Side Effects of fingolimod: A Synthesis of Findings from 28 Studies

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Original Abstract of the Article

Main Research Findings

Fingolimod has been shown to be effective in treating relapsing-remitting multiple sclerosis (RRMS) in numerous clinical trials. 20 However, fingolimod is known to cause a number of side effects, including effects on the heart. 20 Additionally, fingolimod can have effects on the liver in some patients. 23 Furthermore, fingolimod affects the immune system, potentially increasing the risk of infections. 11 It is worth noting that the majority of patients initially treated with interferon or glatiramer acetate discontinued these treatments, while fingolimod, cladribine, and teriflunomide demonstrated higher treatment persistence. 22 This suggests that fingolimod might be a more viable long-term treatment option for many patients.

Reasons for Side Effects

Fingolimod works by sequestering lymphocytes in lymph nodes, preventing them from exiting into the bloodstream and reaching inflamed tissues. 21 This effect occurs because fingolimod acts on sphingosine 1-phosphate receptor 1 (S1P1), a receptor located on the cell membrane of lymphocytes. When fingolimod binds to S1P1, lymphocytes are sequestered in the lymph nodes. However, fingolimod also binds to sphingosine 1-phosphate receptor 2 (S1P2), sphingosine 1-phosphate receptor 3 (S1P3), sphingosine 1-phosphate receptor 4 (S1P4), and sphingosine 1-phosphate receptor 5 (S1P5). 21 These receptors are present in various organs, including the heart, liver, and immune system. Side effects are thought to occur when fingolimod binds to these receptors.

Common Side Effects

Effects on the Heart

Fingolimod can have side effects on the heart. 20 The most common side effect is a decrease in heart rate. After the first dose of fingolimod, a decrease in heart rate and blood pressure can occur, which usually resolves quickly. 19 However, long-term use of fingolimod can lead to persistent decreases in heart rate and blood pressure. Fingolimod can also cause arrhythmias.

Effects on the Liver

Fingolimod can have side effects on the liver. 23 The most common side effect is elevated liver enzymes. Elevated liver enzymes are an indicator that fingolimod is affecting the liver.

Infections

Fingolimod affects the immune system, potentially increasing the risk of infections. 11 The effect of fingolimod on the immune system is to reduce the number of lymphocytes. Lymphocytes play a crucial role in fighting bacteria and viruses that enter the body. When the number of lymphocytes decreases, the risk of infection increases.

Other

Fingolimod can cause a variety of other side effects. For example, headaches, fatigue, gastrointestinal symptoms, skin symptoms, etc. 11 Additionally, fingolimod can affect eye vision. 5 These side effects are usually mild and resolve within a short time. However, in some cases, they can become serious.

Measures for Side Effects

Effects on the Heart

To prevent side effects of fingolimod on the heart, it is important to have your heart checked by a doctor before taking fingolimod. 19 Additionally, it is important to check your heart rate and blood pressure regularly while taking fingolimod.

Effects on the Liver

To prevent side effects of fingolimod on the liver, it is important to have your liver checked by a doctor before taking fingolimod. 23 Additionally, it is important to check your liver enzymes regularly while taking fingolimod.

Infections

To reduce the risk of infections from fingolimod, it is important to maintain a healthy lifestyle. 11 For example, getting enough sleep, eating a balanced diet, exercising regularly, and avoiding stress. Additionally, it is important to be careful to avoid infections such as colds and influenza while taking fingolimod.

Comparison Between Studies

Commonalities Between Studies

Many studies have shown that fingolimod is effective in treating relapsing-remitting multiple sclerosis.

Differences Between Studies

Results may vary between studies regarding the side effects of fingolimod. For example, one study showed that fingolimod is likely to cause side effects on the heart, while another study showed that fingolimod is more likely to cause side effects on the liver.

