Effects of fingolimod: A Synthesis of Findings from 19 Studies

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Original Abstract of the Article

Major Research Findings

Fingolimod is a medication approved for the treatment of relapsing-remitting multiple sclerosis (MS) that works by modulating sphingosine 1-phosphate receptors (S1PRs). 2 6 Research suggests fingolimod effectively reduces MS relapses and slows brain atrophy. 4 Additionally, fingolimod appears to have neuroprotective effects in a cellular model of optic neuritis, a common MS symptom. 19 Interestingly, preliminary studies suggest fingolimod may have potential benefits in treating schizophrenia. 9 These findings indicate fingolimod could have both immunomodulatory and neuroprotective properties, opening up new avenues for treating MS.

Benefits and Risks

Benefit Summary

Fingolimod effectively reduces MS relapses, slows brain atrophy, and may provide neuroprotection against optic neuritis. Preliminary evidence suggests potential benefits in treating schizophrenia.

Risk Summary

Fingolimod can suppress peripheral lymphocyte counts, which may lead to a weakened immune system. 2 Some individuals may experience transient slowing of heart rate and atrioventricular conduction. 5 Fingolimod can affect the liver, so close monitoring is essential. 12 Higher doses of fingolimod can impact pulmonary function, requiring caution for individuals with asthma. 13

Comparison Across Studies

Similarities Among Studies

Multiple studies consistently demonstrate that fingolimod effectively reduces MS relapses and slows brain atrophy. These studies also agree that fingolimod suppresses peripheral lymphocyte counts. 2 6 4

Differences Among Studies

Studies differ in fingolimod dosage, research duration, and patient populations. Furthermore, the specific metrics used to assess fingolimod's effectiveness vary. For example, some studies focus on neuroprotective effects in optic neuritis, while others explore potential benefits in treating schizophrenia.

Consistency and Contradictions in Results

A strong consensus exists regarding fingolimod's effectiveness in reducing MS relapses and slowing brain atrophy. However, conflicting results exist concerning fingolimod's potential impact on pulmonary function. 13 These discrepancies may stem from variations in fingolimod dosage and patient populations.

Considerations for Real-World Application

While fingolimod holds promise as an effective treatment for MS, it's essential to be aware of its potential effects on the heart, liver, and lungs. Individuals with pre-existing conditions like heart disease, liver disease, or asthma should discuss fingolimod use with their doctor carefully.

Limitations of Current Research

Long-term effects of fingolimod require further investigation. More research is also needed to understand how fingolimod interacts with other medications. Additionally, the impact of fingolimod on conditions beyond MS, such as schizophrenia, needs to be studied further.

Future Research Directions

Future research should focus on evaluating fingolimod's long-term effects, its safety profile, and its interactions with other medications. Additional studies exploring the impact of fingolimod on various conditions beyond MS are also warranted.

Conclusion

Fingolimod holds significant potential as a treatment for MS, effectively reducing relapses and slowing brain atrophy. However, it's essential to be aware of its potential side effects and to discuss its use with a doctor, especially if you have existing health conditions. Ongoing research will continue to refine our understanding of fingolimod's benefits, risks, and applications in treating various conditions.

Literature analysis of 19 papers
Positive Content
19
Neutral Content
0
Negative Content
0
Article Type
11
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2
1
19
1.

Placebo-controlled study of the effects of fingolimod on cardiac rate and rhythm and pulmonary function in healthy volunteers.

Author: SchmouderRobert, HarirySam, DavidOlivier J

Oral therapy for relapsing MS

Fingolimod is a medication used to treat relapsing multiple sclerosis. This study investigated its effects on heart rate and lung function.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

3.

Relapse and disability outcomes in patients with multiple sclerosis treated with fingolimod: subgroup analyses of the double-blind, randomised, placebo-controlled FREEDOMS study.

Author: DevonshireVirginia, HavrdovaEva, RadueErnst Wilhelm, O'ConnorPaul, Zhang-AubersonLixin, AgoropoulouCatherine, HäringDieter Adrian, FrancisGordon, KapposLudwig,

Multiple Sclerosis Treatment

This study investigated the consistency of the beneficial treatment effect of fingolimod 0·5 mg once daily for relapsing multiple sclerosis (MS) across subgroups of patients with different baseline characteristics. The FREEDOMS study showed that fingolimod significantly reduced annualized relapse rates (ARRs) and the risk of confirmed disability progression compared with placebo.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

4.

Long-term effects of fingolimod in multiple sclerosis: the randomized FREEDOMS extension trial.

