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Efficacy of fingolimod in multiple sclerosis patients with spinal cord involvement: an open-label study
Fereshteh Ashtari1, Maryam Pirmoradian2, Aryan Kavosh3
1Isfahan Neurosciences Research Center, Isfahan University of Medical Sciences, Isfahan, Iran; Department of Neurology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.
Background:
Spinal cord involvement in people with multiple sclerosis (pwMS) have a high prevalence and can cause significant physical disability. Considering the lack of focused research, we aimed to investigate the efficacy and safety of fingolimod in pwMS with spinal cord involvement.
Methods:
In a prospective cohort study, we recorded demographic, radiological and clinical data from pwMS with spinal cord lesions who were treated with fingolimod for one year. Changes in brain MRI activity, annual relapse rate (ARR) and Expanded Disability Status Scale (EDSS) were used as measures of treatment efficacy.
Results:
A total of 119 pwMS (82.4 % female), with a mean age of 37.60±8.44 were included in the study, 68 of whom had multiple spinal cord lesions. PwMS without spinal cord lesion showed a decreased ARR (2 ± 0.82 vs. 0.55±0.33; p < 0.001), and decreased enhancing brain lesions (21 vs. 2; p < 0.001). EDSS decreased significantly from 2.5 ± 1.09 to 2.29±1.03 (p = 0.009). In patients with spinal cord involvement, decreases in ARR (2.02 vs. 0.7; p = 0.001) and number of enhancing lesions (20 vs. 5; p = 0.001) were detected after the one-year course of fingolimod treatment. However, EDSS increased significantly in this group (from 3.12±1.06 to 3.28±1.37; p = 0.013). Participants with spinal cord involvement were significantly more likely to have a higher EDSS (β = 0.632, 95 % CI = 0.138-1.126; p = 0.013) and ARR (β = 0.532, 95 % CI = 0.282-0.783; p = 0.001) after treatment. In terms of safety profile, the most prevalent adverse effects included increased liver transaminase levels (21.8 %) and gastrointestinal side effects (16.0 %), with no adverse effects necessitating termination of treatment.
Conclusion:
Our study suggests that in pwMS receiving fingolimod, those with multiple spinal cord lesions show a less favorable outcome with regards to disability (measured by EDSS) compared to those without spinal cord lesions. Considering the reduction in ARR and the number of enhancing lesions, the higher EDSS is more likely due to progression independent of relapse activity (PIRA) than relapse associated worsening (RAW). While we recommend further studies with larger sample sizes to confirm our findings, it is likely beneficial to take the presence of spinal cord lesions into account when choosing the appropriate treatment for pwMS.
