Side Effects of dimethyl fumarate: A Synthesis of Findings from 23 Studies

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Original Abstract of the Article

Major Research Findings

Dimethyl fumarate (DMF) is a medication approved for treating relapsing-remitting multiple sclerosis (RRMS). 4 A study showed DMF reduced relapse rates by about 50% compared to a placebo. Additionally, DMF significantly reduced the number of gadolinium-enhancing lesions and T2 lesions on brain MRI. 2 DMF is thought to treat RRMS by suppressing inflammation and having neuroprotective effects. 3 The mechanism of action of DMF is believed to be via the activation of the nuclear factor erythroid 2-related factor 2 (NRF2) pathway, resulting in antioxidant and anti-inflammatory effects.

Reasons for Side Effects

DMF can cause a variety of side effects. 3 DMF can cause non-specific S-alkylation of cysteine thiols and depletion of glutathione, which is believed to be part of the cause of DMF’s severe systemic side effects.

Common Side Effects

Flushing

The most common side effect of DMF is flushing. 4 Flushing is usually temporary and occurs soon after starting DMF treatment. Flushing can be reduced by adjusting the dose of DMF or by slowly increasing the dose. 6

Gastrointestinal Side Effects

DMF can cause gastrointestinal side effects. 4 Gastrointestinal side effects include nausea, vomiting, diarrhea, and abdominal pain. Gastrointestinal side effects can be reduced by adjusting the dose of DMF or by slowly increasing the dose. 6 DMF is available as a new formulation called diroximel fumarate, which has fewer gastrointestinal side effects than dimethyl fumarate. 17

Lymphopenia

DMF can cause lymphopenia. 6 Lymphopenia can increase the risk of infection. Blood tests should be performed regularly during DMF treatment to monitor lymphocyte counts. 6 Lymphopenia induced by DMF may be related to changes in the gut microbiota. 15

Other Side Effects

DMF can cause the following side effects. 20

  • Allergic reaction
  • Liver damage
  • Herpes zoster
  • Abdominal pain
  • Takotsubo cardiomyopathy

Side Effect Management

Flushing

To reduce flushing from DMF, the dose of DMF can be adjusted or the dose can be increased slowly. 6

Gastrointestinal Side Effects

To reduce gastrointestinal side effects from DMF, the dose of DMF can be adjusted or the dose can be increased slowly. 6

Lymphopenia

To prevent lymphopenia from DMF, blood tests should be performed regularly to monitor lymphocyte counts. 6

Other Side Effects

To reduce other side effects from DMF, the dose of DMF can be adjusted or medications can be administered to reduce the symptoms. 20

Comparison Between Studies

Commonalities in Studies

Many studies have shown that DMF is effective in treating RRMS. 4 2 DMF may reduce relapse rates. 4 DMF may reduce the number of lesions on brain MRI. 4 DMF generally has a good safety profile. 4 2

Differences in Studies

The effects and side effects of DMF may vary depending on the patient’s age and treatment history. 5 23 The effects and side effects of DMF may vary depending on the design and methods of the study. 2 5

Cautions for Real-life Applications

While DMF is approved for the treatment of RRMS, it is not suitable for all patients. 4 Before taking DMF, it is important to talk to your doctor and consider the risks and benefits. 4 If you are taking DMF, you should follow your doctor's instructions and have regular blood tests to monitor your lymphocyte count. 6

Limitations of Current Research

Not enough research has been done on DMF. 3 The long-term effects and safety of DMF are not yet fully understood. 5 The effects and side effects of DMF may vary depending on the patient’s age and treatment history. 5

Future Directions for Research

Research is needed to investigate the long-term effects and safety of DMF. 5 Research is needed to investigate how the effects and side effects of DMF vary depending on the patient’s age and treatment history. 5

Conclusion

DMF is an approved treatment for RRMS and may reduce relapse rates. 4 2 DMF can cause side effects such as flushing and gastrointestinal side effects. 4 6 If you are considering taking DMF, you should talk to your doctor and consider the risks and benefits. 4

Literature analysis of 23 papers
Positive Content
21
Neutral Content
0
Negative Content
2
Article Type
0
1
1
5
21
4.

Dimethyl fumarate for treatment of multiple sclerosis: mechanism of action, effectiveness, and side effects.

Author: LinkerRalf A, GoldRalf

MS treatment
Flushing
Gastrointestinal irritation

Dimethyl fumarate, a new treatment for relapsing-remitting multiple sclerosis (MS), demonstrated a significant reduction in relapse rates and disability progression. The drug's immunomodulatory and antioxidative effects, combined with a favorable safety profile, make it a valuable addition to the treatment armamentarium for MS patients.

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

7.

Current and future trends in multiple sclerosis management: Near East perspective.

Author: HatemAnmar, El AyoubiNabil K, HabahbehMajed, GhanimZaid, Al-NaqshbandiMurad, RakiAbed, JoudiHoda, SahraianMohammad Ali

Limited availability

This cross-sectional study investigated the current prescribing practices of neurologists in the Near East (NE) region for patients with multiple sclerosis (MS). The choice of treatment depended on the availability of disease-modifying therapies (DMTs) in the region.