Points to Note Regarding Application to Real Life

Fingolimod is an effective medication for treating relapsing-remitting multiple sclerosis, but it is important to understand the risks of side effects. It is crucial to consult your doctor before taking fingolimod and to choose a treatment plan that is right for your condition.

Limitations of Current Research

Research on the side effects of fingolimod is still incomplete. As such, information on the side effects of fingolimod is still incomplete.

Directions for Future Research

It is important to further research the side effects of fingolimod in the future. Research is particularly needed on the effects of fingolimod on the heart and liver. Additionally, research is also needed on the effects of fingolimod on the immune system.

Conclusion

Fingolimod is an effective medication for treating relapsing-remitting multiple sclerosis, but there are risks of side effects. It is crucial to consult your doctor before taking fingolimod and to choose a treatment plan that is right for your condition.

Literature analysis of 28 papers
Positive Content
19
Neutral Content
2
Negative Content
7
Article Type
3
1
2
7
26
1.

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

2.

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

4.

Fingolimod and changes in hematocrit, hemoglobin and red blood cells of patients with multiple sclerosis.

Author: MomeniAli, AbrishamkarRana, PanahiFatemeh, EslamiSepehr, TavoosiNooshin, Rafiee ZadehAryan

Decreased Hb
Decreased Hct
Decreased RBC

Fingolimod was associated with significant decreases in hematocrit, hemoglobin, and red blood cell count in patients with multiple sclerosis.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Retracted PublicationCases where a publication has been formally withdrawn due to the discovery of serious errors or misconduct.

Language : English

5.

Ocular adverse events from pharmacological treatment in patients with multiple sclerosis-A systematic review of the literature.

Author: Muñoz-OrtizJuliana, Reyes-GuanesJuliana, Zapata-BravoEstefanía, Mora-MuñozLaura, Reyes-HurtadoJuan Antonio, Tierradentro-GarcíaLuis Octavio, Rojas-CarabaliWilliam, Gómez-SuarezMarcela, de-la-TorreAlejandra

Ocular adverse events
Opportunistic infections

This systematic review examined ocular treatment-emergent adverse events (TEAEs) related to pharmacological treatment in patients with multiple sclerosis. The results showed that fingolimod and siponimod were commonly associated with macular edema, interferon β with retinopathy, alemtuzumab with thyroid eye disease, amantadine with corneal edema, and steroids with acute retinal necrosis. The study highlights the need for longitudinal studies and interdisciplinary approaches to monitor ocular symptoms in patients with multiple sclerosis.

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

6.

Fulminant MS Reactivation Following Combined Fingolimod Cessation and Yellow Fever Vaccination.

Author: RolfesLeoni, PawlitzkiMarc, PfeufferSteffen, ThomasChristian, Schmidt-ChanasitJonas, GrossCatharina C, Schulte-MecklenbeckAndreas, WiendlHeinz, MeuthSven G, M GrauerOliver, RuckTobias

MS relapse

This case report describes a patient with multiple sclerosis who experienced severe relapses after receiving a yellow fever vaccination two months after stopping fingolimod, a medication used to treat multiple sclerosis. The patient’s symptoms improved significantly after starting a different medication called natalizumab.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.

Language : English

7.

Targeting the Sphingosine-1-Phosphate Axis for Developing Non-narcotic Pain Therapeutics.

Author: SquillaceSilvia, SpiegelSarah, SalveminiDaniela

Chronic pain treatment
Non-narcotic analgesics

S1P receptor 1 (S1PR1) antagonists, such as fingolimod, are a promising new class of non-narcotic analgesics for chronic pain. This article discusses the role of S1P signaling in pain and the potential for targeting this pathway to develop new pain medications.

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.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

8.

Management of MS Patients Treated With Daclizumab - a Case Series of 267 Patients.

