Verkkoniemi-Ahola Auli, Hartikainen Päivi, Hassi Katja, Kuusisto Hanna, Lahdenperä Sanni, Mehtälä Juha, Viitala Matias, Ylisaukko-Oja Tero, Soilu-Hänninen Merja
Department of Neurology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
Neuro Center, Neurology Outpatient Clinic, Kuopio University Hospital, Kuopio, Finland.
Mult Scler J Exp Transl Clin. 2023 Oct 4;9(4):20552173231204466. doi: 10.1177/20552173231204466. eCollection 2023 Oct-Dec.
The primary objective was to evaluate long-term treatment persistence and safety of natalizumab in Finnish multiple sclerosis patients. The secondary objectives were to assess patient characteristics, use of natalizumab-related safety protocol, and treatment persistence in patients with different anti-John Cunningham virus antibody statuses (John Cunningham virus status).
MATERIALS & METHODS: All adult multiple sclerosis patients in the Finnish multiple sclerosis register who started natalizumab between 1/2006 and 12/2018 were included in this study and followed retrospectively until treatment discontinuation or end of follow-up (12/2019).
In total, 850 patients were included. Median duration of natalizumab treatment was 7.8 years in John Cunningham virus negative ( = 229) and 2.1 years in John Cunningham virus positive patients ( = 115; < 0.001). The most common cause for treatment discontinuation was John Cunningham virus positivity. After natalizumab discontinuation, patients who had a washout duration of less than 6 weeks had fewer relapses during the first 6 months ( = 0.012) and 12 months ( = 0.005) compared with patients who had a washout duration of over 6 weeks. During the median follow-up of 3.6 years, 76% of patients remained stable or improved on their Expanded Disability Status Scale.
Treatment persistence was very high among John Cunningham virus negative patients. The study supports long-term effectiveness of natalizumab and a washout duration of less than 6 weeks after discontinuation.
主要目的是评估那他珠单抗在芬兰多发性硬化症患者中的长期治疗持续性和安全性。次要目的是评估患者特征、那他珠单抗相关安全方案的使用情况,以及不同抗约翰·坎宁安病毒抗体状态(约翰·坎宁安病毒状态)患者的治疗持续性。
本研究纳入了芬兰多发性硬化症登记册中所有在2006年1月至2018年12月期间开始使用那他珠单抗的成年多发性硬化症患者,并进行回顾性随访,直至治疗中断或随访结束(2019年12月)。
总共纳入了850名患者。约翰·坎宁安病毒阴性患者(n = 229)那他珠单抗治疗的中位持续时间为7.8年,约翰·坎宁安病毒阳性患者(n = 115)为2.1年(P < 0.001)。治疗中断的最常见原因是约翰·坎宁安病毒阳性。与洗脱期超过6周的患者相比,那他珠单抗停药后洗脱期少于6周的患者在最初6个月(P = 0.012)和12个月(P = 0.005)内复发较少。在3.6年的中位随访期间,76%的患者在扩展残疾状态量表上保持稳定或改善。
约翰·坎宁安病毒阴性患者的治疗持续性非常高。该研究支持那他珠单抗的长期有效性以及停药后少于6周的洗脱期。