Author: KapposLudwig, O'ConnorPaul, RadueErnst-Wilhelm, PolmanChris, HohlfeldReinhard, SelmajKrzysztof, RitterShannon, SchlosshauerRolf, von RosenstielPhilipp, Zhang-AubersonLixin, FrancisGordon

Reduced ARR
Reduced BVL
Reduced CDP
Sustained efficacy

Fingolimod treatment in patients with relapsing-remitting multiple sclerosis (RRMS) was well-tolerated and reduced relapse rates, disability progression, and MRI effects over four years.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

5.

First-dose effects of fingolimod: Pooled safety data from three phase 3 studies.

Author: DiMarcoJohn P, O'ConnorPaul, CohenJeffrey A, RederAnthony T, Zhang-AubersonLixin, TangDejun, CollinsWilliam, KapposLudwig

Fingolimod treatment
AV conduction delay
Bradycardia

This report presents the first-dose fingolimod effects on cardiac parameters, using pooled data from phase 3 FREEDOMS, FREEDOMS II and TRANSFORMS studies. Fingolimod treatment initiation induced a transient slowing of heart rate and AV conduction, but symptomatic bradycardia and second-degree AV block were uncommon.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

6.

Fingolimod hydrochloride for the treatment of relapsing remitting multiple sclerosis.

Author: ThomasKatja, ProschmannUndine, ZiemssenTjalf

Fingolimod effective
MS treatment
Multiple sclerosis

Fingolimod is a medication used to treat multiple sclerosis. This review discusses the long-term experience with fingolimod use in clinical practice, including its efficacy, safety, and tolerability.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

7.

Preclinical discovery and development of fingolimod for the treatment of multiple sclerosis.

Author: VolpiClaudia, OrabonaCiriana, MacchiaruloAntonio, BianchiRoberta, PuccettiPaolo, GrohmannUrsula

Lymphocyte regulation
MS treatment
Off-target effects
Toxicity

Fingolimod is a medication used to treat multiple sclerosis (MS). It works by blocking certain immune cells from entering the brain, which helps to reduce inflammation and slow the progression of the disease.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

8.

Benefit-harm balance of fingolimod in patients with MS: A modelling study based on FREEDOMS.

Author: SpanuAlessandra, AschmannHélène E, KesselringJürg, PuhanMilo A

Reduced relapses
Slowed disease progression
Side effects

This study evaluates the benefit-harm balance of fingolimod, a medication for multiple sclerosis (MS), using individual patient data from a randomized controlled trial.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

9.

Effects of fingolimod, a sphingosine-1-phosphate (S1P) receptor agonist, on white matter microstructure, cognition and symptoms in schizophrenia.

Author: FrancisMichael M, HummerTom A, LiffickEmily, VohsJenifer L, MehdiyounNikki F, ViscoAndrew C, YangZiyi, KovacsRichard J, ZhangYing, BreierAlan

Cognitive function
WM microstructure

The study assessed the effects of fingolimod, a sphingosine-1-phosphate (S1P) receptor agonist, on white matter (WM) microstructure, cognition, and symptoms in patients with schizophrenia. Fingolimod caused significant reductions in circulating lymphocytes and a non-significant association between DTI-FA change in the WM skeleton and fingolimod. There were no significant fingolimod versus placebo interactions on cognitive or symptom measures.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

10.

Efficacy and safety of adjunctive therapy with fingolimod in patients with schizophrenia: A randomized, double-blind, placebo-controlled clinical trial.

Author: KarbalaeeMonire, JameieMelika, AmanollahiMobina, TaghaviZanjaniFateme, ParsaeiMohammadamin, BastiFatemeh A, MokhtariSaba, MoradiKamyar, ArdakaniMohammad-Reza Khodaei, AkhondzadehShahin

Schizophrenia treatment

Fingolimod is a sphingosine-1-phosphate receptor modulator that has neuroprotective and anti-inflammatory effects. While it is approved to treat relapsing-remitting multiple sclerosis, its efficacy and safety for treating schizophrenia in combination with risperidone are currently being investigated.

Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

11.

Effects of fingolimod, a sphingosine-1-phosphate (S1P) receptor agonist, on white matter microstructure, cognition and symptoms in schizophrenia.

Author: FrancisMichael M, HummerTom A, LiffickEmily, VohsJenifer L, MehdiyounNikki F, ViscoAndrew C, YangZiyi, KovacsRichard J, ZhangYing, BreierAlan

Cognitive function
WM microstructure

The study assessed the effects of fingolimod, a sphingosine-1-phosphate (S1P) receptor agonist, on white matter (WM) microstructure, cognition, and symptoms in patients with schizophrenia. Fingolimod caused significant reductions in circulating lymphocytes and a non-significant association between DTI-FA change in the WM skeleton and fingolimod. There were no significant fingolimod versus placebo interactions on cognitive or symptom measures.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

12.

