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Diroximel Fumarate

Diroximel fumarate, also known as VUMERITY or BIIB098, is a drug being studied in clinical trials for the treatment of relapsing forms of multiple sclerosis (MS). These trials aim to assess the safety, tolerability, effectiveness, and long-term outcomes of diroximel fumarate in patients with MS. The studies are evaluating various aspects such as persistence on treatment, impact on relapses and disability progression, cognitive effects, and patient-reported outcomes. Additionally, some trials are examining the drug’s use during pregnancy and comparing it to other MS treatments.

Table of Contents

What is Diroximel Fumarate?

Diroximel fumarate is a medication used to treat multiple sclerosis (MS). It’s also known by its brand names Vumerity and BIIB098[1]. This drug belongs to a class of medications called disease-modifying therapies (DMTs), which are designed to slow down the progression of MS and reduce the frequency of relapses[2].

How Does It Work?

Diroximel fumarate works by being converted in the body to its active form, called monomethyl fumarate (MMF)[3]. While the exact mechanism isn’t fully understood, it’s believed that MMF helps reduce inflammation in the nervous system and may protect nerve cells from damage. This action helps to slow down the progression of MS and reduce the frequency of relapses[2].

What Conditions Does It Treat?

Diroximel fumarate is primarily used to treat relapsing forms of multiple sclerosis (MS) in adults. This includes:

  • Relapsing-remitting MS (RRMS): The most common form of MS, characterized by periods of symptom flare-ups followed by periods of recovery.
  • Active secondary progressive MS (SPMS): A form of MS that develops after RRMS, where symptoms steadily worsen over time, with or without relapses.
  • Clinically isolated syndrome (CIS): The first episode of neurological symptoms that lasts at least 24 hours and may or may not develop into MS[1].

Clinical Studies

Several clinical trials have been conducted or are ongoing to evaluate the effectiveness and safety of diroximel fumarate:

  • The EXPERIENCE-US study is investigating how well patients stick to their treatment regimen (persistence) when using diroximel fumarate in real-world settings. It’s also looking at the drug’s safety, tolerability, and effectiveness in reducing relapses and improving cognitive function[1].
  • Similar studies, like EXPERIENCE-CA+IL, are being conducted in Canada and Israel to assess the drug’s performance in different populations[2].
  • A study in the Asia-Pacific region is evaluating the safety, tolerability, and how the body processes diroximel fumarate (pharmacokinetics) in East Asian patients with MS[4].

Safety and Side Effects

Like all medications, diroximel fumarate can cause side effects. Common side effects may include:

  • Gastrointestinal (GI) issues: Such as nausea, diarrhea, or stomach pain. These are often mild and tend to decrease over time[1].
  • Flushing: A temporary warmth, redness, or itching of the skin.
  • Decreased white blood cell count: Specifically, a reduction in lymphocytes, which are important for fighting infections[1].

Serious side effects are rare but can include severe allergic reactions or serious infections. Your doctor will monitor your blood cell counts regularly while you’re taking this medication[1].

Administration and Dosage

Diroximel fumarate is taken orally in the form of delayed-release capsules. The typical starting dose is 231 mg twice daily for 7 days, followed by the maintenance dose of 462 mg twice daily[4]. It’s important to take the medication as prescribed by your doctor and not to stop or change your dosage without consulting them first.

Pregnancy and Breastfeeding

If you’re pregnant, planning to become pregnant, or breastfeeding, it’s crucial to discuss the use of diroximel fumarate with your healthcare provider. Studies are ongoing to better understand the effects of this medication during pregnancy:

  • The Vumerity Pregnancy Exposure Registry is collecting data on pregnancy outcomes in women exposed to diroximel fumarate during pregnancy[5].
  • Another study is assessing pregnancy outcomes in women exposed to diroximel fumarate compared to other MS treatments or no treatment[6].

Comparison with Other Treatments

Diroximel fumarate is one of several oral medications available for treating MS. It’s closely related to another drug called dimethyl fumarate (Tecfidera), but it’s designed to cause fewer gastrointestinal side effects[7]. Some studies are comparing diroximel fumarate to other MS treatments:

  • The STATURE study is comparing the treatment burden and medication adherence across six oral MS treatments, including diroximel fumarate[8].
  • Another study is comparing the long-term safety of Vumerity (diroximel fumarate) and Tecfidera (dimethyl fumarate)[7].

Your healthcare provider will consider various factors, including your specific form of MS, other health conditions, and personal preferences, when deciding if diroximel fumarate is the right treatment for you.