Author: RommerPaulus S, BergerKlaus, EllenbergerDavid, FneishFiras, SimbrichAlexandra, StahmannAlexander, ZettlUwe K

Multiple sclerosis treatment
Brain inflammation

This study examines the therapy management of patients who received daclizumab, a drug that was previously used to treat multiple sclerosis (MS), after it was withdrawn from the market due to safety concerns. The study found that most patients switched to other treatments shortly after discontinuing daclizumab.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.

Language : English

9.

Siponimod (Mayzent) Downregulates RhoA and Cell Surface Expression of the S1P1 and CX3CR1 Receptors in Mouse RAW 264.7 Macrophages.

Author: UosefAhmed, VaughnNicole, ChuXiufeng, ElshawwafMahmoud, AbdelshafyAhmed Adel Abbas, ElsaidKamal Mamdoh Kamal, GhobrialRafik Mark, KlocMalgorzata

MS treatment
chronic rejection prevention

Siponimod, a drug similar to Fingolimod, has been found to downregulate the expression of RhoA protein and decrease the cell surface expression of S1P1 and CX3CR1 receptors in macrophages. This suggests that siponimod may have potential as an anti-chronic rejection therapy.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

11.

Efficacy and Safety of the Newer Multiple Sclerosis Drugs Approved Since 2010.

Author: FaissnerSimon, GoldRalf

MS treatment
Bowel symptoms
Cardiac side effects
Infusion reactions
Liver dysfunction
Opportunistic infections
Secondary immunity
Thyroid disorders

Multiple sclerosis treatment options have expanded with the approval of new medications, including fingolimod, dimethyl fumarate, teriflunomide, alemtuzumab, ocrelizumab, and cladribine. While these medications offer significant benefits, they also come with unique safety considerations and risks that must be carefully weighed during treatment.

Historical ArticleA research paper that analyzes past events and developments using primary sources and examines them from a historical perspective.
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.

Language : English

12.

Tumefactive Demyelinating Lesions in a Patient with Multiple Sclerosis Developed two Days after the Injection of Rituximab.

Author: MoghadasiAbdorreza Naser

Tumefactive lesions

Rituximab, a medication for multiple sclerosis (MS), can cause tumefactive demyelinating lesions, a type of brain damage. This case report describes a young MS patient who developed tumefactive lesions after receiving rituximab.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

13.

[Therapeutic Strategies and Disease-Modifying Therapies for Multiple Sclerosis].

Author: MotegiHaruhiko, KitagawaSatoshi, NakaharaJin

Disability progression control
Multiple sclerosis treatment
Progressive multifocal leukoencephalopathy

Multiple sclerosis (MS) is a chronic disease that affects the central nervous system. This article discusses the current treatment options for MS in Japan, including the shift towards personalized medicine and the use of high-efficacy treatments.

English AbstractA summary of a research paper/publication written in English for a wider audience.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : Japanese

16.

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

17.

Efficacy and acceptability of the S1P receptor in the treatment of multiple sclerosis: a meta-analysis.

Author: TongJingyi, ZouQin, ChenYongmin, LiaoXiaoping, ChenRong, MaLin, ZhangDaqi, LiQifu

MS treatment

This network meta-analysis (NMA) evaluated the efficacy and acceptability of S1P receptor modulators for treating multiple sclerosis (MS). It aimed to identify the most effective and well-tolerated treatment strategies for MS patients, providing a reliable basis for prescribing S1P drugs.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
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

19.

Benefit-Risk Profile of Sphingosine-1-Phosphate Receptor Modulators in Relapsing and Secondary Progressive Multiple Sclerosis.

Author: ComiGiancarlo, HartungHans-Peter, BakshiRajesh, WilliamsIan M, WiendlHeinz

Multiple sclerosis treatment
Side effects

Fingolimod is a drug that is used to treat multiple sclerosis. This study looked at the safety and effectiveness of fingolimod and other similar drugs. The study found that these drugs are effective in treating multiple sclerosis and that their safety profile is suitable for long-term treatment.

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.

Language : English

21.

