Dimethyl Fumarate in Multiple Sclerosis Patients: A Real World Study

Abstract

Objective: In this study, we aimed to obtain efficacy and safety data in relapsing multiple sclerosis (MS) patients who used dimethyl fumarate (DMF). Methods: The study was designed as an observational retrospective cohort study. The data of relapsing MS patients who were followed up in the Neurology Department of İstanbul Faculty of Medicine and used DMF between 2014 and 2021 were analyzed. The first EDSS (expanded disability status scale) worsening time, first relapse time, and first new MRI lesion time information was obtained after the onset of DMF, and no evidence of disease activity (NEDA-3) status was determined. Results: A total of 126 MS patients (85 females, 41 males; 116 RRMS, 10 RPMS) were included in the study. DMF was discontinued at a higher rate in patients who used another treatment before DMF, who were progressive with relapse, and who had a longer duration of disease before DMF (p=0.002, p=0.03, and p=0.002). Of the 65 patients diagnosed with RRMS and RPMS with brain MRI data, 25% of them maintained NEDA-3 status during the follow-up period after DMF initiation. However, an EDSS score below three before DMF onset significantly prolonged the time to loss of NEDA-3 status, first attack, and first disability accumulation (p=0.008 for NEDA-3, HR=1.95). Conclusion: The real-life data obtained in our study show a great deal of similarity with the current information. Our findings indicate that if DMF is started in patients with an EDSS score below 3, the risk of developing attacks, new lesions on brain MRI, and disability accumulation is reduced.

Keywords

• dimethyl fumarate
• neuroimmunomodulation
• magnetic resonance imaging

Multipl Skleroz Hastalarında Dimetil Fumarat: Bir Gerçek Yaşam Çalışması

Abstract

Amaç: Çalışmamızda dimetil fumarat (DMF) kullanan ya da daha önce kullanmış olan ataklı multipl skleroz (MS) hastalarında etkinlik ve güvenlik verilerinin elde edilmesi amaçlandı. Yöntem: Çalışma gözlemsel retrospektif kohort çalışması olarak tasarlandı. İstanbul Tıp Fakültesi Nöroloji Ana Bilim Dalında takip edilen ve 2014–2021 yılları arasında DMF kullanmış ataklı yineleyici (RRMS) ve ataklı progresif (RPMS) MS hastalarının verileri incelendi. Hastalarda DMF başlandıktan sonraki ilk genişletilmiş özürlülük durum ölçeği (EDSS) kötüleşmesi, ilk atak ve ilk yeni MRG lezyonu bilgileri elde edilerek hastalık aktivitesi olmaması durumu (NEDA-3) belirlendi. Bulgular: Toplam 126 ataklı MS hastası (85 kadın, 41 erkek; 116 RRMS, 10 RPMS) çalışmaya dahil edildi. DMF öncesi başka bir tedavi kullanmış olan, ataklı progresif olan ve DMF öncesi hastalık süresi daha uzun olan hastalarda DMF daha yüksek oranda kesilmişti (p=0,002, p=0,03 ve p=0,002). Beyin MRG bilgisi olan 65 RRMS ve RPMS tanılı hastanın %25’inde DMF başlandıktan sonraki takip döneminde NEDA-3 durumu sağlandığı görüldü. DMF öncesinde EDSS skorunun 3’ün altında olması NEDA-3 durumunun yitimine, ilk atağa ve ilk özürlülük birikiminin olmasına kadar geçen süreleri anlamlı ölçüde uzattı (NEDA-3 için p=0,008, HR=1,95). Sonuç: Çalışmamızda elde edilen gerçek yaşam verileri güncel bilgiler ile büyük oranda benzerlik göstermektedir. Elde ettiğimiz bulgular EDSS skoru 3’ün altında olan hastalarda başlanan DMF’nin atak, yeni beyin MRG lezyonu ve engellilik birikimi gelişme riskinin azalttığına işaret etmektedir.

Keywords

• Multipl Skleroz
• dimetil fumarat
• Nöroimmünomodülasyon
• Gerçek Yaşam Çalışması

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