Spelman Tim, Eichau Sara, Alroughani Raed, Ozakbas Serkan, Khoury Samia J, Patti Francesco, Kubala Havrdova Eva, Boz Cavit, Terzi Murat, Kuhle Jens, Grammond Pierre, Lechner-Scott Jeanette, Gray Orla, Amato Maria Pia, Laureys Guy, Shaygannejad Vahid, Hyde Robert, Wang Haijue, Bozin Ivan, Belviso Nicholas, Quan Chao, Zeng Feng, van der Walt Anneke, Butzkueven Helmut
MSBase Foundation, Melbourne, Australia.
Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden.
Mult Scler J Exp Transl Clin. 2024 May 25;10(2):20552173241247182. doi: 10.1177/20552173241247182. eCollection 2024 Apr-Jun.
The use of non-specific immunosuppressants (NSIS) to treat multiple sclerosis (MS) remains prevalent in certain geographies despite safety concerns, likely due to resource limitations.
To use MSBase registry data to compare real-world outcomes in adults with relapsing-remitting MS (RRMS) treated with dimethyl fumarate (DMF) or NSIS (azathioprine, cyclosporine, cyclophosphamide, methotrexate, mitoxantrone or mycophenolate mofetil) between January 1, 2014 and April 1, 2022.
Treatment outcomes were compared using inverse probability of treatment weighting (IPTW) Cox regression. Outcomes were annualized relapse rates (ARRs), time to discontinuation, time to first relapse (TTFR) and time to 24-week confirmed disability progression (CDP) or 24-week confirmed disability improvement (CDI; in patients with baseline Expanded Disability Status Scale [EDSS] score ≥2).
After IPTW, ARR was similar for DMF (0.13) and NSIS (0.16; = 0.29). There was no difference in TTFR between cohorts (hazard ratio [HR]: 0.98; = 0.84). The DMF cohort experienced longer times to discontinuation (HR: 0.75; = 0.001) and CDP (HR: 0.53; = 0.001), and shorter time to CDI (HR: 1.99; < 0.008), versus the NSIS cohort.
This analysis supports the use of DMF to treat patients with relapsing forms of MS, and may have implications for MS practices in countries where NSIS are commonly used to treat RRMS.
尽管存在安全担忧,但在某些地区,使用非特异性免疫抑制剂(NSIS)治疗多发性硬化症(MS)仍然很普遍,这可能是由于资源限制。
利用MSBase注册数据,比较2014年1月1日至2022年4月1日期间接受富马酸二甲酯(DMF)或NSIS(硫唑嘌呤、环孢素、环磷酰胺、甲氨蝶呤、米托蒽醌或霉酚酸酯)治疗的复发缓解型MS(RRMS)成年患者的实际治疗效果。
采用治疗权重逆概率(IPTW)Cox回归比较治疗效果。观察指标为年化复发率(ARR)、停药时间、首次复发时间(TTFR)以及至24周确认残疾进展(CDP)或24周确认残疾改善(CDI;基线扩展残疾状态量表[EDSS]评分≥2的患者)的时间。
IPTW后,DMF组的ARR(0.13)与NSIS组(0.16;P = 0.29)相似。两组间的TTFR无差异(风险比[HR]:0.98;P = 0.84)。与NSIS组相比,DMF组的停药时间更长(HR:0.75;P = 0.001)和CDP时间更长(HR:0.53;P = 0.001),而CDI时间更短(HR:1.99;P < 0.008)。
该分析支持使用DMF治疗复发型MS患者,这可能对那些常用NSIS治疗RRMS的国家的MS治疗实践产生影响。