Fingolimod Therapy in Relapsing-Remitting Multiple Sclerosis

Fingolimod represents a first-in-class oral sphingosine-1-phosphate receptor modulator approved for adults with relapsing-remitting multiple sclerosis (RRMS). By sequestering lymphocytes in lymphoid tissues, it reduces central nervous system infiltration, thereby attenuating inflammatory demyelination and axonal damage. Clinical development, spanning pivotal phase III trials through long-term extensions, has demonstrated substantial declines in annualised relapse rate (ARR), delayed disability progression as measured by the Expanded Disability Status Scale (EDSS), and reduced magnetic resonance imaging (MRI) lesion activity, including gadolinium-enhancing and new or enlarging T2 lesions. Over sustained treatment periods of up to 4.5 years, fingolimod has maintained low ARR, preserved brain volume, and exhibited a manageable safety profile, with transient bradycardia at initiation and rare macular oedema being the most frequently observed effects. Real-world evidence further corroborates its efficacy across diverse patient populations, including those switching from injectable therapies, and underscores the importance of baseline disability and prior disease activity in predicting optimal response. The global significance of fingolimod extends to its convenience as a once-daily oral agent, offering an alternative to injectable and infusion therapies, thereby enhancing adherence and broadening therapeutic choice in routine clinical practice.

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Fingolimod Therapy in Relapsing-Remitting Multiple Sclerosis publication trend

The graph below shows the total number of articles in fingolimod therapy in relapsing-remitting multiple sclerosis across all publications each year (not limited to Nature Index journals).

Technical terms

Relapsing-Remitting Multiple Sclerosis (RRMS): A disease course marked by episodes of neurological dysfunction followed by periods of partial or full recovery.

Fingolimod: An oral modulator of sphingosine-1-phosphate receptors that limits lymphocyte egress from lymph nodes, reducing central nervous system inflammation.

Expanded Disability Status Scale (EDSS): A method of quantifying disability in multiple sclerosis on a scale from 0 (normal) to 10 (death due to MS).

Annualised Relapse Rate (ARR): The average number of disease relapses a patient experiences per year.

Disease-Modifying Therapy (DMT): A treatment intended to alter the underlying disease process rather than solely manage symptoms.

Magnetic Resonance Imaging (MRI): A non-invasive imaging technique used to visualise lesions and atrophy in the brain and spinal cord of MS patients.

No Evidence of Disease Activity (NEDA): A composite measure indicating absence of relapses, disability progression and new MRI lesions over a defined period.

References

1. Multiple sclerosis in the real world: A systematic review of fingolimod as a case study. Autoimmunity Reviews (2017).
2. Long-term (up to 4.5 years) treatment with fingolimod in multiple sclerosis: results from the extension of the randomised TRANSFORMS study. Journal of Neurology Neurosurgery & Psychiatry (2015).
3. Assessment of cardiac safety during fingolimod treatment initiation in a real-world relapsing multiple sclerosis population: a phase 3b, open-label study. Journal of Neurology (2013).
4. A non‐randomized clinical trial to evaluate the effect of fingolimod on expanded disability status scale score and number of relapses in relapsing‐remitting multiple sclerosis patients. Clinical and Translational Medicine (2019).
5. Effectiveness, safety and health-related quality of life of multiple sclerosis patients treated with fingolimod: results from a 12-month, real-world, observational PERFORMS study in the Middle East. BMC Neurology (2017).
6. Relapse Rates in Patients with Multiple Sclerosis Switching from Interferon to Fingolimod or Glatiramer Acetate: A US Claims Database Study. PLOS ONE (2014).
7. Efficacy and Safety of Fingolimod in an Unselected Patient Population. PLOS ONE (2016).