Antioxidative effects of silymarin on the reduction of liver complications of fingolimod in patients with relapsing-remitting multiple sclerosis: A clinical trial study.

Author: GhiasianMasoud, NafisiHamid, RanjbarAkram, MohammadiYounes, AtaeiSara

Reduce liver complications
Reduce oxidative stress

This study evaluated the effects of silymarin, an extract from milk thistle, on reducing liver complications and oxidative stress associated with fingolimod, a medication for multiple sclerosis. Silymarin significantly reduced liver enzyme levels, oxidative stress markers, and improved antioxidant capacity in patients with multiple sclerosis taking fingolimod.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

14.

Long-term effects of fingolimod in multiple sclerosis: the randomized FREEDOMS extension trial.

Author: KapposLudwig, O'ConnorPaul, RadueErnst-Wilhelm, PolmanChris, HohlfeldReinhard, SelmajKrzysztof, RitterShannon, SchlosshauerRolf, von RosenstielPhilipp, Zhang-AubersonLixin, FrancisGordon

Reduced ARR
Reduced BVL
Reduced CDP
Sustained efficacy

Fingolimod treatment in patients with relapsing-remitting multiple sclerosis (RRMS) was well-tolerated and reduced relapse rates, disability progression, and MRI effects over four years.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

15.

Diffusion basis spectrum imaging measures anti-inflammatory and neuroprotective effects of fingolimod on murine optic neuritis.

Author: YangRuimeng, LinTsen-Hsuan, ZhanJie, LaiShengsheng, SongChunyu, SunPeng, YeZezhong, WallendorfMichael, GeorgeAjit, CrossAnne H, SongSheng-Kwei

ON diagnosis
ON treatment

This study aimed to evaluate the effectiveness of diffusion basis spectrum imaging (DBSI) in detecting, differentiating, and quantifying inflammation, demyelination, axonal injury, and axon loss in mice with optic neuritis (ON) due to experimental autoimmune encephalomyelitis (EAE). The study also investigated DBSI's accuracy in measuring the effects of fingolimod on underlying pathology.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
Research Support, U.S. Gov't, Non-P.H.S.Research funding provided by US government agencies other than the Public Health Service.

Language : English

16.

Differential Effects of Fingolimod and Natalizumab on B Cell Repertoires in Multiple Sclerosis Patients.

Author: KowarikM C, AstlingD, LepennetierG, RitchieA, HemmerB, OwensG P, BennettJeffrey L

MS treatment

This study investigated the effects of natalizumab and fingolimod on peripheral blood (PB) and cerebrospinal fluid (CSF) B cell repertoires using next-generation deep sequencing. Our findings suggest that natalizumab diminishes the exchange of peripheral and intrathecal B cells without impacting intrathecal clonal expansion.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

18.

Testing effects of glatiramer acetate and fingolimod in an infectious model of CNS immune surveillance.

Author: Castro-RojasCyd, DeasonKrystin, HussainRehana Z, HayardenyLiat, CravensPetra C, YarovinskyFelix, EagarTodd N, ArellanoBenjamine, StüveOlaf

Immune surveillance

Immune surveillance in the central nervous system (CNS) is crucial for fighting off infections. This study used an experimental model of CNS infection to test the effects of two multiple sclerosis (MS) drugs, glatiramer acetate (GA) and fingolimod, on immune responses. This model could be useful for assessing the risk of infections in MS patients treated with these drugs.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

19.

Neuroprotective Effects of Fingolimod in a Cellular Model of Optic Neuritis.

Author: CandadaiAmritha A, LiuFang, VermaArti, AdilMir S, AlfarhanMoaddey, FaganSusan C, SomanathPayaningal R, NarayananS Priya

Neuroprotection
ON treatment

Optic neuritis (ON) is a common neurological manifestation of multiple sclerosis (MS), leading to visual dysfunction and neuronal damage. This study investigated the neuroprotective effects of fingolimod (FTY), an FDA-approved immunomodulatory agent for MS, in a cellular model of ON. FTY significantly reduced TNFα-induced neuronal death in R28 retinal neuronal cells. The study also showed that FTY attenuated TNFα-induced changes in cell survival and stress signaling molecules. These findings suggest that FTY has neuroprotective properties against ON-associated neuronal damage, offering potential for treating this debilitating condition.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

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