Summary

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• This summary is based on the review of 22 systematic review(s)/meta-analysis(es). ^[1-22]
• Brain Volume Loss (BVL): In relapsing multiple sclerosis (RMS), fingolimod reduced BVL significantly compared to placebo over two years with a mean difference (MD) of 0.25 (95% CI (confidence interval): 0.15 - 0.36); interferons and natalizumab had the least effect on BVL.
• Relapse Rates in RRMS: Fingolimod significantly reduced relapse rates compared to placebo in relapsing-remitting multiple sclerosis (RRMS), achieving a 24-month rate ratio (RR) of 0.54 (95% CI: 0.48 - 0.60), with comparable efficacy to natalizumab, cladribine, and alemtuzumab.
• Disability Progression in RRMS: Fingolimod moderately reduced disability worsening over 24 months compared to placebo; natalizumab demonstrated a stronger effect with an RR of 0.59 (95% CI: 0.46 - 0.75).
• No Evidence of Disease Activity (NEDA-4): Fingolimod showed higher odds of no long-term disability progression over six years versus interferon beta, with a pooled odds ratio (OR) of 2.14 (95% CI: 1.36 - 3.37) for confirmed disability progression under NEDA-4 conditions.
• Fingolimod was associated with an increased risk of cardiac autonomic dysfunction, particularly affecting heart rate variability and causing orthostatic intolerance and dizziness in MS patients.
• Fingolimod use increased the risk of cardiovascular adverse events, with a relative risk (RR) of 2.92 for bradyarrhythmia and 2.00 for hypertension.
• Fingolimod increased the incidence of general and serious infections by 16%, with specific risks for lower respiratory infections and herpes virus infections.
• There is no population types or subgroups information available in the reviewed studies.