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

Language : English

8.

Dimethyl fumarate treatment in relapsed and refractory cutaneous T-cell lymphoma: a multicenter phase 2 study.

Author: NicolayJan P, MelchersSusanne, AlbrechtJana D, AssafChalid, DippelEdgar, StadlerRudolf, WehkampUlrike, WobserMarion, ZhaoJing, BurghausIna, SchneiderSven, GülowKarsten, GoerdtSergij, SchürchChristian M, UtikalJochen S, KrammerPeter H

CTCL treatment
NF-κB inhibition
Drug side effects
Relapses

Dimethyl fumarate (DMF) is an effective and excellently tolerable therapeutic option for cutaneous T-cell lymphoma (CTCL). DMF blocked NF-κB and killed CTCL cells in a preclinical study, and this was confirmed in a phase 2 study in 25 patients with CTCL stages Ib to IV over 24 weeks.

Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
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

9.

[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

10.

Neuroprotective effects of dimethyl fumarate against manic-like behavior induced by ketamine in rats.

Author: SaljoughiShiva, KalantarHadi, AzadnasabReza, KhodayarMohammad Javad

MLB prevention

This study investigated the effects of dimethyl fumarate (DMF) on ketamine-induced manic-like behavior in rats. DMF was found to prevent hyperlocomotion, reduce oxidative stress, and modulate inflammation in the rat model.

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

15.

Gut microbiota composition as a candidate risk factor for dimethyl fumarate-induced lymphopenia in multiple sclerosis.

Author: DieboldMartin, MeolaMarco, PurushothamanSrinithi, SiewertLena K, PössneckerElisabeth, RoloffTim, LindbergRaija Lp, KuhleJens, KapposLudwig, DerfussTobias, EgliAdrian, PröbstelAnne-Katrin

Citric acid cycle metabolites
MS treatment
Lymphopenia

This pilot study investigated the impact of dimethyl fumarate (DMF) on gut microbiota and metabolomics in multiple sclerosis (MS) patients. It found that DMF-treatment alters microbiota composition and increases citric acid cycle metabolites. Additionally, DMF-induced lymphopenia, a safety concern, was correlated with specific baseline microbiome signatures.

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

18.

Post marketing new adverse effects of oral therapies in multiple sclerosis: A systematic review.

Author: SahraianMohammad Ali, SalehiAmir Mohammad, JenabiEnsiyeh, EsfahaniMaryam Etminani, AtaeiSara

Post-marketing side effects of DMDs for MS

While medications called disease-modifying drugs (DMDs) are used to manage multiple sclerosis (MS), there isn't enough information about the side effects that may occur after they are released to the market. This review aimed to identify the DMDs used for MS and to highlight the need for more research on their safety profile.

Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.
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.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

20.

Dimethyl Fumarate-Induced Takotsubo Cardiomyopathy in a Patient With Relapsing-Remitting Multiple Sclerosis.

Author: SrichawlaBahadar S

Takotsubo CM

This case report describes a 47-year-old woman who developed takotsubo cardiomyopathy (CM) after initiating dimethyl fumarate (DMF) therapy for multiple sclerosis. This highlights the potential for DMF to induce takotsubo CM and emphasizes the importance of close monitoring for symptoms when starting DMF therapy.

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

21.

Targeting NLRP3 Inflammasome With Nrf2 Inducers in Central Nervous System Disorders.

Author: TastanBora, AriozBurak I, GencSermin

Inflammation control
Side effects

NLRP3 inflammasome activation is involved in several inflammatory diseases. Nrf2 is a transcription factor that regulates cellular stress response and can inhibit NLRP3 inflammasome activation. This review discusses the potential therapeutic use of Nrf2 activators for NLRP3-associated diseases.

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

22.

Real-world disease-modifying therapy usage in persons with relapsing-remitting multiple sclerosis: Cross-sectional data from the Swiss Multiple Sclerosis Registry.

Author: BossartJonas, KammChristian P, KaufmannMarco, StanikićMina, PuhanMilo A, KesselringJürg, ZeccaChiara, GobbiClaudio, RapoldIrene, KurmannRoland, AmmannSabin, von WylViktor,

RRMS treatment

This study used data from the Swiss Multiple Sclerosis Registry (SMSR) to provide a descriptive overview of real-world disease-modifying therapy (DMT) use in patients with relapsing-remitting multiple sclerosis (RRMS) in Switzerland. The study aimed to fill a knowledge gap about the current treatment landscape in this specific population.

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

Language : English

23.

Successful treatment with dimethyl fumarate in a child with relapsing-remitting multiple sclerosis.

Author: SaijoNaoya, AbeYu, OikawaYoshitsugu, OkuboYukimune, EndoWakaba, Numata-UematsuYurika, TakahashiToshiyuki, UematsuMitsugu

DMF treatment

This case report describes the treatment of a pediatric patient with relapsing-remitting multiple sclerosis (MS) using dimethyl fumarate (DMF). The report highlights the potential of DMF as a treatment option for MS in children.

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

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