Cenerimod, a novel selective S1P<sub>1</sub> receptor modulator with unique signaling properties.

Author: PialiLuca, Birker-RobaczewskaMagdalena, LescopCyrille, FroidevauxSylvie, SchmitzNicole, MorrisonKeith, KohlChristopher, ReyMarkus, StuderRolf, VezzaliEnrico, HessPatrick, ClozelMartine, SteinerBeat, BolliMartin H, NaylerOliver

Autoimmune disease treatment
S1P1 modulator side effects

This study describes the development of cenerimod, a new drug that targets the S1P<sub>1</sub> receptor, which is involved in immune cell trafficking. Cenerimod was found to be safe and effective in a mouse model of multiple sclerosis.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

23.

The Disease-Modifying Therapies of Relapsing-Remitting Multiple Sclerosis and Liver Injury: A Narrative Review.

Author: BiolatoMarco, BiancoAssunta, LucchiniMatteo, GasbarriniAntonio, MirabellaMassimiliano, GriecoAntonio

Acute liver failure
Hepatic toxicity

This review analyzes pre-registration and post-marketing data on hepatotoxicity of disease-modifying therapies (DMTs) for relapsing-remitting multiple sclerosis. While rare, serious liver adverse events have been reported for several DMTs. Patients should be informed about potential hepatic side effects and monitored for clinical symptoms of liver injury.

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.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

25.

Liver injury with drugs used for multiple sclerosis: A contemporary analysis of the FDA Adverse Event Reporting System.

Author: AntonazzoIppazio Cosimo, PoluzziElisabetta, ForcesiEmanuele, RiiseTrond, BjornevikKjetil, BaldinElisa, MuratoriLuigi, De PontiFabrizio, RaschiEmanuel

None reported
Drug-induced liver injury

Drug-induced liver injury might be a common feature of multiple sclerosis drugs, particularly fampridine.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

26.

Doxorubicin effect is enhanced by sphingosine-1-phosphate signaling antagonist in breast cancer.

Author: KatsutaEriko, YanLi, NagahashiMasayuki, RazaAli, SturgillJamie L, LyonDebra E, RashidOmar M, HaitNitai C, TakabeKazuaki

Breast cancer treatment
Drug resistance suppression
Drug-induced inflammation suppression

Doxorubicin is a chemotherapy drug for breast cancer, but its use is limited by drug resistance and side effects. This abstract suggests that adding FTY720, a sphingosine-1-phosphate (S1P) receptor functional antagonist, to doxorubicin may potentiate its effects and reduce drug-induced inflammation.

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.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.

Language : English

27.

Heart rate variability decreases after 3 months of sustained treatment with fingolimod.

Author: VehoffJochen, Haegele-LinkStefan, HummAndrea, KaegiGeorg, MuellerStefanie Karin, SauterRafael, TettenbornBarbara Elisabeth, HundsbergerThomas

Cardiovascular side effects

Fingolimod treatment in patients with relapsing-remitting multiple sclerosis (RRMS) was associated with significant changes in heart rate variability (HRV). HRV initially increased, but then substantially decreased within 3 months of continuous treatment. This study highlights the need for further evaluation of the mechanisms and clinical relevance of these HRV changes.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

28.

Alemtuzumab as rescue therapy in a cohort of 50 relapsing-remitting MS patients with breakthrough disease on fingolimod: a multi-center observational study.

Author: HuhnKonstantin, BayasAntonios, DoerckSebastian, FrankBenedikt, GerbershagenKathrin, HellwigKerstin, KallmannBoris, KleinschnitzChristoph, KleiterIngo, LeeDe-Hyung, LimmrothVolker, MäurerMathias, MeuthSven, RieckmannPeter, RuckTobias, GoldRalf, LinkerRalf A

Multiple sclerosis treatment
Side effects

This study explores the efficacy and safety of alemtuzumab following fingolimod treatment in RRMS.

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.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.

Language : English

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