5%; = 0.047) compared with GA 20 mg/ml QD patients after 2 years of treatment. Matching-adjusted peginterferon beta-1a patients (effective = 276) demonstrated a similar ARR at 1 year (0.278 0.318; = 0.375) and significantly lower ARR at 2 years (0.0901 0.203; = 0.032) and 3 years (0.109 0.209; = 0.047) compared with GA 40 mg/ml TIW patients ( = 834).
Results from separate matching comparisons of phase III clinical trials and extension studies suggest that peginterferon beta-1a 125 mcg Q2W may provide better clinical outcomes than GA (20 mg/ml QD or 40 mg/ml TIW).
聚乙二醇化干扰素β-1a和醋酸格拉替雷（GA）是获批用于治疗复发型多发性硬化症的一线疗法，但它们的治疗效果尚未直接比较。
采用倾向评分匹配分析，利用来自ADVANCE和CONFIRM III期临床试验的个体患者数据，比较每2周接受125 mcg聚乙二醇化干扰素β-1a（Q2W）或每日一次接受20 mg/ml GA（QD）治疗的患者在2年时的临床结局，包括无疾病活动证据（NEDA）。此外，使用来自ADVANCE和ADVANCE扩展研究ATTAIN的个体患者数据的匹配调整比较分析，以及来自III期GALA和GALA扩展研究的汇总患者数据，评估每2周接受聚乙二醇化干扰素β-1a Q2W或每周三次接受40 mg/ml GA（TIW）治疗的患者在1至3年时的临床结局。
倾向评分匹配的聚乙二醇化干扰素β-1a患者（n = 336）在治疗2年后的年化复发率显著更低[ARR（0.204对0.282）；率比 = 0.724；P = 0.045]，12周确认残疾恶化的概率显著更低（10.0%对14.6%；风险比 = 0.625；P = 0.048），NEDA率显著更高（20.3%对11.5%；P = 0.047），与每日一次接受20 mg/ml GA治疗的患者相比。匹配调整后的聚乙二醇化干扰素β-1a患者（有效n = 276）在1年时的ARR相似（0.278对0.318；P = 0.375），在2年时（0.0901对0.203；P = 0.032）和3年时（0.109对0.209；P = 0.047）的ARR显著低于每周三次接受40 mg/ml GA治疗的患者（n = 834）。
III期临床试验和扩展研究的单独匹配比较结果表明，每2周一次125 mcg的聚乙二醇化干扰素β-1a可能比GA（每日一次20 mg/ml或每周三次40 mg/ml）提供更好的临床结局。