Aspect Details
Drug Name Diroximel Fumarate (VUMERITY, BIIB098)
Condition Studied Relapsing forms of Multiple Sclerosis (RMS)
Primary Objectives Assess safety, tolerability, and effectiveness in RMS patients
Secondary Objectives Evaluate impact on relapses, disability progression, cognition, and quality of life
Study Designs Observational studies, bioequivalence studies, pregnancy exposure registry
Key Outcome Measures Annualized relapse rate, disability scores, cognitive function tests, adverse events
Special Populations Pregnant women, Asian populations
Comparators Other MS treatments (e.g., Tecfidera, interferon beta, glatiramer acetate)
Safety Monitoring Adverse events, laboratory parameters, lymphocyte counts
Long-term Follow-up Up to 2 years in most studies, longer for pregnancy outcomes

FAQ

  • What is diroximel fumarate and what is it used for? Diroximel fumarate, also known as VUMERITY or BIIB098, is a drug used to treat relapsing forms of multiple sclerosis (MS). It is being studied in clinical trials for its effectiveness in reducing relapses and slowing disability progression in people with MS.
  • What are the main objectives of the clinical trials studying diroximel fumarate? The main objectives include evaluating the safety and tolerability of the drug, assessing its effectiveness in reducing MS relapses, measuring its impact on disability progression, studying its effects on cognition and quality of life, and comparing its outcomes to other MS treatments.
  • How is the effectiveness of diroximel fumarate being measured in these trials? Effectiveness is being measured through various outcomes, including the annualized relapse rate, changes in disability scores, cognitive function tests, patient-reported quality of life measures, and MRI scans to assess brain lesions associated with MS.
  • Are there any studies looking at the use of diroximel fumarate during pregnancy? Yes, there are studies specifically designed to evaluate pregnancy outcomes in women exposed to diroximel fumarate. These studies aim to assess the safety of the drug during pregnancy and its potential effects on fetal development.
  • How long do these clinical trials typically last? The duration of the trials varies, but many of them last for 1-2 years to assess long-term safety and efficacy. Some studies, particularly those looking at pregnancy outcomes or long-term safety, may follow patients for even longer periods.

Ongoing Clinical Trials on Diroximel Fumarate

  • A study to evaluate the use of diroximel fumarate to reduce brain swelling in patients with a stroke caused by bleeding in the brain.

    Recruiting

    3 1 1
    Investigated drugs:
    France

  • Study on Stopping Dimethyl Fumarate and Drug Combination in Patients Aged 55+ with Inactive Relapsing-Remitting Multiple Sclerosis

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on Anti-CD20 Therapy and Drug Combination for Patients with Relapsing-Remitting Multiple Sclerosis

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on the Effectiveness and Tolerability of Ofatumumab Compared to a Drug Combination for Patients with Newly Diagnosed Relapsing Multiple Sclerosis

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy Spain

  • Study on the Safety and Efficacy of BIIB091 and Diroximel Fumarate for Patients with Relapsing Multiple Sclerosis

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Czechia Germany Italy Poland Romania +1

Glossary

  • Relapsing forms of multiple sclerosis (RMS): Types of multiple sclerosis characterized by periods of new or worsening symptoms (relapses) followed by periods of recovery. This includes relapsing-remitting MS and active secondary progressive MS.
  • Annualized Relapse Rate (ARR): A measure used to assess the frequency of MS relapses over a year. It is calculated by dividing the total number of relapses experienced by the number of years on treatment.
  • Expanded Disability Status Scale (EDSS): A method of measuring disability in multiple sclerosis. It is a scale from 0 (normal neurological exam) to 10 (death due to MS), with higher scores indicating more severe disability.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Major Congenital Malformations (MCMs): Structural abnormalities present at birth that are medically or cosmetically significant and persist in postnatal life unless repaired.
  • Adverse Event (AE): Any unfavorable and unintended sign, symptom, or disease that occurs during the use of a medical treatment, whether or not it is considered related to the treatment.
  • Serious Adverse Event (SAE): An adverse event that results in death, is life-threatening, requires hospitalization, causes persistent or significant disability, or is considered medically important.
  • Quality of Life (QoL): A measure of an individual's overall well-being, including physical, mental, and social aspects of health.
  • Disease-Modifying Therapies (DMTs): Medications used in MS treatment that can reduce the frequency and severity of relapses and slow the progression of disability.
  • Lymphopenia: A condition characterized by an abnormally low level of lymphocytes (a type of white blood cell) in the blood, which can affect the immune system.

References

  1. https://clinicaltrials.gov/study/NCT04746976
  2. https://clinicaltrials.gov/study/NCT04948606
  3. https://clinicaltrials.gov/study/NCT05181215
  4. https://clinicaltrials.gov/study/NCT05083923
  5. https://clinicaltrials.gov/study/NCT05658497
  6. https://clinicaltrials.gov/study/NCT05688436
  7. https://clinicaltrials.gov/study/NCT05767736
  8. https://clinicaltrials.gov/study/NCT04676204